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NCT Number: NCT06384911

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.

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Financial Incentives Program

Behavioral

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

Primary outcomes

  1. Time In Range

    Time frame: Change over 12-18 months

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

Secondary outcomes

  1. Time Above Range

    Time frame: Change over 12-18 months

    Continuous glucose monitor sensor glucose measurements collected during the intervention that are above range (>180 mg/dL).

  2. Time Below Range

    Time frame: Change over 12-18 months

    Continuous glucose monitor sensor glucose measurements collected during the intervention that are below range (<70 mg/dL).

  3. Hemoglobin A1c (HbA1c)

    Time frame: Change over 12-18 months

    HbA1c laboratory measurements collected during the intervention.

  4. Diabetes Distress

    Time frame: Change over 12-18 months

    Diabetes distress will be assessed with the Problem Areas in Diabetes Scale -- Teen Version. Higher scores indicate higher diabetes distress (scale: 14-84).

  5. Diabetes Family Conflict

    Time frame: Change over 12-18 months

    Diabetes family conflict will be assessed with the Diabetes Family Conflict Scale. Higher scores indicate higher diabetes family conflict (scale: 19-57).

  6. Adolescent Quality of Life

    Time frame: Change over 12-18 months

    Adolescent health-related quality of life will be assessed with the EQ-5D instrument. High score indicated higher health status (scale: 0-100).

  7. Caregiver Quality of Life

    Time frame: Change over 12-18 months

    Caregiver quality of life will be assessed using the Care-related Quality of Life instrument. Higher scores represent higher caregiving burden (score: 0-100).

  8. Diabetic Ketoacidosis

    Time frame: 12-18 months

    Episodes of severe hypoglycemia requiring emergency department visit or hospital admission will be extracted from medical record data.

  9. Severe Hypoglycemia

    Time frame: 12-18 months

    Episodes of severe hypoglycemia requiring emergency department visit or hospital admission will be extracted from medical record data.

  10. Insulin Adminstration

    Time frame: Change over 12-18 months

    Daily bolus insulin administration will be assessed based on data collected on insulin pump or inPen diabetes data management platforms.

Study contacts

Contact information is provided by the study sponsor or research team.

Catherine Pihoker, MD

CONTACT

[email protected]

206-987-2637

Sponsors and collaborators

Lead sponsor

Harvard Pilgrim Health Care

Other

Collaborators

  • Seattle Children's Hospital

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 25, 2024
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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