What side effects are associated with this type of intervention?

Continuous glucose monitoring (CGM) is generally well-tolerated but can cause skin irritation or allergic reactions at the sensor site. Behavioral modification, including diet and exercise, typically has minimal side effects but may lead to temporary muscle soreness or fatigue. Metformin, a common medication for Type 2 Diabetes, can cause gastrointestinal issues such as nausea, diarrhea, and abdominal discomfort. Sulfonylureas may lead to hypoglycemia and weight gain. Insulin therapy can also cause hypoglycemia and weight gain, along with injection site reactions.

What prior FDA approvals exist?

The FDA has approved several treatments for Type 2 Diabetes that align with the FreeStyle® Libre-assisted behavioral coaching approach. Continuous Glucose Monitoring (CGM) systems like the FreeStyle Libre and Dexcom G6 have been approved to help patients monitor their glucose levels in real-time, facilitating better glycemic control through informed lifestyle and behavioral changes. Additionally, the FDA has approved medications such as GLP-1 receptor agonists (e.g., liraglutide and semaglutide) that support weight loss and improve glycemic control, often used in conjunction with lifestyle interventions. These treatments emphasize the importance of continuous monitoring and behavioral modifications in managing Type 2 Diabetes effectively.

What other types of research exist?

Promising alternatives to FreeStyle® Libre-assisted behavioral coaching for Type 2 Diabetes patients include: 1) Hybrid Closed-Loop (HCL) systems, which combine CGM with automated insulin delivery to optimize glucose control; 2) Multivariable Closed-Loop (MCL) systems that provide automatic carbohydrate recommendations during exercise; and 3) Comprehensive digital health platforms that integrate CGM data with personalized behavioral coaching and telehealth support. These alternatives leverage advanced technology to enhance glycemic control and patient engagement.

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Lifestyle Intervention for Type 2 Diabetes (LIBERATE Trial)

N/A

Recruiting

Led By Sonja M Reichert, MD

Research Sponsored by Western University, Canada

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of Type 2 diabetes, age >18 years old

Be older than 18 years old

Must not have

Active or untreated conditions that would preclude the safe participation of exercise i.e., foot ulcer, CVD, uncontrolled HTN, retinopathy, etc.

Language barrier, severe mental illness, cognitive impairment or significant/unstable psychiatric disease limiting group participation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial uses fitness trackers and glucose monitors to help people with diabetes manage their blood sugar levels. Participants will learn about healthy eating and exercise through online classes. Real-time data from the devices will be used to create personalized health plans.

Who is the study for?

This trial is for adults over 18 with Type 2 diabetes who have internet access, an email address, a compatible smartphone, and are new to using Flash glucose monitors. They must be cleared by a physician to exercise and have an HbA1c level of at least 8.0%. Pregnant individuals or those unable to safely exercise or fully participate in the program are excluded.

What is being tested?

The LIBERATE intervention includes fitness testing, wearable technology (FitBit Inspire 2™ and FreeStyle® Libre sensors) for monitoring glucose levels and activity, bi-weekly then monthly virtual group classes on nutrition and exercise, with optional individualized training prescriptions. The goal is to reduce A1c levels through lifestyle changes.

What are the potential side effects?

While this study focuses on lifestyle interventions rather than medications, potential side effects may include discomfort from wearing devices or injury from increased physical activity if not properly monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 18 and have been diagnosed with Type 2 diabetes.

Exclusion Criteria

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

Select...

I do not have any health conditions that would make exercising unsafe for me.

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I do not have any severe mental, cognitive, or language issues that would prevent me from participating in a group.

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I have not had a heart attack, stroke, or been hospitalized in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in HbA1c from Baseline

Secondary study objectives

Change in rapid insulin use from Baseline

Change in total daily basal insulin use from baseline

Other study objectives

Anthropometric: Change in Height from baseline

Anthropometric: Change in Waist circumference from baseline

Anthropometric: Change in Weight from baseline

+19 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: LIBERATE InterventionExperimental Treatment1 Intervention

0 / 4Eligibility 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

The most common treatments for Type 2 Diabetes include lifestyle modifications, continuous glucose monitoring (CGM), and pharmacologic therapies. Lifestyle modifications, such as diet and exercise, help improve insulin sensitivity and reduce blood glucose levels. CGM devices like the FreeStyle® Libre provide real-time glucose readings, enabling patients to make informed decisions about their diet and activity levels, thus improving glycemic control. Pharmacologic treatments, such as metformin, work by decreasing hepatic glucose production and improving insulin sensitivity. These approaches are crucial for Type 2 Diabetes patients as they help manage blood glucose levels, reduce the risk of complications, and improve overall quality of life.

The Impact of Automated Brief Messages Promoting Lifestyle Changes Delivered Via Mobile Devices to People with Type 2 Diabetes: A Systematic Literature Review and Meta-Analysis of Controlled Trials.Effects of lifestyle modifications on patients with type 2 diabetes: the Japan Diabetes Complications Study (JDCS) study design, baseline analysis and three year-interim report.