InvesT1D: Promoting Adolescent Investment in Diabetes Care
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Financial Incentives Program.
- Who it may be relevant to
- Registry conditions: Type 1 Diabetes. Basic parameters: from 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Behavioral Financial Incentives Program
Adolescent participants will receive financial incentives for meeting diabetes self-management and clinical outcome goals.
Primary outcome measures
- Time In Range [Time frame: Change over 12-18 months]
Secondary outcome measures (10)
- Time Above Range [Time frame: Change over 12-18 months]
- Time Below Range [Time frame: Change over 12-18 months]
- Hemoglobin A1c (HbA1c) [Time frame: Change over 12-18 months]
- Diabetes Distress [Time frame: Change over 12-18 months]
- Diabetes Family Conflict [Time frame: Change over 12-18 months]
- Adolescent Quality of Life [Time frame: Change over 12-18 months]
- Caregiver Quality of Life [Time frame: Change over 12-18 months]
- Diabetic Ketoacidosis [Time frame: 12-18 months]
- Severe Hypoglycemia [Time frame: 12-18 months]
- Insulin Adminstration [Time frame: Change over 12-18 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Seattle Children's — Seattle
Identifiers
NCT: NCT06384911 · STUDY00004543