Type 1 Diabetes Mellitus
Conditions
Keywords
Artificial Pancreas (AP), Type 1 Diabetes Mellitus, Insulin Pump, Continuous Glucose Monitor (CGM), Closed Loop Control (CLC), Sensor-Augmented Pump (SAP)
Brief summary
This is a 3-month extension study (DCLP3 Extension) following a primary trial (DCLP3 or NCT03563313) to assess efficacy and safety of a closed loop system (t:slim X2 with Control-IQ Technology) in a large randomized controlled trial. Upon completion of the NIH 3-month extension study, subjects will be invited to participate in a continued use phase with Control-IQ Technology, funded by Tandem Diabetes Care, until the equipment has received FDA approval for commercial use.
Detailed description
Participants in the 6 month primary trial (DCLP3) will be invited to continue in this 3-month extension study (DCLP3 Extension) following completion of the primary trial. The closed-loop control (CLC) Intervention Group participants from the primary trial will be randomly assigned to continue CLC or to switch to Predictive Low-Glucose Suspend (PLGS) therapy with t:slim X2 with Basal-IQ and Dexcom G6 for 3 months. The Sensor-Augmented Pump (SAP) Control Group participants from the primary trial will be assigned to CLC using t:slim X2 with Control-IQ Technology and Dexcom G6 (CGM) for 3 months. Upon completion of the extension study, subjects will be invited to participate in continued use of the Control-IQ Technology until the equipment has received FDA approval for commercial use. This extension phase has two separate objectives: Objective 1: Among participants who used CLC in the primary trial: the primary efficacy outcome for the randomized controlled trial (RCT) is time in target range 70-180 mg/dL measured by CGM in CLC group vs. PLGS group over 3 months. Safety outcomes also will be assessed Objective 2: Among participants who used SAP in the primary trial: the primary outcome is to obtain additional safety data. Efficacy also will be assessed as a pre-post within participant analysis Note: Primary Trial (DCLP3) is NCT03563313
Interventions
Participants will use the Tandem t:slim X2 insulin pump with Control-IQ Technology & Dexcom G6 CGM for 3 months.
DEVICEt:slim X2 with Basal-IQ & Dexcom G6 CGM
Participants will use a Tandem t:slim X2 insulin pump with Basal-IQ and a study CGM (Dexcom G6) for 3 months.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Jaeb Center for Health Research
Tandem Diabetes Care, Inc.
DexCom, Inc.
Roche Diagnostics GmbH
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
A randomized controlled trial of 3 months at home closed loop system vs. predictive-low glucose suspend.
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Successful completion of the original 6-month RCT within the prior 14 days 2. 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 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. 3. For participants \<18 years old, living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact the participant in case of an emergency. 4. Willingness to not use a personal CGM for the duration of the study 5. Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol 6. Willingness to use only lispro (Humalog) or aspart (Novolog), and to use no other insulin during the study. 7. Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial
Exclusion criteria
1. Concurrent use of any non-insulin glucose-lowering agent other than metformin (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 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 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., Dexcom, Inc., or TypeZero Technologies, LLC, 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 |
|---|---|---|
| Time in Target Range | 13 weeks | The primary exploratory outcome is time in target range 70-180 mg/dL measured by CGM comparing the randomized groups CLC vs PLGS. Results from SAP to CLC group is also included here without the primary intention of comparing to CLC vs PLGS groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| INSPIRE Survey Scores- Adults | 13 weeks | The INSPIRE questionnaire assesses user expectations and experiences with Insulin Delivery Systems: Perceptions, Ideas, Reflections, Expectations (INSPIRE). Survey total scores are computed by calculating the mean of the sum of all item ratings then multiplying the mean by 25 to scale the score to a range from 0 to 100. Higher scores indicate a more positive perception of insulin delivery systems. Items are rated on a 5 point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree). The Adult survey has 22 items. |
| CGM Time Above 180 | 13 weeks | CGM-measured % above 180 mg/dL |
| CGM Mean Glucose | 13 weeks | CGM-measured mean glucose |
| CGM Time Below 70 | 13 weeks | CGM-measured % below 70 mg/dL |
| CGM Time Below 54 | 13 weeks | CGM-measured % below 54 mg/dL |
| CGM Time in Range 70-140 mg/dL | 13 weeks | CGM-measured % in range 70-140 mg/dL |
| Coefficient of Variation | 13 weeks | CGM measured glucose variability measured with the coefficient of variation (CV) |
| Standard Deviation | 13 weeks | CGM measured glucose variability measured with the standard deviation (SD) |
| CGM Time Below 60 | 13 weeks | CGM-measured % below 60 mg/dL |
| HbA1c Relative Change From Baseline to 13 Weeks >10% | 13 weeks | HbA1c relative change from baseline to 13 weeks \>10%. |
| HbA1c Change From Baseline to 13 Weeks >1.0% or HbA1C <7.0% at 13 Weeks | 13 weeks | HbA1c change from baseline to 13 weeks \>1.0% or HbA1c \<7.0% at 13 weeks. |
| LBGI | 13 weeks | Low blood glucose index by CGM with higher index indicating higher risk of hypoglycemia. Values \<1 suggest minimal risk. Index of risk of low blood glucose excursion based on a standard formula for non-linear transformation of the blood glucose scale (Kovatchev BP, Cox DJ, Gonder-Frederick LA, Young-Hyman D, Schlundt D, Clarke WL: Assessment of risk for severe hypoglycemia among adults with IDDM: validation of the low blood glucose index. Diabetes Care 21:1870-1875, 1998) |
| CGM Hypoglycemia Events | 13 weeks | CGM-measured events of at least 15 consecutive minutes \<70 mg/dL |
| CGM Time >250 | 13 weeks | CGM-measured % \>250 mg/dL |
| CGM Time >300 | 13 weeks | CGM-measured % \>300 mg/dL |
| HBGI | 13 weeks | High blood glucose index by CGM with higher values indicating higher risk of hyperglycemia. Index of risk of high blood glucose excursion based on a standard formula for non-linear transformation of the blood glucose scale (Kovatchev BP, Cox DJ, Kumar A, Gonder-Frederick L, Clarke WL. Algorithmic evaluation of metabolic control and risk of severe hypoglycemia in type 1 and type 2 diabetes using self-monitoring blood glucose data. Diabetes Technol Ther 2003;5:817-828pmid:14633347) |
| HbA1c at 13 Weeks | 13 weeks | HbA1c at 13 weeks. |
| HbA1c <7.0% at 13 Weeks | 13 weeks | HbA1c \<7.0% at 13 weeks. |
| HbA1c <7.5% at 13 Weeks | 13 weeks | HbA1c \<7.5% at 13 weeks. |
| HbA1c Change From Baseline to 13 Weeks >0.5% | 13 weeks | HbA1c change from baseline to 13 weeks \>0.5%. |
| HbA1c Change From Baseline to 13 Weeks >1.0% | 13 weeks | HbA1c change from baseline to 13 weeks \>1.0%. |
| HFS-II Adult | 13 weeks | Fear of Hypoglycemia Survey (HFS-II) total score and 3 sub scales (5 point scale with never to almost always) For adults, teens and parents items on this survey are rated on a 5 point Likert scale from never (0) to almost always (4). The survey is scored by summing item responses. Fear of Hypoglycemia Survey (HFS-II) for adults has a total score that is summed from the two subscale scores (33 items) and ranges from 0 to 132 with higher scores indicating greater degrees of fear of hypoglycemia. |
