Real-world Effects of Using Intermittently Scanned Continuous Glucose Monitoring and Pharmacist-led Coaching on the Management of Type 2 Diabetes Among Adults Using Non-insulin Antihyperglycemic Agents
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Change in HbA1c
研究概览
简要总结
The goal of this prospective study is to evaluate diabetes outcomes after initiating second generation intermittently scanned continuous glucose monitoring (isCGM) plus one pharmacist consultation session compared with capillary blood glucose (CBG) monitoring among insulin-naïve adults with type 2 diabetes (T2D) in a specialist endocrinology clinical setting in Canada.
Primary Outcome - To evaluate change in HbA1c at 3-6 months follow-up after initiating isCGM plus one pharmacist consultation (isCGM cohort) compared with CBG monitoring (CBG cohort) among insulin-naïve adults with T2D.
Secondary Outcomes - To determine the change in metabolic outcomes and patient reported outcomes (PROs) and number of non-insulin antihyperglycemic agents (AHAs) prescribed from baseline to 3-6 months (± 6 weeks) in the isCGM cohort compared to the CBG cohort. Another secondary outcome is to assess isCGM metrics and number of isCGM discontinuations in the isCGM cohort at 3-6 months (± 6 weeks) compared to baseline. Additionally the study will describe and/or evaluate glycemic and metabolic outcomes, and PROs in participants who initiate an isCGM device and opt to enroll in a diabetes coaching program (isCGM+coaching cohort) at baseline compared to follow-up at 3-6 months (± 6 weeks).
Exploratory Outcomes - To compare change in HbA1c between the matched isCGM cohort and CBG cohort by subgroups: age (< 65 years old vs ≥ 65 years old) and baseline HbA1c (< 8.5% vs ≥ 8.5%).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •18 years or older
- •Clinical diagnosis of T2D ≥ one year
- •Using at least one AHA
- •Status as a Sun Life group benefits member, initiates isCGM device through Lumino Health™ Pharmacy, and completes one initial pharmacist consultation (isCGM cohort) or completes 2 or more diabetes coaching program consultations (isCGM+coaching cohort); or has private health insurance and uses CBG monitoring (CBG cohort)
- •Baseline HbA1c ≥ 7.0%
- •≥ 1 HbA1c value up to 6 months prior to index date
- •Exclusive use of isCGM for ≥ 3 months
- •Informed consent
排除标准
- •Have a history of insulin use
- •Are pregnant or breastfeeding at the time of study enrollment or become pregnant during the study
- •Have an estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2
- •Previously used rtCGM or isCGM for > 3 months
- •Recent or expectant change to antihyperglycemic medications or doses within 30 days of index date
结局指标
主要结局
Change in HbA1c
时间窗: from enrollment to 3-6 month follow up
Evaluate the change in HbA1c at 3-6 months follow-up (±6 weeks) in the matched isCGM and CBG cohorts among adults with insulin-naïve T2D
次要结局
- Glucose monitoring device satisfaction(from enrollment to 3-6 month follow up)
- Proportion of participants achieving HbA1c ≤ 7.0%(assessed at 3-6 month follow-up)
- Change in Weight(from enrollment to 3-6 month follow up)
- Change in BMI(from enrollment to 3-6 month follow up)
- Change in Blood Pressure(from enrollment to 3-6 month follow up)
- Proportion of Participants Achieving HbA1c ≤ 7.0% at Follow-Up(from enrollment to 3-6 month follow up)
- Proportion of Participants with ≥1 Self-Reported Hypoglycemic Event per Week(from enrollment to 3-6 month follow up)
- Percent Time in Range (TIR)(from enrollment to 3-6 month follow up)
- Percent Time Below Range (TBR)(from enrollment to 3-6 month follow up)
- Percent Time Below Range (TBR) in Level 2 Hypoglycemia(from enrollment to 3-6 month follow up)
- Percent Time Above Range (TAR)(from enrollment to 3-6 month follow up)
- Mean glucose(from enrollment to 3-6 month follow up)
- Estimated Glucose Management Indicator (eGMI)(from enrollment to 3-6 month follow up)
- Glycemic variability(from enrollment to 3-6 month follow up)
- Percent sensor capture(from enrollment to 3-6 month follow up)
- Number of isCGM discontinuations(assessed at 3-6 month follow-up)
- Number of diabetes coaching program discontinuations(from enrollment to 3-6 month follow up)
- Psychological distress(from enrollment to 3-6 month follow up)
- Change in Body Mass Index (BMI)(from enrollment to 3-6 month follow up)
- Proportion of participants with ≥1 self-reported hypoglycemic event per week(from enrollment to 3-6 month follow up)