Type 1 Diabetes Mellitus
Conditions
Keywords
Artificial Pancreas (AP), Control-IQ System, Insulin Pump, Closed Loop Control (CLC), Continuous Glucose Monitor (CGM), Multiple Daily Injections (MDI), Sensor Augmented Pump (SAP)
Brief summary
The purpose of this study is to learn whether an investigational automated insulin delivery system (study system) for children with type 1 diabetes can safely improve blood glucose (sometimes called blood sugar) control. The system uses continuous glucose monitoring (CGM), an insulin pump, and a software algorithm to automatically give insulin and control blood glucose. This is called a closed-loop control system.
Detailed description
After consent is signed, eligibility will be assessed. Eligible participants not currently using an insulin pump and Dexcom CGM with minimum data requirements will initiate a run-in phase of 2-4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) using t:slim X2 with Control-IQ Technology vs. Control Group for 16 weeks. The Control Group will be offered to transition to use CLC and the experimental arm will extend their use of CLC for 12 weeks.
Interventions
Eligible participants will be use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology & Dexcom G6 CGM
DEVICEControl Group
Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Sponsors
Tandem Diabetes Care, Inc.
DexCom, Inc.
Jaeb Center for Health Research
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 13 Years
Healthy volunteers
No
Inclusion criteria
1. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 6 months 2. Familiarity and use of a carbohydrate ratio for meal boluses. 3. Age ≥ 6 and ≤ 13 years old 4. Weight ≥25 kg and ≤140 kg 5. For females, not currently known to be pregnant If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all females of child-bearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued. 6. Living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff. 7. Willingness to suspend use of any personal closed loop system that they use at home for the duration of the clinical trial once the study CGM is in use 8. Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol 9. Willingness to switch to lispro (Humalog) or aspart (Novolog) if not using already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study for participants using to t:slim X2. This includes: * Participants randomized to Control IQ * Participants on the SAP group on MDI treatment that will be provided a Tandem pump to switch to CSII * Participates that are already in Continuous Subcutaneous Insulin Infusion (CSII) randomized to SAP during the extension phase when transition to Control IQ 10. Total daily insulin dose (TDD) at least 10 U/day 11. Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial 12. Participant and parent(s)/guardian(s) willingness to participate in all training sessions as directed by study staff.
Exclusion criteria
1. Concurrent use of any non-insulin glucose-lowering agent other than metformin (including glucagon-like peptide \[GLP-1\] agonists, Symlin, dipeptidyl peptidase 4 \[DPP-4\] inhibitors, sodium-glucose cotransporter-2 (SGLT2) inhibitors, sulfonylureas). 2. Hemophilia or any other bleeding disorder 3. A condition, which in the opinion of the investigator or designee, would put the participant or study at risk (specified on the study procedure manual) 4. Participation in another pharmaceutical or device trial at the time of enrollment or during the study 5. Employed by, or having immediate family members employed by Tandem Diabetes Care, Inc., or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Continuous Glucose Monitor (CGM)-Measured Percent Time in Range 70-180mg/dL Over 16 Week Trial Period | From randomization to data collection completion at the end of 16 weeks | The primary outcome for the first phase is percent of time participants spent in blood sugar target range 70-180 mg/dL as measured by CGM in Closed Loop Control (CLC) group vs. Control Group. Larger percentages of time spent in this range is considered to be a desirable outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CGM-Measured Mean Glucose Over 16 Week Trial Period | From randomization to data collection completion at the end of 16 weeks | Continuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM metrics were calculated by pooling all CGM readings in the 16-week period starting from the randomization visit up through the 16 week visit. If a participant dropped out before completing the 16-week visit, all available data through the last visit date was included for calculating CGM metrics. Minimum 168 hours of CGM data was required to calculate CGM metrics. Lower mean glucose numbers as measured by CGM in mg/dL is considered a positive outcome. |
| Glycated Hemoglobin A1C (HbA1c) Percent at End Of 16 Week Trial Period | At data collection completion at the end of 16 weeks | Glycated Hemoglobin A1C (HbA1c) is a physiological marker of the percentage of red blood cells that have glycated (bonded with a sugar). HbA1c is used to measure changes in average blood sugar over the past three months. 5-6% is normal, 7% and above is correlated with negative long-term health outcomes. |
| CGM-measured Percent of Time Below 70 mg/dL Over 16 Week Trial Period | From randomization to data collection completion at the end of 16 weeks | Continuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM measured blood sugar values below 70 mg/dL are considered to be somewhat dangerous due to the possibility of unconsciousness and death at low blood sugar values. Thus, less time spent below 70mg/dL is considered a positive outcome. |
| CGM-measured Median and Interquartile Range of Percent of Time Below 54 mg/dL Over 16 Week Trial Period | From randomization to data collection completion at the end of 16 weeks | GM measured blood sugar values below 54 mg/dL have the potential to lead to unconsciousness or death. Thus, less time below 54 mg/dL is considered a better outcome. |
| CGM-measured Percent of Time Above 250 mg/dL Over 16 Week Trial Period | From randomization to data collection completion at the end of 16 weeks | CGM measured blood sugar values above 250 mg/dL are considered to be undesirable. Thus, less time spent above 250mg/dL is considered a positive outcome. |
| Continuous Glucose Monitor (CGM)-Measured Glucose Variability Measured With the Coefficient of Variation (CV) Over 16 Week Trial Period | From randomization to data collection completion at the end of 16 weeks | Continuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM metrics were calculated by pooling all CGM readings in the 16-week trial period starting from randomization visit to week 16 visit. If a participant drops out before completing the 16-week visit, all available data through the last visit date will be included for calculating CGM metrics. Minimum 168 hours of CGM data were required to calculate CGM metrics. Coefficient of Variability (CV) is the ratio of the standard deviation to the mean of the blood sugar values of each participant as measured by CGM. The reported value is the mean and standard deviation of the participant outcomes multiplied by 100. This shows the extent of the mean variability of the blood sugar values in the population. Higher CV values (up to 100) indicate greater dispersion of CGM values, which would indicate more blood sugar variability, which is considered a negative outcome. Minimum value is 0. |
| CGM-Measured Percent of Time Above 180 mg/dL Over 16 Week Trial Period | From randomization to data collection completion at the end of 16 weeks | Continuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. Smaller percentages of CGM-measured time above 180 mg/dL is considered a positive outcome. |
| CGM-measured Mean Glucose Over 12 Week Trial Extension Period | From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks | Continuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. Lower mean glucose numbers as measured by CGM in mg/dL is considered a positive outcome. |
| Glycated Hemoglobin Percent (HbA1c) at Conclusion of 12 Week Trial Extension Period | At completion of the extension study, end of week 28 | Hemoglobin A1C (HbA1c) is a physiological marker of the percentage of red blood cells that have glycated (bonded with a sugar). HbA1c is used to measure changes in average blood sugar over the past three months. 5-6% is normal, 7% and above is correlated with negative long-term health outcomes. |
| CGM-measured Percent of Time Below 70 mg/dL Over 12 Week Trial Extension Period | From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks | Continuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM measured blood sugar values below 70 mg/dL are considered to be undesirable. Thus, less time spent below 70mg/dL is considered a positive outcome. |
| CGM-measured Percent of Time Below 54 mg/dL Over 12 Week Trial Extension Period | From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks | Continuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM measured blood sugar values below 54 mg/dL have the potential to lead to unconsciousness or death. Thus, time below 54 mg/dL suggests that the person may have been close to danger. |
| CGM-measured Percent of Time Above 250 mg/dL Over 12 Week Trial Extension Period | From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks | Continuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM measured blood sugar values above 250 mg/dL are considered to be undesireable. Thus, less time spent above 250mg/dL is considered a positive outcome. |
| Continuous Glucose Monitor (CGM)-Measured Glucose Variability Percentage Measured With the Coefficient of Variation (CV) Over 12 Week Trial Extension Period | From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks | Continuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM metrics were calculated by pooling all CGM readings in the 12-week trial extension period starting from 16 week visit to week 28 visit. If a participant drops out before completing the 32-week visit, all available data through the last visit date will be included for calculating CGM metrics. Minimum 168 hours of CGM data were required to calculate CGM metrics. Coefficient of Variability (CV) is the ratio of the standard deviation to the mean of the blood sugar values of each participant as measured by CGM. The reported value is the mean and standard deviation of the participant outcomes multiplied by 100. This shows the extent of the mean variability of the blood sugar values in the study group. Higher CV values (up to 100) indicate greater dispersion of CGM values, which would indicate more blood sugar variability, which is considered a negative outcome. Minimum value is 0. |
| CGM-measured Percent of Time Above 180 mg/dL Over 12 Week Trial Extension Period | From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks | Continuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM metrics were calculated by pooling all CGM readings in the 12-week period starting from the 16 week visit at the end of the main study up through the 28th week visit. If a participant drops out before completing the 28-week visit, all available data through the last visit date will be included for calculating CGM metrics. Minimum 168 hours of CGM data will be required to calculate CGM metrics. Smaller percentages of CGM-measured percentages of time above 180 mg/dL is considered a positive outcome. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Fear of Hypoglycemia Survey (HFS-II) at 16 Weeks | At data collection completion at the end of 16 weeks | The Hypoglycemia Fear Survey-II was developed to measure behaviors and worries related to fear of hypoglycemia in adults with type 1 diabetes and was adapted for children and parents. Items are rated on a 5-point Likert scale (0=never, 4=always), with higher scores indicating higher fear of hypoglycemia. Maximum possible score: 132. Minimum possible score: 0. All questionnaires were administered online and participants/parents could skip specific questionnaires or items within a questionnaire. At least 75% of the questions must have been competed to be included in analysis. The score used for analysis was based on the average among the questions that were answered and then scaled accordingly. |
