Can Glucose Monitoring Improve (CGMi Study)

Study Overview
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Brief Summary
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The purpose of this 2-year randomized controlled trial (RCT) is to implement and evaluate a family-focused behavioral teamwork intervention aimed at overcoming barriers to sustained continuous glucose monitoring (CGM) use in youth with type 1 diabetes (T1D). We hypothesize that CGM implemented with a family-focused, behavioral teamwork intervention will result in sustained CGM use and greater improvement in A1c compared to routine implementation of CGM.

Detailed Description
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Consistent CGM use in youth with T1D has been difficult to sustain historically. Youth with T1D and their families have routinely felt burden related to the introduction of this technology into their care management. Additionally, there can be difficulties with calibration, skin irritation, frequent skips, excessive or nuisance alarms and inaccurate readings which often lead to diminished use or discontinuation entirely. The purpose of this protocol is to implement and evaluate a family-focused behavioral teamwork intervention aimed at overcoming barriers to sustained CGM use in youth with T1D. In this 2-year RCT, we will assess the long-term acceptability and durability of CGM use and its associated glycemic and psychological outcomes in youth with T1D and their families. We will randomize 120 families to one of two groups: (1) CGM implemented according to usual care (CGM-Usual Care, CGM-UC) or (2) CGM implemented with a family teamwork intervention (CGM-Teamwork, CGM-TW). This intervention will allow participants and families to overcome barriers to sustained CGM use and achieve glycemic benefits that have been afforded to adults using CGM as demonstrated in other research. In year 1, all CGM supplies will be provided and covered by study resources. In year 2, study participants will be asked to cover the costs associated with sensor use and any costs associated with replacement of CGM components in a manner consistent with routine clinical care as the investigators believe that it is important to assess durability of CGM use in clinical practice.

Official Title
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Optimizing CGM Use and Metabolic Outcomes in Youth With Type 1 Diabetes

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Behavioral: CGM Family Teamwork Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 8-17 years Planning to be living at home for 2 years Type 1 diabetes of at least 1 year duration Daily insulin dose ≥0.5 units/kg A1c ≥6.5% and ≤10.0% Insulin therapy with continuous subcutaneous insulin infusion (CSII) or multiple daily injections (≥3 injections/day) Blood glucose (BG) monitoring frequency ≥4 times/day Agreement to wear a CGM device Fluency in English for child and parent/guardian Stable living situation for ≥6 months (e.g., no Department of Youth Services Involvement) Joslin Clinic attendance: At least one Joslin Clinic visit in last year AND Anticipated care at Joslin Clinic for duration of study Exclusion Criteria: Consistent CGM use, defined as 6+ days/week during the previous 6 months History of severe, life-threatening skin reactions to the adhesive used with the CGM device Pregnancy in the youth participant or intention to become pregnant within the next 2 years Significant developmental or cognitive disorder in the youth or parent/guardian that would prevent full participation in a family-based, behavioral intervention or implementation of CGM Inpatient psychiatric admission within the previous 6 months Participation in another intervention study during the previous 3 months Intent to enroll in another intervention study during the study period

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 17 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: CGM-Usual Care<br>Routine CGM education | |
| Experimental: CGM-Teamwork<br>Routine CGM education CGM Family Teamwork Intervention | Behavioral: CGM Family Teamwork Intervention<br>* The family-focused behavioral intervention targets barriers associated with sustained CGM use in youth with type 1 diabetes. During months 1-18, families in the intervention group will participate in the intervention at each study visit for about an additional 30 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in glycemic control, assessed by hemoglobin A1c |  | Baseline and 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in psychosocial factors (e.g., self-efficacy, fear of hypoglycemia, quality of life, diabetes-specific family conflict, diabetes responsibility sharing, diabetes-specific burden, anxiety, depressive symptoms) |  | Baseline and 1 year | 
| Change in glycemic control, assessed by hemoglobin A1c | Durability of the intervention will be assessed by change in A1c from 1 year to 2 years | 1 year and 2 years | 
| Change in psychosocial factors (e.g., self-efficacy, fear of hypoglycemia, quality of life, diabetes-specific family conflict, diabetes responsibility sharing, diabetes-specific burden, anxiety, depressive symptoms) |  | 1 year and 2 years |