Type 1 Diabetes
Conditions
Keywords
Type 1 Diabetes, Closed-Loop Control (CLC), Continuous Glucose Monitoring (CGM), Artificial Pancreas (AP), Tandem t:slim Insulin Pump with Control-IQ Technology
Brief summary
This study is intended to test a Web-based Information Tool (WIT) software providing additional information regarding time in range, GMI, hypo- and hyperglycemia risks, variability tracker, daily glycemic profiles, and potential changes of insulin pump parameters, to users of a commercially available Closed-Loop Control (CLC) System (Control-IQ Technology).
Detailed description
This is a randomized two-arm crossover group trial in which both groups will use the CLC (Control-IQ) plus WIT. The difference between the two groups will be the order of the interventions. Each group will undergo screening and collection of baseline data from their personal AID system (Control-IQ) followed by randomization 1:1 into two groups. Both groups will have the same three interventions but will progress in the study in a different order allowing for crossover comparisons. The three interventions are: * Use of personal CLC system for 2 weeks * Use of personal CLC system and adding a behavioral adaptation module (BAM) for 4 weeks * Use of personal CLC system and adding the ABC which includes: BAM and PAM (which includes ATM and WST described below) for 16 weeks. The BAM will consist of modules in which information only is given to participants (e.g. time in range, Glucose Management Indicator (GMI), hyper-and hypoglycemic risks, daily glycemic profiles, and variability tracker). The PAM includes auto suggestions for titration of insulin pump parameters every two weeks (ATM) and is aided by a web simulation tool (WST) which can replay 'what if' scenarios for the participant based on various combinations of insulin pump parameter changes.
Interventions
DEVICECLC + BAM
Closed Loop Control with the Behavioral Adaption Module for 4 weeks
DEVICECLC + ABC
Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
Sponsors
Sue Brown
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Tandem Diabetes Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥18.0 and ≤70 years old at time of consent 2. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year 3. Currently using an insulin pump for at least six months 4. Currently using insulin for at least six months 5. Currently using the t:slim X2 insulin pump for at least two months 6. Currently using or anticipated to be using the t:slim X2 insulin pump with Control-IQ technology at randomization (Visit 3). 7. Using or willing to use insulin parameters such as carbohydrate ratio and correction factors consistently on their pump in order to dose insulin for meals or corrections 8. Access to internet and willingness to upload data during the study as needed 9. Willing to use an app on a smart phone during the study. 10. For females, not currently known to be pregnant or breastfeeding 11. If female, sexually active, and of childbearing potential, 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 childbearing 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. 12. Willingness to use only insulin analogs approved for use in the t:slim X2 pump such as lispro (Humalog) or as part (Novolog) and not use ultra-rapid acting insulin analogs (e.g., FiAsp) during the study 13. Total daily insulin dose (TDD) at least 10 units per day 14. Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial (including metformin (biguanides), GLP-1 receptor agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas) 15. An understanding and willingness to follow the protocol and signed informed consent
Exclusion criteria
1. Concurrent use of any non-insulin glucose-lowering agent other than metformin or GLP-1 receptor agonists following screening (including pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas) 2. A condition, which in the opinion of the investigator or designee, would put the participant at risk or interfere with the completion of the protocol. 3. History of diabetic ketoacidosis (DKA) in the 12 months prior to enrollment 4. Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment 5. Currently being treated for a seizure disorder 6. Hemophilia or any other bleeding disorder 7. Planned surgery during study duration 8. Participation in another pharmaceutical or device trial at the time of enrollment or during the study 9. Having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (e.g., 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 |
|---|---|---|
| CGM-measured Percent Time in Range 70-180 mg/dL | 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC | The primary outcome for this study is CGM-measured percent time in range 70-180 mg/dL over the last 4-week periods on CLC+ABC versus 2 weeks of the current CLC system. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CGM-measured Percent Above 180 mg/dL During the Day | 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC | A key secondary outcome is CGM-measured percent above 180mg/dL during the day comparing last 4 weeks of CLC+ABC to 2 weeks of the CLC system alone. |
| CGM-measured Percent Below 70 mg/dL During the Day | 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC | A key secondary outcome is CGM-measured percent below 70mg/dL during the day comparing last 4 weeks of CLC+ABC to 2 weeks of the CLC system alone. |
| CGM-measured Mean Glucose | 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC | A key secondary outcome is CGM-measured mean glucose comparing the last 4 weeks of CLC+ABC to 2 weeks of the CLC system alone. |
| CGM-measured Coefficient of Variation During the Day | 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC | A key secondary outcome is CGM-measured percent coefficient of variation during the day comparing last 4 weeks of CLC+ABC to 2 weeks of the CLC system alone. |