| HFS-II Teen | 13 weeks | Fear of Hypoglycemia Survey (HFS-II) total score and 3 sub scales (5 point scale with never to almost always) For adults, teens and parents items on this survey are rated on a 5 point Likert scale from never (0) to almost always (4). The survey is scored by summing item responses.The teen survey has a total of 25 items and the range of Total scores is 0 to 100. |
| HFS-II Parents | 13 weeks | Fear of Hypoglycemia Survey (HFS-II) total score and 3 sub scales (5 point scale with never to almost always) For adults, teens and parents items on this survey are rated on a 5 point Likert scale from never (0) to almost always (4). The parent version of the survey has a total of 26 items with Total scores that range from 0 to 108. |
| Hyperglycemia Avoidance Scale | 13 weeks | Hyperglycemia Avoidance Scale total score is the sum of 21 items rated on a 4 point Likert scale from 0 (never) to 4 (almost always) and ranges from 0 to 84 with a higher score indicating greater degrees of avoiding hyperglycemia. |
| Diabetes Distress Scale | 13 weeks | Diabetes Distress Scale for adults has 28 items rated on a 6 point Likert scale that ranges from 1 (not a problem) to 6 (a very serious problem). The total score is the mean of the sum of responses and ranges from 1 to 6 where a higher score indicates greater degrees of diabetes distress. |
| Hypoglycemia Confidence Scale | 13 weeks | Hypoglycemia Confidence Scale has 9 items which are self-rated on a 4-point Likert Scale ranging from 1 (not confident at all) to 4 (very confident) with higher scores indicating higher confidence in dealing with hypoglycemia. A single score is computed by calculating the mean of the sum of all items and ranges from 1 to 4. |
| Clarke Hypoglycemia Awareness Scores | 13 weeks | Clarke Hypoglycemia Awareness Scores (0-7 score with higher scores associated with impaired awareness) |
| BMI | 13 weeks | Body Mass Index (BMI) kg/m2 |
| INSPIRE Survey Scores- Teens | 13 weeks | The INSPIRE questionnaire assesses user expectations and experiences with Insulin Delivery Systems: Perceptions, Ideas, Reflections, Expectations (INSPIRE). Survey total scores are computed by calculating the mean of the sum of all item ratings then multiplying the mean by 25 to scale the score to a range from 0 to 100. Higher scores indicate a more positive perception of insulin delivery systems. Items are rated on a 5 point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree). The Teens/Adolescents survey has 17 items. |
| INSPIRE Survey Scores- Parents | 13 weeks | The INSPIRE questionnaire assesses user expectations and experiences with Insulin Delivery Systems: Perceptions, Ideas, Reflections, Expectations (INSPIRE). Survey total scores are computed by calculating the mean of the sum of all item ratings then multiplying the mean by 25 to scale the score to a range from 0 to 100. Higher scores indicate a more positive perception of insulin delivery systems. Items are rated on a 5 point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree). The Parent survey has 21 items. |
| System Usability Scores (SUS) | 13 weeks | System Usability Scores (SUS)-composite score from 0 to 100 with higher scores indicating better perceived usability |
| Technology Acceptance Questionnaire | 13 weeks | Technology Acceptance Survey measures the user's perceptions regarding the burdens and the barriers associated with a technology with a higher score indicates increased technology acceptance. There total score uses 37 items with items are rated on a 5 point scale ranging from 1 (strongly disagree) to 5 (strongly agree) for total score range of 37-185. |
| Total Daily Insulin | 13 weeks | Total Daily Insulin (units/kg) |
| Basal:Bolus Insulin Ratio | 13 weeks | Basal:Bolus Insulin Ratio. |
| Weight | 13 weeks | Weight (kg) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Ketone Events Defined as Day With Ketone Level >1.0 mmol/L | 13 weeks | Ketone events defined as day with ketone level \> 1.0 mmol/L |
| CGM-measured Hyperglycemic Events (>15 Minutes With Glucose Concentration >300 mg/dL) | 13 weeks | CGM-measured hyperglycemic events (\>15 minutes with glucose concentration \>300 mg/dL). |
| Worsening of HbA1c From Randomization to 13 Weeks by >0.5% | 13 weeks | Worsening of HbA1c from randomization to 13 weeks by \>0.5%. |
| Serious Adverse Events With a Possible or Greater Relationship to a Study Device (Including Anticipated and Unanticipated Adverse Device Effects) | 13 weeks | Serious adverse events with a possible or greater relationship to a study device (including anticipated and unanticipated adverse device effects). |
| Adverse Device Effects (ADE) That do Not Meet Criteria for SAE | 13 weeks | Adverse device effects (ADE) that do not meet criteria for SAE. |
| Other Serious Adverse Events Not Related to a Study Device | 13 weeks | Other serious adverse events not related to a study device. |
| Severe Hypoglycemic Events | 13 weeks | Number of Severe Hypoglycemic events over initial 13 weeks of trial |
| Severe Hypoglycemic Event Rate Per 100 Person-years | 13 weeks | Number of severe hypoglycemic events per 100 person-years over initial 13 weeks of trial |
| Diabetic Ketoacidosis (DKA) Events | 13 weeks | Number of DKA events over initial 13 weeks of trial |
| Diabetic Ketoacidosis (DKA) Event Rate Per 100 Person-years | 13 weeks | Number of DKA events per 100 person-years over initial 13 weeks |
| Any Adverse Event Rate Per 100 Person-years | 13 weeks | Number of adverse events per 100 person-years over initial 13 weeks |
| Time in Target Range From Months 4-12 | Months 4-12 | CGM time in target range 70-180mg/dL for all participants using CLC from Months 4-12. |
| CGM Time Above 180 From Months 4-12 | Months 4-12 | CGM-measured % above 180mg/dL from Months 4-12 |
| CGM Mean Glucose From Months 4-12 | Months 4-12 | CGM-measured mean glucose from Months 4-12 |
| CGM Time Below 70 From Months 4-12 | Months 4-12 | CGM-measured % below 70 mg/dL from Months 4-12 |
| CGM Time Below 54 From Months 4-12 | Months 4-12 | CGM-measured % time below 54mg/dL from Months 4-12 |
| CGM Time in Range 70-140 mg/dL From Months 4-12 | Months 4-12 | CGM-measured % time in range 70-140mg/dL from Months 4-12 |
| Coefficient of Variation From Months 4-12 | Months 4-12 | CGM measured glucose variability measured with the coefficient of variation from Months 4-12 |
| Standard Deviation From Months 4-12 | Months 4-12 | CGM measured glucose variability measured with the standard deviation (SD) from Months 4-12 |
| CGM Time Below 60 From Months 4-12 | Months 4-12 | CGM-measured % below 60mg/dL from Months 4-12 |
| LBGI From Months 4-12 | Months 4-12 | LBGI from Months 4-12. Low blood glucose index by CGM with higher index indicating higher risk of hypoglycemia. Values \<1 suggest minimal risk. Index of risk of low blood glucose excursion based on a standard formula for non-linear transformation of the blood glucose scale (Kovatchev BP, Cox DJ, Gonder-Frederick LA, Young-Hyman D, Schlundt D, Clarke WL: Assessment of risk for severe hypoglycemia among adults with IDDM: validation of the low blood glucose index. Diabetes Care 21:1870-1875, 1998) |
