Digital Twin Technology for Type 2 Diabetes

(TPT Trial)

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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)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare the effectiveness of a new approach, Twin Precision Treatment (TPT), against usual care for people with Type 2 Diabetes. TPT combines artificial intelligence with lifestyle coaching to help manage diabetes. Participants will be divided into two groups: one receiving TPT and the other continuing with standard diabetes care. This trial suits individuals who have had Type 2 Diabetes for 15 years or less, own a smartphone, and currently manage diabetes with medication. As an unphased trial, it offers a unique opportunity to explore innovative diabetes management strategies.

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 prior data suggests that this digital twin technology is safe for Type 2 Diabetes patients?

Research has shown that the Twin Precision Treatment (TPT), which combines artificial intelligence and lifestyle coaching, has been well-received. A study by the Cleveland Clinic found that TPT improved health outcomes for people with type 2 diabetes. Importantly, these studies reported no major safety issues.

Earlier studies also examined health indicators like blood sugar levels and medication use. They found that TPT reduced the need for diabetes medications and maintained blood sugar control without significant side effects. This suggests the treatment is safe and manageable for patients.

Overall, the evidence indicates that TPT is a promising and safe option for people with type 2 diabetes.12345

Why are researchers excited about this trial?

Researchers are excited about the Twin Precision Treatment for type 2 diabetes because it combines artificial intelligence with personalized lifestyle coaching. Unlike traditional treatments that often rely solely on medication management and standard lifestyle advice, this approach uses digital twin technology to create a customized model of a patient's metabolism. This allows for more precise adjustments in diet and activity, potentially leading to better blood sugar control and overall health outcomes. By harnessing the power of AI, Twin Precision Treatment offers a tailored intervention that could be more effective than one-size-fits-all methods.

What evidence suggests that the Twin Precision Treatment might be an effective treatment for Type 2 Diabetes?

Research has shown that the Twin Precision Treatment (TPT) can help manage Type 2 Diabetes. In this trial, some participants will receive TPT, which uses artificial intelligence and personalized lifestyle coaching. One study found that TPT helped over 70% of participants lower their blood sugar levels and reduce or stop their diabetes medications. Another study demonstrated that TPT was more effective than standard care in improving diabetes outcomes. These results suggest that TPT could be a promising option for better managing diabetes.12367

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.
See 2 more

Exclusion Criteria

I have not had major surgery or a serious injury in the last 28 days.
I am currently using, or have used in the past 3 months, medication primarily for weight loss.
Your HbA1C level is higher than 11%.
See 14 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Twin Precision Treatment (TPT)Experimental Treatment1 Intervention
Group II: Usual Care (UC)Active Control1 Intervention

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+

Citations

One-year outcomes of a digital twin intervention for type 2 ...This retrospective observational study, building on prior research that demonstrated the efficacy of the Digital Twin (DT) Precision Treatment Program over ...
New Peer-Reviewed Study in New England Journal of ...Cleveland Clinic-led study finds Twin Health's precision AI and hyper-personalized care outperforms standard diabetes treatment—reducing A1C ...
Study Details | NCT05181449 | Randomized Controlled ...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) ...
AI-Supported Coaching Program Improved T2D OutcomesMore than 70% of people with type 2 diabetes using a new AI-powered lifestyle app reduced their HbA1C and reduced or eliminated medications.
Personalized nutrition in type 2 diabetes remissionThis study aims to present the development and application of a Digital Twin (DT) technology—a machine learning (ML)-powered platform designed ...
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/39461977/
One-year outcomes of a digital twin intervention for type 2 ...Outcome measures included HbA1c change, medication reduction, anthropometrics, insulin markers, and continuous glucose monitoring (CGM) metrics.
New Peer-Reviewed Study in New England Journal of ...Cleveland Clinic-led study finds Twin Health's precision AI and hyper-personalized care outperforms standard diabetes treatment—reducing A1C ...
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