Status:
ACTIVE_NOT_RECRUITING
The FreeStyle Libre Enabled Reduction of A1c Through Effective Eating and Exercise Study
Lead Sponsor:
Western University, Canada
Collaborating Sponsors:
Abbott Diabetes Care
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
NA
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. Jose...
Detailed Description
PROTOCOL TIMELINE A. Pre-study Eligibility Criteria Confirmation and Study Review and Scheduling of Participant The research coordinator will phone potential participants to answer any questions abo...
Eligibility Criteria
Inclusion
- \- • 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
- • 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.…)
Key Trial Info
Start Date :
September 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT05261906
Start Date
September 26 2022
End Date
October 1 2025
Last Update
June 5 2025
Active Locations (1)
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1
St. Joseph's Family Medical and Dental Centre
London, Ontario, Canada, N6G 1J1