| HBGI From Months 4-12 | Months 4-12 | HBGI from Months 4-12. High blood glucose index by CGM with higher values indicating higher risk of hyperglycemia. Index of risk of high blood glucose excursion based on a standard formula for non-linear transformation of the blood glucose scale (Kovatchev BP, Cox DJ, Kumar A, Gonder-Frederick L, Clarke WL. Algorithmic evaluation of metabolic control and risk of severe hypoglycemia in type 1 and type 2 diabetes using self-monitoring blood glucose data. Diabetes Technol Ther 2003;5:817-828pmid:14633347) |
| CGM Hypoglycemia Events From Months 4-12 | Months 4-12 | CGM-measured events of at least 15 consecutive minutes \<70mg/dL from Months 4-12 |
| CGM Time >250 From Months 4-12 | Months 4-12 | CGM-measured % time \>250 mg/dL from Months 4-12 |
| CGM Time >300 From Months 4-12 | Months 4-12 | CGM-measured % time \>300 mg/dL from Months 4-12 |
| HbA1c at Month 6 | Month 6 of study | HbA1c measured at Month 6 of this extension study |
| HbA1c at Month 9 | Month 9 of study | HbA1c measured at month 9 of this extension study |
| HbA1c at Month 12 | Month 12 of study | HbA1c measured at Month 12 of this extension study |
| Ketone Events Defined as Days With Ketone Level >1.0 mmol/L From Months 4-12 | Months 4-12 | Ketone Events Defined as Number of Days with at least one Ketone Level \>1.0 mmol/L from Months 4-12 |
| CGM-measured Hypoglycemia Events (>15 Minutes With Glucose Concentration <54mg/dL) From Months 4-12 | Months 4-12 | CGM-measured Hypoglycemia Events (\>15 minutes with glucose concentration \<54mg/dL) from Months 4-12 measured as a rate per week. |
| CGM-measured Hyperglycemic Events From Months 4-12 | Months 4-12 | CGM-measured Hyperglycemic Events (\>15 consecutive minutes with CGM glucose \>300mg/dL) from Months 4-12 |
| Number of Severe Hypoglycemic Events From Months 4-12 | Months 4-12 | Number of Severe Hypoglycemic Events from Months 4-12. |
| Number of Diabetic Ketoacidosis (DKA) Events From Months 4-12 | Months 4-12 | Number of Diabetic Ketoacidosis (DKA) events from Months 4-12. |
| Other Serious Adverse Events Not Related to a Study Device From Months 4-12 | Months 4-12 | Other Serious Adverse Events Not Related to a Study Device from Months 4-12. |
| Any Adverse Event Rate Per 100 Person-years From Months 4-12 | Months 4-12 | Any Adverse Event Rate per 100 person-years from Months 4-12. |
| CGM-measured Hypoglycemic Events (>15 Minutes With Glucose Concentration <54 mg/dL) | 13 weeks | CGM-measured hypoglycemic events (\>15 minutes with glucose concentration \<54 mg/dL). |
Countries
United States
Participant flow
Recruitment details
Objective 1 (Primary): Participants with 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial) were randomized to either CLC or PLGS with outcomes evaluated during the 3 mo extension. Objective 2: Participants with 6 mos of SAP in the primary trial (DCLP3 Pivotal Trial) were then transitioned to CLC during the 3-mo extension. Objective 3: All participants who completed the initial 3 mos of the extension trial continued use of CLC until the system was commercially available.
Participants by arm
| Arm | Count |
|---|---|
| Closed Loop Control (CLC) Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will continue to use CLC through commercial availability of the device after completion of the 3 months extension (Objective 3 of the trial). | 54 |
| Predictive-Low Glucose Suspend (PLGS) Participants randomized to Predictive-Low Glucose Suspend (PLGS) arm will use the t:slim X2 with Basal-IQ & Dexcom G6 CGM for 3 months. Participants in this arm had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial). Participants in this arm are analyzed as part of the Objective 1 of the trial to compare CLC vs PLGS for 3 months following the use of 6 mos of CLC in the primary trial (DCLP3 Pivotal Trial).
Participants in this arm will use CLC through commercial availability of the device after the 3 months extension (Objective 3 of the trial). | 55 |
| SAP to CLC Group Participants in this arm were transitioned to CLC (t:slim X2 with Control-IQ Technology & Dexcom G6 CGM) after the extension began. Participants in this arm had previously been randomized to Sensor-Augmented Pump (SAP) in the prior Pivotal Trial. This arm was not compared to the randomized groups CLC and PLGS that were randomized during the extension. This group met Objective 2 of the study.Participants in this arm will continue to use CLC through commercial availability of the device after the 3 months extension | 55 |
| Total | 164 |
Baseline characteristics
| Characteristic | Closed Loop Control (CLC) | Predictive-Low Glucose Suspend (PLGS) | SAP to CLC Group | Total |
|---|---|---|---|---|
| Age, Continuous | 32 years STANDARD_DEVIATION 14 | 34 years STANDARD_DEVIATION 17 | 34 years STANDARD_DEVIATION 17 | 33 years STANDARD_DEVIATION 16 |
| Annual household income >= $100,000 | 29 Participants | 26 Participants | 30 Participants | 85 Participants |
| Annual household income <$50,000 | 5 Participants | 5 Participants | 2 Participants | 12 Participants |
| Annual household income $50,000 to < $100,000 | 8 Participants | 13 Participants | 18 Participants | 39 Participants |
| Annual household income Did Not Answer | 12 Participants | 11 Participants | 5 Participants | 28 Participants |
| BMI | 26 kg/m^2 | 25 kg/m^2 | 26 kg/m^2 | 25 kg/m^2 |
| Diabetes duration | 18 years | 16 years | 16 years | 17 years |
| Highest education level Advanced degree | 19 Participants | 24 Participants | 22 Participants | 65 Participants |
| Highest education level Bachelor's degree | 26 Participants | 23 Participants | 21 Participants | 70 Participants |
| Highest education level Did Not Answer | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Highest education level Less than a bachelor's degree | 8 Participants | 8 Participants | 12 Participants | 28 Participants |
| Insurance Did Not Answer | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Insurance No Insurance | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Insurance Other Insurance | 2 Participants | 3 Participants | 4 Participants | 9 Participants |
| Insurance Private Insurance | 49 Participants | 51 Participants | 50 Participants | 150 Participants |
| Race/Ethnicity, Customized Race Did Not Answer | 1 Participants | 2 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Race Non-White | 7 Participants | 7 Participants | 3 Participants | 17 Participants |
| Race/Ethnicity, Customized Race White | 46 Participants | 46 Participants | 52 Participants | 144 Participants |
| Region of Enrollment United States | 54 participants | 55 participants | 55 participants | 164 participants |
| Sex: Female, Male Female | 28 Participants | 25 Participants | 30 Participants | 83 Participants |
| Sex: Female, Male Male | 26 Participants | 30 Participants | 25 Participants | 81 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 54 | 0 / 55 | 0 / 55 |
| other Total, other adverse events | 0 / 54 | 3 / 55 | 2 / 55 |
| serious Total, serious adverse events | 0 / 54 | 0 / 55 | 0 / 55 |
Outcome results
Primary
Time in Target Range
The primary exploratory outcome is time in target range 70-180 mg/dL measured by CGM comparing the randomized groups CLC vs PLGS. Results from SAP to CLC group is also included here without the primary intention of comparing to CLC vs PLGS groups.
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | Time in Target Range | 67.6 percentage of time in range | Standard Deviation 12.6 |
| Predictive-Low Glucose Suspend (PLGS) | Time in Target Range | 60.4 percentage of time in range | Standard Deviation 17.1 |
| SAP to CLC Group | Time in Target Range | 69 percentage of time in range | Standard Deviation 11 |
p-value: <0.001Mixed Models Analysis
Secondary
Basal:Bolus Insulin Ratio
Basal:Bolus Insulin Ratio.
