Diabetes Mellitus, Type 2 Clinical Trial
— LIBERATEOfficial title:
The Libre Enabled Reduction of A1c Through Effective Eating and Exercise Study: LIBERATE
NCT number | NCT05261906 |
Other study ID # | 119334 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | September 26, 2022 |
Est. completion date | March 2026 |
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.
Status | Recruiting |
Enrollment | 184 |
Est. completion date | March 2026 |
Est. primary completion date | October 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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.…) |
Country | Name | City | State |
---|---|---|---|
Canada | St. Joseph's Family Medical and Dental Centre | London | Ontario |
Lead Sponsor | Collaborator |
---|---|
Western University, Canada | Abbott Diabetes Care |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in sulfonylurea use from Baseline | Sulfonylurea use, measured at baseline, 3 months, and 6 months | 6 months | |
Other | Change in Average minutes per day of time out of range from Baseline | Measured by the FreeStyle Libre sensor | 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 | |
Other | Change in Estimated A1c from baseline | Measured by the FreeStyle Libre sensor | 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 | |
Other | Change in Number of Scans within a 24-hour period from baseline | Measured by the FreeStyle Libre sensor | 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 | |
Other | Average minutes per day of time in range from baseline | Measured by the FreeStyle Libre sensor | 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 | |
Other | Change in Percent Sensor Capture from baseline | Measured by the FreeStyle Libre sensor | 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 | |
Other | Change in Diabetes Status | Looking for an A1c reduction to below <6.5% (remission) | This will be evaluated at 6 months. | |
Other | Anthropometric: Change in Weight from baseline | in kilograms, measured at baseline, 3 months, and 6 months | 6 months | |
Other | Anthropometric: Change in Height from baseline | in centimeters, measured at baseline, 3 months, and 6 months | 6 months | |
Other | Anthropometric: Change in Waist circumference from baseline | in cm, measured at baseline, 3 months, and 6 months | 6 months | |
Other | Fitness Capacity: change in Six Minute Walk Test score from baseline and 3 months | The six-minute walking test (6MWT) has been used in populations with T2D and is a validated (Nolen-Doerr et al., 2018) measure of estimated aerobic exercise capacity. The test is a practical, sub-maximal test that ideally requires a 30m corridor or track to be completed (with markings at least every 3 metres). However, the shorter the travelling distance results in less distance completed in the six-minutes due to time taken to reverse directions (American Thoracic Society, 2002). Participants are able to stop whenever and use walking aids if they wish (Regensteiner, 2004). | 6 months | |
Other | Fitness Capacity: Change in Handgrip Strength Test score from baseline and 3 months | Long standing diabetes has been linked to significantly lower grip strength (which is an overall indicator of full body strength and risk of mortality) compared to healthy individuals (Ezema et al., 2012; Sayer et al., 2005). This will be assessed using the Southampton Protocol | 6 months | |
Other | Psychological: Change in Health-related Quality of Life score from baseline | EQ-5D-5L | 6 months | |
Other | Psychological: Change in Diabetes Self Efficacy score from baseline | Stanford Diabetes Self-efficacy scale (Lorig et al., 2009) | 6 months | |
Other | Psychological: Change in Intrinsic Motivation for Exercise scores from baseline | Behavioural Regulation in Exericse Questionnaire BREQ-3 (Markland and Tobin (2004) and Wilson et al. (2006) | 6 months | |
Other | Change in Step count from baseline | Bi-weekly mean of daily step count; measured by the FitBit Inspire 2™, measured at baseline, 3 months, and 6 months | 6 months | |
Other | Change in Sedentary Time from baseline | Bi-weekly mean of sedentary time in minutes; measured by the FitBit Inspire 2™, measured at baseline, 3 months, and 6 months | 6 months | |
Other | change in Light Physical Activity from baseline | Bi-weekly mean of light physical activity in minutes; measured by the FitBit - Inspire 2™; measured at baseline, 3 months, and 6 months | 6 months | |
Other | Change in Moderate Physical Activity from baseline | Bi-weekly mean of moderate physical activity in minutes; measured by the FitBit Inspire 2™, measured at baseline, 3 months, and 6 months | 6 months | |
Other | Change in Vigorous Physical Activity from baseline | Bi-weekly mean of vigorous physical activity in minutes; measured by the FitBit Inspire 2™, measured at baseline, 3 months, and 6 months | 6 months | |
Other | Change in Nutrition (ASA-24) scores from baseline and 3 months | ASA-24 Canada Survey.- used to reflect the Canadian food supply, portion sizes, and nutrient composition. | Baseline - 6 months | |
Other | Participant Feedback | Assessed using an Exit Survey: completed at the end of the study, to receive feedback about experience/improvements etc. | Assessed at 6 months | |
Primary | Change in HbA1c from Baseline | HbA1c measured at baseline, 3 months, and 6 months | 6 months | |
Secondary | Change in total daily basal insulin use from baseline | Daily basal insulin use, measured at baseline, 3 months, and 6 months | 6 months | |
Secondary | Change in rapid insulin use from Baseline | Rapid insulin use, measured at baseline, 3 months, and 6 months | 6 months |
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