T2D Pilot Study for Patients With Uncontrolled Type 2 Diabetes

Completed · Not applicable

Conditions studied: Diabetes Mellitus, Health Behavior, Diabetes Mellitus, Type 2, Group Meetings

In brief

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).

Key facts

Study ID
NCT06988540
Run by
Duke University
People needed
92
Starts
2022-09-01
Expected to finish
2024-02-28
Last updated by the study team
2025-06-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

You may not qualify if…

Where it is running

Full record on ClinicalTrials.gov

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