Time frame: 13 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Closed Loop Control (CLC) | Basal:Bolus Insulin Ratio | Baseline | 0.9 Basal:Bolus Ratio |
| Closed Loop Control (CLC) | Basal:Bolus Insulin Ratio | At 13-week Follow Up | 1.0 Basal:Bolus Ratio |
| Predictive-Low Glucose Suspend (PLGS) | Basal:Bolus Insulin Ratio | Baseline | 0.8 Basal:Bolus Ratio |
| Predictive-Low Glucose Suspend (PLGS) | Basal:Bolus Insulin Ratio | At 13-week Follow Up | 0.9 Basal:Bolus Ratio |
| SAP to CLC Group | Basal:Bolus Insulin Ratio | Baseline | 0.88 Basal:Bolus Ratio |
| SAP to CLC Group | Basal:Bolus Insulin Ratio | At 13-week Follow Up | 0.96 Basal:Bolus Ratio |
Secondary
BMI
Body Mass Index (BMI) kg/m2
Time frame: 13 weeks
Population: Data not available in all participants
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Closed Loop Control (CLC) | BMI | Baseline | 25.7 kg/m^2 |
| Closed Loop Control (CLC) | BMI | At 13-week Follow Up | 25.6 kg/m^2 |
| Predictive-Low Glucose Suspend (PLGS) | BMI | Baseline | 25.1 kg/m^2 |
| Predictive-Low Glucose Suspend (PLGS) | BMI | At 13-week Follow Up | 25.1 kg/m^2 |
| SAP to CLC Group | BMI | Baseline | 26 kg/m^2 |
| SAP to CLC Group | BMI | At 13-week Follow Up | 26 kg/m^2 |
Secondary
CGM Hypoglycemia Events
CGM-measured events of at least 15 consecutive minutes \<70 mg/dL
Time frame: 13 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Closed Loop Control (CLC) | CGM Hypoglycemia Events | 3.0 Events per Week |
| Predictive-Low Glucose Suspend (PLGS) | CGM Hypoglycemia Events | 3.1 Events per Week |
| SAP to CLC Group | CGM Hypoglycemia Events | 3.8 Events per Week |
Secondary
CGM Mean Glucose
CGM-measured mean glucose
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | CGM Mean Glucose | 160 mg/dL | Standard Deviation 20 |
| Predictive-Low Glucose Suspend (PLGS) | CGM Mean Glucose | 170 mg/dL | Standard Deviation 30 |
| SAP to CLC Group | CGM Mean Glucose | 158 mg/dL | Standard Deviation 17 |
Secondary
CGM Time >250
CGM-measured % \>250 mg/dL
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | CGM Time >250 | 7 percentage of time | Standard Deviation 6.5 |
| Predictive-Low Glucose Suspend (PLGS) | CGM Time >250 | 13.6 percentage of time | Standard Deviation 12.4 |
| SAP to CLC Group | CGM Time >250 | 7.8 percentage of time | Standard Deviation 6.6 |
Secondary
CGM Time >300
CGM-measured % \>300 mg/dL
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | CGM Time >300 | 2.3 percentage of time | Standard Deviation 3.4 |
| Predictive-Low Glucose Suspend (PLGS) | CGM Time >300 | 5.2 percentage of time | Standard Deviation 6.3 |
| SAP to CLC Group | CGM Time >300 | 2.7 percentage of time | Standard Deviation 3.5 |
Secondary
CGM Time Above 180
CGM-measured % above 180 mg/dL
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | CGM Time Above 180 | 31 percentage of time | Standard Deviation 13 |
| Predictive-Low Glucose Suspend (PLGS) | CGM Time Above 180 | 38 percentage of time | Standard Deviation 18 |
| SAP to CLC Group | CGM Time Above 180 | 29 percentage of time | Standard Deviation 11 |
Secondary
CGM Time Below 54
CGM-measured % below 54 mg/dL
Time frame: 13 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Closed Loop Control (CLC) | CGM Time Below 54 | 0.2 percentage of time |
| Predictive-Low Glucose Suspend (PLGS) | CGM Time Below 54 | 0.22 percentage of time |
| SAP to CLC Group | CGM Time Below 54 | 0.19 percentage of time |
Secondary
CGM Time Below 60
CGM-measured % below 60 mg/dL
Time frame: 13 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Closed Loop Control (CLC) | CGM Time Below 60 | 0.43 percentage of time |
| Predictive-Low Glucose Suspend (PLGS) | CGM Time Below 60 | 0.46 percentage of time |
| SAP to CLC Group | CGM Time Below 60 | 0.51 percentage of time |
Secondary
CGM Time Below 70
CGM-measured % below 70 mg/dL
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | CGM Time Below 70 | 0.53 percentage of time | Standard Deviation 0.34 |
| Predictive-Low Glucose Suspend (PLGS) | CGM Time Below 70 | 0.59 percentage of time | Standard Deviation 0.37 |
| SAP to CLC Group | CGM Time Below 70 | 1.76 percentage of time | Standard Deviation 1.07 |
Secondary
CGM Time in Range 70-140 mg/dL
CGM-measured % in range 70-140 mg/dL
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | CGM Time in Range 70-140 mg/dL | 42 percentage of time | Standard Deviation 12.5 |
| Predictive-Low Glucose Suspend (PLGS) | CGM Time in Range 70-140 mg/dL | 37.1 percentage of time | Standard Deviation 14.2 |
| SAP to CLC Group | CGM Time in Range 70-140 mg/dL | 45 percentage of time | Standard Deviation 10 |
Secondary
Clarke Hypoglycemia Awareness Scores
Clarke Hypoglycemia Awareness Scores (0-7 score with higher scores associated with impaired awareness)
Time frame: 13 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Closed Loop Control (CLC) | Clarke Hypoglycemia Awareness Scores | 1 total score on a scale |
| Predictive-Low Glucose Suspend (PLGS) | Clarke Hypoglycemia Awareness Scores | 1 total score on a scale |
| SAP to CLC Group | Clarke Hypoglycemia Awareness Scores | 1 total score on a scale |
Secondary
Coefficient of Variation
CGM measured glucose variability measured with the coefficient of variation (CV)
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | Coefficient of Variation | 34 percentage SD of Mean | Standard Deviation 4 |
| Predictive-Low Glucose Suspend (PLGS) | Coefficient of Variation | 35 percentage SD of Mean | Standard Deviation 5 |
| SAP to CLC Group | Coefficient of Variation | 35 percentage SD of Mean | Standard Deviation 5 |
Secondary
Diabetes Distress Scale
Diabetes Distress Scale for adults has 28 items rated on a 6 point Likert scale that ranges from 1 (not a problem) to 6 (a very serious problem). The total score is the mean of the sum of responses and ranges from 1 to 6 where a higher score indicates greater degrees of diabetes distress.
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | Diabetes Distress Scale | 1.8 total score on a scale | Standard Deviation 0.7 |
| Predictive-Low Glucose Suspend (PLGS) | Diabetes Distress Scale | 1.7 total score on a scale | Standard Deviation 0.7 |
| SAP to CLC Group | Diabetes Distress Scale | 1.7 total score on a scale | Standard Deviation 0.7 |
Secondary
HbA1c <7.0% at 13 Weeks
HbA1c \<7.0% at 13 weeks.
