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NCT06988540 · ClinicalTrials.gov registry record · NA
T2D Pilot Study for Patients With Uncontrolled Type 2 Diabetes
A NA study of Diabetes Mellitus, Type 2 and Diabetes Mellitus, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 92
- Enrollment target
- 1
- Study location
NCT06988540 is a NA study of Diabetes Mellitus, Type 2 and Diabetes Mellitus that has completed, run by Duke University. The registered enrollment target is 92 participants, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06988540, a NA study of Diabetes Mellitus, Type 2 and Diabetes Mellitus, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 92 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective of the study is to evaluate implementation and determine the effectiveness of a telehealth personal health planning program for individuals with uncontrolled Type 2 Diabetes Mellitus. For this study, participants will be randomized into either the Telehealth Program or the standard of care group. The personal health planning (PHP) Type 2 Diabetes program is a virtual, 8 session/16- week behavioral health program. The program includes development of a personal health plan supported by a patient-provider health risk assessment; group session structure supplemented by educational, on-demand video sessions; lessons, discussions, and activities based on understanding behavioral modification, health engagement, and diabetes distress; goal progress tracking; social support; mindful awareness practices; 3 and 6-month post program sessions and qualitative health evaluations via surveys and a one-on-one consultation with a personal health coach. Those in the control group will receive usual care by the participants personal care team. All participants will come to the Duke Research at Pickett Road facility for a pre and post-program fasting A1C and lipid panel blood draw (if required).
Conditions Studied
Interventions
- OTHER Usual Care
- OTHER Personalized Health Planning Program Administration
Study Locations (1)
North Carolina
- Duke Health System - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2022-09-01 |
| Est. Completion | 2024-02-28 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06988540
The ClinicalTrials.gov registry entry for NCT06988540 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 92 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,485-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (98% lower). The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 2 interventions - of which Usual Care is the first listed.
NCT06988540 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT06988540 about?
NCT06988540 is a clinical study titled "T2D Pilot Study for Patients With Uncontrolled Type 2 Diabetes". The primary objective of the study is to evaluate implementation and determine the effectiveness of a telehealth personal health planning program for individuals with uncontrolled Type 2 Diabetes Mellitus. For this study, participants will be randomized into either the Telehealth Program or the stan...
What is the current status of trial NCT06988540?
This trial is currently completed. It is a NA study. The enrollment target is 92 participants. The study started on 2022-09-01. Estimated completion is 2024-02-28.
What conditions does trial NCT06988540 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2, Diabetes Mellitus, Health Behavior, Group Meetings.
What interventions are being tested in trial NCT06988540?
The interventions under investigation include: Usual Care (OTHER), Personalized Health Planning Program Administration (OTHER).
Who is sponsoring clinical trial NCT06988540?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06988540 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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