| Clarke Hypoglycemia Awareness Scores Questionnaire at 16 Weeks | At data collection completion at the end of 16 weeks | The scale comprises eight questions characterizing the participant's exposure to episodes of moderate and severe hypoglycemia. It also examines the glycemic threshold for, and symptomatic responses to hypoglycemia. A score of four or more on a scale of 0 to 7 implies impaired awareness of hypoglycemia. Parents and children took the questionnaire independently. |
| Problem Areas in Diabetes Survey (PAID) at 16 Weeks | At data collection completion at the end of 16 weeks | The Problem Areas In Diabetes Survey is a measure of diabetes-related emotional distress and consists of a scale of 16 items for the Parent version and 11 items for the Child version. Patients and parents rate the degree to which each item is currently problematic for them on a 6-point Likert scale, from 1 (no problem) to 6 (serious problem). Parent version maximum score: 96, minimum score 16. Child version maximum score 66, minimum score 11. |
| Insulin Delivery Systems: Perceptions, Ideas, Reflections and Expections (INSPIRE) Survey Scores at 16 Weeks | At data collection completion at the end of 16 weeks | The INSPIRE (Insulin Delivery Systems: Perceptions, Ideas, Reflections and Expectations) survey was developed to assess various aspects of a user's experience regarding automated insulin delivery for both patients and family members. The surveys include various topics important to patients with type 1 diabetes and their family members based upon \>200 hours of qualitative interviews and focus groups. Response options for all surveys include a 5-point Likert scale from strongly agree to strongly disagree, along with an N/A option. Total scores on the INSPIRE questionnaires were calculated by obtaining a mean score across items, then multiplying the mean score by 25 to scale total INSPIRE measure scores from 0 to 100, with higher scores indicating greater positive expectations for automated insulin delivery systems. |
| Pediatric Quality of Life Inventory (PedsQL Diabetes Module) at 16 Weeks | At data collection completion at the end of 16 weeks | This is a 33-item scale developed and validated for the measurement of diabetes-specific quality of life. Separate forms have been validated for child self-report (5-7 year old; 8-12 year old; and 12-18 year old) and parent report for these same age groups. Participants record the extent to which they (or their child) experienced each of 33 problems related to diabetes in the prior month using a 5-point Likert-type response scale (0= never a problem; 1 = almost never a problem 2 =sometimes a problem 3= often a problem 4 = almost always a problem). Items are reverse-scored and linearly transformed to a 0-100 scale (0=100, 1=7, 2=50, 3=25, 4=0) so that lower score demonstrate more diabetes symptoms and management problems, and hence lower diabetes-specific health-related quality of life. Higher scores indicate fewer symptoms or problems |
| Pittsburgh Sleep Quality Index (Parent Only) at 16 Weeks (Parent Only) | At data collection completion at the end of 16 weeks | Pittsburgh Sleep Quality Index (PSQI) is a 10-item questionnaire that measures the sleep quality and pattern of sleep in adults. Seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. |
| System Usability Scale (SUS) at 16 Weeks | At data collection completion at the end of 16 weeks | System Usability Scores (SUS)-composite score from 0 to 100 with higher scores indicating better perceived usability |
| Total Daily Insulin (Units/kg/Day) Over 16 Weeks | From randomization to data collection completion at the end of 16 weeks | Total Daily Insulin (Units/kg/day) over 16 weeks. Total daily insulin dose is calculated as the sum of all insulin doses delivered by the insulin delivery system divided by the weight of the participant in kilograms and the actual duration of the treatment period in days. |
| Basal: Bolus Insulin Ratio Over 16 Weeks | 7 days leading up to the final study visit in week 16 | Insulin metrics were calculated at randomization and 16 weeks using Tandem pump data where available, otherwise using data reported on the CRF. Insulin metrics were calculated from the pump data using data in the 7 days prior to the visit. The basal:bolus ratio describes the amount of insulin used by participants to keep the blood sugar stable (basal insulin) as opposed to the amount of insulin used to metabolize consumed carbs (bolus insulin) within the total amount of insulin delivered per day. |
| Weight at 16 Weeks | At data collection completion at the end of 16 weeks | Participant Weight in kg measured at 16 weeks |
| CGM-Measured Percent of Time in Range 70-180mg/dL Over 12 Week Trial Extension Period | From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks | The primary outcome for the extension phase is improving the percent of time in the blood sugar range 70-180 mg/dL over the 12 weeks of the extension phase of the study |
| CGM-Measured Percent of Time in Range 70-140 mg/dL Over 12 Week Trial Extension Period | From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks | CGM-Measured percent of time in blood sugar range 70-140 mg/dL over the 12 week extension study. Larger percentages of time spent in this range is considered to be a desireable outcome. |
| Glucose Variability of Blood Sugar as Measured by Continuous Glucose Monitor (CGM), Measured With the Standard Deviation (SD) Over 16 Weeks | From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks | Continuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM metrics were calculated by pooling all CGM readings in the 16-week trial period starting from the randomization visit to week 16 visit. If a participant drops out before completing the 16-week visit, all available data through the last visit date will be included for calculating CGM metrics. Minimum 168 hours of CGM data were required to calculate CGM metrics. Coefficient of Variability (CV) is the ratio of the standard deviation to the mean of the blood sugar values of each participant as measured by CGM. The reported value is the mean and standard deviation of the participant outcomes multiplied by 100. This shows the extent of the mean variability of the blood sugar values in the population. Higher CV values (up to 100) indicate greater dispersion of CGM values, which would indicate more blood sugar variability, which is considered a negative outcome. Minimum value is 0. |
| Continuous Blood Glucose Monitor (CGM)-Measured Percent of Time Less Than 60 mg/dL Over 16 Weeks | From randomization to data collection completion at the end of 16 weeks | Continuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM metrics were calculated by pooling all CGM readings in the 16-week trial period starting from the randomization visit to week 16 visit. If a participant drops out before completing the 16-week visit, all available data through the last visit date will be included for calculating CGM metrics. Minimum 168 hours of CGM data were required to calculate CGM metrics. Coefficient of Variability (CV) is the ratio of the standard deviation to the mean of the blood sugar values of each participant as measured by CGM. The reported value is the mean and standard deviation of the participant outcomes multiplied by 100. This shows the extent of the mean variability of the blood sugar values in the population. Higher CV values (up to 100) indicate greater dispersion of CGM values, which would indicate more blood sugar variability, which is considered a negative outcome. Minimum value is 0. |
| Continuous Blood Glucose Monitor (CGM)-Measured Low Blood Glucose Index (LBGI) Over 12 Week Trial Extension Period | From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks | Continuous Blood Glucose Monitor (CGM) metrics were calculated by pooling all CGM readings in the 12-week period starting from the end of the 16th week of the main trial up through the 28 week visit (end of study extension). If a participant dropped out before completing the 28-week visit, all available data through the last visit date was included for calculating CGM metrics. Minimum 168 hours of CGM data was required to calculate CGM metrics. The low blood glucose index (LBGI) is a Glucose-variability-based metric of the risk for hypoglycemia. LBGI increases with the frequency and extent of hypoglycemic excursions and has been used as a predictor of severe events. The minimum value possible is 0, indicating no risk of low blood sugar. The maximum possible value is 100, indicating maximum possible risk of low blood sugar. |
| Number of Hypoglycemia Events (Defined as at Least 15 Consecutive Minutes Less Than 70 mg\dL as Measured by Continuous Glucose Meter) Over 12 Week Trial Extension Period | From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks | CGM metrics were calculated by pooling all CGM readings in the 12-week period starting from the 16th week of the main trial through the 12th week of the extension. If a participant drops out before completing the 12-week visit, all available data through the last visit date will be included for calculating CGM metrics. Minimum 168 hours of CGM data will be required to calculate CGM metrics. A hypoglycemic event is defined as 15 consecutive minutes with a sensor glucose value below 54 mg/dL. Fewer glycemic events per week is considered a better outcome. |
| CGM-Measured Percent of Time Above 300 mg/dL Over 12 Week Trial Extension Period | From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks | CGM measured blood sugar values above 300 mg/dL are considered to be undesireable. Thus, less time spent above 300mg/dL is considered a positive outcome |
| High Blood Glucose Index (HBGI) Over 12 Weeks of Trial Extension Period | From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks | Continuous Blood Glucose Monitor (CGM) metrics were calculated by pooling all CGM readings in the 12-week period starting from the end of the 16th week of the main trial up through the 28 week visit (end of study extension). If a participant dropped out before completing the 28-week visit, all available data through the last visit date was included for calculating CGM metrics. Minimum 168 hours of CGM data was required to calculate CGM metrics. The High Blood Glucose Index (HBGI) is a Glucose-variability-based metric of the risk for hyperglycemia that can be calculated from CGM readings. HBGI increases with the frequency and extent of hyperglycemic excursions and has been used as a predictor of severe events. The minimum value possible is 0, indicating no risk of high blood sugar. The maximum possible value is 100, indicating maximum possible risk of high blood sugar. |
| Glycated Hemoglobin Percent (HbA1c) Less Than 7.0% at Conclusion of 12 Week Trial Extension Period | At completion of the extension study, end of week 28 | HbA1c is a physiological marker that is used to measure changes in average blood sugar over the past three months. Numbers less than 7.0 are considered better for long-term health; thus, larger numbers or percentages of people with an HbA1c less than 7.0 is considered a positive outcome. |
| Glycated Hemoglobin Percent (HbA1c) Less Than 7.5% at Conclusion of 12 Week Trial Extension Period | At completion of the extension study, end of week 28 | HbA1c is a physiological marker that is used to measure changes in average blood sugar over the past three months. Numbers less than 7.5 are considered better for long-term health; thus, larger numbers or percentages of people with an HbA1c less than 7.5 is considered a positive outcome. |
| Fear of Hypoglycemia Survey (HFS-II) at Conclusion of 12 Week Trial Extension Period | At completion of the extension study, end of week 28 | The Hypoglycemia Fear Survey-II was developed to measure behaviors and worries related to fear of hypoglycemia in adults with type 1 diabetes and was adapted for children and parents. Items are rated on a 5-point Likert scale (0=never, 4=always), with higher scores indicating higher fear of hypoglycemia. Maximum possible score: 132. Minimum possible score: 0. All questionnaires were administered online and participants/parents could skip specific questionnaires or items within a questionnaire. At least 75% of the questions must have been competed to be included in analysis. The score used for analysis was based on the average among the questions that were answered and then scaled accordingly. |
| Clarke Hypoglycemia Awareness Scores Questionnaire at Conclusion of 12 Week Trial Extension Period | At completion of the extension study, end of week 28 | The scale comprises eight questions characterizing the participant's exposure to episodes of moderate and severe hypoglycemia. It also examines the glycemic threshold for, and symptomatic responses to hypoglycemia. A score of four or more on a scale of 0 to 7 implies impaired awareness of hypoglycemia. |