Time frame: 13 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Closed Loop Control (CLC) | HbA1c <7.0% at 13 Weeks | 23 Participants |
| Predictive-Low Glucose Suspend (PLGS) | HbA1c <7.0% at 13 Weeks | 15 Participants |
| SAP to CLC Group | HbA1c <7.0% at 13 Weeks | 26 Participants |
Secondary
HbA1c <7.5% at 13 Weeks
HbA1c \<7.5% at 13 weeks.
Time frame: 13 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Closed Loop Control (CLC) | HbA1c <7.5% at 13 Weeks | 35 Participants |
| Predictive-Low Glucose Suspend (PLGS) | HbA1c <7.5% at 13 Weeks | 32 Participants |
| SAP to CLC Group | HbA1c <7.5% at 13 Weeks | 39 Participants |
Secondary
HbA1c at 13 Weeks
HbA1c at 13 weeks.
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | HbA1c at 13 Weeks | 7.18 % of glycated hemoglobin | Standard Deviation 0.8 |
| Predictive-Low Glucose Suspend (PLGS) | HbA1c at 13 Weeks | 7.53 % of glycated hemoglobin | Standard Deviation 1.14 |
| SAP to CLC Group | HbA1c at 13 Weeks | 7.09 % of glycated hemoglobin | Standard Deviation 0.74 |
Secondary
HbA1c Change From Baseline to 13 Weeks >0.5%
HbA1c change from baseline to 13 weeks \>0.5%.
Time frame: 13 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Closed Loop Control (CLC) | HbA1c Change From Baseline to 13 Weeks >0.5% | 1 Participants |
| Predictive-Low Glucose Suspend (PLGS) | HbA1c Change From Baseline to 13 Weeks >0.5% | 2 Participants |
| SAP to CLC Group | HbA1c Change From Baseline to 13 Weeks >0.5% | 14 Participants |
Secondary
HbA1c Change From Baseline to 13 Weeks >1.0%
HbA1c change from baseline to 13 weeks \>1.0%.
Time frame: 13 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Closed Loop Control (CLC) | HbA1c Change From Baseline to 13 Weeks >1.0% | 0 Participants |
| Predictive-Low Glucose Suspend (PLGS) | HbA1c Change From Baseline to 13 Weeks >1.0% | 0 Participants |
| SAP to CLC Group | HbA1c Change From Baseline to 13 Weeks >1.0% | 5 Participants |
Secondary
HbA1c Change From Baseline to 13 Weeks >1.0% or HbA1C <7.0% at 13 Weeks
HbA1c change from baseline to 13 weeks \>1.0% or HbA1c \<7.0% at 13 weeks.
Time frame: 13 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Closed Loop Control (CLC) | HbA1c Change From Baseline to 13 Weeks >1.0% or HbA1C <7.0% at 13 Weeks | 23 Participants |
| Predictive-Low Glucose Suspend (PLGS) | HbA1c Change From Baseline to 13 Weeks >1.0% or HbA1C <7.0% at 13 Weeks | 15 Participants |
| SAP to CLC Group | HbA1c Change From Baseline to 13 Weeks >1.0% or HbA1C <7.0% at 13 Weeks | 30 Participants |
Secondary
HbA1c Relative Change From Baseline to 13 Weeks >10%
HbA1c relative change from baseline to 13 weeks \>10%.
Time frame: 13 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Closed Loop Control (CLC) | HbA1c Relative Change From Baseline to 13 Weeks >10% | 0 Participants |
| Predictive-Low Glucose Suspend (PLGS) | HbA1c Relative Change From Baseline to 13 Weeks >10% | 0 Participants |
| SAP to CLC Group | HbA1c Relative Change From Baseline to 13 Weeks >10% | 8 Participants |
Secondary
HBGI
High blood glucose index by CGM with higher values indicating higher risk of hyperglycemia. Index of risk of high blood glucose excursion based on a standard formula for non-linear transformation of the blood glucose scale (Kovatchev BP, Cox DJ, Kumar A, Gonder-Frederick L, Clarke WL. Algorithmic evaluation of metabolic control and risk of severe hypoglycemia in type 1 and type 2 diabetes using self-monitoring blood glucose data. Diabetes Technol Ther 2003;5:817-828pmid:14633347)
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | HBGI | 6.4 index | Standard Deviation 3.1 |
| Predictive-Low Glucose Suspend (PLGS) | HBGI | 9.2 index | Standard Deviation 5.3 |
| SAP to CLC Group | HBGI | 6.6 index | Standard Deviation 3 |
Secondary
HFS-II Adult
Fear of Hypoglycemia Survey (HFS-II) total score and 3 sub scales (5 point scale with never to almost always) For adults, teens and parents items on this survey are rated on a 5 point Likert scale from never (0) to almost always (4). The survey is scored by summing item responses. Fear of Hypoglycemia Survey (HFS-II) for adults has a total score that is summed from the two subscale scores (33 items) and ranges from 0 to 132 with higher scores indicating greater degrees of fear of hypoglycemia.
Time frame: 13 weeks
Population: Adults
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | HFS-II Adult | 29 total score on a scale | Standard Deviation 11 |
| Predictive-Low Glucose Suspend (PLGS) | HFS-II Adult | 35 total score on a scale | Standard Deviation 16 |
| SAP to CLC Group | HFS-II Adult | 33 total score on a scale | Standard Deviation 14 |
Secondary
HFS-II Parents
Fear of Hypoglycemia Survey (HFS-II) total score and 3 sub scales (5 point scale with never to almost always) For adults, teens and parents items on this survey are rated on a 5 point Likert scale from never (0) to almost always (4). The parent version of the survey has a total of 26 items with Total scores that range from 0 to 108.
Time frame: 13 weeks
Population: Parent
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | HFS-II Parents | 35 total score on a scale | Standard Deviation 12 |
| Predictive-Low Glucose Suspend (PLGS) | HFS-II Parents | 40 total score on a scale | Standard Deviation 18 |
| SAP to CLC Group | HFS-II Parents | 37 total score on a scale | Standard Deviation 14 |
Secondary
HFS-II Teen
Fear of Hypoglycemia Survey (HFS-II) total score and 3 sub scales (5 point scale with never to almost always) For adults, teens and parents items on this survey are rated on a 5 point Likert scale from never (0) to almost always (4). The survey is scored by summing item responses.The teen survey has a total of 25 items and the range of Total scores is 0 to 100.
Time frame: 13 weeks
Population: Teens
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | HFS-II Teen | 35 total score on a scale | Standard Deviation 9 |
| Predictive-Low Glucose Suspend (PLGS) | HFS-II Teen | 30 total score on a scale | Standard Deviation 12 |
| SAP to CLC Group | HFS-II Teen | 30 total score on a scale | Standard Deviation 13 |
Secondary
Hyperglycemia Avoidance Scale
Hyperglycemia Avoidance Scale total score is the sum of 21 items rated on a 4 point Likert scale from 0 (never) to 4 (almost always) and ranges from 0 to 84 with a higher score indicating greater degrees of avoiding hyperglycemia.
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | Hyperglycemia Avoidance Scale | 37 total score on a scale | Standard Deviation 9 |
| Predictive-Low Glucose Suspend (PLGS) | Hyperglycemia Avoidance Scale | 37 total score on a scale | Standard Deviation 11 |
| SAP to CLC Group | Hyperglycemia Avoidance Scale | 36 total score on a scale | Standard Deviation 10 |
Secondary
Hypoglycemia Confidence Scale
Hypoglycemia Confidence Scale has 9 items which are self-rated on a 4-point Likert Scale ranging from 1 (not confident at all) to 4 (very confident) with higher scores indicating higher confidence in dealing with hypoglycemia. A single score is computed by calculating the mean of the sum of all items and ranges from 1 to 4.
