T2D Pilot Study for Patients With Uncontrolled Type 2 Diabetes

NCT06988540 | Completed

• 1 other identifier: Pro00110685
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1c

  Blood test to determine average blood sugar

  Day 1 (Preintervention) and Month 5 (Postintervention)

Secondary Outcomes (13)

• Attendance at Personalized Health Program Group Meetings

  16 weeks

• Diabetes Empowerment Scale

  Day 1 (Preintervention) and Month 5 (Postintervention)

• Diabetes Distress

  Day 1 (Preintervention) and Month 5 (Postintervention)

• Triglycerides

  Day 1 (Preintervention) and Month 5 (Postintervention)

• HDL Cholesterol

  Day 1 (Preintervention) and Month 5 (Postintervention)

Other Outcomes (3)

• Diabetes Care Profile

  Day 1 (preintervention)

• Post Program Satisfaction

  Month 5 (Postintervention)

• Patient Goals

  Obtained during sessions 3-8 during the intervention for the intervention group

Study Arms (2)

Personalized Health Planning Program Participant with Type 2 Diabetes

EXPERIMENTAL

A novel virtual group visit care model for individuals with T2D for long-term health improvements and disease management. This intervention group will receive a 16-week virtual, Personal Health Planning (PHP) T2D Program emphasizing behavioral engagement, utilizing a mixed methods research design. Outcomes include cardiometabolic labs and surveys.

Other: Personalized Health Planning Program Administration

Usual Care (Type 2 DM)

PLACEBO COMPARATOR

The control group will receive usual care. They will be asked to have laboratory tests and answer survey questions regarding diabetes distress and diabetes empowerment.

Other: Usual Care

Interventions

Personalized Health Planning Program Administration OTHER

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.

Personalized Health Planning Program Participant with Type 2 Diabetes

Usual Care OTHER

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.

Usual Care (Type 2 DM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 Diabetes diagnosis
• and over
• A1C results in last 18 months
• A1C of 8-12
• Access to a electronic device with internet
• Duke Patient

You may not qualify if:

• Type 1 Diabetes
• Pregnant
• Blind
• Deaf
• Cognitive Impairment

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Health System

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Health Behavior; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Study Officials

• Susan E Spratt, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial with intervention receiving a 16 week personalized health plan and control group receiving usual care

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: May 25, 2025
• Study Start: September 1, 2022
• Primary Completion: June 29, 2023
• Study Completion: February 28, 2024
• Last Updated: June 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)