Recruiting

Observational Study

Sponsor:

Harvard Pilgrim Health Care

Code:

NCT06384911

Conditions

Type 1 Diabetes

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Interventions

Financial Incentives Program

Study Details

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.

Conditions

Type 1 Diabetes

Study ID

NCT06384911

Start date

Jun 25, 2024

Status verified date

Dec, 2025

Completion date

Oct 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

96 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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.

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

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.

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

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.

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

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.

no intervention: Group E (usual care, 6 months [24 weeks])

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.

no intervention: Group F (usual care, 12 months [48 weeks])

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.

Interventions

Financial Incentives Program

Adolescent participants will receive financial incentives for meeting diabetes self-management and clinical outcome goals.

Primary outcome measure

  • Time In Range [ Time Frame: Change over 12-18 months ]

Central Contacts and Locations

Central contacts

Locations

Seattle Children's

Recruiting

Seattle, Washington, United States, 98105

Contacts

Principal Investigator:

Catherine Pihoker, MD

More Information

Sponsor

Harvard Pilgrim Health Care

Last update posted

Dec 16, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Harvard Pilgrim Health Care on 2025-12-16.