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NCT01007266 · ClinicalTrials.gov registry record · Phase 2
Partners for Better Health in Adolescent Type 2 Diabetes: The Buddy Study
A Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT01007266 is a Phase 2 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 10 participants.
The verdict
NCT01007266, a Phase 2 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study Summary
Background: * Type 2 diabetes mellitus (T2DM) is becoming more common among youth, particularly in minority populations. Few drug treatments are approved for T2DM in adolescents, and behavioral and lifestyle factors may contribute to their difficulties in following strict treatment regimens. * It is unknown whether a minimally invasive patient partner ( buddy ) program, which has been developed to help improve diabetes control and quality of life, will be successful in a population of pediatric patients with T2DM. Objectives: * To evaluate the effect of a minimally invasive intervention (being assigned a patient partner, or buddy ) on blood sugar levels in adolescents with T2DM. * 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. 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: * Participants will be divided by chance into two groups: in one group, participants will have a buddy and receive standard care; while in the other group, participants will receive standard care alone. * The buddy is not a health care professional and is not authorized to provide any medical advice. * Participants will be followed in the study for a total of 6 months. All study participants will receive standard treatment for T2DM. * All patients will be asked to fill out a screening questionnaire (on paper or online) at the beginning of the study and a quality of life and eating behaviors questionnaire at the beginning and at the end of the study. These forms will include questions on medical history, emotions, well-being, and eating habits. * Participants in both groups will have one diabetes clinic visit at the NIH Clinical Center or at Children s National Medical Center (CNMC) at the beginning of the study and two follow-up visi
Interventions
- BEHAVIORAL Assignment of a Lay Patient Partner
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2009-10-09 |
| Est. Completion | 2013-01-24 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01007266
The ClinicalTrials.gov registry entry for NCT01007266 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Assignment of a Lay Patient Partner is the first listed.
NCT01007266 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01007266 about?
NCT01007266 is a clinical study titled "Partners for Better Health in Adolescent Type 2 Diabetes: The Buddy Study". Background: * Type 2 diabetes mellitus (T2DM) is becoming more common among youth, particularly in minority populations. Few drug treatments are approved for T2DM in adolescents, and behavioral and lifestyle factors may contribute to their difficulties in following strict treatment regimens. * It i...
What is the current status of trial NCT01007266?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2009-10-09. Estimated completion is 2013-01-24.
What interventions are being tested in trial NCT01007266?
The interventions under investigation include: Assignment of a Lay Patient Partner (BEHAVIORAL).
Who is sponsoring clinical trial NCT01007266?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
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