The Libre Enabled Reduction of A1c Through Effective Eating and Exercise Study: LIBERATE
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 184
- 试验地点
- 2
- 主要终点
- Change in HbA1c from Baseline
研究概览
简要总结
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.
详细描述
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 about the study and confirm eligibility criteria. One the same call, the research coordinator will be setting up a phone call time (within the week) to review the LOI with the potential participant. After the phone call, the research coordinator will send the LOI for review via email. The time from this call to program start may vary between participants. This is due to the need to fill the group capacity of 6-8 participants/class before initiating a participant.
If a patient self-refers from the community, we will access OLIS for recent blood work. If an A1c has not been completed in the last 3 months, we will need to consent them over the phone using the e-consent via REDCap first and then they will be given an OHIP lab requisition to complete the test within one week. This is done so that potential participants are not having to go through the entire onboarding testing before knowing if they are eligible to participate in the study.
On the phone call (within the week of the pre-screening call), we will review the Letter of Information and Consent with the participant. We will answer any questions they may have.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- • 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
排除标准
- •• 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.…)
研究组 & 干预措施
LIBERATE Intervention
干预措施: LIBERATE (Behavioral)
结局指标
主要结局
Change in HbA1c from Baseline
时间窗: 6 months
HbA1c measured at baseline, 3 months, and 6 months
次要结局
- Change in rapid insulin use from Baseline(6 months)
- Change in total daily basal insulin use from baseline(6 months)
研究者
Sonja Reichert
Associate Professor, Department of Family Medicine; Dr. Brian W. Gilbert Chair in Primary Health Care Research
Western University, Canada