Promoting Adolescent Investment In Diabetes Care

Not Applicable

Completed

• Conditions: Type 1 Diabetes

• Registration Number: NCT04516694
• Lead Sponsor: Harvard Pilgrim Health Care

Brief Summary

Two financial incentive strategies targeting adolescents with type 1 diabetes will be compared to usual care for motivating adolescents to engage in improved self-care to manage their diabetes.

Detailed Description

Participants will be asked to choose a self-care goal relevant to the device(s) they use to manage their diabetes from a pre-defined list of self-care targets. A randomized 3 (treatment) x 3 (occasion) crossover design will be used to compare treatments that are administered to participants in a predetermined sequence. The intervention arms include financial incentives administered in a gain- and loss-frame for adherence to daily self-care goals. The control arm is usual care. Participants can also earn additional incentives for meeting clinical care goals such as an improvement in the percentage of time glucose levels are consistent with hyperglycemia (\>180 mg/dL). The primary outcome will be HbA1c at 12 weeks compared to baseline. Secondary outcomes will include frequency of insulin administration, engagement in diabetes self-care (SCI-R), patient-reported outcomes (Problem Areas in Diabetes - Teen version and Diabetes Family Conflict Scale).

Study Timeline

• Study First Submitted: 2020-08-13
• Study First Submitted QC: 2020-08-14
• Study First Posted: 2020-08-18
• Study Start: 2020-09-10
• Primary Completion: 2021-12-21
• Study Completion: 2022-01-08
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-02
• Last Update Posted: 2024-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• >12 and ≤18 years old
• Diagnosed with type 1 diabetes ≥12 months
• Speaks English fluently
• Cognitively able to participate in incentive program and complete surveys.
• Have access to a mobile phone to receive goal-obtainment and incentive updates
• Receives diabetes-related clinical care from Seattle Children's Hospital Diabetes Clinic
• Have the ability to upload medical data remotely from home per usual care processes employed by Seattle Children's Hospital Diabetes Clinics

Exclusion Criteria

• Patient is already participating in another research study to improve diabetes self-care and/or glycemic control
• Baseline daily average glucose checks are greater than 4 checks per day OR baseline daily CGM active wear is greater than 70% of the time AND baseline average insulin bolus score is greater than 3 times a day OR they do not use an insulin pump (or are unwilling to use a smart insulin pen)
• Patient refusal to participate (any age), or caregiver refusal to participate for patients less than 18 years of age
• Cognitively or physically unable to participate
• Patient is unable to speak in the English language
• Patient is unable to read in the English language
• Patient is a ward of the state
• Patient has severe comorbidities including other major chronic health conditions that significantly impact daily management demands or health outcomes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
HbA1c	12 weeks	Change in HbA1c from baseline to 12 weeks

Secondary Outcome Measures

Name	Time	Method
Time in Range	12 weeks	Evaluation of percentage of time spent in goal range via continuous glucose monitor system
Insulin Administration	12 weeks	Insulin pumps and smart insulin pens track administration of all insulin manually delivered by the participant
PAID-T	12 weeks	Problem Areas in Diabetes- Teen version
DFCS	12 weeks	Diabetes Family Conflict Scale
Glucose monitoring	12 weeks	Frequency of glucose monitoring
SCI-R	12 weeks	The Self Care Inventory Revised is a 14-item self-report measure of perceived adherence to diabetes self-care recommendations

Trial Locations

Locations (1)

Seattle Children's Research Institute; 🇺🇸 Seattle, Washington, United States