Diabetes MellitusNCT06988540
T2D Pilot Study for Patients With Uncontrolled Type 2 Diabetes
A study testing Personalized Health Planning Program Administration in people with Diabetes Mellitus and Health Behavior, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Health Behavior, Diabetes Mellitus, Type 2
- What is being tested?
- Personalized Health Planning Program Administration
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 28 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Type 1 Diabetes
- Pregnant
- Blind
- Deaf
- Cognitive Impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Telehealth Personal Health Planning Program 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).
- Being tested
- Personalized Health Planning Program Administration, Usual Care
- Medical subject headings
- Diabetes Mellitus, Health Behavior, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Health Planning Program AdministrationOther
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 CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c
Blood test to determine average blood sugar
Measured: Day 1 (Preintervention) and Month 5 (Postintervention)
Secondary outcomes (13)
Attendance at Personalized Health Program Group Meetings
Measured: 16 weeks
Diabetes Empowerment Scale
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
Measured: Day 1 (Preintervention) and Month 5 (Postintervention)
Diabetes Distress
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
Measured: Day 1 (Preintervention) and Month 5 (Postintervention)
Triglycerides
Triglycerides is a type of lipid measurement
Measured: Day 1 (Preintervention) and Month 5 (Postintervention)
HDL Cholesterol
HDL Cholesterol is a type of lipid measurement
Measured: Day 1 (Preintervention) and Month 5 (Postintervention)
LDL Cholesterol
LDL Cholesterol is a type of lipid measurement
Measured: Day 1 (Preintervention) and Month 5 (Postintervention)
Total Cholesterol
Total Cholesterol is a type of lipid measurement
Measured: Day 1 (Preintervention) and Month 5 (Postintervention)
Body Mass Index (BMI)
A measure of weight standardize for height to assess whether patient is considered normal, overweight, or obese
Measured: Day 1 (Preintervention) and Month 5 (Postintervention)
Systolic Blood Pressure
Measured: Day 1 (Preintervention) and Month 5 (Postintervention)
Diastolic Blood Pressure
Measured: Day 1 (Preintervention) and Month 5 (Postintervention)
Hemoglobin A1c
Blood test to determine average blood sugar
Measured: Month 17
Patient Goals Progress
Participant rated success based on a 1-5 likert scale, 5 being higher success rate
Measured: Sessions 3-8 during the intervention
Fasting Plasma Glucose
Measured: Day1 (preintervention), Month 5 (post intervention), Month 17 (1 year post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start1 Sep 2022
- Primary completion29 Jun 2023
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial with intervention receiving a 16 week personalized health plan and control group receiving usual care
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan E Spratt, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06988540
- Sponsor's protocol ID
- Pro00110685
- Status last verified
- Apr 2025
- First submitted
- 16 May 2025
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Telehealth Personal Health Planning Program for Patients With Uncontrolled Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06988540
- Acronym / sponsor ID
- Pro00110685
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 29 Jun 2023 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial with intervention receiving a 16 week personalized health plan and control group receiving usual care
| Arm | Type | Receives |
|---|---|---|
| Personalized Health Planning Program Participant with Type 2 Diabetes | Experimental | Other: Personalized Health Planning Program AdministrationA 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. |
| Usual Care (Type 2 DM) | Placebo comparator | Other: Usual CareThe control group will receive usual care. They will be asked to have laboratory tests and answer survey questions regarding diabetes distress and diabetes empowerment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- Type 1 Diabetes
- Pregnant
- Blind
- Deaf
- Cognitive Impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized Health Planning Program AdministrationThe 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 | Personalized Health Planning Program Participant with Type 2 Diabetes |
| Usual CarePatients 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. | Other | Usual Care (Type 2 DM) |
Primary outcome
Hemoglobin A1c
Time frame: Day 1 (Preintervention) and Month 5 (Postintervention)
Blood test to determine average blood sugar
13 secondary outcomes
Attendance at Personalized Health Program Group Meetings
Time frame: 16 weeks
Diabetes Empowerment Scale
Time frame: Day 1 (Preintervention) and Month 5 (Postintervention)
Diabetes Distress
Time frame: Day 1 (Preintervention) and Month 5 (Postintervention)
Triglycerides
Time frame: Day 1 (Preintervention) and Month 5 (Postintervention)
HDL Cholesterol
Time frame: Day 1 (Preintervention) and Month 5 (Postintervention)
LDL Cholesterol
Time frame: Day 1 (Preintervention) and Month 5 (Postintervention)
Total Cholesterol
Time frame: Day 1 (Preintervention) and Month 5 (Postintervention)
Body Mass Index (BMI)
Time frame: Day 1 (Preintervention) and Month 5 (Postintervention)
Systolic Blood Pressure
Time frame: Day 1 (Preintervention) and Month 5 (Postintervention)
Diastolic Blood Pressure
Time frame: Day 1 (Preintervention) and Month 5 (Postintervention)
Hemoglobin A1c
Time frame: Month 17
Patient Goals Progress
Time frame: Sessions 3-8 during the intervention
Fasting Plasma Glucose
Time frame: Day1 (preintervention), Month 5 (post intervention), Month 17 (1 year post intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan E Spratt, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Health Planning Program Administration in people with Diabetes Mellitus and Health Behavior, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A1c (time frame: Day 1 (Preintervention) and Month 5 (Postintervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.