Time frame: 13 weeks
Population: Reporting first item on the scale: exercise
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Closed Loop Control (CLC) | Hypoglycemia Confidence Scale | 2.0 score on a scale |
| Predictive-Low Glucose Suspend (PLGS) | Hypoglycemia Confidence Scale | 2.1 score on a scale |
| SAP to CLC Group | Hypoglycemia Confidence Scale | 1.9 score on a scale |
Secondary
INSPIRE Survey Scores- Adults
The INSPIRE questionnaire assesses user expectations and experiences with Insulin Delivery Systems: Perceptions, Ideas, Reflections, Expectations (INSPIRE). Survey total scores are computed by calculating the mean of the sum of all item ratings then multiplying the mean by 25 to scale the score to a range from 0 to 100. Higher scores indicate a more positive perception of insulin delivery systems. Items are rated on a 5 point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree). The Adult survey has 22 items.
Time frame: 13 weeks
Population: Adults
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | INSPIRE Survey Scores- Adults | 87 total score on a scale | Standard Deviation 13 |
| Predictive-Low Glucose Suspend (PLGS) | INSPIRE Survey Scores- Adults | 87 total score on a scale | Standard Deviation 13 |
| SAP to CLC Group | INSPIRE Survey Scores- Adults | 84 total score on a scale | Standard Deviation 17 |
Secondary
INSPIRE Survey Scores- Parents
The INSPIRE questionnaire assesses user expectations and experiences with Insulin Delivery Systems: Perceptions, Ideas, Reflections, Expectations (INSPIRE). Survey total scores are computed by calculating the mean of the sum of all item ratings then multiplying the mean by 25 to scale the score to a range from 0 to 100. Higher scores indicate a more positive perception of insulin delivery systems. Items are rated on a 5 point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree). The Parent survey has 21 items.
Time frame: 13 weeks
Population: Parent.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | INSPIRE Survey Scores- Parents | 86 total score on a scale | Standard Deviation 17 |
| Predictive-Low Glucose Suspend (PLGS) | INSPIRE Survey Scores- Parents | 87 total score on a scale | Standard Deviation 13 |
| SAP to CLC Group | INSPIRE Survey Scores- Parents | 86 total score on a scale | Standard Deviation 11 |
Secondary
INSPIRE Survey Scores- Teens
The INSPIRE questionnaire assesses user expectations and experiences with Insulin Delivery Systems: Perceptions, Ideas, Reflections, Expectations (INSPIRE). Survey total scores are computed by calculating the mean of the sum of all item ratings then multiplying the mean by 25 to scale the score to a range from 0 to 100. Higher scores indicate a more positive perception of insulin delivery systems. Items are rated on a 5 point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree). The Teens/Adolescents survey has 17 items.
Time frame: 13 weeks
Population: Teens
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | INSPIRE Survey Scores- Teens | 80 total score on a scale | Standard Deviation 16 |
| Predictive-Low Glucose Suspend (PLGS) | INSPIRE Survey Scores- Teens | 89 total score on a scale | Standard Deviation 15 |
| SAP to CLC Group | INSPIRE Survey Scores- Teens | 77 total score on a scale | Standard Deviation 16 |
Secondary
LBGI
Low blood glucose index by CGM with higher index indicating higher risk of hypoglycemia. Values \<1 suggest minimal risk. Index of risk of low blood glucose excursion based on a standard formula for non-linear transformation of the blood glucose scale (Kovatchev BP, Cox DJ, Gonder-Frederick LA, Young-Hyman D, Schlundt D, Clarke WL: Assessment of risk for severe hypoglycemia among adults with IDDM: validation of the low blood glucose index. Diabetes Care 21:1870-1875, 1998)
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | LBGI | 0.53 index | Standard Deviation 0.34 |
| Predictive-Low Glucose Suspend (PLGS) | LBGI | 0.59 index | Standard Deviation 0.37 |
| SAP to CLC Group | LBGI | 0.54 index | Standard Deviation 0.24 |
Secondary
Standard Deviation
CGM measured glucose variability measured with the standard deviation (SD)
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | Standard Deviation | 55 mg/dL | Standard Deviation 12 |
| Predictive-Low Glucose Suspend (PLGS) | Standard Deviation | 60 mg/dL | Standard Deviation 15 |
| SAP to CLC Group | Standard Deviation | 56 mg/dL | Standard Deviation 12 |
Secondary
System Usability Scores (SUS)
System Usability Scores (SUS)-composite score from 0 to 100 with higher scores indicating better perceived usability
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | System Usability Scores (SUS) | 85 total score on a scale | Standard Deviation 12.3 |
| Predictive-Low Glucose Suspend (PLGS) | System Usability Scores (SUS) | 86.6 total score on a scale | Standard Deviation 11.3 |
| SAP to CLC Group | System Usability Scores (SUS) | 85.2 total score on a scale | Standard Deviation 16.9 |
Secondary
Technology Acceptance Questionnaire
Technology Acceptance Survey measures the user's perceptions regarding the burdens and the barriers associated with a technology with a higher score indicates increased technology acceptance. There total score uses 37 items with items are rated on a 5 point scale ranging from 1 (strongly disagree) to 5 (strongly agree) for total score range of 37-185.
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | Technology Acceptance Questionnaire | 151 total score on a scale | Standard Deviation 17 |
| Predictive-Low Glucose Suspend (PLGS) | Technology Acceptance Questionnaire | 149 total score on a scale | Standard Deviation 25 |
| SAP to CLC Group | Technology Acceptance Questionnaire | 145 total score on a scale | Standard Deviation 28 |
Secondary
Total Daily Insulin
Total Daily Insulin (units/kg)
Time frame: 13 weeks
Population: Data not available in all participants
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Closed Loop Control (CLC) | Total Daily Insulin | Baseline | 0.59 Units of insulin per kg |
| Closed Loop Control (CLC) | Total Daily Insulin | At 13-week Follow Up | 0.62 Units of insulin per kg |
| Predictive-Low Glucose Suspend (PLGS) | Total Daily Insulin | Baseline | 0.68 Units of insulin per kg |
| Predictive-Low Glucose Suspend (PLGS) | Total Daily Insulin | At 13-week Follow Up | 0.67 Units of insulin per kg |
| SAP to CLC Group | Total Daily Insulin | Baseline | 0.62 Units of insulin per kg |
| SAP to CLC Group | Total Daily Insulin | At 13-week Follow Up | 0.64 Units of insulin per kg |
Secondary
Weight
Weight (kg)
Time frame: 13 weeks
Population: Data not available in all participants.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Closed Loop Control (CLC) | Weight | Baseline | 77.2 kg |
| Closed Loop Control (CLC) | Weight | At 13-week Follow Up | 79.2 kg |
| Predictive-Low Glucose Suspend (PLGS) | Weight | Baseline | 73.0 kg |
| Predictive-Low Glucose Suspend (PLGS) | Weight | At 13-week Follow Up | 72.8 kg |
| SAP to CLC Group | Weight | Baseline | 74 kg |
| SAP to CLC Group | Weight | At 13-week Follow Up | 75 kg |
Other Pre-specified
Adverse Device Effects (ADE) That do Not Meet Criteria for SAE
Adverse device effects (ADE) that do not meet criteria for SAE.
