Digital Twin Technology for Type 2 Diabetes

(TPT Trial)

Overseen By Kevin Pantalone, DO

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Must be taking: Glucose lowering

Must not be taking: Anti-obesity, Corticosteroids

Disqualifiers: Type 1 diabetes, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

150 Participants Needed

What You Need to Know Before You Apply

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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should not have been on anti-obesity or weight loss medications in the past 3 months.

Is Digital Twin Technology for Type 2 Diabetes safe for humans?

The available research does not provide specific safety data for Digital Twin Technology in humans, but it does not report any safety concerns either. ^{1 2 3 4 5}

How does the Twin Precision Treatment for Type 2 Diabetes differ from other treatments?

The Twin Precision Treatment uses digital twin technology, which creates a virtual model of the patient to personalize diabetes management. This approach allows for more precise insulin infusion and improved glucose control by simulating and predicting individual patient responses, making it unique compared to standard treatments. ^{6 7 8 9 10}

What data supports the effectiveness of the Twin Precision Treatment for Type 2 Diabetes?

Research shows that using Digital Twin Technology in the Twin Precision Nutrition Program can help lower blood sugar levels (HbA1c) and reduce the need for diabetes medications in people with Type 2 Diabetes after 90 days. ^{1 6 11 12 13}

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Twin Precision Treatment (TPT) or usual care for Type 2 Diabetes

12 months

Regular virtual and in-person visits for monitoring and coaching

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Open-label extension (optional)

Participants in the TPT arm may continue treatment for an additional year, and UC patients may cross over to TPT

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Twin Precision Treatment

Trial Overview 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.

How Is the Trial Designed?

Group I: Twin Precision Treatment (TPT) Experimental Treatment 1 Intervention

Twin Precision Treatment (combination of AI and lifestyle coaching)

Group II: Usual Care (UC) Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Twin Health

Collaborator

Trials

1

Recruited

150+

Twin Health

Collaborator

Trials

1

Recruited

150+

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Reducing HbA1c in Type 2 Diabetes Using Digital Twin Technology-Enabled Precision Nutrition: A Retrospective Analysis. [2020]

2. Germany pubmed.ncbi.nlm.nih.gov

Concordance rate for type II diabetes mellitus in monozygotic twins: actuarial analysis. [2006]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Human Digital Twin for Personalized Elderly Type 2 Diabetes Management. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Second international consensus report on gaps and opportunities for the clinical translation of precision diabetes medicine. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Personalized approach for type 2 diabetes pharmacotherapy: where are we and where do we need to be? [2022]

6. England pubmed.ncbi.nlm.nih.gov

Low birthweight and metabolic abnormalities in twins with increased susceptibility to Type 2 diabetes mellitus. [2019]

7. England pubmed.ncbi.nlm.nih.gov

DEVELOPING twin-specific 75-g oral glucose tolerance test diagnostic thresholds for gestational diabetes based on the risk of future maternal diabetes: a population-based cohort study. [2021]

8. England pubmed.ncbi.nlm.nih.gov

The Concordance and Heritability of Type 2 Diabetes in 34,166 Twin Pairs From International Twin Registers: The Discordant Twin (DISCOTWIN) Consortium. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Glycemic control and neonatal outcomes in twin pregnancies with gestational diabetes mellitus. [2023]

10. England pubmed.ncbi.nlm.nih.gov

A multi-scale digital twin for adiposity-driven insulin resistance in humans: diet and drug effects. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Validating a dimensionless number for glucose homeostasis in humans. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

ReplayBG: A Digital Twin-Based Methodology to Identify a Personalized Model From Type 1 Diabetes Data and Simulate Glucose Concentrations to Assess Alternative Therapies. [2023]

13. Denmark pubmed.ncbi.nlm.nih.gov

Neonatal diabetes due to potassium channel mutation: Response to sulfonylurea according to the genotype. [2021]