Type 1 Diabetes Clinical Trial
— InvesT1DOfficial title:
Promoting Adolescent Investment In Diabetes Care
Verified date | March 2024 |
Source | Harvard Pilgrim Health Care |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 39 |
Est. completion date | January 8, 2022 |
Est. primary completion date | December 21, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 12 Years to 18 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Seattle Children's Research Institute | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Harvard Pilgrim Health Care | Seattle Children's Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | HbA1c | Change in HbA1c from baseline to 12 weeks | 12 weeks | |
Secondary | Glucose monitoring | Frequency of glucose monitoring | 12 weeks | |
Secondary | Insulin Administration | Insulin pumps and smart insulin pens track administration of all insulin manually delivered by the participant | 12 weeks | |
Secondary | SCI-R | The Self Care Inventory Revised is a 14-item self-report measure of perceived adherence to diabetes self-care recommendations | 12 weeks | |
Secondary | PAID-T | Problem Areas in Diabetes- Teen version | 12 weeks | |
Secondary | DFCS | Diabetes Family Conflict Scale | 12 weeks | |
Secondary | Time in Range | Evaluation of percentage of time spent in goal range via continuous glucose monitor system | 12 weeks |
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