Type 1 Diabetes
Conditions
Keywords
behavioral economics, financial incentive, diabetes, type 1 diabetes, adolescent, AYA, young adult
Brief summary
Two financial incentive strategies targeting adolescents with type 1 diabetes will be compared to usual care for motivating adolescents to engage in improved self-care to manage their diabetes.
Detailed description
Participants will be asked to choose a self-care goal relevant to the device(s) they use to manage their diabetes from a pre-defined list of self-care targets. A randomized 3 (treatment) x 3 (occasion) crossover design will be used to compare treatments that are administered to participants in a predetermined sequence. The intervention arms include financial incentives administered in a gain- and loss-frame for adherence to daily self-care goals. The control arm is usual care. Participants can also earn additional incentives for meeting clinical care goals such as an improvement in the percentage of time glucose levels are consistent with hyperglycemia (\>180 mg/dL). The primary outcome will be HbA1c at 12 weeks compared to baseline. Secondary outcomes will include frequency of insulin administration, engagement in diabetes self-care (SCI-R), patient-reported outcomes (Problem Areas in Diabetes - Teen version and Diabetes Family Conflict Scale).
Interventions
BEHAVIORALFinancial incentive (gain)
Participants will receive a daily financial incentive framed as a gain with money allocated each day of adherence to a self-care coal. Participants will receive an additional weekly incentive for meeting a clinical outcome goal.
BEHAVIORALFinancial incentive (loss)
Participants will receive a daily financial incentive framed as a loss with money allocated up front and taken away each day of non-adherence to a self-care coal. An additional weekly incentive will be deducted for failure to meet a clinical outcome goal.
Sponsors
Seattle Children's Hospital
Harvard Pilgrim Health Care
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
* \>12 and ≤18 years old * Diagnosed with type 1 diabetes ≥12 months * Speaks English fluently * Cognitively able to participate in incentive program and complete surveys. * Have access to a mobile phone to receive goal-obtainment and incentive updates * Receives diabetes-related clinical care from Seattle Children's Hospital Diabetes Clinic * Have the ability to upload medical data remotely from home per usual care processes employed by Seattle Children's Hospital Diabetes Clinics
Exclusion criteria
* Patient is already participating in another research study to improve diabetes self-care and/or glycemic control * Baseline daily average glucose checks are greater than 4 checks per day OR baseline daily CGM active wear is greater than 70% of the time AND baseline average insulin bolus score is greater than 3 times a day OR they do not use an insulin pump (or are unwilling to use a smart insulin pen) * Patient refusal to participate (any age), or caregiver refusal to participate for patients less than 18 years of age * Cognitively or physically unable to participate * Patient is unable to speak in the English language * Patient is unable to read in the English language * Patient is a ward of the state * Patient has severe comorbidities including other major chronic health conditions that significantly impact daily management demands or health outcomes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 12 weeks | Change in HbA1c from baseline to 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insulin Administration | 12 weeks | Insulin pumps and smart insulin pens track administration of all insulin manually delivered by the participant |
| SCI-R | 12 weeks | The Self Care Inventory Revised is a 14-item self-report measure of perceived adherence to diabetes self-care recommendations |
| Glucose monitoring | 12 weeks | Frequency of glucose monitoring |
| DFCS | 12 weeks | Diabetes Family Conflict Scale |
| Time in Range | 12 weeks | Evaluation of percentage of time spent in goal range via continuous glucose monitor system |
| PAID-T | 12 weeks | Problem Areas in Diabetes- Teen version |
Countries
United States
Outcome results
None listed