Diabetes MellitusVITAL-CGMNCT05935514
Improving Glycemic Control Using a Virtual Weight Control Program and Continuous Glucose Monitoring
A study testing WW Intervention in people with Diabetes Mellitus and Type 2 Diabetes, run by Pennington Biomedical Research Center at 3 sites in United States.
Trial summary
This study is a randomized clinical trial with the primary aim examining the efficacy of a novel integrated solution of a digitally delivered behavioral weight management program tailored for diabetes utilizing a continuous glucose monitor (CGM) built into the WW digital platform for adults with type 2 diabetes (T2D)… Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Diabetes Mellitus, Type 2 Diabetes, Obesity
- What is being tested?
- WW Intervention
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 3 sitesUnited States
- Study dates
- 22 Aug 2023to 23 Oct 2025
- 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 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18.0 - <70 years of age
- Participant-reported diagnosis of type 2 diabetes
- HbA1c 7.5%-11% (inclusive)
- Overweight or obesity (BMI 25-50 kg/m2 or BMI 23-50 kg/m2 if Asian or Asian American)
- On stable regimen of medications that can affect weight or diabetes outcomes for at least 3 months (brief regimens of medications such as antibiotics, steroids, etc. are permitted)
- Weight stable (+/- 5%) over previous:
Show all 16Show fewer
- 3 months
- Or 6 months if on medications that impact weight like GLP-1 diabetes medications.
- Willingness to attend weekly WW Virtual Workshops and Weekly Check-Ins and participate in WW Digital program
- Willingness to lose weight through a diet and lifestyle change intervention
- Access to a smartphone/tablet that can download the WW app
- Willingness to wear a continuous glucose monitor for duration of the trial
- Willing and able to provide a valid email address for use in the study
- Be able to communicate (oral and written) in English
- Be under the care of a physician who will be responsible for managing the subject's diabetes and a participant who is willing to give release to provide their treating MD with information about the trial
- Be able to provide informed consent
Who cannot join
- Participation in a structured, formal weight control program within the past 3 months
- Use of a continuous glucose monitor within the past 3 months (consistently for 4 weeks or more where blood sugar recordings could be seen/monitored in real time)
- Weight loss surgery (sleeve or bypass)
- History of major surgery within 6 months of enrollment
- Type 1 diabetes
- More than 1 severe hypoglycemic event (requiring emergency medical services) in the past 12 months, unless the participant's physician provides written clearance for participation
Show all 23Show fewer
- Any history of significant kidney or liver disease or malnutrition that in investigator judgment should exclude participation
- Hemoglobinopathy that interferes with measurement of HbA1c
- Class II or higher congestive heart failure
- Unstable heart disease (an ongoing workup or treatment for a cardiac symptom such as unstable angina, coronary ischemia)
- Presence of implanted cardiac defibrillator
- Blood pressure ≥160/100 mm Hg. If a potential participant has a blood pressure ≥160/100 mm Hg it is acceptable to re-test this potential participant within one week of the original test
- Thyroid disease for which the participant is untreated or has had treatment changed within the last 6 months. History of thyroid disease or current thyroid disease treated with a stable medication regimen for at least 2 months is acceptable
- Orthopedic limitations that would interfere with ability to engage in regular physical activity
- Uncontrolled gastrointestinal disorders including chronic malabsorptive conditions, peptic ulcer disease, Crohn's disease, chronic diarrhea or active gallbladder disease
- Current cancer or cancer treatment, or a history of cancer or cancer treatment within the last 3 years. Exceptions include 1) successfully resected non-melanoma carcinoma of the skin, 2) basal or squamous cell skin cancer, 3) stage 0 non-invasive carcinoma of the cervix, 4) stage 0 non-invasive prostate cancer
- Dementia, psychiatric illness, or substance abuse that may interfere with adherence (e.g., illness that is currently unstable or resistant to first-line therapy; substance abuse in the past year)
- History of clinically diagnosed eating disorder including anorexia nervosa or bulimia nervosa.
