InvesT1D: Promoting Adolescent Investment in Diabetes Care

Type 1 Diabetes Clinical Trial

Official title:

InvesT1D: Promoting Adolescent Investment in Diabetes Care

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06384911
• Other study ID #: STUDY00004543
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: February 2028

Study information

• Verified date: April 2024
• Source: Seattle Children's Hospital
• Contact: Faisal S Malik, MD, MSHS
• Phone: 206-987-0121
• Email: faisal.malik[@]seattlechildrens.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 and person-reported outcomes between groups.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 96
• Est. completion date: February 2028
• Est. primary completion date: August 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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
• Parents 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
• Parents are not willing to participate in study and complete surveys

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type 1 Diabetes

Intervention

Behavioral:
• Financial Incentives Program
Adolescent participants will receive financial incentives for meeting diabetes self-management and clinical outcome goals.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Seattle Children's Hospital	Harvard Pilgrim Health Care

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Hemoglobin A1c (HbA1c)	HbA1c laboratory measurements collected during the intervention.	Change over 12-18 months
Secondary	Diabetes Distress	Diabetes distress will be assessed with the Problem Areas in Diabetes Scale -- Teen Version. Higher scores indicate higher diabetes distress.	Change over 12-18 months
Secondary	Diabetes Family Conflict	Diabetes family conflict will be assessed with the Diabetes Family Conflict Scale. Higher scores indicate higher diabetes family conflict.	Change over 12-18 months
Secondary	Adolescent Quality of Life	Adolescent health-related quality of life will be assessed with the EQ-5D instrument. High score indicated higher health status.	Change over 12-18 months
Secondary	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.	Change over 12-18 months
Secondary	Diabetic Ketoacidosis	Episodes of severe hypoglycemia requiring emergency department visit or hospital admission will be extracted from medical record data.	12-18 months
Secondary	Severe Hypoglycemia	Episodes of severe hypoglycemia requiring emergency department visit or hospital admission will be extracted from medical record data.	12-18 months
Secondary	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