| CGM-Measured Percent of Time in Range 70-140 mg/dL Over 16 Weeks | From randomization to data collection completion at the end of 16 weeks | Continuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM-Measured percent of time in blood sugar range 70-140 mg/dL. Larger percentages of time spent in this range is considered to be a desirable outcome. |
| Insulin Delivery Systems: Perceptions, Ideas, Reflections and Expectations (INSPIRE) Survey Scores at Conclusion of 12 Week Trial Extension Period | At completion of the extension study, end of week 28 | The INSPIRE (Insulin Delivery Systems: Perceptions, Ideas, Reflections and Expectations) survey was developed to assess various aspects of a user's experience regarding automated insulin delivery for both patients and family members. The surveys include various topics important to patients with type 1 diabetes and their family members based upon \>200 hours of qualitative interviews and focus groups. Response options for all surveys include a 5-point Likert scale from strongly agree to strongly disagree, along with an N/A option. Total scores on the INSPIRE questionnaires were calculated by obtaining a mean score across items, then multiplying the mean score by 25 to scale total INSPIRE measure scores from 0 to 100, with higher scores indicating greater positive expectations for automated insulin delivery systems. |
| Pediatric Quality of Life Inventory (PedsQL Diabetes Module) at Conclusion of 12 Week Trial Extension Period | At completion of the extension study, end of week 28 | This is a 33-item scale developed and validated for the measurement of diabetes-specific quality of life. Separate forms have been validated for child self-report (5-7 year old; 8-12 year old; and 12-18 year old) and parent report for these same age groups. Participants record the extent to which they (or their child) experienced each of 33 problems related to diabetes in the prior month using a 5-point Likert-type response scale (0= never a problem; 1 = almost never a problem 2 =sometimes a problem 3= often a problem 4 = almost always a problem). Items are reverse-scored and linearly transformed to a 0-100 scale (0=100, 1=7, 2=50, 3=25, 4=0) so that lower score demonstrate more diabetes symptoms and management problems, and hence lower diabetes-specific health-related quality of life. Higher scores indicate fewer symptoms or problems. |
| Pittsburgh Sleep Quality Index (Parent Only) at Conclusion of 12 Week Trial Extension Period | At completion of the extension study, end of week 28 | Pittsburgh Sleep Quality Index (PSQI) is a 10-item questionnaire that measures the sleep quality and pattern of sleep in adults. Seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. |
| System Usability Scale (SUS) at Conclusion of 12 Week Trial Extension Period | At completion of the extension study, end of week 28 | System Usability Scores (SUS)-composite score from 0 to 100 with higher scores indicating better perceived usability. |
| Total Daily Insulin (TDI) (Units/kg/Day) Over 12 Week Trial Extension Period | From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks | Total Daily Insulin (Units/kg/day) over 12 weeks. Total daily insulin dose is calculated as the sum of all insulin doses delivered by the insulin delivery system divided by the weight of the participant in kilograms and the actual duration of the treatment period in days. |
| Basal: Bolus Insulin Ratio at Conclusion of 12 Week Trial Extension Period | 7 days leading up to the final extension study visit in week 28 | Insulin metrics were calculated at 16 weeks and 28 weeks using Tandem pump data where available, otherwise using data reported on the CRF. Insulin metrics were calculated from the pump data using data in the 7 days prior to the visit. The basal:bolus ratio describes the amount of insulin used by participants to keep the blood sugar stable (basal insulin) as opposed to the amount of insulin used to metabolize consumed carbs (bolus insulin) within the total amount of insulin delivered per day. |
| Body Mass Index (BMI) at Conclusion of 12 Week Trial Extension Period | At completion of the extension study, end of week 28 | Body Mass Index (BMI) is a calculation of participant body weight in kilograms and height in centimeters. The z-score was calculated from values taken at the end of the 28 weeks of the study. Z-score of zero represents the US population mean for their age and sex group. Positive Z scores indicate higher body mass index values than the population mean, which is generally considered undesirable |
| Problem Areas in Diabetes Survey (PAID) at Conclusion of 12 Week Trial Extension Period | At completion of the extension study, end of week 28 | The Problem Areas In Diabetes Survey is a measure of diabetes-related emotional distress and consists of a scale of 16 items for the Parent version and 11 items for the Child version. Patients and parents rate the degree to which each item is currently problematic for them on a 6-point Likert scale, from 1 (no problem) to 6 (serious problem). Parent version maximum score: 96, minimum score 16. Child version maximum score 66, minimum score 11. |
| Glucose Variability Measured With the Standard Deviation (SD) Over 16 Weeks | From randomization to data collection completion at the end of 16 weeks | Continuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM metrics were calculated by pooling all CGM readings in the 16-week period starting from the randomization visit up through the 16 week visit. If a participant dropped out before completing the 16-week visit, all available data through the last visit date will be included for calculating CGM metrics. Minimum 168 hours of CGM data will be required to calculate CGM metrics. Standard Deviation represents how much glucose levels fluctuate over time from a given average. |
| CGM-Measured Percent of Time Below 60 mg/dL Over 16 Weeks | From randomization to data collection completion at the end of 16 weeks | CGM measured blood sugar values below 60 mg/dL are considered to be undesirable. Thus, less time spent below 60mg/dL is considered a positive outcome |
| Low Blood Glucose Index (LBGI) Over 16 Weeks | From randomization to data collection completion at the end of 16 weeks | Continuous Blood Glucose Monitor (CGM) metrics were calculated by pooling all CGM readings in the 16-week period starting from the randomization visit up through the 16 week visit. If a participant dropped out before completing the 16-week visit, all available data through the last visit date was included for calculating CGM metrics. Minimum 168 hours of CGM data was required to calculate CGM metrics. The low blood glucose index (LBGI) is a Glucose-variability-based metric of the risk for hypoglycemia. LBGI increases with the frequency and extent of hypoglycemic excursions and has been used as a predictor of severe events. The minimum value possible is 0, indicating no risk of low blood sugar. The maximum possible value is 100, indicating maximum possible risk of low blood sugar. |
| Hypoglycemia Events (Defined as at Least 15 Consecutive Minutes <70 mg\dL) Over 16 Weeks | From randomization to data collection completion at the end of 16 weeks | A Hypoglycemic event was defined as at least 15 consecutive minutes where the CGM was lower than 70mg/dL. Fewer hypoglycemia events are considered better. |
| CGM-Measured Percent of Time >300 mg/dL Over 16 Weeks | From randomization to data collection completion at the end of 16 weeks | CGM measured blood sugar values above 300 mg/dL are considered to be undesirable. Thus, less time spent above 300 mg/dL is considered a positive outcome |
| High Blood Glucose Index (HBGI) Over 16 Weeks | From randomization to data collection completion at the end of 16 weeks | Continuous Blood Glucose Monitor (CGM) metrics were calculated by pooling all CGM readings in the 16-week period starting from the randomization visit up through the 16 week visit (end of study). If a participant dropped out before completing the 16-week visit, all available data through the last visit date was included for calculating CGM metrics. Minimum 168 hours of CGM data was required to calculate CGM metrics. The High Blood Glucose Index (HBGI) is a Glucose-variability-based metric of the risk for hyperglycemia that can be calculated from CGM readings. HBGI increases with the frequency and extent of hyperglycemic excursions and has been used as a predictor of severe events. The minimum value possible is 0, indicating no risk of high blood sugar. The maximum possible value is 100, indicating maximum possible risk of high blood sugar. |
| CGM-Measured Percent Time in Range 70-180 mg/dL Improvement From Baseline to 16 Weeks ≥5% | From randomization to data collection completion at the end of 16 weeks | This is a comparison of a binary CGM outcome indicating how many participants and what percent of participants experienced an improvement of greater than 5% in the percentage of time they were in the safe blood sugar range of 70-180 mg/dL. More participants (a greater percentage of participants) improving by this much is considered positive. |
| Absolute Glycated Hemoglobin Percent (HbA1c) Improvement From Baseline to 16 Weeks Greater Than 1.0% | From randomization to data collection completion at the end of 16 weeks | HbA1c is a physiological marker that is used to measure changes in average blood sugar over the past three months. Improvements of 1.0% or greater are considered clinically significant improvements |
| CGM-Measured Percent Time in Range 70-180 mg/dL Improvement From Baseline to 16 Weeks ≥10% | From randomization to data collection completion at the end of 16 weeks | This is a comparison of a binary CGM outcome indicating how many participants and what percent of participants experienced an improvement of greater than 10% in the percentage of time they were in the ideal blood sugar range of 70-140 mg/dL. More participants (a greater percentage of participants) improving this much is considered positive |
| Glycated Hemoglobin Percent (HbA1c) Less Than 7.0% at 16 Weeks | From randomization to data collection completion at the end of 16 weeks | HbA1c is a physiological marker that is used to measure changes in average blood sugar over the past three months. Numbers less than 7.0 are considered better for long-term health; thus, larger numbers or percentages of people with an HbA1c less than 7.0 is considered a positive outcome |
| Glycated Hemoglobin Percent (HbA1c) Less Than 7.5% at 16 Weeks | From randomization to data collection completion at the end of 16 weeks | HbA1c is a physiological marker that is used to measure changes in average blood sugar over the past three months. Numbers less than 7.5 are considered better for long-term health; thus, larger numbers or percentages of people with an HbA1c less than 7.5 is considered a positive outcome |
| Absolute Glycated Hemoglobin Percent HbA1c Improvement From Baseline to 16 Weeks Greater Than 0.5% | From randomization to data collection completion at the end of 16 weeks | HbA1c is a physiological marker that is used to measure changes in average blood sugar over the past three months. Improvements of 0.5% or greater are considered clinically significant improvements. |
| Glycated Hemoglobin Percent (HbA1c) Relative Improvement From Baseline to 16 Weeks Greater Than 10% | From randomization to data collection completion at the end of 16 weeks | HbA1c is a physiological marker that is used to measure changes in average blood sugar over the past three months. Improvements of 1.0% or greater are considered clinically significant improvements. |
| Glycated Hemoglobin Percent HbA1c Reduction From Baseline to 16 Weeks Greater Than 1.0% or HbA1c Less Than 7.0% | From randomization to data collection completion at the end of 16 weeks | HbA1c is a physiological marker that is used to measure changes in average blood sugar over the past three months. Improvements of 1.0% or greater are considered clinically significant improvements, HbA1c values less than 7.0 are considered better for long-term health. |
Countries
United States
Participant flow
Recruitment details
Between June 21, 2019, and August 30, 2019, a total of 101 patients (19 to 28 per trial site) were randomly assigned to the closed-loop group (78 patients) or the control group (23 patients).