- Women who are pregnant, lactating, trying to become pregnant or unwilling to use an effective means of birth control
- Currently consuming >14 alcoholic drinks (1 drink = 12 fl oz beer, 4 fl oz wine or 1.5 fl oz liquor) per week and unwilling to limit intake to less than 3 drinks per day during study participation
- Participation in another clinical trial within 30 days prior to enrollment
- Participation in WW anytime in the last 12 months
- Any other condition or factor which in the opinion of the study physician or investigator makes it inadvisable for the candidate to participate in the trial
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
Stanford University
Stanford, California, 94305
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27101
About this study
Official title: Improving Glycemic Control Using a Virtual Weight Control Program and Continuous Glucose Monitoring in Adults With Type 2 Diabetes
This study is a randomized clinical trial with the primary aim examining the efficacy of a novel integrated solution of a digitally delivered behavioral weight management program tailored for diabetes utilizing a continuous glucose monitor (CGM) built into the WW digital platform for adults with type 2 diabetes (T2D) for the reduction of HbA1c.
Read the detailed description
This study is a 12-month, two-arm, parallel controlled trial. A total of 152 adults with overweight or obesity and type 2 diabetes were randomized to either 1) intervention, or 2) usual care. The intervention arm will participate in the WW program modified for people with T2D including weekly Virtual Workshops and use of the WW App plus FreeStyle Libre 2 continuous glucose sensors. The WW program is a widely available, commercial weight management program that encourages healthy habits in the areas of food, activity, mindset, and sleep, with topics specific to diabetes. Participants in the usual care arm will receive their normal, usual care from their healthcare providers in addition to a session with a Registered Dietician at baseline. All participants will participate in the collection of patient-reported outcomes at baseline and at 6 and 12 months.
- Conditions
- Diabetes Mellitus, Type 2 Diabetes, Obesity
- Being tested
- WW Intervention, Usual Care
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WW InterventionBehavioural
The core of the WW food program is the Points® system which assigns each food and beverage a Points® value. Participants will be assigned a personalized daily and weekly Points® Budget, based on reported goals, and designed to create an energy deficit, using the Mifflin St-Jeor formula, which uses age, sex, height, and weight to estimate resting energy expenditure. Participants will also be provided with the FreeStyle Libre 2 Flash Glucose Monitoring System, which is intended to monitor interstitial fluid glucose levels to aid users in the management of diabetes. The System consists of the following primary components: 1) A disposable sensor that incorporates a subcutaneously implanted electrochemical glucose sensor and associated on-body electronics, and 2) A disposable, sensor application device, which is used to adhere the sensor to the skin of the user and to insert the sensor tail just below the surface of the skin.
Usual CareBehavioural
The Usual Care arm will continue to receive routine medical care by their provider, in addition to a 50-minute virtual, on-line session with a Registered Dietician, with additional materials at the time of their 6- and 12-month follow-up assessments.
| Study group | Role | What they receive |
|---|---|---|
| WW Intervention | Experimental | Participants in the intervention arm will receive a voucher code that provides 12 months of access to the WW program and instructions for redeeming the code by study staff. The program will include access to weekly Virtual Workshops and the WW App. WW is a widely available, commercial behavioral weight management program that encourages healthy habits in the areas of food, activity, mindset, and sleep, with topics tailored specific to T2D. Participants will also be provided with the FreeStyle Libre 2 Flash Glucose Monitoring System to wear for the duration of the trial. Receives: Behavioral: WW Intervention |
| Usual Care | Active comparator | Patients in the Usual Care group will continue to receive routine medical care by their healthcare provider. In addition, within 4 weeks of the baseline visit, participants in the Usual Care group will receive one 50-minute virtual on-line session of nutrition counseling with a registered dietitian with additional materials at the time of their 6- and 12-month follow-up assessments, based on current recommendations of the American Diabetes Association. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c% at 6 months
Hemoglobin A1c levels (%) are measured using standard laboratory methods
Measured: Baseline to 6 months
Secondary outcomes (19)
Change in HbA1c% at 12 months
Hemoglobin A1c levels (%) are measured using standard laboratory methods
Measured: Baseline and 12 months
Percent weight loss at 6 months
Body weight is measured using standard methods with the patient wearing light clothing
Measured: Baseline and 6 months
Percent weight loss at 12 months
Body weight is measured using standard methods with the patient wearing light clothing
Measured: Baseline and 12 months
Change in systolic blood pressure at 6 months
Systolic blood pressure is measured using standard clinical methods
Measured: Baseline and 6 months
Change in systolic blood pressure at 12 months
Systolic blood pressure is measured using standard clinical methods
Measured: Baseline and 12 months
Change in diastolic blood pressure at 6 months
Diastolic blood pressure is measured using standard clinical methods
Measured: Baseline and 6 months
Change in diastolic blood pressure at 12 months
Diastolic blood pressure is measured using standard clinical methods
Measured: Baseline and 12 months
Change in diabetes distress at 6 months
The Diabetes Distress Scale (DDS-17) contains 17 total items with 4 subscales: Emotional Burden (items 1, 3, 8, 11, 14), Physician-related distress (items 2, 4, 9, 15), Regimen-related distress (items 5, 6, 10, 12, 16), and Interpersonal distress (7, 13, 17). The total score is calculated by taking an average of participant responses to all 17 items. In the same manner, each subscale can have its own score by taking an average of subscale specific participant responses. A mean item score of 3 or higher is considered moderate distress and a level of distress worthy of clinical attention. The Diabetes Distress scale has been tested for reliability and validity in US based populations and abroad.
