InvesT1D: Promoting Adolescent Investment in Diabetes Care

Harvard Pilgrim Health Care

Status: Enrolling

Conditions: Type 1 Diabetes

Treatments: Behavioral: Financial Incentives Program

Study type: Interventional

Funder types: Other

Identifiers

NCT06384911

STUDY00004543

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 estimated patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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96 participants in 6 patient groups

Group A (low-value incentive, 6 months [24 weeks])

Experimental group

Description:

If the participant is assigned to Group A, they would receive $1.75 for each day that they meet their diabetes self-management goal. This equates to up to $49 every 4 weeks ($1.75 x 28 days = $49), or up to $294 over a period of 24 weeks. They would also receive $2.75 for each week that they meet their clinical outcome goal. This equates to up to $11 every 4 weeks ($2.75 x 4 weeks), or up to $66 over a period of 24 weeks. In total, they could earn up to $60 ($49 + $11) every 4 weeks, or up to $360 over a period of 24 weeks.

Treatment:

Behavioral: Financial Incentives Program

Group B (high-value incentive, 6 months [24 weeks])

Experimental group

Description:

If the participant is assigned to Group B, they would receive $3.50 for each day that they meet their diabetes self-management goal. This equates to up to $98 every 4 weeks ($3.50 x 28 days = $98), or up to $588 over a period of 24 weeks. They would also receive $5.50 for each week that they meet their clinical outcome goal. This equates to up to $22 every 4 weeks ($5.50 x 4 weeks), or up to $132 over a period of 24 weeks. In total, they could earn up to $120 ($98 + $22) every 4 weeks, or up to $720 over a period of 24 weeks.

Treatment:

Behavioral: Financial Incentives Program

Group C (low-value incentive, 12 months [48 weeks])

Experimental group

Description:

If the participant is assigned to Group C, they would receive $1.75 for each day that they meet their diabetes self-management goal. This equates to up to $49 every 4 weeks ($1.75 x 28 days = $49), or up to $588 over a period of 48 weeks. They would also receive $2.75 for each week that they meet their clinical outcome goal. This equates to up to $11 every 4 weeks ($2.75 x 4 weeks), or up to $132 over a period of 48 weeks. In total, they could earn up to $60 ($49 + $11) every 4 weeks, or up to $720 over a period of 48 weeks.

Treatment:

Behavioral: Financial Incentives Program

Group D (high-value incentive, 12 months [48 weeks])

Experimental group

Description:

If the participant is assigned to Group C, they would receive $1.75 for each day that they meet their diabetes self-management goal. This equates to up to $49 every 4 weeks ($1.75 x 28 days = $49), or up to $588 over a period of 48 weeks. They would also receive $2.75 for each week that they meet their clinical outcome goal. This equates to up to $11 every 4 weeks ($2.75 x 4 weeks), or up to $132 over a period of 48 weeks. In total, they could earn up to $60 ($49 + $11) every 4 weeks, or up to $720 over a period of 48 weeks.

Treatment:

Behavioral: Financial Incentives Program

Group E (usual care, 6 months [24 weeks])

No Intervention group

Description:

Usual care reflects the standard treatment currently provided to adolescents with type 1 diabetes at Seattle Children's Hospital. All adolescent participants in the study will have access to the multidisciplinary care team including a diabetes provider, registered diabetes nurse, social worker, and nutritionist. They will continue to be offered routine diabetes clinic appointments as is the standard of care. Telephone consultations are available 24/7 as often as necessary between clinic visits.

Group F (usual care, 12 months [48 weeks])

No Intervention group

Description:

Usual care reflects the standard treatment currently provided to adolescents with type 1 diabetes at Seattle Children's Hospital. All adolescent participants in the study will have access to the multidisciplinary care team including a diabetes provider, registered diabetes nurse, social worker, and nutritionist. They will continue to be offered routine diabetes clinic appointments as is the standard of care. Telephone consultations are available 24/7 as often as necessary between clinic visits.