NCT06384911 InvesT1D: Promoting Adolescent Investment in Diabetes Care
| NCT ID | NCT06384911 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Harvard Pilgrim Health Care |
| Condition | Type 1 Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 96 participants |
| Start Date | 2024-06-25 |
| Primary Completion | 2027-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 96 participants in total. It began in 2024-06-25 with a primary completion date of 2027-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06384911 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, studying Type 1 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06384911 currently recruiting?
Yes, NCT06384911 is actively recruiting participants. Contact the research team at catherine.pihoker@seattlechildrens.org for enrollment information.
Where is the NCT06384911 trial being conducted?
This trial is being conducted at Seattle, United States.
Who is sponsoring the NCT06384911 clinical trial?
NCT06384911 is sponsored by Harvard Pilgrim Health Care. The trial plans to enroll 96 participants.
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