Participants by arm
| Arm | Count |
|---|---|
| Closed Loop Control (CLC) Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology & Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
t:slim X2 with Control-IQ Technology & Dexcom G6 CGM: Eligible participants will be use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology & Dexcom G6 CGM | 78 |
| Standard of Care Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group: Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. | 23 |
| Total | 101 |
Baseline characteristics
| Characteristic | Closed Loop Control (CLC) | Total | Standard of Care |
|---|---|---|---|
| Age, Customized Ages 10 to 13 | 57 Participants | 72 Participants | 15 Participants |
| Age, Customized Ages 6 to 9 | 21 Participants | 29 Participants | 8 Participants |
| Annual Household Income $100,000 - <$200,000 | 27 Participants | 35 Participants | 8 Participants |
| Annual Household Income ≥$200,000 | 26 Participants | 33 Participants | 7 Participants |
| Annual Household Income <$25,000 | 0 Participants | 0 Participants | 0 Participants |
| Annual Household Income $25,000 - <$35,000 | 2 Participants | 2 Participants | 0 Participants |
| Annual Household Income $35,000 - <$50,000 | 1 Participants | 3 Participants | 2 Participants |
| Annual Household Income $50,000 - <$75,000 | 5 Participants | 5 Participants | 0 Participants |
| Annual Household Income $75,000 - <$100,000 | 13 Participants | 17 Participants | 4 Participants |
| Annual Household Income Missing Data | 4 Participants | 6 Participants | 2 Participants |
| Body Mass Index (BMI) Z-score | 0.4 Z-score STANDARD_DEVIATION 1 | 0.45 Z-score STANDARD_DEVIATION 1 | 0.5 Z-score STANDARD_DEVIATION 1 |
| C-peptide (nmol/L) <0.2 nmol/L | 72 Participants | 93 Participants | 21 Participants |
| C-peptide (nmol/L) ≥0.2 nmol/L | 6 Participants | 8 Participants | 2 Participants |
| Diabetes Duration 1 to 4 years | 42 Participants | 49 Participants | 7 Participants |
| Diabetes Duration 5 to 10 years | 28 Participants | 42 Participants | 14 Participants |
| Diabetes Duration More than 10 years | 8 Participants | 10 Participants | 2 Participants |
| Diabetic Ketoacidosis (DKA) in Last 12 Months 1 DKA event in the last 12 months | 3 Participants | 3 Participants | 0 Participants |
| Diabetic Ketoacidosis (DKA) in Last 12 Months 2 DKA events in the last 12 months | 1 Participants | 1 Participants | 0 Participants |
| Diabetic Ketoacidosis (DKA) in Last 12 Months No DKA events in the last 12 months | 74 Participants | 97 Participants | 23 Participants |
| HbA1c Central Lab at Randomization <8.0% | 50 Participants | 61 Participants | 11 Participants |
| HbA1c Central Lab at Randomization 8.0%<9.0% | 20 Participants | 30 Participants | 10 Participants |
| HbA1c Central Lab at Randomization ≥9.0% | 8 Participants | 10 Participants | 2 Participants |
| HbA1c Local Lab at Screening <8.0% | 50 Participants | 62 Participants | 12 Participants |
| HbA1c Local Lab at Screening 8.0%<9.0% | 18 Participants | 26 Participants | 8 Participants |
| HbA1c Local Lab at Screening ≥9.0% | 10 Participants | 13 Participants | 3 Participants |
| Health Insurance CHP or other government sponsored/Medicaid | 6 Participants | 7 Participants | 1 Participants |
| Health Insurance Military | 2 Participants | 3 Participants | 1 Participants |
| Health Insurance None | 0 Participants | 0 Participants | 0 Participants |
| Health Insurance Other | 0 Participants | 0 Participants | 0 Participants |
| Health Insurance Private | 70 Participants | 91 Participants | 21 Participants |
| Insulin Modality Insulin Pump | 62 Participants | 81 Participants | 19 Participants |
| Insulin Modality Multiple Daily Injection (MDI) | 16 Participants | 20 Participants | 4 Participants |
| Parents Education Associates Degree or Some College but no Degree | 5 Participants | 6 Participants | 1 Participants |
| Parents Education Bachelor's Degree | 32 Participants | 41 Participants | 9 Participants |
| Parents Education Doctoral or Prof Degree | 5 Participants | 7 Participants | 2 Participants |
| Parents Education ≤H.S. Diploma | 2 Participants | 2 Participants | 0 Participants |
| Parents Education Master's Degree | 34 Participants | 45 Participants | 11 Participants |
| Prior Continuous Glucose Monitor Use Current | 72 Participants | 93 Participants | 21 Participants |
| Prior Continuous Glucose Monitor Use In past, but not current | 4 Participants | 6 Participants | 2 Participants |
| Prior Continuous Glucose Monitor Use Never | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Black/African-American | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized HIspanic or Latino | 6 Participants | 8 Participants | 2 Participants |
| Race/Ethnicity, Customized More than one race | 7 Participants | 9 Participants | 2 Participants |
| Race/Ethnicity, Customized White, non-Hispanic | 64 Participants | 82 Participants | 18 Participants |
| Severe Hypoglycemia (SH) in Last 12 Months | 78 Participants | 101 Participants | 23 Participants |
| Sex: Female, Male Female | 38 Participants | 50 Participants | 12 Participants |
| Sex: Female, Male Male | 40 Participants | 51 Participants | 11 Participants |
| Total Daily Insulin | 0.89 Units of Insulin per kg per day STANDARD_DEVIATION 0.24 | 0.92 Units of Insulin per kg per day STANDARD_DEVIATION 0.24 | 0.94 Units of Insulin per kg per day STANDARD_DEVIATION 0.24 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 78 | 0 / 23 | 0 / 78 | 0 / 22 |
| other Total, other adverse events | 15 / 78 | 2 / 23 | 6 / 78 | 2 / 22 |
| serious Total, serious adverse events | 1 / 78 | 0 / 23 | 0 / 78 | 0 / 22 |
Outcome results
Primary
Continuous Glucose Monitor (CGM)-Measured Percent Time in Range 70-180mg/dL Over 16 Week Trial Period
The primary outcome for the first phase is percent of time participants spent in blood sugar target range 70-180 mg/dL as measured by CGM in Closed Loop Control (CLC) group vs. Control Group. Larger percentages of time spent in this range is considered to be a desirable outcome.
Time frame: From randomization to data collection completion at the end of 16 weeks
Population: One participant in the control group was missing follow-up data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | Continuous Glucose Monitor (CGM)-Measured Percent Time in Range 70-180mg/dL Over 16 Week Trial Period | 67 Percentage of Time | Standard Deviation 10 |
| Control Group | Continuous Glucose Monitor (CGM)-Measured Percent Time in Range 70-180mg/dL Over 16 Week Trial Period | 55 Percentage of Time | Standard Deviation 13 |
Secondary
CGM-measured Mean Glucose Over 12 Week Trial Extension Period
Continuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. Lower mean glucose numbers as measured by CGM in mg/dL is considered a positive outcome.
Time frame: From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | CGM-measured Mean Glucose Over 12 Week Trial Extension Period | 165 mg/dL | Standard Deviation 19 |
| Control Group | CGM-measured Mean Glucose Over 12 Week Trial Extension Period | 167 mg/dL | Standard Deviation 18 |
Secondary
CGM-Measured Mean Glucose Over 16 Week Trial Period
Continuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM metrics were calculated by pooling all CGM readings in the 16-week period starting from the randomization visit up through the 16 week visit. If a participant dropped out before completing the 16-week visit, all available data through the last visit date was included for calculating CGM metrics. Minimum 168 hours of CGM data was required to calculate CGM metrics. Lower mean glucose numbers as measured by CGM in mg/dL is considered a positive outcome.
Time frame: From randomization to data collection completion at the end of 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | CGM-Measured Mean Glucose Over 16 Week Trial Period | 162 mg/dL | Standard Deviation 18 |
| Control Group | CGM-Measured Mean Glucose Over 16 Week Trial Period | 179 mg/dL | Standard Deviation 26 |
Secondary
CGM-measured Median and Interquartile Range of Percent of Time Below 54 mg/dL Over 16 Week Trial Period
GM measured blood sugar values below 54 mg/dL have the potential to lead to unconsciousness or death. Thus, less time below 54 mg/dL is considered a better outcome.
Time frame: From randomization to data collection completion at the end of 16 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Closed Loop Control (CLC) | CGM-measured Median and Interquartile Range of Percent of Time Below 54 mg/dL Over 16 Week Trial Period | 0.23 percentage of time |
| Control Group | CGM-measured Median and Interquartile Range of Percent of Time Below 54 mg/dL Over 16 Week Trial Period | 0.29 percentage of time |
Secondary
CGM-measured Percent of Time Above 180 mg/dL Over 12 Week Trial Extension Period
Continuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM metrics were calculated by pooling all CGM readings in the 12-week period starting from the 16 week visit at the end of the main study up through the 28th week visit. If a participant drops out before completing the 28-week visit, all available data through the last visit date will be included for calculating CGM metrics. Minimum 168 hours of CGM data will be required to calculate CGM metrics. Smaller percentages of CGM-measured percentages of time above 180 mg/dL is considered a positive outcome.
Time frame: From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | CGM-measured Percent of Time Above 180 mg/dL Over 12 Week Trial Extension Period | 33 Percentage of Time | Standard Deviation 11 |
| Control Group | CGM-measured Percent of Time Above 180 mg/dL Over 12 Week Trial Extension Period | 34 Percentage of Time | Standard Deviation 10 |
Secondary
CGM-Measured Percent of Time Above 180 mg/dL Over 16 Week Trial Period
Continuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. Smaller percentages of CGM-measured time above 180 mg/dL is considered a positive outcome.
Time frame: From randomization to data collection completion at the end of 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | CGM-Measured Percent of Time Above 180 mg/dL Over 16 Week Trial Period | 31 Percentage of Time | Standard Deviation 10 |
| Control Group | CGM-Measured Percent of Time Above 180 mg/dL Over 16 Week Trial Period | 43 Percentage of Time | Standard Deviation 14 |
Secondary
CGM-measured Percent of Time Above 250 mg/dL Over 12 Week Trial Extension Period
Continuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM measured blood sugar values above 250 mg/dL are considered to be undesireable. Thus, less time spent above 250mg/dL is considered a positive outcome.
Time frame: From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Closed Loop Control (CLC) | CGM-measured Percent of Time Above 250 mg/dL Over 12 Week Trial Extension Period | 9.0 percentage of time |
| Control Group | CGM-measured Percent of Time Above 250 mg/dL Over 12 Week Trial Extension Period | 10.1 percentage of time |
Secondary
CGM-measured Percent of Time Above 250 mg/dL Over 16 Week Trial Period
CGM measured blood sugar values above 250 mg/dL are considered to be undesirable. Thus, less time spent above 250mg/dL is considered a positive outcome.
Time frame: From randomization to data collection completion at the end of 16 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Closed Loop Control (CLC) | CGM-measured Percent of Time Above 250 mg/dL Over 16 Week Trial Period | 7.8 Percentage of Time |
| Control Group | CGM-measured Percent of Time Above 250 mg/dL Over 16 Week Trial Period | 18.4 Percentage of Time |
Secondary
CGM-measured Percent of Time Below 54 mg/dL Over 12 Week Trial Extension Period
Continuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM measured blood sugar values below 54 mg/dL have the potential to lead to unconsciousness or death. Thus, time below 54 mg/dL suggests that the person may have been close to danger.
Time frame: From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Closed Loop Control (CLC) | CGM-measured Percent of Time Below 54 mg/dL Over 12 Week Trial Extension Period | 0.25 Percentage of Time |
| Control Group | CGM-measured Percent of Time Below 54 mg/dL Over 12 Week Trial Extension Period | 0.25 Percentage of Time |
Secondary
CGM-measured Percent of Time Below 70 mg/dL Over 12 Week Trial Extension Period
Continuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM measured blood sugar values below 70 mg/dL are considered to be undesirable. Thus, less time spent below 70mg/dL is considered a positive outcome.
Time frame: From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Closed Loop Control (CLC) | CGM-measured Percent of Time Below 70 mg/dL Over 12 Week Trial Extension Period | 1.50 Percentage of Time |
| Control Group | CGM-measured Percent of Time Below 70 mg/dL Over 12 Week Trial Extension Period | 1.34 Percentage of Time |
Secondary
CGM-measured Percent of Time Below 70 mg/dL Over 16 Week Trial Period
Continuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM measured blood sugar values below 70 mg/dL are considered to be somewhat dangerous due to the possibility of unconsciousness and death at low blood sugar values. Thus, less time spent below 70mg/dL is considered a positive outcome.
Time frame: From randomization to data collection completion at the end of 16 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Closed Loop Control (CLC) | CGM-measured Percent of Time Below 70 mg/dL Over 16 Week Trial Period | 1.57 Percentage of Time |
| Control Group | CGM-measured Percent of Time Below 70 mg/dL Over 16 Week Trial Period | 1.80 Percentage of Time |
Secondary
Continuous Glucose Monitor (CGM)-Measured Glucose Variability Measured With the Coefficient of Variation (CV) Over 16 Week Trial Period
Continuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM metrics were calculated by pooling all CGM readings in the 16-week trial period starting from randomization visit to week 16 visit. If a participant drops out before completing the 16-week visit, all available data through the last visit date will be included for calculating CGM metrics. Minimum 168 hours of CGM data were required to calculate CGM metrics. Coefficient of Variability (CV) is the ratio of the standard deviation to the mean of the blood sugar values of each participant as measured by CGM. The reported value is the mean and standard deviation of the participant outcomes multiplied by 100. This shows the extent of the mean variability of the blood sugar values in the population. Higher CV values (up to 100) indicate greater dispersion of CGM values, which would indicate more blood sugar variability, which is considered a negative outcome. Minimum value is 0.
