InvesT1D: Promoting Adolescent Investment in Diabetes Care

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.

Study Overview

• Status: Recruiting
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Behavioral: Financial Incentives Program

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.

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Catherine Pihoker, MD; Phone Number: 206-987-2637; Email: catherine.pihoker@seattlechildrens.org

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98105
      • Recruiting
      • Seattle Children's
      • Contact: Ciara A DeGraff, BA; Phone Number: 206-884-1809; Email: ciara.degraff@seattlechildrens.org
      • Contact: Beth Loots, MPH, MSW; Phone Number: 206-884-4488; Email: beth.loots@seattlechildrens.org
      • Principal Investigator: Catherine Pihoker, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Financial Incentives Program; Adolescent participants will receive financial incentives for meeting diabetes self-management and clinical outcome goals.
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.	Behavioral: Financial Incentives Program; Adolescent participants will receive financial incentives for meeting diabetes self-management and clinical outcome goals.
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.	Behavioral: Financial Incentives Program; Adolescent participants will receive financial incentives for meeting diabetes self-management and clinical outcome goals.
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.	Behavioral: Financial Incentives Program; Adolescent participants will receive financial incentives for meeting diabetes self-management and clinical outcome goals.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time Above Range	Continuous glucose monitor sensor glucose measurements collected during the intervention that are above range (>180 mg/dL).	Change over 12-18 months
Time Below Range	Continuous glucose monitor sensor glucose measurements collected during the intervention that are below range (<70 mg/dL).	Change over 12-18 months
Hemoglobin A1c (HbA1c)	HbA1c laboratory measurements collected during the intervention.	Change over 12-18 months
Diabetic Ketoacidosis	Episodes of severe hypoglycemia requiring emergency department visit or hospital admission will be extracted from medical record data.	12-18 months
Severe Hypoglycemia	Episodes of severe hypoglycemia requiring emergency department visit or hospital admission will be extracted from medical record data.	12-18 months
Insulin Adminstration	Daily bolus insulin administration will be assessed based on data collected on insulin pump or inPen diabetes data management platforms.	Change over 12-18 months
Diabetes Distress	Diabetes distress will be assessed with the Problem Areas in Diabetes Scale -- Teen Version. Higher scores indicate higher diabetes distress (scale: 14-84).	Change over 12-18 months
Diabetes Family Conflict	Diabetes family conflict will be assessed with the Diabetes Family Conflict Scale. Higher scores indicate higher diabetes family conflict (scale: 19-57).	Change over 12-18 months
Adolescent Quality of Life	Adolescent health-related quality of life will be assessed with the EQ-5D instrument. High score indicated higher health status (scale: 0-100).	Change over 12-18 months
Caregiver Quality of Life	Caregiver quality of life will be assessed using the Care-related Quality of Life instrument. Higher scores represent higher caregiving burden (score: 0-100).	Change over 12-18 months

Collaborators and Investigators

• Sponsor: Harvard Pilgrim Health Care
• Collaborators: Seattle Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2024
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): October 31, 2027

Study Registration Dates

• First Submitted: April 22, 2024
• First Submitted That Met QC Criteria: April 22, 2024
• First Posted (Actual): April 25, 2024

Study Record Updates

• Last Update Posted (Actual): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1
• Other Study ID Numbers: STUDY00004543

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Harvard Dataverse repository 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.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No