Randomized Controlled Trial of Digital Twin Precision Treatment: A Novel Whole Body Digital Twin Enabled Precision Treatment for Type 2 Diabetes

NCT05181449 | Active Not Recruiting DMC

• 1 other identifier: 21-989
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Type 2 Diabetes

Keywords

Diabetes

Outcome Measures

Primary Outcomes (1)

• 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).

  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).

  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).

  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).

  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).

  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).

  90 and 180 days

Study Arms (2)

Twin Precision Treatment (TPT)

EXPERIMENTAL

Twin Precision Treatment (combination of AI and lifestyle coaching)

Behavioral: Twin Precision Treatment

Usual Care (UC)

NO INTERVENTION

Usual care prescribed by Cleveland Clinic diabetes specialists and primary care physicians

Interventions

Twin Precision Treatment BEHAVIORAL

Combination of Artificial Intelligence algorithms based on daily sensor input and live nutrition, exercise, sleep and breath coaching to help treat type 2 diabetes

Twin Precision Treatment (TPT)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Twin Health: collaborator

Study Sites (1)

Cleveland Clinic

Twinsburg, Ohio, 44087, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: December 23, 2021
• First Posted: January 6, 2022
• Study Start: February 1, 2022
• Primary Completion: May 15, 2025
• Study Completion (Estimated): November 29, 2026
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)