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| ID | Type | Description | Link |
|---|---|---|---|
| 10-DK-0002 |
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Background:
Objectives:
Eligibility:
- Adolescents and young adults between 12 and 20 years of age who have been diagnosed with type 2 diabetes and whose blood glucose control needs improvement.
Design:
Background
Type 2 diabetes mellitus (T2DM) is becoming increasingly prevalent among youth, particularly in minority populations. Few pharmacologic agents are approved for the treatment of T2DM in adolescents, and behavioral and lifestyle factors may contribute to adolescents difficulty adhering to treatment regimens. A minimally-invasive buddy-intervention (to help improve diabetes control and to foster improvement in quality of life) has not been systematically evaluated in a population of pediatric patients with T2DM.
Objectives
Methods
Patients will be randomized to conventional treatment versus interventional group (buddy arm), and will be followed for 6 months. During this period, all patients should undergo two visits including laboratory testing (HbA1c) approximately 3 months apart. Those in the buddy arm will have weekly phone or online contact and once-monthly home visits from the buddy (a volunteer patient partner), with the use of systematic questionnaires and a secure database for data collection and maintenance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Other | Buddy Group - Individuals with type 2 diabetes receive conventional diabetes treatment and are assigned a patient partner (Buddy) |
|
| Group B | Active Comparator | Individuals receive conventional treatment for type 2 diabetes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Assignment of a Lay Patient Partner | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effect of a minimally invasive intervention (the buddy system) on hemoglobin A1c levels in adolescents with T2DM. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| To assess changes between groups in body weight, number of home glucose monitor checks, compliance with medications, adherence to visit schedule, and psychological well-being. | 6 months |
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Any patient with type 2 diabetes mellitus as documented by his or her primary physician
EXCLUSION CRITERIA:
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| Name | Affiliation | Role |
|---|---|---|
| Kristina I Rother, M.D. | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Childrens National Medical Center | Washington D.C. | District of Columbia | United States | |||
| National Institutes of Health Clinical Center, 9000 Rockville Pike |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9135953 | Background | Yokoyama H, Okudaira M, Otani T, Takaike H, Miura J, Saeki A, Uchigata Y, Omori Y. Existence of early-onset NIDDM Japanese demonstrating severe diabetic complications. Diabetes Care. 1997 May;20(5):844-7. doi: 10.2337/diacare.20.5.844. | |
| 10358675 | Background | Krieger J, Collier C, Song L, Martin D. Linking community-based blood pressure measurement to clinical care: a randomized controlled trial of outreach and tracking by community health workers. Am J Public Health. 1999 Jun;89(6):856-61. doi: 10.2105/ajph.89.6.856. |
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| Bethesda |
| Maryland |
| 20892 |
| United States |
| 16651496 | Background | Duncan GE. Prevalence of diabetes and impaired fasting glucose levels among US adolescents: National Health and Nutrition Examination Survey, 1999-2002. Arch Pediatr Adolesc Med. 2006 May;160(5):523-8. doi: 10.1001/archpedi.160.5.523. |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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