CGM Intervention in Teens and Young Adults With Type 1 Diabetes (T1D)

Study Overview
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Brief Summary
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Adolescents and young adults with T1D and poor glycemic control (age 14-< 25 years, T1D duration >12 months, HbA1c 7.5-<11.0%, using an insulin pump or MDI)) will be randomly assigned to either CGM or BGM. Sample size will be 150. The primary outcome assessment will be HbA1c after 6 months. Secondary outcomes will include HbA1c, CGM metrics (control group will wear blinded CGM at 13 and 24 weeks), and quality of life measures. The randomized trial will be followed by a 6-month extension study during which the RCT control group will initiate CGM and the RCT CGM group will continue CGM.

Official Title
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CGM Intervention in Teens and Young Adults With T1D (CITY): A Randomized Clinical Trial to Assess the Efficacy and Safety of Continuous Glucose Monitoring in Young Adults 14-<25 With Type 1 Diabetes

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Device: Continuous Glucose Monitor (CGM)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of T1D, with either age of T1D diagnosis < 10 years of age OR a history of positive T1D related antibodies in the medical record Age 14-<25 years Diabetes duration ≥ 1 year Total daily insulin requirement ≥ 0.4 units/kg/day HbA1c 7.5% to <11.0% (Point of care device or local lab measured as part of study at screening visit) Insulin regimen involves a consistent modality of insulin administration with either use of an insulin pump or at least 3 multiple daily injections of basal and bolus (meal time) analogue insulin. Insulin pump must not have been started within 3 months of consent with no plans to change regimens in the next 6 months Perform at least 2 blood glucose meter checks per day from self-report at screening and an average of at least 2 checks per day from meter download during blinded CGM run in Blinded CGM must be used a minimum of 200 hours (equivalent to 8.3 days) with an average of 1.8 calibrations per day during the blinded CGM screening period. Participant comprehends written and spoken English Participant understands the study protocol and agrees to it (if applicable) Exclusion Criteria: Use of unblinded personal CGM and/or flash CGM, outside of a research study, as part of real-time diabetes management in the last 3 months Unable to use CGM device for minimum number of hours during blinded pre-randomization period or skin reaction from adhesive that would preclude participation in the randomized trial Started on non-insulin medication for blood glucose control within the past 3 months or plans to begin within the next 6 months The presence of a significant medical disorder that in the judgment of the investigator will affect the wearing of the sensors (such as a skin condition), or the completion of any aspect of the protocol. More than 1 episode of DKA in the past 6 months as defined in the adverse events chapter. The presence of any of the following diseases: Asthma or any condition present in the last 6 months where treatment is a systemic or daily inhaled corticosteroid (Intermittent treatment with inhaled corticosteroids does not exclude subjects from enrollment) Cystic fibrosis Addison's disease (Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment) Inpatient psychiatric treatment in the past 6 months or daily intensive outpatient psychiatric day treatment in the past 3 months. Pregnant (positive test confirmed at screening) or planning to become pregnant in the next 12 months. Need for use of acetaminophen or acetaminophen-containing products on a regular basis during the 6 months of the trial Participation in a diabetes related intervention study in the past 6 weeks. Any medical, psychological or social situation where per investigator discretion it may be difficult for participant to participate fully in the intervention Any condition, per investigator assessment, that could impact reliability of the A1C measurement, such as (but not limited to) hemoglobinopathy, hemolytic anemia, chronic liver disease; chronic GI blood loss, red blood cell transfusion or erythropoietin administration within 3 months prior to screening

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CGM<br> | Device: Continuous Glucose Monitor (CGM)<br>* Participants randomized to the CGM Group will receive a Dexcom CGM device and be instructed on how to utilize the CGM data in real time for diabetes management.<br>|
| No Intervention: BGM<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c from baseline to 26 weeks adjusted for baseline |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % with HbA1c <7.0% |  | 6 months | 
| % with HbA1c <7.5% |  | 6 months | 
| % with relative reduction ≥ 10% |  | 6 months | 
| % with absolute reduction ≥ 0.5% |  | 6 months | 
| % with absolute reduction ≥ 1% |  | 6 months | 
| % with absolute reduction ≥ 1% or HbA1c < 7.0% |  | 6 months | 
| CGM % time in range 70-180 mg/dl |  | 6 months | 
| CGM mean glucose |  | 6 months | 
| CGM glucose variability measured by coefficient of variation |  | 6 months | 
| CGM % time > 180 mg/dl |  | 6 months | 
| CGM % time > 300 mg/dl |  | 6 months | 
| CGM % time < 54 mg/dl |  | 6 months | 
| CGM % time < 70 mg/dl |  | 6 months | 
| Rate of CGM measured hypoglycemic episodes (using <54 mg/dL) |  | 6 months | 
| CGM Self Efficacy Questionnaire Score | Questionnaire containing 15 questions with possible responses 0-6. Total score is calculated by taking the mean of the non-missing responses. Then multiply by 100 and divide by 6 to put on the scale 0-100. Higher total score indicates higher perceived ability. | 6 months | 
| Problem Areas in Diabetes (PAID) Questionnaire Score | Survey containing 20 questions with possible responses 0-5. Total score is calculated by taking the mean of the non-missing items and multiplying by 20 to put on the scale 0-100. A higher total score indicates more of a problem. | 6 months | 
| Glucose Monitoring Satisfaction Questionnaire Score | Survey containing 15 questions. Total score ranges from 0-100. A higher total score indicates more satisfaction with their current glucose monitor. | 6 months | 
| Hypoglycemia Confidence Questionnaire Score | Survey containing 9 questions with possible responses 0-4. Total score is calculated by taking the mean of non-missing responses and multiplying by 25 to put on the scale 0-100. Higher total score indicates more confidence. | 6 months | 
| Diabetes Technology Attitudes Questionnaire Score | Survey containing 5 questions with possible responses 0-4. Total score is calculated by taking the mean of non-missing responses and multiplying by 25 to put on the scale 0-100. Higher total score indicates a more positive attitude towards diabetes technology. | 6 months | 
| Pittsburgh Sleep Quality Index | Survey containing 19 questions. Total score ranges from 0-21. A lower score indicates a healthier sleep quality. | 6 months |