Randomized Controlled Trial of Digital Twin Precision Treatment: A Novel Whole Body Digital Twin Enabled Precision Treatment for Type 2 Diabetes
NCT05181449 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2025-09-18
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
Interventions
- BEHAVIORAL
-
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
Sponsors & Collaborators
-
Twin Health
collaborator OTHER -
The Cleveland Clinic
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-02-01
- Primary Completion
- 2025-05-15
- Completion
- 2026-11-29
Countries
- United States
Study Locations
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