Randomized Controlled Trial of Digital Twin Precision Treatment: A Novel Whole Body Digital Twin Enabled Precision Treatment for Type 2 Diabetes
Trial ID: NCT05181449
Status: ACTIVE_NOT_RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2022-02-01
Completion date: 2026-11-29
Sponsor: The Cleveland Clinic
Collaborators: Twin Health
Conditions: Type 2 Diabetes
Interventions: Twin Precision Treatment
Locations: Cleveland Clinic
Countries: United States
Enrollment: 150
Age range: 18 Years - 75 Years
Sex: ALL

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. 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

Eligibility criteria:
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

Outcomes:
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).