Type 2 DiabetesTPTNCT05181449
Randomized Controlled Trial of Digital Twin Precision Treatment: A Novel Whole Body Digital Twin Enabled Precision Treatment for Type 2 Diabetes
A study testing Twin Precision Treatment in people with Type 2 Diabetes, run by The Cleveland Clinic at 1 site in United States.
Trial summary
This is a randomized study comparing outcomes of patients diagnosed with Type 2 Diabetes (T2D) who are enrolled into the Twin Health Precision Treatment (TPT) system versus usual care. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Twin Precision Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2022to 29 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women between ages 18 and 75
- Self-reported duration of Type 2 diabetes less than or equal to 15 Years
- Own smartphone and compatible with TPT and sensors (iPhone and android)
- Baseline HbA1c of ≥ 7.5% and ≤ 11% or baseline A1c ≥ 6.5% but < 7.5% on any glucose lowering medication (inclusive of Metformin). For patients with a baseline A1c of < 6.5%, the patient must be on at least one glucose lowering medication with or without Metformin.
- BMI: ≥ 27 Kg/2
- NAFLD Fibrosis Score > -1.00 to be screened and enrolled for additional subset MRE evaluation (optional for patient to consent to MRE evaluation) of liver steatosis/fibrosis (30 patients from TPT group and 15 patients from the Usual Care group)
Who cannot join
- HbA1C >11%
- Type 1 diabetes, latent autoimmune diabetes in adults (LADA), maturity onset diabetes of the young (MODY), pancreatic diabetes, gestational diabetes mellitus, any secondary diabetes by clinical history, or fasting C Peptide < 1 mmol/L or GAD-65 antibody positivity
- Currently or in past 3 months receiving an anti-obesity medication or any other medication used for the primary intent of weight loss
- History of hospitalization (within the last 12 months) for diabetic ketoacidosis
- History of acute coronary syndrome, myocardial infarction, or stroke within the prior 12 months
- Inadequate hepatic function as measured by AST/ALT > 3.0 x ULN
Show all 17Show fewer
- Inadequate renal function as measured by eGFR < 30 mL/min/1.73 m2
- Current chronic corticosteroid therapy (≥ 5 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids)
- Major surgical procedure or significant traumatic injury within 28 days prior to Enrollment Date
- Patients who have undergone or are planning for any bariatric procedure
- Pregnant, planning pregnancy in the next 12 months and lactating/nursing females
- Any medical or surgical condition that the principal investigator considers making the patient unfit for the trial (e.g., psychiatric disorders, malignancy, etc.)
- Mental incapacity or language barrier
- Excessive alcohol intake (defined as self-reported greater than or equal to 3 drinks per day)
- History of Congestive Heart Failure
- Any condition, unwillingness, or inability, not covered by any of the other exclusion criteria, which, in the study clinician's opinion, might jeopardize the subject's safety or compliance with the protocol
- Patients who do not have any insurance (government or commercial) coverage at the time of enrollment to avoid confounders in data
Trial locations and contacts
1 site in 1 country.
About this study
This is a randomized study comparing outcomes of patients diagnosed with Type 2 Diabetes (T2D) who are enrolled into the Twin Health Precision Treatment (TPT) system versus usual care. The study will last for a year with a 1 year optional extension for the TPT arm patients to continue for another year, and for the usual care (UC) patients to cross over to the TPT treatment for a year.
150 patients will be enrolled with 100 being randomized to the TPT arm and 50 being enrolled to the UC arm
Read the detailed description
This is a randomized study comparing outcomes of usual care patients diagnosed with Type 2 Diabetes (T2D) with patients diagnosed with T2D enrolled onto Twin Health's TPT system. Twin Precision Treatment (TPT) system utilizes live, exercise and nutrition coaching based on computer algorithm learning to attempt to improve patients overall health and reverse type 2 diabetes (T2D). The TPT system does so by measuring and addressing glucose aberrations associated with meals. Using Whole Body Digital Twin (WBDT) platform powered by Artificial Intelligence (AI) and the Internet of Things (IoT) technologies, the Whole Body Digital Twin platform captures data on up to 174 health markers, up to 3000 daily data points to provide precision nutrition guidance to the patient that precisely balances 87 essential nutrient factors. The platform captures daily weight using Bluetooth scales and captures daily blood pressure, particularly in patients with underlying HTN using Bluetooth blood pressure measurement. Additionally, the Whole Body Digital Twin platform captures daily physical activity and sleep data, and provides precision guidance on activity and sleep for the patient to follow.
