Randomized Controlled Trial of Digital Twin Precision Treatment: A Novel Whole Body Digital Twin Enabled Precision Treatment for Type 2 Diabetes
NCT ID: NCT05181449
Last Updated: 2025-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
150 participants
INTERVENTIONAL
2022-02-01
2026-11-29
Brief Summary
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150 patients will be enrolled with 100 being randomized to the TPT arm and 50 being enrolled to the UC arm
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Twin Precision Treatment (TPT)
Twin Precision Treatment (combination of AI and lifestyle coaching)
Twin Precision Treatment
Combination of Artificial Intelligence algorithms based on daily sensor input and live nutrition, exercise, sleep and breath coaching to help treat type 2 diabetes
Usual Care (UC)
Usual care prescribed by Cleveland Clinic diabetes specialists and primary care physicians
No interventions assigned to this group
Interventions
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Twin Precision Treatment
Combination of Artificial Intelligence algorithms based on daily sensor input and live nutrition, exercise, sleep and breath coaching to help treat type 2 diabetes
Eligibility Criteria
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Inclusion Criteria
2. Self-reported duration of Type 2 diabetes less than or equal to 15 Years
3. Own smartphone and compatible with TPT and sensors (iPhone and android)
4. 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.
5. BMI: ≥ 27 Kg/2
6. 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)
Exclusion Criteria
2. 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
3. Currently or in past 3 months receiving an anti-obesity medication or any other medication used for the primary intent of weight loss
4. History of hospitalization (within the last 12 months) for diabetic ketoacidosis
5. History of acute coronary syndrome, myocardial infarction, or stroke within the prior 12 months
6. Inadequate hepatic function as measured by AST/ALT \> 3.0 x ULN
7. Inadequate renal function as measured by eGFR \< 30 mL/min/1.73 m2
8. Current chronic corticosteroid therapy (≥ 5 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids)
9. Major surgical procedure or significant traumatic injury within 28 days prior to Enrollment Date
10. Patients who have undergone or are planning for any bariatric procedure
11. Pregnant, planning pregnancy in the next 12 months and lactating/nursing females
12. Any medical or surgical condition that the principal investigator considers making the patient unfit for the trial (e.g., psychiatric disorders, malignancy, etc.)
13. Mental incapacity or language barrier
14. Excessive alcohol intake (defined as self-reported greater than or equal to 3 drinks per day)
15. History of Congestive Heart Failure
17. Patients who do not have any insurance (government or commercial) coverage at the time of enrollment to avoid confounders in data
18 Years
75 Years
ALL
No
Sponsors
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Twin Health
OTHER
The Cleveland Clinic
OTHER
Responsible Party
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Locations
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Cleveland Clinic
Twinsburg, Ohio, United States
Countries
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Other Identifiers
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21-989
Identifier Type: -
Identifier Source: org_study_id
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