NCT06988540

T2D Pilot Study for Patients With Uncontrolled Type 2 Diabetes

Evaluation of a Telehealth Personal Health Planning Program for Patients With Uncontrolled Type 2 Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Diabetes Mellitus
• Health Behavior
• Diabetes Mellitus, Type 2
• Group Meetings

Interventions

Type	Name	Description
OTHER	Personalized Health Planning Program Administration	The T2D PHP program is 8 hour-long sessions offered over 16 weeks. The program includes development of a personal health plan supported by a patient-provider health risk assessment; group session structure supplemented by educational, video sessions; lessons, discussions, and activities based on behavioral modification, health engagement, and diabetes distress; goal progress tracking; social support; mindful awareness practices and qualitative health evaluations via surveys and a one-on-one consultation with a personal health coach. Participants will be provided a group participant notebook that provides information discussed during the program. The T2D PHP program is a complement to routine care.
OTHER	Usual Care	Patients will be encouraged to see their diabetes provider. Patients will not participate in the T2D PHP program but will complete laboratory tests and surveys as listed in the section on outcomes.

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-06-29
• Completion: 2024-02-28
• First posted: 2025-05-25
• Last updated: 2025-06-06

Locations

1 site across 1 country: United States