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Behavioral Intervention

Digital Twin Technology for Type 2 Diabetes (TPT Trial)

N/A
Waitlist Available
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 360 days
Awards & highlights

TPT Trial Summary

This trial is comparing a new treatment system for Type 2 Diabetes against usual care. The study will last for one year, with the option to extend for another year. 225 patients will be enrolled.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves a digital treatment system rather than medication, traditional side effects like those seen with drugs might not apply. However, potential issues could include technical difficulties with the app or sensors that could affect treatment management.

TPT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~360 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 360 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To compare the percentage of patients in the TPT and Usual Care groups who have a HbA1c less than 6.5 and are not on any glucose lowering medications (excluding Metformin up to 2000 mg/day) at 12 months (360 days).
Secondary outcome measures
To compare the percentage of patients in the TPT and Usual Care groups who have a HbA1c less than at 6.5 and are not on any glucose lowering medications at 12 months (360 days).

TPT Trial Design

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 Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor
1,026 Previous Clinical Trials
1,365,926 Total Patients Enrolled
Twin HealthUNKNOWN

Media Library

Twin Precision Treatment (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05181449 — N/A
Type 2 Diabetes Research Study Groups: Usual Care (UC), Twin Precision Treatment (TPT)
Type 2 Diabetes Clinical Trial 2023: Twin Precision Treatment Highlights & Side Effects. Trial Name: NCT05181449 — N/A
Twin Precision Treatment (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05181449 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals aged 18 and over being accepted as participants for this investigation?

"This clinical trial is suitable for adults aged between 18 and 75. Additionally, there are 192 studies specifically tailored to minors as well as 1,104 trials targeting those older than 65 years of age."

Answered by AI

Is enrollment for the study available to eligible participants?

"Affirmative. The information hosted on clinicaltrials.gov notes that, since its inception in February 1st 2022, this research endeavour is actively recruiting patients to fill up 225 spots at one medical centre."

Answered by AI

What are the eligibility requirements for participating in this research?

"This clinical investigation is searching for 225 participants aged 18-75 who have been diagnosed with type 2 diabetes. Eligible volunteers should own a smartphone compatible with TPT and accompanying sensors, possess baseline hemoglobin A1c values between 7.5% and 11%, or if lower than 7.5%, be on at least one glucose medication in combination with metformin; they must also demonstrate body mass index of 27 kg/m2 or greater plus NAFLD Fibrosis Score above -1.00 (optional). Additionally, 30 individuals from the TPT group and 15 people from Usual Care will partake in additional Magnetic Resonance Evaluation"

Answered by AI

What is the number of participants being monitored for this research?

"Yes, according to clinicaltrials.gov records this trial is actively seeking enrollees. The data was first uploaded on February 1st 2022 and the listing was recently amended onFebruary 14th 2022. This research requires 225 participants from one site."

Answered by AI

Who else is applying?

What site did they apply to?
Cleveland Clinic
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I’d like to learn for once and for all how to address my condition from a lifestyle point of view. Yes, modern medicine is great and I appreciate that I can manage my diabetes with it. I want to fully understand how changes in my lifestyle can perhaps reduce or eliminate my dependency on medication.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Randomized Controlled Trial of Digital Twin Precision Treatment: A Novel Whole Body Digital Twin Enabled Precision Treatment for Type 2 Diabetes
2022. "Randomized Controlled Trial of Digital Twin Precision Treatment: A Novel Whole Body Digital Twin Enabled Precision Treatment for Type 2 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05181449.
~94 spots leftby Dec 2027
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