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

Diabetes Mellitus, Type 2

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.

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    18 and up

Participation 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....)

Study Location

St. Joseph's Family Medical and Dental Centre
St. Joseph's Family Medical and Dental Centre
London, Ontario
Canada

Contact Study Team

Primary Contact

Daniel Henke, MSc

[email protected]
5199020879
Study Sponsored By
Western University, Canada
Participants Required
More Information
Study ID: NCT05261906