Using FreeStyle Libre to Improve A1c Levels Through Diet and Exercise

The Libre Enabled Reduction of A1c Through Effective Eating and Exercise Study: LIBERATE

This study is testing if using FreeStyle Libre glucose monitors along with diet and exercise classes can help people with Type 2 diabetes lower their A1c levels.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 184 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Western University, Canada (other)
• Locations: 1 site (London, Ontario)
• Trial ID: NCT05261906 on ClinicalTrials.gov

What this trial studies

This pilot study aims to evaluate the effectiveness of a lifestyle intervention program that incorporates the use of FreeStyle Libre glucose monitoring technology and exercise prescriptions to help individuals with Type 2 diabetes lower their A1c levels. Participants will engage in a series of group education classes delivered via videoconferencing, focusing on nutrition and physical activity. The study will take place over two years across two sites in Ontario, Canada, with a total of 184 participants. Data collection will include baseline fitness testing and continuous glucose monitoring to assess the impact of the intervention.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old with a diagnosis of Type 2 diabetes and an A1c level of 8.0% or higher who are interested in using glucose monitoring technology.

Not a fit: Patients who lack access to technology or have severe mental health issues that limit participation may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve blood sugar control and overall health for patients with Type 2 diabetes.

How similar studies have performed: Previous studies utilizing technology-assisted lifestyle interventions for diabetes management have shown promising results, indicating potential success for this approach.

Eligibility criteria

Inclusion Criteria:

- • Diagnosis of Type 2 diabetes, age \>18 years old

* Baseline HbA1c ≥ 8.0% (if no recent A1c (last 3 months) you can ask, or we will ask them to complete a new test).
* Naïve to Flash glucose monitors BUT interested in using this technology
* Ownership of either a smartphone (iPhone v7 (iOS of 13.2+) or Samsung Galaxy Note 8, S7 Edge, S8, S8+, S9, S10; Google Pixel, Pixel 2, Pixel 2 XL, Pixel 3, Pixel 3 XL, Pixel 4, Pixel 4 X; LG Nexus 5X (with Android OS of 8 or higher). Other smartphones may be compatible but must be confirmed. https://freestyleserver.com/Payloads/IFU/2022/q2/ART39109-002_rev-J-web.pdf
* Have an email address
* Access to Internet connection
* Physician cleared to participate in exercise

Exclusion Criteria:

* • Lack of access/knowledge of technology that would prevent virtual participation (Self-reported)

  * • Language barrier, severe mental illness, cognitive impairment or significant/unstable psychiatric disease limiting group participation
  * Pregnancy
  * Active or untreated conditions that would preclude the safe participation of exercise i.e., foot ulcer, CVD, uncontrolled HTN, retinopathy, etc.
  * Recent (\<3 months) medically unstable condition i.e., recent MI, stroke, hospitalization, etc.
  * Inability to participate in the full program (e.g., upcoming surgery, relocating, etc....)

Where this trial is running

London, Ontario

• St. Joseph's Family Medical and Dental Centre — London, Ontario, Canada (RECRUITING)

Study contacts

• Principal investigator: Sonja M Reichert, MD — Western University
• Study coordinator: Sonja M Reichert, MD

Conditions: Diabetes Mellitus, Type 2, lifestyle medicine, flash glucose monitor, exercise prescription, nutrition, biofeedback, self-monitoring, wearable activity monitor