The machine learning algorithm is devised to integrate these multi-dimensional data and accurately predict personalized glucose responses. Dietary intake is a central determinant of blood glucose levels, and thus, to achieve optimal glucose levels, it is imperative to make food choices that induce normal postprandial glycemic responses. Thus, the platform will suggest the right food to the right participant at the right time.
Depending on the likes and dislikes of the patient, the Whole Body Digital Twin platform will recommend a meal plan that is balanced across macro, micro and biota nutrients to reduce glucotoxicity and lipotoxicity, which helps in ameliorating inflammation, fatty liver and insulin resistance. This precise management of nutrition, activity and sleep ensures that the average blood glucose of the day will be consistently maintained within the optimal range. The intervention will continuously offer precision nutrition, precision sleep and precision activity recommendations. Nutritional, activity, and sleep counseling will be provided by trained health coaches through the app and via telephone.
In the usual care of type 2 diabetes, glucose-lowering medications are added progressively with lifestyle modification to improve glycemia and optimize glycated hemoglobin values (HbA1c) so as to reduce the risk of developing long-term complications. Standard of care is to take such a glucose-centric approach to T2D management rather than focusing treatment on the underlying root causes of the disease. It is rare to attempt to target remission of the diabetes process since remission occurs in usual care regimens in only a very small percentage of patients with type 2 diabetes (21). Studies that target other metabolic disease states, such as obesity, have been proven to also impact T2D progression and achieve remission states, but these types of approaches are rare in the usual care setting (22). Only three therapeutic approaches have been associated with remission of diabetes: 1. Bariatric surgery, 2. Very Low-Calorie diet, and 3. Ketogenic diet with near elimination of carbohydrate (23). Our study attempts to determine if precision nutritional, activity and sleep guidance associated with the Whole Body Digital Twin (WBDT) platform and Twin Precision Treatment (TPT) can lead to diabetes remission in a population of patients with T2D.
- Conditions
- Type 2 Diabetes
- Being tested
- Twin Precision Treatment
- Keywords
- Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Twin Precision TreatmentBehavioural
Combination of Artificial Intelligence algorithms based on daily sensor input and live nutrition, exercise, sleep and breath coaching to help treat type 2 diabetes
| Study group | Role | What they receive |
|---|---|---|
| Twin Precision Treatment (TPT) | Experimental | Twin Precision Treatment (combination of AI and lifestyle coaching) Receives: Behavioral: Twin Precision Treatment |
| Usual Care (UC) | No intervention | Usual care prescribed by Cleveland Clinic diabetes specialists and primary care physicians |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the percentage of patients in the TPT and Usual Care groups who have a HbA1c less than 6.5 and are not on any glucose lowering medications (excluding Metformin up to 2000 mg/day) at 12 months (360 days).
Measured: 360 days
Secondary outcomes (16)
To compare the percentage of patients in the TPT and Usual Care groups who have a HbA1c less than at 6.5 and are not on any glucose lowering medications at 12 months (360 days).
Measured: 360 days
To compare the percentage of patients in the TPT and Usual Care groups who have a HbA1c less than 6.5 and are not on any glucose lowering medications (excluding Metformin up to 2000 mg/day) for at least 90 days at 12 months (360 days).
Measured: 360 days
To compare the percentage of patients in the TPT and Usual Care groups who have a HbA1c less than at 6.5 and are not on any glucose lowering medications for at least 90 days at 12 months (360 days).
Measured: 360 days
To compare the percentage of patients in TPT and Usual Care Groups with an HbA1c of less than 6.5 and on no glucose lowering medications (excluding Metformin up to 2000 mg/day) at 6 months (180 days).
Measured: 360 days
To compare the percentage of patients in TPT and Usual Care Groups with a HbA1c of less than 6.5 and no glucose lowering medications at 3 months (90 days) that can sustain a HbA1c below 6.5 when checked again at 6 months (180 days).