Measured: Baseline and 6 months
Change in diabetes distress at 12 months
The Diabetes Distress Scale (DDS-17) contains 17 total items with 4 subscales: Emotional Burden (items 1, 3, 8, 11, 14), Physician-related distress (items 2, 4, 9, 15), Regimen-related distress (items 5, 6, 10, 12, 16), and Interpersonal distress (7, 13, 17). The total score is calculated by taking an average of participant responses to all 17 items. In the same manner, each subscale can have its own score by taking an average of subscale specific participant responses. A mean item score of 3 or higher is considered moderate distress and a level of distress worthy of clinical attention. The Diabetes Distress scale has been tested for reliability and validity in US based populations and abroad.
Measured: Baseline and 12 months
Change in diabetes treatment satisfaction at 6 months
This survey is an 8-item survey that measures satisfaction of treatment plan for diabetes that includes use of medications, diet, and lifestyle change methods. DTSQ is not only used for comparisons between different treatment strategies but also used to assess quality of diabetes care in clinical settings. Each question is scored from zero to six, and the scores are summed, with higher scores indicating higher treatment satisfaction.
Measured: Baseline and 6 months
Change in diabetes treatment satisfaction at 12 months
This survey is an 8-item survey that measures satisfaction of treatment plan for diabetes that includes use of medications, diet, and lifestyle change methods. DTSQ is not only used for comparisons between different treatment strategies but also used to assess quality of diabetes care in clinical settings. Each question is scored from zero to six, and the scores are summed, with higher scores indicating higher treatment satisfaction.
Measured: Baseline and 12 months
Change in quality of life at 6 months
The Impact of Weight on Quality of Life-Lite is a validated self-report measure for an individuals perception of how their weight affects their day-to-day life. There are 31 items rated on a Likert scale 5-Always True to 1-Never True. Items are broken into subscales for physical function, self-esteem, sexual life, public distress, and work. Scale scores are obtained by adding item scores, and the total score is obtained by adding scale scores. Higher scores indicate poorer quality of life. Transformed scores range from 0 to 100, with higher scores indicating greater quality of life.
Measured: Baseline and 6 months
Change in quality of life at 12 months
The Impact of Weight on Quality of Life-Lite is a validated self-report measure for an individuals perception of how their weight affects their day-to-day life. There are 31 items rated on a Likert scale 5-Always True to 1-Never True. Items are broken into subscales for physical function, self-esteem, sexual life, public distress, and work. Scale scores are obtained by adding item scores, and the total score is obtained by adding scale scores. Higher scores indicate poorer quality of life. Transformed scores range from 0 to 100, with higher scores indicating greater quality of life.
Measured: Baseline and 12 months
Percentage of patients achieving 3% weight loss at 6 months
Body weight is measured using standard methods with the patient wearing light clothing
Measured: Baseline and 6 months
Percentage of patients achieving 3% weight loss at 12 months
Body weight is measured using standard methods with the patient wearing light clothing
Measured: Baseline and 12 months
Percentage of patients achieving 5% weight loss at 6 months
Body weight is measured using standard methods with the patient wearing light clothing
Measured: Baseline and 6 months
Percentage of patients achieving 5% weight loss at 12 months
Body weight is measured using standard methods with the patient wearing light clothing
Measured: Baseline and 12 months
Percentage of patients achieving 10% weight loss at 6 months
Body weight is measured using standard methods with the patient wearing light clothing
Measured: Baseline and 6 months
Percentage of patients achieving 10% weight loss at 12 months
Body weight is measured using standard methods with the patient wearing light clothing
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start22 Aug 2023
- Primary completion23 Oct 2025
- Study completion23 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- WW International Inc
- Responsible party
- Principal investigator, Peter T. Katzmarzyk, Pennington Biomedical Research Center
- Investigators
- Peter T Katzmarzyk, PhD, Principal investigator, Pennington Biomedical Research CenterJamy D Ard, MD, Principal investigator, Wake Forest University Health SciencesTracey L McLaughlin, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05935514
- Sponsor's protocol ID
- PBRC 2022-048
- Acronym
- VITAL-CGM
- Status last verified
- Feb 2026
- First submitted
- 29 Jun 2023
- Last updated
- 4 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A de-identified individual-level dataset will be made available to researchers making a reasonable request to the principal investigator. Data will be made available 1 year after publication of the primary outcomes manuscript.