Time frame: From randomization to data collection completion at the end of 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | Continuous Glucose Monitor (CGM)-Measured Glucose Variability Measured With the Coefficient of Variation (CV) Over 16 Week Trial Period | 38 Percentage | Standard Deviation 4 |
| Control Group | Continuous Glucose Monitor (CGM)-Measured Glucose Variability Measured With the Coefficient of Variation (CV) Over 16 Week Trial Period | 39 Percentage | Standard Deviation 4 |
Secondary
Continuous Glucose Monitor (CGM)-Measured Glucose Variability Percentage Measured With the Coefficient of Variation (CV) Over 12 Week Trial Extension Period
Continuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM metrics were calculated by pooling all CGM readings in the 12-week trial extension period starting from 16 week visit to week 28 visit. If a participant drops out before completing the 32-week visit, all available data through the last visit date will be included for calculating CGM metrics. Minimum 168 hours of CGM data were required to calculate CGM metrics. Coefficient of Variability (CV) is the ratio of the standard deviation to the mean of the blood sugar values of each participant as measured by CGM. The reported value is the mean and standard deviation of the participant outcomes multiplied by 100. This shows the extent of the mean variability of the blood sugar values in the study group. Higher CV values (up to 100) indicate greater dispersion of CGM values, which would indicate more blood sugar variability, which is considered a negative outcome. Minimum value is 0.
Time frame: From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | Continuous Glucose Monitor (CGM)-Measured Glucose Variability Percentage Measured With the Coefficient of Variation (CV) Over 12 Week Trial Extension Period | 38 Percentage | Standard Deviation 4 |
| Control Group | Continuous Glucose Monitor (CGM)-Measured Glucose Variability Percentage Measured With the Coefficient of Variation (CV) Over 12 Week Trial Extension Period | 38 Percentage | Standard Deviation 4 |
Secondary
Glycated Hemoglobin A1C (HbA1c) Percent at End Of 16 Week Trial Period
Glycated Hemoglobin A1C (HbA1c) is a physiological marker of the percentage of red blood cells that have glycated (bonded with a sugar). HbA1c is used to measure changes in average blood sugar over the past three months. 5-6% is normal, 7% and above is correlated with negative long-term health outcomes.
Time frame: At data collection completion at the end of 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | Glycated Hemoglobin A1C (HbA1c) Percent at End Of 16 Week Trial Period | 7.0 Percent of Hemoglobin that was Glycated | Standard Deviation 0.8 |
| Control Group | Glycated Hemoglobin A1C (HbA1c) Percent at End Of 16 Week Trial Period | 7.6 Percent of Hemoglobin that was Glycated | Standard Deviation 0.9 |
Secondary
Glycated Hemoglobin Percent (HbA1c) at Conclusion of 12 Week Trial Extension Period
Hemoglobin A1C (HbA1c) is a physiological marker of the percentage of red blood cells that have glycated (bonded with a sugar). HbA1c is used to measure changes in average blood sugar over the past three months. 5-6% is normal, 7% and above is correlated with negative long-term health outcomes.
Time frame: At completion of the extension study, end of week 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | Glycated Hemoglobin Percent (HbA1c) at Conclusion of 12 Week Trial Extension Period | 7.2 Percent of Hemoglobin that was Glycated | Standard Deviation 0.9 |
| Control Group | Glycated Hemoglobin Percent (HbA1c) at Conclusion of 12 Week Trial Extension Period | 7.3 Percent of Hemoglobin that was Glycated | Standard Deviation 0.7 |
Other Pre-specified
Absolute Glycated Hemoglobin Percent HbA1c Improvement From Baseline to 16 Weeks Greater Than 0.5%
HbA1c is a physiological marker that is used to measure changes in average blood sugar over the past three months. Improvements of 0.5% or greater are considered clinically significant improvements.
Time frame: From randomization to data collection completion at the end of 16 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Closed Loop Control (CLC) | Absolute Glycated Hemoglobin Percent HbA1c Improvement From Baseline to 16 Weeks Greater Than 0.5% | 40 Participants |
| Control Group | Absolute Glycated Hemoglobin Percent HbA1c Improvement From Baseline to 16 Weeks Greater Than 0.5% | 11 Participants |
Other Pre-specified
Absolute Glycated Hemoglobin Percent (HbA1c) Improvement From Baseline to 16 Weeks Greater Than 1.0%
HbA1c is a physiological marker that is used to measure changes in average blood sugar over the past three months. Improvements of 1.0% or greater are considered clinically significant improvements
Time frame: From randomization to data collection completion at the end of 16 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Closed Loop Control (CLC) | Absolute Glycated Hemoglobin Percent (HbA1c) Improvement From Baseline to 16 Weeks Greater Than 1.0% | 19 Participants |
| Control Group | Absolute Glycated Hemoglobin Percent (HbA1c) Improvement From Baseline to 16 Weeks Greater Than 1.0% | 2 Participants |
Other Pre-specified
Basal: Bolus Insulin Ratio at Conclusion of 12 Week Trial Extension Period
Insulin metrics were calculated at 16 weeks and 28 weeks using Tandem pump data where available, otherwise using data reported on the CRF. Insulin metrics were calculated from the pump data using data in the 7 days prior to the visit. The basal:bolus ratio describes the amount of insulin used by participants to keep the blood sugar stable (basal insulin) as opposed to the amount of insulin used to metabolize consumed carbs (bolus insulin) within the total amount of insulin delivered per day.
Time frame: 7 days leading up to the final extension study visit in week 28
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Closed Loop Control (CLC) | Basal: Bolus Insulin Ratio at Conclusion of 12 Week Trial Extension Period | 0.84 ratio |
| Control Group | Basal: Bolus Insulin Ratio at Conclusion of 12 Week Trial Extension Period | 1.0 ratio |
Other Pre-specified
Basal: Bolus Insulin Ratio Over 16 Weeks
Insulin metrics were calculated at randomization and 16 weeks using Tandem pump data where available, otherwise using data reported on the CRF. Insulin metrics were calculated from the pump data using data in the 7 days prior to the visit. The basal:bolus ratio describes the amount of insulin used by participants to keep the blood sugar stable (basal insulin) as opposed to the amount of insulin used to metabolize consumed carbs (bolus insulin) within the total amount of insulin delivered per day.
Time frame: 7 days leading up to the final study visit in week 16
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | Basal: Bolus Insulin Ratio Over 16 Weeks | 0.87 ratio | Standard Deviation 0.3 |
| Control Group | Basal: Bolus Insulin Ratio Over 16 Weeks | 0.84 ratio | Standard Deviation 0.38 |
Other Pre-specified
Body Mass Index (BMI) at Conclusion of 12 Week Trial Extension Period
Body Mass Index (BMI) is a calculation of participant body weight in kilograms and height in centimeters. The z-score was calculated from values taken at the end of the 28 weeks of the study. Z-score of zero represents the US population mean for their age and sex group. Positive Z scores indicate higher body mass index values than the population mean, which is generally considered undesirable
Time frame: At completion of the extension study, end of week 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | Body Mass Index (BMI) at Conclusion of 12 Week Trial Extension Period | .46 Z-score | Standard Deviation 0.97 |
| Control Group | Body Mass Index (BMI) at Conclusion of 12 Week Trial Extension Period | 0.68 Z-score | Standard Deviation 1.03 |
Other Pre-specified
CGM-Measured Percent of Time >300 mg/dL Over 16 Weeks
CGM measured blood sugar values above 300 mg/dL are considered to be undesirable. Thus, less time spent above 300 mg/dL is considered a positive outcome
Time frame: From randomization to data collection completion at the end of 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | CGM-Measured Percent of Time >300 mg/dL Over 16 Weeks | 4.1 Percentage of Time | Standard Deviation 4.1 |
| Control Group | CGM-Measured Percent of Time >300 mg/dL Over 16 Weeks | 7.7 Percentage of Time | Standard Deviation 6.3 |
Other Pre-specified
CGM-Measured Percent of Time Above 300 mg/dL Over 12 Week Trial Extension Period
CGM measured blood sugar values above 300 mg/dL are considered to be undesireable. Thus, less time spent above 300mg/dL is considered a positive outcome
Time frame: From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Closed Loop Control (CLC) | CGM-Measured Percent of Time Above 300 mg/dL Over 12 Week Trial Extension Period | 2.9 Percentage of Time |
| Control Group | CGM-Measured Percent of Time Above 300 mg/dL Over 12 Week Trial Extension Period | 3.5 Percentage of Time |
Other Pre-specified
CGM-Measured Percent of Time Below 60 mg/dL Over 16 Weeks
CGM measured blood sugar values below 60 mg/dL are considered to be undesirable. Thus, less time spent below 60mg/dL is considered a positive outcome
Time frame: From randomization to data collection completion at the end of 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | CGM-Measured Percent of Time Below 60 mg/dL Over 16 Weeks | 0.67 Percentage of Time | Standard Deviation 0.62 |
| Control Group | CGM-Measured Percent of Time Below 60 mg/dL Over 16 Weeks | 0.75 Percentage of Time | Standard Deviation 0.55 |
Other Pre-specified
CGM-Measured Percent of Time in Range 70-140 mg/dL Over 12 Week Trial Extension Period
CGM-Measured percent of time in blood sugar range 70-140 mg/dL over the 12 week extension study. Larger percentages of time spent in this range is considered to be a desireable outcome.
Time frame: From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | CGM-Measured Percent of Time in Range 70-140 mg/dL Over 12 Week Trial Extension Period | 42 Percentage of Time | Standard Deviation 11 |
| Control Group | CGM-Measured Percent of Time in Range 70-140 mg/dL Over 12 Week Trial Extension Period | 42 Percentage of Time | Standard Deviation 8 |
Other Pre-specified
CGM-Measured Percent of Time in Range 70-140 mg/dL Over 16 Weeks
Continuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM-Measured percent of time in blood sugar range 70-140 mg/dL. Larger percentages of time spent in this range is considered to be a desirable outcome.
Time frame: From randomization to data collection completion at the end of 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | CGM-Measured Percent of Time in Range 70-140 mg/dL Over 16 Weeks | 44 Percentage of Time | Standard Deviation 10 |
| Control Group | CGM-Measured Percent of Time in Range 70-140 mg/dL Over 16 Weeks | 35 Percentage of Time | Standard Deviation 11 |
Other Pre-specified
CGM-Measured Percent of Time in Range 70-180mg/dL Over 12 Week Trial Extension Period
The primary outcome for the extension phase is improving the percent of time in the blood sugar range 70-180 mg/dL over the 12 weeks of the extension phase of the study
Time frame: From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | CGM-Measured Percent of Time in Range 70-180mg/dL Over 12 Week Trial Extension Period | 66 Percentage of Time | Standard Deviation 10 |
| Control Group | CGM-Measured Percent of Time in Range 70-180mg/dL Over 12 Week Trial Extension Period | 65 Percentage of Time | Standard Deviation 10 |
Other Pre-specified
CGM-Measured Percent Time in Range 70-180 mg/dL Improvement From Baseline to 16 Weeks ≥10%
This is a comparison of a binary CGM outcome indicating how many participants and what percent of participants experienced an improvement of greater than 10% in the percentage of time they were in the ideal blood sugar range of 70-140 mg/dL. More participants (a greater percentage of participants) improving this much is considered positive
Time frame: From randomization to data collection completion at the end of 16 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Closed Loop Control (CLC) | CGM-Measured Percent Time in Range 70-180 mg/dL Improvement From Baseline to 16 Weeks ≥10% | 44 Participants |
| Control Group | CGM-Measured Percent Time in Range 70-180 mg/dL Improvement From Baseline to 16 Weeks ≥10% | 7 Participants |
Other Pre-specified
CGM-Measured Percent Time in Range 70-180 mg/dL Improvement From Baseline to 16 Weeks ≥5%
This is a comparison of a binary CGM outcome indicating how many participants and what percent of participants experienced an improvement of greater than 5% in the percentage of time they were in the safe blood sugar range of 70-180 mg/dL. More participants (a greater percentage of participants) improving by this much is considered positive.