(excluding Metformin up to 2000 mg/day)
Measured: 90 and 180 days
To assess the percentage of patients in the TPT Group on no glucose lowering medications (excluding Metformin up to 2000 mg/day) who have a 60 day eA1c less than 6.5 at 3 months (90 days) and 6 months (180 days).
Measured: 90 and 180 days
To compare the percentage of patients in the TPT and Usual Care Groups who are on no glucose lowering medications and have a HbA1c less than 6.5 at 6 months (180 days).
Measured: 180 days
To compare the percentage of patients in TPT and Usual Care Groups with a HbA1c of less than 6.5 and no glucose lowering medications at 3 months (90 days) that can sustain a HbA1c below 6.5 when checked again at 6 months (180 days).
Measured: 180 days
To assess the percentage of patients in the TPT Group on no glucose lowering medications who have a 60 day eA1c less than 6.5 at 3 months (90 days) and 6 months (180 days).
Measured: 90 and 180 days
To compare the percentage of patients in TPT and Usual Care Groups with an HbA1c of less than 7.0 and on no glucose lowering medications (excluding Metformin up to 2000 mg/day) at 6 months (180 days) and 12 months (360 days).
Measured: 180 and 360 days
To compare the percentage of patients in TPT and Usual Care Groups with an HbA1c of less than 7.0 and on no glucose lowering medications at 6 months (180 days) and 12 months (360 days).
Measured: 180 and 360 days
For patients in the TPT and Usual Care Groups with an enrollment HbA1c greater than 9.0, compare the n (%) of patients who achieve a HbA1c less than 7.0 on no glucose lowering medications (excluding Metformin up to 2000 mg /day) at 12 months.
Measured: 12 months
For patients in the TPT and Usual Care Groups with an enrollment HbA1c greater than 9.0, compare the n (%) of patients who achieve a HbA1c less than 7.0 on no glucose lowering medications at 12 months.
Measured: 12 months
To compare HbA1c (mean change between groups) at 6 and 12 months (180 and 360 days).
Measured: 180 and 360 days
To compare weight (mean % change between groups) at 6 and 12 months (180 and 360 days).
Measured: 180 and 360 days
To compare waist circumference (mean change between groups) at 6 and 12 months (180 and 360 days) between the TPT and Usual Care groups.
Measured: 180 and 360 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start1 Feb 2022
- Primary completion15 May 2025
- Study completion29 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The randomization is a 2 to 1 block design (2 intervention patients for each control patient), with the intervention group receiving Twin Precision Treatment (TPT) compared to the control group receiving usual care delivered by primary care providers managing T2D
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Twin Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05181449
- Sponsor's protocol ID
- 21-989
- Acronym
- TPT
- Status last verified
- Sep 2025
- First submitted
- 23 Dec 2021
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Digital Twin Precision Treatment: A Novel Whole Body Digital Twin Enabled Precision Treatment for Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05181449
- Acronym / sponsor ID
- TPT / 21-989
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetes
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Twin Health
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 29 Nov 2026 (estimated)
- First posted
- 6 Jan 2022 (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 is a randomized study comparing outcomes of patients diagnosed with Type 2 Diabetes (T2D) who are enrolled into the Twin Health Precision Treatment (TPT) system versus usual care. The study will last for a year with a 1 year optional extension for the TPT arm patients to continue for another year, and for the usual care (UC) patients to cross over to the TPT treatment for a year.
150 patients will be enrolled with 100 being randomized to the TPT arm and 50 being enrolled to the UC arm
Detailed description
This is a randomized study comparing outcomes of usual care patients diagnosed with Type 2 Diabetes (T2D) with patients diagnosed with T2D enrolled onto Twin Health's TPT system. Twin Precision Treatment (TPT) system utilizes live, exercise and nutrition coaching based on computer algorithm learning to attempt to improve patients overall health and reverse type 2 diabetes (T2D). The TPT system does so by measuring and addressing glucose aberrations associated with meals. Using Whole Body Digital Twin (WBDT) platform powered by Artificial Intelligence (AI) and the Internet of Things (IoT) technologies, the Whole Body Digital Twin platform captures data on up to 174 health markers, up to 3000 daily data points to provide precision nutrition guidance to the patient that precisely balances 87 essential nutrient factors. The platform captures daily weight using Bluetooth scales and captures daily blood pressure, particularly in patients with underlying HTN using Bluetooth blood pressure measurement. Additionally, the Whole Body Digital Twin platform captures daily physical activity and sleep data, and provides precision guidance on activity and sleep for the patient to follow.
