Type 1 Diabetes Clinical Trial
Official title:
A Comparison of Two Models for Transition of Adolescents and Young Adults With Diabetes From Pediatric to Adult Care
The purpose of the study is to compare two interventions for preparing diabetic teens and young adults for transition from pediatric to adult diabetes care.
Status | Completed |
Enrollment | 28 |
Est. completion date | May 2012 |
Est. primary completion date | May 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 16 Years to 29 Years |
Eligibility |
Inclusion Criteria: - Age 16-29 - Diagnosis of type 1 diabetes, or type 2 diabetes managed with insulin, at least one year prior to study initiation - English-speaking - Some form of private or public (e.g., Medicaid) health insurance Exclusion Criteria: - Cystic fibrosis-related or pancreatitis-related diabetes - Diabetes related to a known specific genetic defect such as Down's Syndrome, Lipoatrophic Diabetes, Leprechaunism or Rabson-Mendenhall Syndrome, etc. - Chronic liver disease - History of chronic renal failure - Serious psychiatric illness that in the judgment of the investigators would preclude the individual's ability to complete the study - Pregnant or planning to become pregnant within 6 months |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Kansas Medical Center | Kansas City | Kansas |
Lead Sponsor | Collaborator |
---|---|
University of Kansas Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measure and compare change in self-efficacy and change in diabetes knowledge, diabetes quality of life, family conflict, and treatment satisfaction for and between the two groups. | 6 months and 12 months | No | |
Secondary | Make exploratory baseline comparisons between the two groups regarding locus of diabetes care (kind of provider), comparing numbers of subjects in each group who made a successful transition to adult care | 6 months and 12 months | No | |
Secondary | Make exploratory baseline comparisons between the two groups of using some form of social networking by the two groups as an adjunt of diabetes care. | 6 months and 12 months | No | |
Secondary | Make exploratory baseline comparisons between the two groups regarding provider and educator time devoted in each arm of the intervention (in order to prepare for a robust comparative effectiveness analysis in a subsequent study). | 6 months | No | |
Secondary | Make exploratory baseline comparisons between the two groups of HgbA1c | 6 months and 12 months | No |
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