Time frame: From randomization to data collection completion at the end of 16 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Closed Loop Control (CLC) | CGM-Measured Percent Time in Range 70-180 mg/dL Improvement From Baseline to 16 Weeks ≥5% | 62 Participants |
| Control Group | CGM-Measured Percent Time in Range 70-180 mg/dL Improvement From Baseline to 16 Weeks ≥5% | 12 Participants |
Other Pre-specified
Clarke Hypoglycemia Awareness Scores Questionnaire at 16 Weeks
The scale comprises eight questions characterizing the participant's exposure to episodes of moderate and severe hypoglycemia. It also examines the glycemic threshold for, and symptomatic responses to hypoglycemia. A score of four or more on a scale of 0 to 7 implies impaired awareness of hypoglycemia. Parents and children took the questionnaire independently.
Time frame: At data collection completion at the end of 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | Clarke Hypoglycemia Awareness Scores Questionnaire at 16 Weeks | 1.2 score on a scale | Standard Deviation 1.1 |
| Control Group | Clarke Hypoglycemia Awareness Scores Questionnaire at 16 Weeks | 1.6 score on a scale | Standard Deviation 1.1 |
| Closed-Loop Control (CLC) Group (Child Versions) | Clarke Hypoglycemia Awareness Scores Questionnaire at 16 Weeks | 1.3 score on a scale | Standard Deviation 1.1 |
| Control (SAP) Group (Child Versions) | Clarke Hypoglycemia Awareness Scores Questionnaire at 16 Weeks | 1.2 score on a scale | Standard Deviation 1.1 |
Other Pre-specified
Clarke Hypoglycemia Awareness Scores Questionnaire at Conclusion of 12 Week Trial Extension Period
The scale comprises eight questions characterizing the participant's exposure to episodes of moderate and severe hypoglycemia. It also examines the glycemic threshold for, and symptomatic responses to hypoglycemia. A score of four or more on a scale of 0 to 7 implies impaired awareness of hypoglycemia.
Time frame: At completion of the extension study, end of week 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | Clarke Hypoglycemia Awareness Scores Questionnaire at Conclusion of 12 Week Trial Extension Period | 1.1 score on a scale | Standard Deviation 1.1 |
| Control Group | Clarke Hypoglycemia Awareness Scores Questionnaire at Conclusion of 12 Week Trial Extension Period | 1.5 score on a scale | Standard Deviation 1.2 |
| Closed-Loop Control (CLC) Group (Child Versions) | Clarke Hypoglycemia Awareness Scores Questionnaire at Conclusion of 12 Week Trial Extension Period | 1.5 score on a scale | Standard Deviation 1.2 |
| Control (SAP) Group (Child Versions) | Clarke Hypoglycemia Awareness Scores Questionnaire at Conclusion of 12 Week Trial Extension Period | 1.7 score on a scale | Standard Deviation 1.1 |
Other Pre-specified
Continuous Blood Glucose Monitor (CGM)-Measured Low Blood Glucose Index (LBGI) Over 12 Week Trial Extension Period
Continuous Blood Glucose Monitor (CGM) metrics were calculated by pooling all CGM readings in the 12-week period starting from the end of the 16th week of the main trial up through the 28 week visit (end of study extension). If a participant dropped out before completing the 28-week visit, all available data through the last visit date was included for calculating CGM metrics. Minimum 168 hours of CGM data was required to calculate CGM metrics. The low blood glucose index (LBGI) is a Glucose-variability-based metric of the risk for hypoglycemia. LBGI increases with the frequency and extent of hypoglycemic excursions and has been used as a predictor of severe events. The minimum value possible is 0, indicating no risk of low blood sugar. The maximum possible value is 100, indicating maximum possible risk of low blood sugar.
Time frame: From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Closed Loop Control (CLC) | Continuous Blood Glucose Monitor (CGM)-Measured Low Blood Glucose Index (LBGI) Over 12 Week Trial Extension Period | 0.48 units on a scale |
| Control Group | Continuous Blood Glucose Monitor (CGM)-Measured Low Blood Glucose Index (LBGI) Over 12 Week Trial Extension Period | 0.48 units on a scale |
Other Pre-specified
Continuous Blood Glucose Monitor (CGM)-Measured Percent of Time Less Than 60 mg/dL Over 16 Weeks
Continuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM metrics were calculated by pooling all CGM readings in the 16-week trial period starting from the randomization visit to week 16 visit. If a participant drops out before completing the 16-week visit, all available data through the last visit date will be included for calculating CGM metrics. Minimum 168 hours of CGM data were required to calculate CGM metrics. Coefficient of Variability (CV) is the ratio of the standard deviation to the mean of the blood sugar values of each participant as measured by CGM. The reported value is the mean and standard deviation of the participant outcomes multiplied by 100. This shows the extent of the mean variability of the blood sugar values in the population. Higher CV values (up to 100) indicate greater dispersion of CGM values, which would indicate more blood sugar variability, which is considered a negative outcome. Minimum value is 0.
Time frame: From randomization to data collection completion at the end of 16 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Closed Loop Control (CLC) | Continuous Blood Glucose Monitor (CGM)-Measured Percent of Time Less Than 60 mg/dL Over 16 Weeks | 0.48 Percentage of Time |
| Control Group | Continuous Blood Glucose Monitor (CGM)-Measured Percent of Time Less Than 60 mg/dL Over 16 Weeks | 0.60 Percentage of Time |
Other Pre-specified
Fear of Hypoglycemia Survey (HFS-II) at 16 Weeks
The Hypoglycemia Fear Survey-II was developed to measure behaviors and worries related to fear of hypoglycemia in adults with type 1 diabetes and was adapted for children and parents. Items are rated on a 5-point Likert scale (0=never, 4=always), with higher scores indicating higher fear of hypoglycemia. Maximum possible score: 132. Minimum possible score: 0. All questionnaires were administered online and participants/parents could skip specific questionnaires or items within a questionnaire. At least 75% of the questions must have been competed to be included in analysis. The score used for analysis was based on the average among the questions that were answered and then scaled accordingly.
Time frame: At data collection completion at the end of 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | Fear of Hypoglycemia Survey (HFS-II) at 16 Weeks | 37 score on a scale | Standard Deviation 13 |
| Control Group | Fear of Hypoglycemia Survey (HFS-II) at 16 Weeks | 45 score on a scale | Standard Deviation 13 |
| Closed-Loop Control (CLC) Group (Child Versions) | Fear of Hypoglycemia Survey (HFS-II) at 16 Weeks | 31 score on a scale | Standard Deviation 12 |
| Control (SAP) Group (Child Versions) | Fear of Hypoglycemia Survey (HFS-II) at 16 Weeks | 36 score on a scale | Standard Deviation 14 |
Other Pre-specified
Fear of Hypoglycemia Survey (HFS-II) at Conclusion of 12 Week Trial Extension Period
The Hypoglycemia Fear Survey-II was developed to measure behaviors and worries related to fear of hypoglycemia in adults with type 1 diabetes and was adapted for children and parents. Items are rated on a 5-point Likert scale (0=never, 4=always), with higher scores indicating higher fear of hypoglycemia. Maximum possible score: 132. Minimum possible score: 0. All questionnaires were administered online and participants/parents could skip specific questionnaires or items within a questionnaire. At least 75% of the questions must have been competed to be included in analysis. The score used for analysis was based on the average among the questions that were answered and then scaled accordingly.
Time frame: At completion of the extension study, end of week 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | Fear of Hypoglycemia Survey (HFS-II) at Conclusion of 12 Week Trial Extension Period | 36 score on a scale | Standard Deviation 12 |
| Control Group | Fear of Hypoglycemia Survey (HFS-II) at Conclusion of 12 Week Trial Extension Period | 43 score on a scale | Standard Deviation 17 |
| Closed-Loop Control (CLC) Group (Child Versions) | Fear of Hypoglycemia Survey (HFS-II) at Conclusion of 12 Week Trial Extension Period | 30 score on a scale | Standard Deviation 11 |
| Control (SAP) Group (Child Versions) | Fear of Hypoglycemia Survey (HFS-II) at Conclusion of 12 Week Trial Extension Period | 32 score on a scale | Standard Deviation 14 |
Other Pre-specified
Glucose Variability Measured With the Standard Deviation (SD) Over 16 Weeks
Continuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM metrics were calculated by pooling all CGM readings in the 16-week period starting from the randomization visit up through the 16 week visit. If a participant dropped out before completing the 16-week visit, all available data through the last visit date will be included for calculating CGM metrics. Minimum 168 hours of CGM data will be required to calculate CGM metrics. Standard Deviation represents how much glucose levels fluctuate over time from a given average.
Time frame: From randomization to data collection completion at the end of 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | Glucose Variability Measured With the Standard Deviation (SD) Over 16 Weeks | 61 mg/dL | Standard Deviation 11 |
| Control Group | Glucose Variability Measured With the Standard Deviation (SD) Over 16 Weeks | 70 mg/dL | Standard Deviation 13 |
Other Pre-specified
Glucose Variability of Blood Sugar as Measured by Continuous Glucose Monitor (CGM), Measured With the Standard Deviation (SD) Over 16 Weeks
Continuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM metrics were calculated by pooling all CGM readings in the 16-week trial period starting from the randomization visit to week 16 visit. If a participant drops out before completing the 16-week visit, all available data through the last visit date will be included for calculating CGM metrics. Minimum 168 hours of CGM data were required to calculate CGM metrics. Coefficient of Variability (CV) is the ratio of the standard deviation to the mean of the blood sugar values of each participant as measured by CGM. The reported value is the mean and standard deviation of the participant outcomes multiplied by 100. This shows the extent of the mean variability of the blood sugar values in the population. Higher CV values (up to 100) indicate greater dispersion of CGM values, which would indicate more blood sugar variability, which is considered a negative outcome. Minimum value is 0.
Time frame: From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | Glucose Variability of Blood Sugar as Measured by Continuous Glucose Monitor (CGM), Measured With the Standard Deviation (SD) Over 16 Weeks | 62 mg/dL | Standard Deviation 11 |
| Control Group | Glucose Variability of Blood Sugar as Measured by Continuous Glucose Monitor (CGM), Measured With the Standard Deviation (SD) Over 16 Weeks | 64 mg/dL | Standard Deviation 12 |
Other Pre-specified
Glycated Hemoglobin Percent (HbA1c) Less Than 7.0% at 16 Weeks
HbA1c is a physiological marker that is used to measure changes in average blood sugar over the past three months. Numbers less than 7.0 are considered better for long-term health; thus, larger numbers or percentages of people with an HbA1c less than 7.0 is considered a positive outcome
Time frame: From randomization to data collection completion at the end of 16 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Closed Loop Control (CLC) | Glycated Hemoglobin Percent (HbA1c) Less Than 7.0% at 16 Weeks | 39 Participants |
| Control Group | Glycated Hemoglobin Percent (HbA1c) Less Than 7.0% at 16 Weeks | 4 Participants |
Other Pre-specified
Glycated Hemoglobin Percent (HbA1c) Less Than 7.0% at Conclusion of 12 Week Trial Extension Period
HbA1c is a physiological marker that is used to measure changes in average blood sugar over the past three months. Numbers less than 7.0 are considered better for long-term health; thus, larger numbers or percentages of people with an HbA1c less than 7.0 is considered a positive outcome.