The machine learning algorithm is devised to integrate these multi-dimensional data and accurately predict personalized glucose responses. Dietary intake is a central determinant of blood glucose levels, and thus, to achieve optimal glucose levels, it is imperative to make food choices that induce normal postprandial glycemic responses. Thus, the platform will suggest the right food to the right participant at the right time.
Depending on the likes and dislikes of the patient, the Whole Body Digital Twin platform will recommend a meal plan that is balanced across macro, micro and biota nutrients to reduce glucotoxicity and lipotoxicity, which helps in ameliorating inflammation, fatty liver and insulin resistance. This precise management of nutrition, activity and sleep ensures that the average blood glucose of the day will be consistently maintained within the optimal range. The intervention will continuously offer precision nutrition, precision sleep and precision activity recommendations. Nutritional, activity, and sleep counseling will be provided by trained health coaches through the app and via telephone.
In the usual care of type 2 diabetes, glucose-lowering medications are added progressively with lifestyle modification to improve glycemia and optimize glycated hemoglobin values (HbA1c) so as to reduce the risk of developing long-term complications. Standard of care is to take such a glucose-centric approach to T2D management rather than focusing treatment on the underlying root causes of the disease. It is rare to attempt to target remission of the diabetes process since remission occurs in usual care regimens in only a very small percentage of patients with type 2 diabetes (21). Studies that target other metabolic disease states, such as obesity, have been proven to also impact T2D progression and achieve remission states, but these types of approaches are rare in the usual care setting (22). Only three therapeutic approaches have been associated with remission of diabetes: 1. Bariatric surgery, 2. Very Low-Calorie diet, and 3. Ketogenic diet with near elimination of carbohydrate (23). Our study attempts to determine if precision nutritional, activity and sleep guidance associated with the Whole Body Digital Twin (WBDT) platform and Twin Precision Treatment (TPT) can lead to diabetes remission in a population of patients with T2D.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The randomization is a 2 to 1 block design (2 intervention patients for each control patient), with the intervention group receiving Twin Precision Treatment (TPT) compared to the control group receiving usual care delivered by primary care providers managing T2D
| Arm | Type | Receives |
|---|---|---|
| Twin Precision Treatment (TPT) | Experimental | Behavioral: Twin Precision TreatmentTwin Precision Treatment (combination of AI and lifestyle coaching) |
| Usual Care (UC) | No intervention | –Usual care prescribed by Cleveland Clinic diabetes specialists and primary care physicians |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women between ages 18 and 75
- Self-reported duration of Type 2 diabetes less than or equal to 15 Years
- Own smartphone and compatible with TPT and sensors (iPhone and android)
- Baseline HbA1c of ≥ 7.5% and ≤ 11% or baseline A1c ≥ 6.5% but < 7.5% on any glucose lowering medication (inclusive of Metformin). For patients with a baseline A1c of < 6.5%, the patient must be on at least one glucose lowering medication with or without Metformin.
- BMI: ≥ 27 Kg/2
Key exclusion criteria (17 listed)
- HbA1C >11%
- Type 1 diabetes, latent autoimmune diabetes in adults (LADA), maturity onset diabetes of the young (MODY), pancreatic diabetes, gestational diabetes mellitus, any secondary diabetes by clinical history, or fasting C Peptide < 1 mmol/L or GAD-65 antibody positivity
- Currently or in past 3 months receiving an anti-obesity medication or any other medication used for the primary intent of weight loss
- History of hospitalization (within the last 12 months) for diabetic ketoacidosis
- History of acute coronary syndrome, myocardial infarction, or stroke within the prior 12 months
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 |
|---|---|---|
| Twin Precision TreatmentCombination of Artificial Intelligence algorithms based on daily sensor input and live nutrition, exercise, sleep and breath coaching to help treat type 2 diabetes | Behavioural | Twin Precision Treatment (TPT) |
Primary outcome
To compare the percentage of patients in the TPT and Usual Care groups who have a HbA1c less than 6.5 and are not on any glucose lowering medications (excluding Metformin up to 2000 mg/day) at 12 months (360 days).
