150 Participants Needed

Digital Twin Technology for Type 2 Diabetes

(TPT Trial)

SD
AS
SD
KP
Overseen ByKevin Pantalone, DO
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: The Cleveland Clinic
Must be taking: Glucose lowering
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.

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.12345

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.16789

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.310111213

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.
See 2 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.
See 14 more

Timeline

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

Treatment Details

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.
Participant Groups
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

Find a Clinic Near You

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+

References

Reducing HbA1c in Type 2 Diabetes Using Digital Twin Technology-Enabled Precision Nutrition: A Retrospective Analysis. [2020]
Concordance rate for type II diabetes mellitus in monozygotic twins: actuarial analysis. [2006]
Human Digital Twin for Personalized Elderly Type 2 Diabetes Management. [2023]
Second international consensus report on gaps and opportunities for the clinical translation of precision diabetes medicine. [2023]
Personalized approach for type 2 diabetes pharmacotherapy: where are we and where do we need to be? [2022]
Low birthweight and metabolic abnormalities in twins with increased susceptibility to Type 2 diabetes mellitus. [2019]
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]
The Concordance and Heritability of Type 2 Diabetes in 34,166 Twin Pairs From International Twin Registers: The Discordant Twin (DISCOTWIN) Consortium. [2022]
Glycemic control and neonatal outcomes in twin pregnancies with gestational diabetes mellitus. [2023]
A multi-scale digital twin for adiposity-driven insulin resistance in humans: diet and drug effects. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
Validating a dimensionless number for glucose homeostasis in humans. [2023]
12.United Statespubmed.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]
Neonatal diabetes due to potassium channel mutation: Response to sulfonylurea according to the genotype. [2021]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security