Time frame: At completion of the extension study, end of week 28
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Closed Loop Control (CLC) | Glycated Hemoglobin Percent (HbA1c) Less Than 7.0% at Conclusion of 12 Week Trial Extension Period | 32 Participants |
| Control Group | Glycated Hemoglobin Percent (HbA1c) Less Than 7.0% at Conclusion of 12 Week Trial Extension Period | 4 Participants |
Other Pre-specified
Glycated Hemoglobin Percent (HbA1c) Less Than 7.5% at 16 Weeks
HbA1c is a physiological marker that is used to measure changes in average blood sugar over the past three months. Numbers less than 7.5 are considered better for long-term health; thus, larger numbers or percentages of people with an HbA1c less than 7.5 is considered a positive outcome
Time frame: From randomization to data collection completion at the end of 16 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Closed Loop Control (CLC) | Glycated Hemoglobin Percent (HbA1c) Less Than 7.5% at 16 Weeks | 57 Participants |
| Control Group | Glycated Hemoglobin Percent (HbA1c) Less Than 7.5% at 16 Weeks | 10 Participants |
Other Pre-specified
Glycated Hemoglobin Percent (HbA1c) Less Than 7.5% at Conclusion of 12 Week Trial Extension Period
HbA1c is a physiological marker that is used to measure changes in average blood sugar over the past three months. Numbers less than 7.5 are considered better for long-term health; thus, larger numbers or percentages of people with an HbA1c less than 7.5 is considered a positive outcome.
Time frame: At completion of the extension study, end of week 28
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Closed Loop Control (CLC) | Glycated Hemoglobin Percent (HbA1c) Less Than 7.5% at Conclusion of 12 Week Trial Extension Period | 48 Participants |
| Control Group | Glycated Hemoglobin Percent (HbA1c) Less Than 7.5% at Conclusion of 12 Week Trial Extension Period | 13 Participants |
Other Pre-specified
Glycated Hemoglobin Percent HbA1c Reduction From Baseline to 16 Weeks Greater Than 1.0% or HbA1c Less Than 7.0%
HbA1c is a physiological marker that is used to measure changes in average blood sugar over the past three months. Improvements of 1.0% or greater are considered clinically significant improvements, HbA1c values less than 7.0 are considered better for long-term health.
Time frame: From randomization to data collection completion at the end of 16 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Closed Loop Control (CLC) | Glycated Hemoglobin Percent HbA1c Reduction From Baseline to 16 Weeks Greater Than 1.0% or HbA1c Less Than 7.0% | 47 Participants |
| Control Group | Glycated Hemoglobin Percent HbA1c Reduction From Baseline to 16 Weeks Greater Than 1.0% or HbA1c Less Than 7.0% | 6 Participants |
Other Pre-specified
Glycated Hemoglobin Percent (HbA1c) Relative Improvement From Baseline to 16 Weeks Greater Than 10%
HbA1c is a physiological marker that is used to measure changes in average blood sugar over the past three months. Improvements of 1.0% or greater are considered clinically significant improvements.
Time frame: From randomization to data collection completion at the end of 16 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Closed Loop Control (CLC) | Glycated Hemoglobin Percent (HbA1c) Relative Improvement From Baseline to 16 Weeks Greater Than 10% | 28 Participants |
| Control Group | Glycated Hemoglobin Percent (HbA1c) Relative Improvement From Baseline to 16 Weeks Greater Than 10% | 4 Participants |
Other Pre-specified
High Blood Glucose Index (HBGI) Over 12 Weeks of Trial Extension Period
Continuous Blood Glucose Monitor (CGM) metrics were calculated by pooling all CGM readings in the 12-week period starting from the end of the 16th week of the main trial up through the 28 week visit (end of study extension). If a participant dropped out before completing the 28-week visit, all available data through the last visit date was included for calculating CGM metrics. Minimum 168 hours of CGM data was required to calculate CGM metrics. The High Blood Glucose Index (HBGI) is a Glucose-variability-based metric of the risk for hyperglycemia that can be calculated from CGM readings. HBGI increases with the frequency and extent of hyperglycemic excursions and has been used as a predictor of severe events. The minimum value possible is 0, indicating no risk of high blood sugar. The maximum possible value is 100, indicating maximum possible risk of high blood sugar.
Time frame: From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | High Blood Glucose Index (HBGI) Over 12 Weeks of Trial Extension Period | 8.0 units on a scale | Standard Deviation 3.3 |
| Control Group | High Blood Glucose Index (HBGI) Over 12 Weeks of Trial Extension Period | 8.3 units on a scale | Standard Deviation 3.2 |
Other Pre-specified
High Blood Glucose Index (HBGI) Over 16 Weeks
Continuous Blood Glucose Monitor (CGM) metrics were calculated by pooling all CGM readings in the 16-week period starting from the randomization visit up through the 16 week visit (end of study). If a participant dropped out before completing the 16-week visit, all available data through the last visit date was included for calculating CGM metrics. Minimum 168 hours of CGM data was required to calculate CGM metrics. The High Blood Glucose Index (HBGI) is a Glucose-variability-based metric of the risk for hyperglycemia that can be calculated from CGM readings. HBGI increases with the frequency and extent of hyperglycemic excursions and has been used as a predictor of severe events. The minimum value possible is 0, indicating no risk of high blood sugar. The maximum possible value is 100, indicating maximum possible risk of high blood sugar.
Time frame: From randomization to data collection completion at the end of 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | High Blood Glucose Index (HBGI) Over 16 Weeks | 7.5 Score on a scale | Standard Deviation 3.1 |
| Control Group | High Blood Glucose Index (HBGI) Over 16 Weeks | 10.8 Score on a scale | Standard Deviation 4.5 |
Other Pre-specified
Hypoglycemia Events (Defined as at Least 15 Consecutive Minutes <70 mg\dL) Over 16 Weeks
A Hypoglycemic event was defined as at least 15 consecutive minutes where the CGM was lower than 70mg/dL. Fewer hypoglycemia events are considered better.
Time frame: From randomization to data collection completion at the end of 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | Hypoglycemia Events (Defined as at Least 15 Consecutive Minutes <70 mg\dL) Over 16 Weeks | 4.0 Hypoglycemic Event | Standard Deviation 2.8 |
| Control Group | Hypoglycemia Events (Defined as at Least 15 Consecutive Minutes <70 mg\dL) Over 16 Weeks | 4.6 Hypoglycemic Event | Standard Deviation 2.5 |
Other Pre-specified
Insulin Delivery Systems: Perceptions, Ideas, Reflections and Expectations (INSPIRE) Survey Scores at Conclusion of 12 Week Trial Extension Period
The INSPIRE (Insulin Delivery Systems: Perceptions, Ideas, Reflections and Expectations) survey was developed to assess various aspects of a user's experience regarding automated insulin delivery for both patients and family members. The surveys include various topics important to patients with type 1 diabetes and their family members based upon \>200 hours of qualitative interviews and focus groups. Response options for all surveys include a 5-point Likert scale from strongly agree to strongly disagree, along with an N/A option. Total scores on the INSPIRE questionnaires were calculated by obtaining a mean score across items, then multiplying the mean score by 25 to scale total INSPIRE measure scores from 0 to 100, with higher scores indicating greater positive expectations for automated insulin delivery systems.
Time frame: At completion of the extension study, end of week 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | Insulin Delivery Systems: Perceptions, Ideas, Reflections and Expectations (INSPIRE) Survey Scores at Conclusion of 12 Week Trial Extension Period | 89 score on a scale | Standard Deviation 12 |
| Control Group | Insulin Delivery Systems: Perceptions, Ideas, Reflections and Expectations (INSPIRE) Survey Scores at Conclusion of 12 Week Trial Extension Period | 86 score on a scale | Standard Deviation 17 |
| Closed-Loop Control (CLC) Group (Child Versions) | Insulin Delivery Systems: Perceptions, Ideas, Reflections and Expectations (INSPIRE) Survey Scores at Conclusion of 12 Week Trial Extension Period | 76 score on a scale | Standard Deviation 17 |
| Control (SAP) Group (Child Versions) | Insulin Delivery Systems: Perceptions, Ideas, Reflections and Expectations (INSPIRE) Survey Scores at Conclusion of 12 Week Trial Extension Period | 78 score on a scale | Standard Deviation 14 |
Other Pre-specified
Insulin Delivery Systems: Perceptions, Ideas, Reflections and Expections (INSPIRE) Survey Scores at 16 Weeks
The INSPIRE (Insulin Delivery Systems: Perceptions, Ideas, Reflections and Expectations) survey was developed to assess various aspects of a user's experience regarding automated insulin delivery for both patients and family members. The surveys include various topics important to patients with type 1 diabetes and their family members based upon \>200 hours of qualitative interviews and focus groups. Response options for all surveys include a 5-point Likert scale from strongly agree to strongly disagree, along with an N/A option. Total scores on the INSPIRE questionnaires were calculated by obtaining a mean score across items, then multiplying the mean score by 25 to scale total INSPIRE measure scores from 0 to 100, with higher scores indicating greater positive expectations for automated insulin delivery systems.
Time frame: At data collection completion at the end of 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | Insulin Delivery Systems: Perceptions, Ideas, Reflections and Expections (INSPIRE) Survey Scores at 16 Weeks | 87 score on a scale | Standard Deviation 12 |
| Control Group | Insulin Delivery Systems: Perceptions, Ideas, Reflections and Expections (INSPIRE) Survey Scores at 16 Weeks | 75 score on a scale | Standard Deviation 16 |
Other Pre-specified
Low Blood Glucose Index (LBGI) Over 16 Weeks
Continuous Blood Glucose Monitor (CGM) metrics were calculated by pooling all CGM readings in the 16-week period starting from the randomization visit up through the 16 week visit. If a participant dropped out before completing the 16-week visit, all available data through the last visit date was included for calculating CGM metrics. Minimum 168 hours of CGM data was required to calculate CGM metrics. The low blood glucose index (LBGI) is a Glucose-variability-based metric of the risk for hypoglycemia. LBGI increases with the frequency and extent of hypoglycemic excursions and has been used as a predictor of severe events. The minimum value possible is 0, indicating no risk of low blood sugar. The maximum possible value is 100, indicating maximum possible risk of low blood sugar.
