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Completed

NCT Number: NCT06988540

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 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).

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Key information

Conditions

Diabetes Mellitus Behavior Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Group Meetings Health Behavior Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke Health System

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Hemoglobin A1c

    Time frame: Day 1 (Preintervention) and Month 5 (Postintervention)

    Blood test to determine average blood sugar

Secondary outcomes

  1. Attendance at Personalized Health Program Group Meetings

    Time frame: 16 weeks

  2. Diabetes Empowerment Scale

    Time frame: Day 1 (Preintervention) and Month 5 (Postintervention)

    The Diabetes Empowerment Scale (DES) is a tool designed to measure the psychosocial self-efficacy of people with diabetes. It helps assess how confident individuals feel about managing their diabetes and making necessary lifestyle changes. The DES consists of 28 items divided into three subscales: Managing the Psychosocial Aspects of Diabetes, Assessing Dissatisfaction and Readiness to Change, Setting and Achieving Goals. Each item on the DES is rated on a 5-point Likert scale, with 1 indicating strongly disagree and 5 indicating strongly agree. Total score is obtained by dividing by number of questions answered so total score range would be 1-5. Higher scores indicate greater empowerment and confidence in managing diabetes. Lower scores suggest areas where the individual may need more support or education

  3. Diabetes Distress

    Time frame: Day 1 (Preintervention) and Month 5 (Postintervention)

    The Diabetes Distress Scale (DDS) is a tool designed to measure the emotional burden and stress associated with managing diabetes. It consists of 17 items that assess various aspects of diabetes-related distress over the past month 1. Each item, subdomain scale, and total scale is rated on a 6-point scale, ranging from 1 (not a problem) to 6 (a very serious problem). The subdomains are: Emotional Burden Physician-related Distress Regimen-related Distress Interpersonal Distress

  4. Triglycerides

    Time frame: Day 1 (Preintervention) and Month 5 (Postintervention)

    Triglycerides is a type of lipid measurement

  5. HDL Cholesterol

    Time frame: Day 1 (Preintervention) and Month 5 (Postintervention)

    HDL Cholesterol is a type of lipid measurement

  6. LDL Cholesterol

    Time frame: Day 1 (Preintervention) and Month 5 (Postintervention)

    LDL Cholesterol is a type of lipid measurement

  7. Total Cholesterol

    Time frame: Day 1 (Preintervention) and Month 5 (Postintervention)

    Total Cholesterol is a type of lipid measurement

  8. Body Mass Index (BMI)

    Time frame: Day 1 (Preintervention) and Month 5 (Postintervention)

    A measure of weight standardize for height to assess whether patient is considered normal, overweight, or obese

  9. Systolic Blood Pressure

    Time frame: Day 1 (Preintervention) and Month 5 (Postintervention)

  10. Diastolic Blood Pressure

    Time frame: Day 1 (Preintervention) and Month 5 (Postintervention)

  11. Hemoglobin A1c

    Time frame: Month 17

    Blood test to determine average blood sugar

  12. Patient Goals Progress

    Time frame: Sessions 3-8 during the intervention

    Participant rated success based on a 1-5 likert scale, 5 being higher success rate

  13. Fasting Plasma Glucose

    Time frame: Day1 (preintervention), Month 5 (post intervention), Month 17 (1 year post intervention)

Other outcomes

  1. Diabetes Care Profile

    Time frame: Day 1 (preintervention)

    The DCP is a self-administered questionnaire that assesses the social and psychological factors related to diabetes and its treatment. The instrument contains 234 items and sixteen scales. These scales assess diabetes attitudes, diabetes beliefs, self-reported diabetes self-care, and difficulties with diabetes mgt. IT will be administered pre intervention to personalize each individual's care plan.

  2. Post Program Satisfaction

    Time frame: Month 5 (Postintervention)

    Post Program Satisfaction for intervention group only

  3. Patient Goals

    Time frame: Obtained during sessions 3-8 during the intervention for the intervention group

    Patient selected diabetes management goals

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
May 25, 2025
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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