Digital Twin Technology for Type 2 Diabetes
(TPT Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: The Cleveland Clinic

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial is testing a personalized health program called the TPT system for people with Type 2 Diabetes. The program uses advanced technology to give tailored advice on diet, exercise, and sleep. The goal is to manage blood sugar levels better and potentially reverse diabetes.

Eligibility Criteria

Adults aged 18-75 with Type 2 Diabetes, a BMI of ≥27, and an HbA1c level between ≥7.5% and <11%. Participants must have had diabetes for no more than 15 years, own a compatible smartphone, and may consent to optional liver evaluation. Excluded are those on weight loss drugs or with recent major surgery/trauma, poor liver/kidney function, recent severe heart issues or strokes, excessive alcohol intake, certain chronic conditions or medications.

Inclusion Criteria

My HbA1c is between 7.5% and 11%, or it's below 7.5% but I'm on diabetes medication.

You weigh more than what is considered healthy for your height.

I own a smartphone that works with the trial's technology.

+3 more

Exclusion Criteria

I have not had major surgery or a serious injury in the last 28 days.

Your HbA1C level is higher than 11%.

I am currently using, or have used in the past 3 months, medication primarily for weight loss.

+14 more

Participant Groups

The trial is testing the Twin Health Precision Treatment (TPT) system against usual care in managing Type 2 Diabetes over one year with an optional second-year extension. It involves randomly assigning patients either to TPT (100 participants) or usual care (50 participants), with the option for crossover after the first year.

2Treatment groups

Experimental Treatment

Active Control

Group I: Twin Precision Treatment (TPT)Experimental Treatment1 Intervention

Twin Precision Treatment (combination of AI and lifestyle coaching)

Group II: Usual Care (UC)Active Control1 Intervention

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