Your digital twin could help beat diabetes
NCT ID NCT05181449
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This Cleveland Clinic study tests a digital twin system that uses AI and daily sensor data to give personalized coaching on diet, exercise, sleep, and breathing. 150 adults with type 2 diabetes will either use the system or receive usual care for one year. The goal is to see if more people can achieve healthy blood sugar levels without diabetes medications.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Digital twin precision treatment system (AI coaching based on daily sensor data)
- What this could lead to
- If successful, this could offer a personalized, medication-free way to manage type 2 diabetes using daily coaching and sensors.
- What could go wrong
- This is a relatively small, early-stage trial. The digital system may not work for everyone, and results may not apply to all diabetes patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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150 people
The number who actually took part.
- Started
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Feb 2022
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Men and women between ages 18 and 75 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: 1. HbA1C \>11% 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 16. 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 17. Patients who do not have any insurance (government or commercial) coverage at the time of enrollment to avoid confounders in data
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cleveland Clinic
Twinsburg, Ohio, 44087, United States
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Other studies related to the condition(s) this trial covers.
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