Publications
Katzmarzyk PT, Drews K, Ard JD, McLaughlin TL, Harris MN, Lee A, Foster GD, Lee HJ, Dunn TC, Martin CK, Greenway FL, Cardel MI. Virtual Weight Management and Continuous Glucose Monitoring in Patients With Type 2 Diabetes: A Randomized Controlled Trial. Obesity (Silver Spring). 2026 Jun;34(6):1254-1264. doi: 10.1002/oby.70204. Epub 2026 Apr 28.
PubMed 42047631
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Glycemic Control Using a Virtual Weight Control Program and Continuous Glucose Monitoring in Adults With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05935514
- Acronym / sponsor ID
- VITAL-CGM / PBRC 2022-048
- Conditions
- Diabetes Mellitus, Type 2 Diabetes, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- WW International Inc
- Study start
- 22 Aug 2023 (actual)
- Primary completion
- 23 Oct 2025 (actual)
- Study completion
- 23 Oct 2025 (actual)
- First posted
- 7 Jul 2023 (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.
This study is a randomized clinical trial with the primary aim examining the efficacy of a novel integrated solution of a digitally delivered behavioral weight management program tailored for diabetes utilizing a continuous glucose monitor (CGM) built into the WW digital platform for adults with type 2 diabetes (T2D) for the reduction of HbA1c.
Detailed description
This study is a 12-month, two-arm, parallel controlled trial. A total of 152 adults with overweight or obesity and type 2 diabetes were randomized to either 1) intervention, or 2) usual care. The intervention arm will participate in the WW program modified for people with T2D including weekly Virtual Workshops and use of the WW App plus FreeStyle Libre 2 continuous glucose sensors. The WW program is a widely available, commercial weight management program that encourages healthy habits in the areas of food, activity, mindset, and sleep, with topics specific to diabetes. Participants in the usual care arm will receive their normal, usual care from their healthcare providers in addition to a session with a Registered Dietician at baseline. All participants will participate in the collection of patient-reported outcomes at baseline and at 6 and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WW Intervention | Experimental | Behavioral: WW InterventionParticipants in the intervention arm will receive a voucher code that provides 12 months of access to the WW program and instructions for redeeming the code by study staff. The program will include access to weekly Virtual Workshops and the WW App. WW is a widely available, commercial behavioral weight management program that encourages healthy habits in the areas of food, activity, mindset, and sleep, with topics tailored specific to T2D. Participants will also be provided with the FreeStyle Libre 2 Flash Glucose Monitoring System to wear for the duration of the trial. |
| Usual Care | Active comparator | Behavioral: Usual CarePatients in the Usual Care group will continue to receive routine medical care by their healthcare provider. In addition, within 4 weeks of the baseline visit, participants in the Usual Care group will receive one 50-minute virtual on-line session of nutrition counseling with a registered dietitian with additional materials at the time of their 6- and 12-month follow-up assessments, based on current recommendations of the American Diabetes Association. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 18.0 - <70 years of age
- Participant-reported diagnosis of type 2 diabetes
- HbA1c 7.5%-11% (inclusive)
- Overweight or obesity (BMI 25-50 kg/m2 or BMI 23-50 kg/m2 if Asian or Asian American)
- On stable regimen of medications that can affect weight or diabetes outcomes for at least 3 months (brief regimens of medications such as antibiotics, steroids, etc. are permitted)
Key exclusion criteria (23 listed)
- Participation in a structured, formal weight control program within the past 3 months
- Use of a continuous glucose monitor within the past 3 months (consistently for 4 weeks or more where blood sugar recordings could be seen/monitored in real time)
- Weight loss surgery (sleeve or bypass)
- History of major surgery within 6 months of enrollment
- Type 1 diabetes
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 |
|---|---|---|