Time frame: 360 days
16 secondary outcomes
To compare the percentage of patients in the TPT and Usual Care groups who have a HbA1c less than at 6.5 and are not on any glucose lowering medications at 12 months (360 days).
Time frame: 360 days
To compare the percentage of patients in the TPT and Usual Care groups who have a HbA1c less than 6.5 and are not on any glucose lowering medications (excluding Metformin up to 2000 mg/day) for at least 90 days at 12 months (360 days).
Time frame: 360 days
To compare the percentage of patients in the TPT and Usual Care groups who have a HbA1c less than at 6.5 and are not on any glucose lowering medications for at least 90 days at 12 months (360 days).
Time frame: 360 days
To compare the percentage of patients in TPT and Usual Care Groups with an HbA1c of less than 6.5 and on no glucose lowering medications (excluding Metformin up to 2000 mg/day) at 6 months (180 days).
Time frame: 360 days
To compare the percentage of patients in TPT and Usual Care Groups with a HbA1c of less than 6.5 and no glucose lowering medications at 3 months (90 days) that can sustain a HbA1c below 6.5 when checked again at 6 months (180 days).
Time frame: 90 and 180 days
To assess the percentage of patients in the TPT Group on no glucose lowering medications (excluding Metformin up to 2000 mg/day) who have a 60 day eA1c less than 6.5 at 3 months (90 days) and 6 months (180 days).
Time frame: 90 and 180 days
To compare the percentage of patients in the TPT and Usual Care Groups who are on no glucose lowering medications and have a HbA1c less than 6.5 at 6 months (180 days).
Time frame: 180 days
To compare the percentage of patients in TPT and Usual Care Groups with a HbA1c of less than 6.5 and no glucose lowering medications at 3 months (90 days) that can sustain a HbA1c below 6.5 when checked again at 6 months (180 days).
Time frame: 180 days
To assess the percentage of patients in the TPT Group on no glucose lowering medications who have a 60 day eA1c less than 6.5 at 3 months (90 days) and 6 months (180 days).
Time frame: 90 and 180 days
To compare the percentage of patients in TPT and Usual Care Groups with an HbA1c of less than 7.0 and on no glucose lowering medications (excluding Metformin up to 2000 mg/day) at 6 months (180 days) and 12 months (360 days).
Time frame: 180 and 360 days
To compare the percentage of patients in TPT and Usual Care Groups with an HbA1c of less than 7.0 and on no glucose lowering medications at 6 months (180 days) and 12 months (360 days).
Time frame: 180 and 360 days
For patients in the TPT and Usual Care Groups with an enrollment HbA1c greater than 9.0, compare the n (%) of patients who achieve a HbA1c less than 7.0 on no glucose lowering medications (excluding Metformin up to 2000 mg /day) at 12 months.
Time frame: 12 months
For patients in the TPT and Usual Care Groups with an enrollment HbA1c greater than 9.0, compare the n (%) of patients who achieve a HbA1c less than 7.0 on no glucose lowering medications at 12 months.
Time frame: 12 months
To compare HbA1c (mean change between groups) at 6 and 12 months (180 and 360 days).
Time frame: 180 and 360 days
To compare weight (mean % change between groups) at 6 and 12 months (180 and 360 days).
Time frame: 180 and 360 days
To compare waist circumference (mean change between groups) at 6 and 12 months (180 and 360 days) between the TPT and Usual Care groups.
Time frame: 180 and 360 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Twin Precision Treatment in people with Type 2 Diabetes, run by The Cleveland Clinic 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 17 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: under way, not looking for participants, as of the sponsor's last update on 18 Sep 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
To compare the percentage of patients in the TPT and Usual Care groups who have a HbA1c less than 6.5 and are not on any glucose lowering medications (excluding Metformin up to 2000 mg/day) at 12 months (360 days). (time frame: 360 days). 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 18 Sep 2025.