Time frame: From randomization to data collection completion at the end of 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | Low Blood Glucose Index (LBGI) Over 16 Weeks | 0.55 Score on a Scale | Standard Deviation 0.33 |
| Control Group | Low Blood Glucose Index (LBGI) Over 16 Weeks | 0.64 Score on a Scale | Standard Deviation 0.3 |
Other Pre-specified
Number of Hypoglycemia Events (Defined as at Least 15 Consecutive Minutes Less Than 70 mg\dL as Measured by Continuous Glucose Meter) Over 12 Week Trial Extension Period
CGM metrics were calculated by pooling all CGM readings in the 12-week period starting from the 16th week of the main trial through the 12th week of the extension. If a participant drops out before completing the 12-week visit, all available data through the last visit date will be included for calculating CGM metrics. Minimum 168 hours of CGM data will be required to calculate CGM metrics. A hypoglycemic event is defined as 15 consecutive minutes with a sensor glucose value below 54 mg/dL. Fewer glycemic events per week is considered a better outcome.
Time frame: From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Closed Loop Control (CLC) | Number of Hypoglycemia Events (Defined as at Least 15 Consecutive Minutes Less Than 70 mg\dL as Measured by Continuous Glucose Meter) Over 12 Week Trial Extension Period | 3.4 Hypoglycemic Event |
| Control Group | Number of Hypoglycemia Events (Defined as at Least 15 Consecutive Minutes Less Than 70 mg\dL as Measured by Continuous Glucose Meter) Over 12 Week Trial Extension Period | 2.9 Hypoglycemic Event |
Other Pre-specified
Pediatric Quality of Life Inventory (PedsQL Diabetes Module) at 16 Weeks
This is a 33-item scale developed and validated for the measurement of diabetes-specific quality of life. Separate forms have been validated for child self-report (5-7 year old; 8-12 year old; and 12-18 year old) and parent report for these same age groups. Participants record the extent to which they (or their child) experienced each of 33 problems related to diabetes in the prior month using a 5-point Likert-type response scale (0= never a problem; 1 = almost never a problem 2 =sometimes a problem 3= often a problem 4 = almost always a problem). Items are reverse-scored and linearly transformed to a 0-100 scale (0=100, 1=7, 2=50, 3=25, 4=0) so that lower score demonstrate more diabetes symptoms and management problems, and hence lower diabetes-specific health-related quality of life. Higher scores indicate fewer symptoms or problems
Time frame: At data collection completion at the end of 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | Pediatric Quality of Life Inventory (PedsQL Diabetes Module) at 16 Weeks | 77 score on a scale | Standard Deviation 10 |
| Control Group | Pediatric Quality of Life Inventory (PedsQL Diabetes Module) at 16 Weeks | 72 score on a scale | Standard Deviation 12 |
| Closed-Loop Control (CLC) Group (Child Versions) | Pediatric Quality of Life Inventory (PedsQL Diabetes Module) at 16 Weeks | 76 score on a scale | Standard Deviation 13 |
| Control (SAP) Group (Child Versions) | Pediatric Quality of Life Inventory (PedsQL Diabetes Module) at 16 Weeks | 76 score on a scale | Standard Deviation 16 |
Other Pre-specified
Pediatric Quality of Life Inventory (PedsQL Diabetes Module) at Conclusion of 12 Week Trial Extension Period
This is a 33-item scale developed and validated for the measurement of diabetes-specific quality of life. Separate forms have been validated for child self-report (5-7 year old; 8-12 year old; and 12-18 year old) and parent report for these same age groups. Participants record the extent to which they (or their child) experienced each of 33 problems related to diabetes in the prior month using a 5-point Likert-type response scale (0= never a problem; 1 = almost never a problem 2 =sometimes a problem 3= often a problem 4 = almost always a problem). Items are reverse-scored and linearly transformed to a 0-100 scale (0=100, 1=7, 2=50, 3=25, 4=0) so that lower score demonstrate more diabetes symptoms and management problems, and hence lower diabetes-specific health-related quality of life. Higher scores indicate fewer symptoms or problems.
Time frame: At completion of the extension study, end of week 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | Pediatric Quality of Life Inventory (PedsQL Diabetes Module) at Conclusion of 12 Week Trial Extension Period | 77 score on a scale | Standard Deviation 11 |
| Control Group | Pediatric Quality of Life Inventory (PedsQL Diabetes Module) at Conclusion of 12 Week Trial Extension Period | 77 score on a scale | Standard Deviation 15 |
| Closed-Loop Control (CLC) Group (Child Versions) | Pediatric Quality of Life Inventory (PedsQL Diabetes Module) at Conclusion of 12 Week Trial Extension Period | 78 score on a scale | Standard Deviation 13 |
| Control (SAP) Group (Child Versions) | Pediatric Quality of Life Inventory (PedsQL Diabetes Module) at Conclusion of 12 Week Trial Extension Period | 77 score on a scale | Standard Deviation 18 |
Other Pre-specified
Pittsburgh Sleep Quality Index (Parent Only) at 16 Weeks (Parent Only)
Pittsburgh Sleep Quality Index (PSQI) is a 10-item questionnaire that measures the sleep quality and pattern of sleep in adults. Seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Time frame: At data collection completion at the end of 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | Pittsburgh Sleep Quality Index (Parent Only) at 16 Weeks (Parent Only) | 4.3 score on a scale | Standard Deviation 2.9 |
| Control Group | Pittsburgh Sleep Quality Index (Parent Only) at 16 Weeks (Parent Only) | 6.5 score on a scale | Standard Deviation 3.9 |
Other Pre-specified
Pittsburgh Sleep Quality Index (Parent Only) at Conclusion of 12 Week Trial Extension Period
Pittsburgh Sleep Quality Index (PSQI) is a 10-item questionnaire that measures the sleep quality and pattern of sleep in adults. Seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Time frame: At completion of the extension study, end of week 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | Pittsburgh Sleep Quality Index (Parent Only) at Conclusion of 12 Week Trial Extension Period | 4.4 score on a scale | Standard Deviation 2.9 |
| Control Group | Pittsburgh Sleep Quality Index (Parent Only) at Conclusion of 12 Week Trial Extension Period | 5.4 score on a scale | Standard Deviation 3.6 |
Other Pre-specified
Problem Areas in Diabetes Survey (PAID) at 16 Weeks
The Problem Areas In Diabetes Survey is a measure of diabetes-related emotional distress and consists of a scale of 16 items for the Parent version and 11 items for the Child version. Patients and parents rate the degree to which each item is currently problematic for them on a 6-point Likert scale, from 1 (no problem) to 6 (serious problem). Parent version maximum score: 96, minimum score 16. Child version maximum score 66, minimum score 11.
Time frame: At data collection completion at the end of 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | Problem Areas in Diabetes Survey (PAID) at 16 Weeks | 36 units on a scale | Standard Deviation 12 |
| Control Group | Problem Areas in Diabetes Survey (PAID) at 16 Weeks | 45 units on a scale | Standard Deviation 17 |
| Closed-Loop Control (CLC) Group (Child Versions) | Problem Areas in Diabetes Survey (PAID) at 16 Weeks | 34 units on a scale | Standard Deviation 16 |
| Control (SAP) Group (Child Versions) | Problem Areas in Diabetes Survey (PAID) at 16 Weeks | 37 units on a scale | Standard Deviation 17 |
Other Pre-specified
Problem Areas in Diabetes Survey (PAID) at Conclusion of 12 Week Trial Extension Period
The Problem Areas In Diabetes Survey is a measure of diabetes-related emotional distress and consists of a scale of 16 items for the Parent version and 11 items for the Child version. Patients and parents rate the degree to which each item is currently problematic for them on a 6-point Likert scale, from 1 (no problem) to 6 (serious problem). Parent version maximum score: 96, minimum score 16. Child version maximum score 66, minimum score 11.
Time frame: At completion of the extension study, end of week 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | Problem Areas in Diabetes Survey (PAID) at Conclusion of 12 Week Trial Extension Period | 36 score on a scale | Standard Deviation 13 |
| Control Group | Problem Areas in Diabetes Survey (PAID) at Conclusion of 12 Week Trial Extension Period | 40 score on a scale | Standard Deviation 17 |
| Closed-Loop Control (CLC) Group (Child Versions) | Problem Areas in Diabetes Survey (PAID) at Conclusion of 12 Week Trial Extension Period | 30 score on a scale | Standard Deviation 11 |
| Control (SAP) Group (Child Versions) | Problem Areas in Diabetes Survey (PAID) at Conclusion of 12 Week Trial Extension Period | 37 score on a scale | Standard Deviation 19 |
Other Pre-specified
System Usability Scale (SUS) at 16 Weeks
System Usability Scores (SUS)-composite score from 0 to 100 with higher scores indicating better perceived usability
Time frame: At data collection completion at the end of 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | System Usability Scale (SUS) at 16 Weeks | 86 score on a scale | Standard Deviation 15 |
| Control Group | System Usability Scale (SUS) at 16 Weeks | 79 score on a scale | Standard Deviation 15 |
Other Pre-specified
System Usability Scale (SUS) at Conclusion of 12 Week Trial Extension Period
System Usability Scores (SUS)-composite score from 0 to 100 with higher scores indicating better perceived usability.
Time frame: At completion of the extension study, end of week 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | System Usability Scale (SUS) at Conclusion of 12 Week Trial Extension Period | 86 score on a scale | Standard Deviation 21 |
| Control Group | System Usability Scale (SUS) at Conclusion of 12 Week Trial Extension Period | 84 score on a scale | Standard Deviation 22 |
| Closed-Loop Control (CLC) Group (Child Versions) | System Usability Scale (SUS) at Conclusion of 12 Week Trial Extension Period | 81 score on a scale | Standard Deviation 18 |
| Control (SAP) Group (Child Versions) | System Usability Scale (SUS) at Conclusion of 12 Week Trial Extension Period | 83 score on a scale | Standard Deviation 10 |
Other Pre-specified
Total Daily Insulin (TDI) (Units/kg/Day) Over 12 Week Trial Extension Period
Total Daily Insulin (Units/kg/day) over 12 weeks. Total daily insulin dose is calculated as the sum of all insulin doses delivered by the insulin delivery system divided by the weight of the participant in kilograms and the actual duration of the treatment period in days.
Time frame: From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | Total Daily Insulin (TDI) (Units/kg/Day) Over 12 Week Trial Extension Period | 0.93 units of insulin per kg per day | Standard Deviation 0.25 |
| Control Group | Total Daily Insulin (TDI) (Units/kg/Day) Over 12 Week Trial Extension Period | 1.04 units of insulin per kg per day | Standard Deviation 0.34 |
Other Pre-specified
Total Daily Insulin (Units/kg/Day) Over 16 Weeks
Total Daily Insulin (Units/kg/day) over 16 weeks. Total daily insulin dose is calculated as the sum of all insulin doses delivered by the insulin delivery system divided by the weight of the participant in kilograms and the actual duration of the treatment period in days.
Time frame: From randomization to data collection completion at the end of 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | Total Daily Insulin (Units/kg/Day) Over 16 Weeks | 0.94 units of insulin per kg per day | Standard Deviation 0.25 |
| Control Group | Total Daily Insulin (Units/kg/Day) Over 16 Weeks | 0.98 units of insulin per kg per day | Standard Deviation 0.32 |
Other Pre-specified
Weight at 16 Weeks
Participant Weight in kg measured at 16 weeks
Time frame: At data collection completion at the end of 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | Weight at 16 Weeks | 46 Kg | Standard Deviation 14 |
| Control Group | Weight at 16 Weeks | 45 Kg | Standard Deviation 20 |