| WW InterventionThe core of the WW food program is the Points® system which assigns each food and beverage a Points® value. Participants will be assigned a personalized daily and weekly Points® Budget, based on reported goals, and designed to create an energy deficit, using the Mifflin St-Jeor formula, which uses age, sex, height, and weight to estimate resting energy expenditure. Participants will also be provided with the FreeStyle Libre 2 Flash Glucose Monitoring System, which is intended to monitor interstitial fluid glucose levels to aid users in the management of diabetes. The System consists of the following primary components: 1) A disposable sensor that incorporates a subcutaneously implanted electrochemical glucose sensor and associated on-body electronics, and 2) A disposable, sensor application device, which is used to adhere the sensor to the skin of the user and to insert the sensor tail just below the surface of the skin. | Behavioural | WW Intervention |
| Usual CareThe Usual Care arm will continue to receive routine medical care by their provider, in addition to a 50-minute virtual, on-line session with a Registered Dietician, with additional materials at the time of their 6- and 12-month follow-up assessments. | Behavioural | Usual Care |
Primary outcome
Change in HbA1c% at 6 months
Time frame: Baseline to 6 months
Hemoglobin A1c levels (%) are measured using standard laboratory methods
19 secondary outcomes
Change in HbA1c% at 12 months
Time frame: Baseline and 12 months
Percent weight loss at 6 months
Time frame: Baseline and 6 months
Percent weight loss at 12 months
Time frame: Baseline and 12 months
Change in systolic blood pressure at 6 months
Time frame: Baseline and 6 months
Change in systolic blood pressure at 12 months
Time frame: Baseline and 12 months
Change in diastolic blood pressure at 6 months
Time frame: Baseline and 6 months
Change in diastolic blood pressure at 12 months
Time frame: Baseline and 12 months
Change in diabetes distress at 6 months
Time frame: Baseline and 6 months
Change in diabetes distress at 12 months
Time frame: Baseline and 12 months
Change in diabetes treatment satisfaction at 6 months
Time frame: Baseline and 6 months
Change in diabetes treatment satisfaction at 12 months
Time frame: Baseline and 12 months
Change in quality of life at 6 months
Time frame: Baseline and 6 months
Change in quality of life at 12 months
Time frame: Baseline and 12 months
Percentage of patients achieving 3% weight loss at 6 months
Time frame: Baseline and 6 months
Percentage of patients achieving 3% weight loss at 12 months
Time frame: Baseline and 12 months
Percentage of patients achieving 5% weight loss at 6 months
Time frame: Baseline and 6 months
Percentage of patients achieving 5% weight loss at 12 months
Time frame: Baseline and 12 months
Percentage of patients achieving 10% weight loss at 6 months
Time frame: Baseline and 6 months
Percentage of patients achieving 10% weight loss at 12 months
Time frame: Baseline and 12 months
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 4 Feb 2026.
- Derived from this study: PubMed 42047631Katzmarzyk PT, Drews K, Ard JD, McLaughlin TL, Harris MN, Lee A, Foster GD, Lee HJ, Dunn TC, Martin CK, Greenway FL, Cardel MI. Virtual Weight Management and Continuous Glucose Monitoring in Patients With Type 2 Diabetes: A Randomized Controlled Trial. Obesity (Silver Spring). 2026 Jun;34(6):1254-1264. doi: 10.1002/oby.70204. Epub 2026 Apr 28.
- Individual participant dataSharing planned: Yes. A de-identified individual-level dataset will be made available to researchers making a reasonable request to the principal investigator. Data will be made available 1 year after publication of the primary outcomes manuscript.
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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.
Peter T Katzmarzyk, PhD principal investigator
Pennington Biomedical Research Center
Jamy D Ard, MD principal investigator
Wake Forest University Health Sciences
Tracey L McLaughlin, MD principal investigator
Stanford University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WW Intervention in people with Diabetes Mellitus and Type 2 Diabetes, run by Pennington Biomedical Research Center at 3 sites 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 16 inclusion and 23 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 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. 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?
Change in HbA1c% at 6 months (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05935514, which also lists 1 linked publication.
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 4 Feb 2026; AzTrials last refreshed its copy on 1 Nov 2026.