Time frame: 13 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Closed Loop Control (CLC) | Adverse Device Effects (ADE) That do Not Meet Criteria for SAE | 0 Events |
| Predictive-Low Glucose Suspend (PLGS) | Adverse Device Effects (ADE) That do Not Meet Criteria for SAE | 0 Events |
| SAP to CLC Group | Adverse Device Effects (ADE) That do Not Meet Criteria for SAE | 0 Events |
Other Pre-specified
Any Adverse Event Rate Per 100 Person-years
Number of adverse events per 100 person-years over initial 13 weeks
Time frame: 13 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Closed Loop Control (CLC) | Any Adverse Event Rate Per 100 Person-years | 0 Events per 100 person-years |
| Predictive-Low Glucose Suspend (PLGS) | Any Adverse Event Rate Per 100 Person-years | 22.2 Events per 100 person-years |
| SAP to CLC Group | Any Adverse Event Rate Per 100 Person-years | 14.6 Events per 100 person-years |
Other Pre-specified
Any Adverse Event Rate Per 100 Person-years From Months 4-12
Any Adverse Event Rate per 100 person-years from Months 4-12.
Time frame: Months 4-12
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Closed Loop Control (CLC) | Any Adverse Event Rate Per 100 Person-years From Months 4-12 | 39 events rate per 100 person-years |
Other Pre-specified
CGM Hypoglycemia Events From Months 4-12
CGM-measured events of at least 15 consecutive minutes \<70mg/dL from Months 4-12
Time frame: Months 4-12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | CGM Hypoglycemia Events From Months 4-12 | 2.9 Events per Week | Standard Deviation 1.9 |
Other Pre-specified
CGM Mean Glucose From Months 4-12
CGM-measured mean glucose from Months 4-12
Time frame: Months 4-12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | CGM Mean Glucose From Months 4-12 | 161 mg/dL | Standard Deviation 21 |
Other Pre-specified
CGM-measured Hyperglycemic Events (>15 Minutes With Glucose Concentration >300 mg/dL)
CGM-measured hyperglycemic events (\>15 minutes with glucose concentration \>300 mg/dL).
Time frame: 13 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Closed Loop Control (CLC) | CGM-measured Hyperglycemic Events (>15 Minutes With Glucose Concentration >300 mg/dL) | 1.6 Event Rate per Week |
| Predictive-Low Glucose Suspend (PLGS) | CGM-measured Hyperglycemic Events (>15 Minutes With Glucose Concentration >300 mg/dL) | 2.3 Event Rate per Week |
| SAP to CLC Group | CGM-measured Hyperglycemic Events (>15 Minutes With Glucose Concentration >300 mg/dL) | 1.0 Event Rate per Week |
Other Pre-specified
CGM-measured Hyperglycemic Events From Months 4-12
CGM-measured Hyperglycemic Events (\>15 consecutive minutes with CGM glucose \>300mg/dL) from Months 4-12
Time frame: Months 4-12
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Closed Loop Control (CLC) | CGM-measured Hyperglycemic Events From Months 4-12 | 1.5 Event rate per week |
Other Pre-specified
CGM-measured Hypoglycemia Events (>15 Minutes With Glucose Concentration <54mg/dL) From Months 4-12
CGM-measured Hypoglycemia Events (\>15 minutes with glucose concentration \<54mg/dL) from Months 4-12 measured as a rate per week.
Time frame: Months 4-12
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Closed Loop Control (CLC) | CGM-measured Hypoglycemia Events (>15 Minutes With Glucose Concentration <54mg/dL) From Months 4-12 | 0.3 Events per Week |
Other Pre-specified
CGM-measured Hypoglycemic Events (>15 Minutes With Glucose Concentration <54 mg/dL)
CGM-measured hypoglycemic events (\>15 minutes with glucose concentration \<54 mg/dL).
Time frame: 13 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Closed Loop Control (CLC) | CGM-measured Hypoglycemic Events (>15 Minutes With Glucose Concentration <54 mg/dL) | 0.4 event rate per week |
| Predictive-Low Glucose Suspend (PLGS) | CGM-measured Hypoglycemic Events (>15 Minutes With Glucose Concentration <54 mg/dL) | 0.5 event rate per week |
| SAP to CLC Group | CGM-measured Hypoglycemic Events (>15 Minutes With Glucose Concentration <54 mg/dL) | 0.4 event rate per week |
Other Pre-specified
CGM Time >250 From Months 4-12
CGM-measured % time \>250 mg/dL from Months 4-12
Time frame: Months 4-12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | CGM Time >250 From Months 4-12 | 8.9 percentage of time | Standard Deviation 8.4 |
Other Pre-specified
CGM Time >300 From Months 4-12
CGM-measured % time \>300 mg/dL from Months 4-12
Time frame: Months 4-12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | CGM Time >300 From Months 4-12 | 3.5 percentage of time | Standard Deviation 5 |
Other Pre-specified
CGM Time Above 180 From Months 4-12
CGM-measured % above 180mg/dL from Months 4-12
Time frame: Months 4-12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | CGM Time Above 180 From Months 4-12 | 30 percentage of time | Standard Deviation 13 |
Other Pre-specified
CGM Time Below 54 From Months 4-12
CGM-measured % time below 54mg/dL from Months 4-12
Time frame: Months 4-12
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Closed Loop Control (CLC) | CGM Time Below 54 From Months 4-12 | 0.17 percentage of time |
Other Pre-specified
CGM Time Below 60 From Months 4-12
CGM-measured % below 60mg/dL from Months 4-12
Time frame: Months 4-12
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Closed Loop Control (CLC) | CGM Time Below 60 From Months 4-12 | 0.37 percentage of time |
Other Pre-specified
CGM Time Below 70 From Months 4-12
CGM-measured % below 70 mg/dL from Months 4-12
Time frame: Months 4-12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | CGM Time Below 70 From Months 4-12 | 1.38 percentage of time | Standard Deviation 0.98 |
Other Pre-specified
CGM Time in Range 70-140 mg/dL From Months 4-12
CGM-measured % time in range 70-140mg/dL from Months 4-12
Time frame: Months 4-12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | CGM Time in Range 70-140 mg/dL From Months 4-12 | 43.6 percentage of time | Standard Deviation 11.4 |
Other Pre-specified
Coefficient of Variation From Months 4-12
CGM measured glucose variability measured with the coefficient of variation from Months 4-12
Time frame: Months 4-12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | Coefficient of Variation From Months 4-12 | 34 percentage SD of mean | Standard Deviation 5 |
Other Pre-specified
Diabetic Ketoacidosis (DKA) Event Rate Per 100 Person-years
Number of DKA events per 100 person-years over initial 13 weeks
Time frame: 13 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Closed Loop Control (CLC) | Diabetic Ketoacidosis (DKA) Event Rate Per 100 Person-years | 0 Events per 100 person-years |
| Predictive-Low Glucose Suspend (PLGS) | Diabetic Ketoacidosis (DKA) Event Rate Per 100 Person-years | 0 Events per 100 person-years |
| SAP to CLC Group | Diabetic Ketoacidosis (DKA) Event Rate Per 100 Person-years | 0 Events per 100 person-years |
Other Pre-specified
Diabetic Ketoacidosis (DKA) Events
Number of DKA events over initial 13 weeks of trial
Time frame: 13 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Closed Loop Control (CLC) | Diabetic Ketoacidosis (DKA) Events | 0 Events |
| Predictive-Low Glucose Suspend (PLGS) | Diabetic Ketoacidosis (DKA) Events | 0 Events |
| SAP to CLC Group | Diabetic Ketoacidosis (DKA) Events | 0 Events |
Other Pre-specified
HbA1c at Month 12
HbA1c measured at Month 12 of this extension study
Time frame: Month 12 of study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | HbA1c at Month 12 | 6.92 % of glycated hemoglobin | Standard Deviation 0.74 |
