What is the mechanism of action of this treatment?

Common treatments for Type 2 Diabetes include lifestyle interventions, oral medications, and insulin therapy. Lifestyle interventions, such as diet and exercise, improve insulin sensitivity and glycemic control. Oral medications like metformin reduce hepatic glucose production and increase insulin sensitivity, while sulfonylureas stimulate insulin secretion from the pancreas. Insulin therapy directly supplements insulin levels. Personalized medical approaches, like the Twin Health Precision Treatment, leverage data analytics and continuous monitoring to tailor interventions specifically to the patient's needs, optimizing treatment efficacy and minimizing complications. This matters for Type 2 Diabetes patients as it allows for more precise management of blood glucose levels, potentially improving long-term outcomes and quality of life.

What side effects are associated with this type of intervention?

Common treatments for Type 2 Diabetes include metformin, which can cause gastrointestinal issues like diarrhea and nausea; sulfonylureas, which may lead to hypoglycemia and weight gain; and insulin, which also carries a risk of hypoglycemia and weight gain. GLP-1 receptor agonists can cause gastrointestinal side effects and, rarely, pancreatitis. SGLT2 inhibitors may lead to urinary tract infections, genital infections, and an increased risk of dehydration. Personalized medical approaches, such as those studied in the Twin Health Precision Treatment, aim to minimize these side effects by tailoring interventions based on continuous monitoring and data analytics, potentially improving overall treatment efficacy and patient outcomes.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of Type 2 Diabetes that align with personalized medical approaches. Notably, GLP-1 receptor agonists such as exenatide (Bydureon BCise) and dulaglutide have been approved for their efficacy in improving glycemic control with tailored dosing regimens. These drugs, along with SGLT2 inhibitors, have shown benefits in cardiovascular outcomes, which is crucial for personalized treatment plans. Additionally, the use of continuous glucose monitoring systems and data analytics in managing T2DM has been supported by the FDA, enabling more precise and individualized treatment strategies.

What other types of research exist?

Promising novel alternatives to the Twin Health Precision Treatment for Type 2 Diabetes patients include: 1) GLP-1 receptor agonists (GLP1-RA) and SGLT2 inhibitors (SGLT2-i), which have demonstrated cardiovascular benefits and glycemic control in recent trials. 2) Digital health platforms that integrate continuous glucose monitoring (CGM) with personalized treatment plans, such as those being developed by various tech-health companies. 3) Machine learning-based drug repurposing methods that identify new uses for existing antidiabetic agents, offering personalized treatment options. These alternatives leverage data analytics and continuous monitoring to tailor interventions for individual patients.

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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

Must not have

Major surgical procedure or significant traumatic injury within 28 days prior to Enrollment Date

Type 1 diabetes, latent autoimmune diabetes in adults (LADA), maturity onset diabetes of the young (MODY), pancreatic diabetes, gestational diabetes mellitus, any secondary diabetes by clinical history, or fasting C Peptide < 1 mmol/L or GAD-65 antibody positivity

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 and 180 days

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have a specific type of diabetes or my tests show low C Peptide or positive GAD-65.

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My liver tests are not more than three times the normal limit.

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I have had or am planning to have weight loss surgery.

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I have a history of heart failure.

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I am on a daily dose of 5 mg or more of prednisone or its equivalent.

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I do not have any mental incapacity or language barriers that prevent understanding.

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My kidney function is low, with an eGFR under 30.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 and 180 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 and 180 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 and 180 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

To compare the percentage of patients in TPT and Usual Care Groups with a HbA1c of less than 6.5 and no glucose lowering medications at 3 months (90 days) that can sustain a HbA1c below 6.5 when checked again at 6 months (180 days).

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Type 2 Diabetes include lifestyle interventions, oral medications, and insulin therapy. Lifestyle interventions, such as diet and exercise, improve insulin sensitivity and glycemic control. Oral medications like metformin reduce hepatic glucose production and increase insulin sensitivity, while sulfonylureas stimulate insulin secretion from the pancreas. Insulin therapy directly supplements insulin levels. Personalized medical approaches, like the Twin Health Precision Treatment, leverage data analytics and continuous monitoring to tailor interventions specifically to the patient's needs, optimizing treatment efficacy and minimizing complications. This matters for Type 2 Diabetes patients as it allows for more precise management of blood glucose levels, potentially improving long-term outcomes and quality of life.

Impact on guidelines: The general practitioner point of view.A cost analysis of intensified vs conventional multifactorial therapy in individuals with type 2 diabetes: a post hoc analysis of the Steno-2 study.SCORE-IT (Selecting Core Outcomes for Randomised Effectiveness trials In Type 2 diabetes): a systematic review of registered trials.