InvesT1D: Promoting Adolescent Investment in Diabetes Care

NCT06384911 | Recruiting DMC

• 1 other identifier: STUDY00004543
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Time In Range

  Continuous glucose monitor sensor glucose measurements collected during the intervention that are in range (70-180 mg/dL)

  Change over 12-18 months

Secondary Outcomes (10)

• Time Above Range

  Change over 12-18 months

• Time Below Range

  Change over 12-18 months

• Hemoglobin A1c (HbA1c)

  Change over 12-18 months

• Diabetes Distress

  Change over 12-18 months

• Diabetes Family Conflict

  Change over 12-18 months

Study Arms (6)

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

EXPERIMENTAL

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.

Behavioral: Financial Incentives Program

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

EXPERIMENTAL

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.

Behavioral: Financial Incentives Program

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

EXPERIMENTAL

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.

Behavioral: Financial Incentives Program

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

EXPERIMENTAL

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.

Behavioral: Financial Incentives Program

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

NO INTERVENTION

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

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 BEHAVIORAL

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

Group A (low-value incentive, 6 months [24 weeks]); Group B (high-value incentive, 6 months [24 weeks]); Group C (low-value incentive, 12 months [48 weeks]); Group D (high-value incentive, 12 months [48 weeks])

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Harvard Pilgrim Health Care: lead
• Seattle Children's Hospital: collaborator

Study Sites (1)

Seattle Children's

Seattle, Washington, 98105, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Catherine Pihoker, MD

CONTACT

206-987-2637; catherine.pihoker@seattlechildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: April 25, 2024
• Study Start: June 25, 2024
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Data requests can be submitted at the end of the funding period and the data will be made accessible for up to 10 years.
• Access Criteria: The Harvard Dataverse repository, is an open-source web application that provides searchable study-level metadata for dataset discovery. The repository assigns DOIs as persistent identifiers and has a robust preservation plan to ensure long-term access. Data will be discoverable online through standard web search of the study-level metadata as well as the persistent pointer from the DOI to the dataset. The dataset will be tagged with the NIH award number to facilitate searches.

Locations

US (1)