Clinical trial NCT06384911: InvesT1D: Promoting Adolescent Investment in Diabetes Care
Official title: InvesT1D: Promoting Adolescent Investment in Diabetes Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: Harvard Pilgrim Health Care
Sponsor class: OTHER
Collaborators: name: Seattle Children's Hospital
First posted: 2024-04-25
Enrollment: 96
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Time In Range
timeFrame: Change over 12-18 months
Secondary outcomes:
measure: Time Above Range
timeFrame: Change over 12-18 months
measure: Time Below Range
timeFrame: Change over 12-18 months
measure: Hemoglobin A1c (HbA1c)
timeFrame: Change over 12-18 months
measure: Diabetes Distress
timeFrame: Change over 12-18 months
measure: Diabetes Family Conflict
timeFrame: Change over 12-18 months
measure: Adolescent Quality of Life
timeFrame: Change over 12-18 months
measure: Caregiver Quality of Life
timeFrame: Change over 12-18 months
measure: Diabetic Ketoacidosis
timeFrame: 12-18 months
measure: Severe Hypoglycemia
timeFrame: 12-18 months
measure: Insulin Adminstration
timeFrame: Change over 12-18 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Children's
state: Washington
Study officials:
References: