Optimizing Adherence and Glycemia in Youth With New Insulin-dependent Diabetes Mellitus (IDDM)
Not Applicable
Completed
- Conditions
- Type 1 Diabetes Mellitus
- Registration Number
- NCT00745342
- Lead Sponsor
- Joslin Diabetes Center
- Brief Summary
This 2-year randomized, controlled trial examined the impact of a clinic-based, family teamwork intervention on glycemic control in youth with recently diagnosed type 1 diabetes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 105
Inclusion Criteria
- 8 to 17 years old
- Duration of type 1 diabetes between 2 months and 6 years
- Residence in New England or New York
- At least 1 outpatient visit in the past year
Exclusion Criteria
- Major co-morbid psychiatric or medical illness in youth
- Diagnosis of an active major psychiatric disorder in either parent
- Diagnosis of a life-threatening medical illness in either parent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Glycemic control, assessed by hemoglobin A1c 2 years Change in A1c from baseline to 2 years, measured every 3 months
- Secondary Outcome Measures
Name Time Method Youth quality of life, measured using the youth PedsQL survey and the parent-proxy PedsQL survey 2 years Measured at baseline, 1 year, and 2 years
Diabetes-specific family conflict, measured using the Diabetes Family Conflict survey (youth and parent versions) 2 years Measured at baseline, 1 year, and 2 years
Parent involvement in diabetes management tasks, measured using the Diabetes Family Responsibility Questionnaire (youth and parent versions) 2 years Measured at baseline, 1 year, and 2 years
Trial Locations
- Locations (1)
Joslin Diabetes Center
🇺🇸Boston, Massachusetts, United States
Joslin Diabetes Center🇺🇸Boston, Massachusetts, United States