Type 1 Diabetes
Conditions
Brief summary
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
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.
Interventions
BEHAVIORALCGM Family Teamwork Intervention
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.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Jaeb Center for Health Research
Joslin Diabetes Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in glycemic control, assessed by hemoglobin A1c | Baseline and 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 1 year and 2 years | Durability of the intervention will be assessed by change in A1c from 1 year to 2 years |
Countries
United States
Outcome results
None listed