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

NCT05261906 | Active Not Recruiting

• 1 other identifier: 119334
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

Brief Summary

This two-year multisite, real-world, before-after prospective six-month pilot study utilizing a single-group cohort design (n=184) which will first occur in London, Ontario (n=92) through the St. Joseph's Primary Care for Diabetes Support (PCDSP) program. To test fidelity, the intervention will be delivered again in Hamilton, Ontario through the Hamilton Health Sciences' Boris Clinic in Diabetes Care and Research Program (n=92). Participants will begin by attending the first class at the PCDSP clinic to complete baseline fitness testing as well as receive/set up their wearable technology (FitBit Inspire 2™ and FreeStyle® Libre sensors). Two weeks of baseline data collection will following (glucose values and step counts). Five bi-weekly, followed by three monthly, one-hour videoconferencing group education classes via Microsoft Teams video platform will be offered. Participants will be given the choice to communicate with the LIBERATE clinical team (exercise specialist, physician, and/or registered) weekly between the group classes using their preferred method of communication i.e., email. Classes will offer FreeStyle® Libre-assisted behavioural coaching (i.e., nutrition and exercise). FreeStyle® Libres will be used during the first three months of the program and optionally in the last three months of the intervention. The FitBit Inspire 2™ monitors will be worn for six months. Participants are provided the option to receive individualized aerobic and resistance training prescriptions. The primary outcome is change in glycated hemoglobin. A main goal of this study is to create a "toolkit" for other Canadian Diabetes Management centres (DMCs) to use in the future.

Conditions

Diabetes Mellitus, Type 2

Keywords

lifestyle medicine; flash glucose monitor; exercise prescription; nutrition; biofeedback; self-monitoring; wearable activity monitor; virtual care; group education; coaching; behaviour change

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c from Baseline

  HbA1c measured at baseline, 3 months, and 6 months

  6 months

Secondary Outcomes (2)

• Change in total daily basal insulin use from baseline

  6 months

• Change in rapid insulin use from Baseline

  6 months

Other Outcomes (22)

• Change in sulfonylurea use from Baseline

  6 months

• Change in Average minutes per day of time out of range from Baseline

  This will be measured and evaluated continuously bi-weekly for the duration of the 6 month study while subjects are using the FreeStyle Libre sensor

• Change in Estimated A1c from baseline

  This will be measured and evaluated continuously bi-weekly for the duration of the 6 month study while subjects are using the FreeStyle Libre sensor

Study Arms (1)

LIBERATE Intervention

EXPERIMENTAL

Behavioral: LIBERATE

Interventions

LIBERATE BEHAVIORAL

Five bi-weekly, followed by three monthly, one-hour videoconferencing group education classes via Microsoft Teams video platform will be offered. Participants will be given the choice to communicate with the LIBERATE clinical team (exercise specialist, MD, and/or RN) weekly between the group classes using their preferred method of communication i.e., email. Classes will offer FreeStyle® Libre-assisted behavioural coaching (i.e., nutrition and exercise). FreeStyle® Libres will be used during the first three months of the program and optionally in the last three months of the intervention. The FitBit Inspire 2™ monitors will be worn for six months. Participants are provided the option to receive individualized aerobic and resistance training prescriptions.

LIBERATE Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- • 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

You may not qualify if:

• 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.…)

Sponsors & Collaborators

• Western University, Canada: lead
• Abbott Diabetes Care: collaborator

Study Sites (1)

St. Joseph's Family Medical and Dental Centre

London, Ontario, N6G 1J1, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Sonja M Reichert, MD

  Western University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Family Medicine; Dr. Brian W. Gilbert Chair in Primary Health Care Research

Model Details: All participants will be in the treatment group. This is a multisite intervention; the intervention will be first delivered at the Primary Care for Diabetes Support Program in London, Ontario with 92 participants. Following intervention completion in London, ON, the Boris Clinic in Diabetes Care and Research Program (DCRP) in Hamilton, ON will deliver the intervention as a fidelity check, with another 92 participants.

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: March 2, 2022
• Study Start: September 26, 2022
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)