| Time in Range (70-140 mg/dL) | 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC | A key secondary outcome is CGM-measured time in range from 70-140 mg/dL comparing the last 4 weeks of CLC+ABC to 2 weeks of the CLC system alone. |
| TIR <60 mg/dL | 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC | Time below 60 mg/dL as measured by CGM. |
| Low Blood Glucose Index (LBGI) | 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC | The low blood glucose index (LBGI) is based on a nonlinear transformation of blood glucose values that corrects for the asymmetry of the glucose scale. This transformation maps glucose values into a risk space (minimum risk = 0), where higher values correspond to higher risk. Values \<1 suggest low risk of hypoglycemia. |
| High Blood Glucose Index (HBGI) | 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC | The high blood glucose index (HBGI) is based on a nonlinear transformation of blood glucose values that corrects for the asymmetry of the glucose scale. This transformation maps glucose values into a risk space (minimum risk = 0), where higher values correspond to higher risk. Values below 10 suggest low to moderate risk. |
| TIR >250 mg/dL | 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC | Time above 250 mg/dL as measured by CGM. |
| TIR >300 mg/dL | 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC | Time above 300 mg/dL as measured by CGM. |
| HbA1c (%) at End of Study | Labs taken at the completion of study, approximately 6 months after enrollment; hence, results are stratified only by arm and not by intervention. | The percentage of glycated hemoglobin. A higher percentage indicates a worse outcome. |
| Technology Expectations Survey | Participant baseline | This questionnaire is rated on a 5-point Likert scale and is the baseline version of the Technology Acceptance Survey. Technology Expectations and Technology Experience Survey have identical items, except future tense is used in the Technology Expectations Survey (administered at randomization), while past tense is used in the Technology Experience Survey (administered at the end of each intervention). These surveys yield two subscale scores (burdens and benefits); the score of the items in the burden subscale are inverted before averaging the score of all the items to obtain the total technology acceptance reported here (range: 1-5, with 5 indicating higher acceptance). |
| Clarke's Hypoglycemia Awareness Scale | 22 weeks | Number of individuals with hypoglycemia awareness, reduced hypoglycemia awareness, and in between, based on Clarke's Hypoglycemia Awareness Scale. |
| Technology Experience Survey | At participant completion, approximately 6 months | This questionnaire is rated on a 5-point Likert scale and is the endpoint version of the Technology Acceptance Survey. Technology Expectations and Technology Experience Survey have identical items, except future tense is used in the Technology Expectations Survey (administered at randomization), while past tense is used in the Technology Experience Survey (administered at the end of each intervention). These surveys yield two subscale scores (burdens and benefits); the score of the items in the burden subscale are inverted before averaging the score of all the items to obtain the total technology acceptance reported here (range: 1-5, with 5 indicating higher acceptance). The score is not reported for CLC only, as no technology was used during this intervention. |
| High Blood Glucose Levels Survey | 22 weeks | This questionnaire evaluates generalized avoidance of hyperglycemia across 4 subcategories using items rated on a 5-point Likert scale. Range is 1-5, with 5 indicating higher hyperglycemia avoidance and worry. The total score reported is obtained by averaging the scores of all the items in the survey. |
| Hypoglycemia Fear Survey | 22 weeks | This questionnaire evaluates Fear of Hypoglycemia and each item is rated on a 5-point Likert scale. Range is 1-5, with 5 indicating higher hypoglycemia fear and worry. The total score reported is obtained by averaging the scores of all the items in the survey. |
| Diabetes Distress Scale | 22 weeks | A questionnaire evaluating different domains of diabetes-related distress. Each item is scored on a 6 point Likert scale. Range is 1-6- with scores of 2-2.9 indicating moderate distress and scores \> 3.0 indicating severe distress. The total score reported is obtained by averaging the scores of all the items in the survey. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSue Brown, MD
University of Virginia Center for Diabetes Technology
Participant flow
Pre-assignment details
73 participants were randomized but 1 participant from the "CLC+ABC, then CLC+BAM, then CLC" arm did not complete the study. 72 participants completed.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 42.8 years STANDARD_DEVIATION 15.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Height (cm) | 168.0 cm STANDARD_DEVIATION 9.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 36 Participants |
| Screening glycated hemoglobin (%) | 6.8 percentage of glycated hemoglobin STANDARD_DEVIATION 0.8 |
| Sex/Gender, Customized Female | 39 Participants |
| Sex/Gender, Customized Male | 22 Participants |
| Sex/Gender, Customized Not disclosed | 0 Participants |
| Sex/Gender, Customized Other | 1 Participants |
| Weight (kg) | 82.7 kg STANDARD_DEVIATION 18.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 38 | 0 / 38 | 0 / 35 | 0 / 34 | 0 / 34 |
| other Total, other adverse events | 0 / 38 | 0 / 38 | 0 / 38 | 0 / 35 | 0 / 34 | 0 / 34 |
| serious Total, serious adverse events | 0 / 38 | 0 / 38 | 0 / 38 | 0 / 35 | 0 / 34 | 0 / 34 |
Outcome results
None listed