Other Pre-specified
HbA1c at Month 6
HbA1c measured at Month 6 of this extension study
Time frame: Month 6 of study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | HbA1c at Month 6 | 7.04 % of glycated hemoglobin | Standard Deviation 0.76 |
Other Pre-specified
HbA1c at Month 9
HbA1c measured at month 9 of this extension study
Time frame: Month 9 of study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | HbA1c at Month 9 | 6.95 % of glycated hemoglobin | Standard Deviation 0.8 |
Other Pre-specified
HBGI From Months 4-12
HBGI from Months 4-12. High blood glucose index by CGM with higher values indicating higher risk of hyperglycemia. Index of risk of high blood glucose excursion based on a standard formula for non-linear transformation of the blood glucose scale (Kovatchev BP, Cox DJ, Kumar A, Gonder-Frederick L, Clarke WL. Algorithmic evaluation of metabolic control and risk of severe hypoglycemia in type 1 and type 2 diabetes using self-monitoring blood glucose data. Diabetes Technol Ther 2003;5:817-828pmid:14633347)
Time frame: Months 4-12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | HBGI From Months 4-12 | 7.1 index | Standard Deviation 3.8 |
Other Pre-specified
Ketone Events Defined as Days With Ketone Level >1.0 mmol/L From Months 4-12
Ketone Events Defined as Number of Days with at least one Ketone Level \>1.0 mmol/L from Months 4-12
Time frame: Months 4-12
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Closed Loop Control (CLC) | Ketone Events Defined as Days With Ketone Level >1.0 mmol/L From Months 4-12 | 38 days |
Other Pre-specified
Ketone Events Defined as Day With Ketone Level >1.0 mmol/L
Ketone events defined as day with ketone level \> 1.0 mmol/L
Time frame: 13 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Closed Loop Control (CLC) | Ketone Events Defined as Day With Ketone Level >1.0 mmol/L | 5 Participants |
| Predictive-Low Glucose Suspend (PLGS) | Ketone Events Defined as Day With Ketone Level >1.0 mmol/L | 1 Participants |
| SAP to CLC Group | Ketone Events Defined as Day With Ketone Level >1.0 mmol/L | 7 Participants |
Other Pre-specified
LBGI From Months 4-12
LBGI from Months 4-12. Low blood glucose index by CGM with higher index indicating higher risk of hypoglycemia. Values \<1 suggest minimal risk. Index of risk of low blood glucose excursion based on a standard formula for non-linear transformation of the blood glucose scale (Kovatchev BP, Cox DJ, Gonder-Frederick LA, Young-Hyman D, Schlundt D, Clarke WL: Assessment of risk for severe hypoglycemia among adults with IDDM: validation of the low blood glucose index. Diabetes Care 21:1870-1875, 1998)
Time frame: Months 4-12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | LBGI From Months 4-12 | 0.45 index | Standard Deviation 0.25 |
Other Pre-specified
Number of Diabetic Ketoacidosis (DKA) Events From Months 4-12
Number of Diabetic Ketoacidosis (DKA) events from Months 4-12.
Time frame: Months 4-12
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Closed Loop Control (CLC) | Number of Diabetic Ketoacidosis (DKA) Events From Months 4-12 | 3 events |
Other Pre-specified
Number of Severe Hypoglycemic Events From Months 4-12
Number of Severe Hypoglycemic Events from Months 4-12.
Time frame: Months 4-12
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Closed Loop Control (CLC) | Number of Severe Hypoglycemic Events From Months 4-12 | 4 events |
Other Pre-specified
Other Serious Adverse Events Not Related to a Study Device
Other serious adverse events not related to a study device.
Time frame: 13 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Closed Loop Control (CLC) | Other Serious Adverse Events Not Related to a Study Device | 0 Events |
| Predictive-Low Glucose Suspend (PLGS) | Other Serious Adverse Events Not Related to a Study Device | 0 Events |
| SAP to CLC Group | Other Serious Adverse Events Not Related to a Study Device | 0 Events |
Other Pre-specified
Other Serious Adverse Events Not Related to a Study Device From Months 4-12
Other Serious Adverse Events Not Related to a Study Device from Months 4-12.
Time frame: Months 4-12
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Closed Loop Control (CLC) | Other Serious Adverse Events Not Related to a Study Device From Months 4-12 | 4 events |
Other Pre-specified
Serious Adverse Events With a Possible or Greater Relationship to a Study Device (Including Anticipated and Unanticipated Adverse Device Effects)
Serious adverse events with a possible or greater relationship to a study device (including anticipated and unanticipated adverse device effects).
Time frame: 13 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Closed Loop Control (CLC) | Serious Adverse Events With a Possible or Greater Relationship to a Study Device (Including Anticipated and Unanticipated Adverse Device Effects) | 0 Events |
| Predictive-Low Glucose Suspend (PLGS) | Serious Adverse Events With a Possible or Greater Relationship to a Study Device (Including Anticipated and Unanticipated Adverse Device Effects) | 0 Events |
| SAP to CLC Group | Serious Adverse Events With a Possible or Greater Relationship to a Study Device (Including Anticipated and Unanticipated Adverse Device Effects) | 0 Events |
Other Pre-specified
Severe Hypoglycemic Event Rate Per 100 Person-years
Number of severe hypoglycemic events per 100 person-years over initial 13 weeks of trial
Time frame: 13 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Closed Loop Control (CLC) | Severe Hypoglycemic Event Rate Per 100 Person-years | 0 Events per 100 person-years |
| Predictive-Low Glucose Suspend (PLGS) | Severe Hypoglycemic Event Rate Per 100 Person-years | 0 Events per 100 person-years |
| SAP to CLC Group | Severe Hypoglycemic Event Rate Per 100 Person-years | 0 Events per 100 person-years |
Other Pre-specified
Severe Hypoglycemic Events
Number of Severe Hypoglycemic events over initial 13 weeks of trial
Time frame: 13 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Closed Loop Control (CLC) | Severe Hypoglycemic Events | 0 Events |
| Predictive-Low Glucose Suspend (PLGS) | Severe Hypoglycemic Events | 0 Events |
| SAP to CLC Group | Severe Hypoglycemic Events | 0 Events |
Other Pre-specified
Standard Deviation From Months 4-12
CGM measured glucose variability measured with the standard deviation (SD) from Months 4-12
Time frame: Months 4-12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | Standard Deviation From Months 4-12 | 56 mg/dL | Standard Deviation 14 |
Other Pre-specified
Time in Target Range From Months 4-12
CGM time in target range 70-180mg/dL for all participants using CLC from Months 4-12.
Time frame: Months 4-12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Closed Loop Control (CLC) | Time in Target Range From Months 4-12 | 68.8 percentage time in range | Standard Deviation 12.4 |
Other Pre-specified
Worsening of HbA1c From Randomization to 13 Weeks by >0.5%
Worsening of HbA1c from randomization to 13 weeks by \>0.5%.
Time frame: 13 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Closed Loop Control (CLC) | Worsening of HbA1c From Randomization to 13 Weeks by >0.5% | 8 Participants |
| Predictive-Low Glucose Suspend (PLGS) | Worsening of HbA1c From Randomization to 13 Weeks by >0.5% | 20 Participants |
| SAP to CLC Group | Worsening of HbA1c From Randomization to 13 Weeks by >0.5% | 3 Participants |