Type 1 Diabetes
Conditions
Brief summary
The goal of this clinical trial is to see if a financial incentives program called InvesT1D is helpful to support diabetes management in adolescents with type 1 diabetes. Adolescent participants will be randomized to usual care or receive financial incentives for meeting diabetes self-management and clinical outcomes goals during the study. Researchers will compare changes in glucose levels, as well as adolescent and caregiver person-reported outcomes between groups.
Detailed description
Adolescents face many challenges as they transition from childhood to adulthood. For adolescents with type 1 diabetes, there are additional responsibilities that come with daily diabetes self-management. The goal of this study is to find out whether financial incentives can help adolescents with their daily self-management. Adolescent participants will be assigned to one of 6 groups. Some participants will be asked to choose diabetes self-management goals such as increasing daily bolus insulin administration or increasing their continuous glucose monitoring system wear time, and then will be provided with financial incentives (money) when they meet their selected goals. Other participants will be asked to continue their diabetes management as usual. Researchers will collect data from 96 adolescent participants and their caregivers to assess change in glucose levels, as well as adolescent and caregiver person-reported outcomes.
Interventions
BEHAVIORALFinancial Incentives Program
Adolescent participants will receive financial incentives for meeting diabetes self-management and clinical outcome goals.
Sponsors
Seattle Children's Hospital
Harvard Pilgrim Health Care
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with type 1 diabetes ≥12 months * Utilize a continuous glucose monitor (CGM) to support diabetes management * Average daily CGM use is less than or equal to 70% of the time and/or their baseline average insulin bolus administration is less than or equal to 3 times a day * Are using diabetes technology that allows for tracking of bolus insulin administration if participant wants to work on improving daily bolus insulin administration * Cognitively able to participate in incentive program and complete surveys * Have access to a mobile phone to receive information about goal attainment and incentive updates * Have the ability to upload glucose and insulin administration data remotely per processes used by participant's diabetes care team * Caregivers are willing to participate in study and complete surveys
Exclusion criteria
* At time of screening, average CGM wear is greater than 70% of the time or baseline average insulin bolus administration is greater than 3 times a day * Adolescent is not interested in using diabetes technology that allows for tracking of bolus insulin administration if participant wants to work on improving daily bolus insulin administration * Cognitively or physically unable to participate * Adolescent is a ward of the state * Severe comorbidities including other major chronic health conditions that significantly impact daily management demands or health outcomes * Caregivers are not willing to participate in study and complete surveys
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time In Range | Change over 12-18 months | Continuous glucose monitor sensor glucose measurements collected during the intervention that are in range (70-180 mg/dL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time Below Range | Change over 12-18 months | Continuous glucose monitor sensor glucose measurements collected during the intervention that are below range (\<70 mg/dL). |
| Hemoglobin A1c (HbA1c) | Change over 12-18 months | HbA1c laboratory measurements collected during the intervention. |
| Diabetes Distress | Change over 12-18 months | Diabetes distress will be assessed with the Problem Areas in Diabetes Scale -- Teen Version. Higher scores indicate higher diabetes distress (scale: 14-84). |
| Diabetes Family Conflict | Change over 12-18 months | Diabetes family conflict will be assessed with the Diabetes Family Conflict Scale. Higher scores indicate higher diabetes family conflict (scale: 19-57). |
| Time Above Range | Change over 12-18 months | Continuous glucose monitor sensor glucose measurements collected during the intervention that are above range (\>180 mg/dL). |
| Caregiver Quality of Life | Change over 12-18 months | Caregiver quality of life will be assessed using the Care-related Quality of Life instrument. Higher scores represent higher caregiving burden (score: 0-100). |
| Diabetic Ketoacidosis | 12-18 months | Episodes of severe hypoglycemia requiring emergency department visit or hospital admission will be extracted from medical record data. |
| Severe Hypoglycemia | 12-18 months | Episodes of severe hypoglycemia requiring emergency department visit or hospital admission will be extracted from medical record data. |
| Insulin Adminstration | Change over 12-18 months | Daily bolus insulin administration will be assessed based on data collected on insulin pump or inPen diabetes data management platforms. |
| Adolescent Quality of Life | Change over 12-18 months | Adolescent health-related quality of life will be assessed with the EQ-5D instrument. High score indicated higher health status (scale: 0-100). |
Countries
United States
Contacts
Primary ContactCatherine Pihoker, MD
Outcome results
None listed