Clinical trials

The goal of this study is to better understand the real-world effectiveness of semaglutide use on cardio-kidney-metabolic outcomes among adults with T2D and adults with obesity (without diabetes mellitus). This is a retrospective longitudinal analysis using the LMC Diabetes Registry. The primary outcome of the study is to evaluate the change in HbA1c between baseline to 3 years of follow-up among adults with T2D who initiated semaglutide compared to adults with T2D who initiated other AHAs, including sulfonylurea, dipeptidyl peptidase-4 inhibitors, and sodium-glucose cotransporter-2 inhibitors.

The goal of the study is to evaluate the effectiveness of intermittently scanned continuous glucose monitoring compared to capillary blood glucose monitoring among people with type 2 diabetes initiating low calorie meal replacement plus diabetes self-management education in improving the proportion of patients achieving remission of type 2 diabetes. This is an open-label randomized controlled trial with 2 treatment arms randomized in a 1:1 manner. The Investigators hypothesize that the use of intermittently scanned continuous glucose monitoring will improve the percentage of participants achieving remission of type 2 diabetes (remission to prediabetes or remission to normoglycemia), among adults with type 2 diabetes starting low calorie meal replacement and diabetes self-management education compared to a control group using capillary blood glucose monitoring at 18-30 weeks follow-up (end of Phase 2). The primary outcome of the study is to compare the percentage of participants who achieve remission of type 2 diabetes (remission to prediabetes with HbA1c 6.0% to 6.4% or remission to normoglycemia with HbA1c \< 6.0% using no antihyperglycemic agents for ≥ 3 consecutive months) at 18-30 weeks follow-up between intermittently scanned continuous glucose monitoring vs. capillary blood glucose monitoring, when combined with low calorie meal replacement and diabetes self-management education. Participants in both arms complete 3 phases of the study. Phase 1: total dietary replacement, Phase 2: food re-introduction and Phase 3: remission, while receiving diabetes self-management education sessions over a span of 18 months.

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%).

The goal of this prospective study is to evaluate diabetes outcomes and patient experience following a switch from second generation intermittently scanned continuous glucose monitor (isCGM) to real-time continuous glucose monitor (rtCGM) compared with participants with continued isCGM use among adults with insulin-treated type 2 diabetes (T2D) in a specialist endocrinology clinic setting in Canada. The study aims include: Primary outcome - Evaluate change in percent time in range (TIR) at 3-6 months follow-up after switching from a second generation isCGM system to a rtCGM system compared with participants with continued second generation isCGM use. Secondary outcomes - Compare glycemic and metabolic outcomes (ie. additional CGM metrics, HbA1c, and weight), and outcomes related to diabetes management (ie. self-reported hypoglycemia and change in total daily dose \[TDD\] of insulin) at 3-6 months follow-up in the rtCGM switch and isCGM cohorts among adults with insulin-treated T2D. Exploratory outcomes - Evaluate patient-reported outcomes (PROs) in the rtCGM switch cohort only. PROs will include questions about device satisfaction and psychological distress at baseline and 3-6 months follow-up, and protocol-specific questions about Dexcom Care following use of the rtCGM device at 3-6 months follow-up. Additionally this study will compare percent TIR, percent TBR, percent TAR, and HbA1c between rtCGM switch and isCGM cohorts by insulin therapy subgroup (basal vs MDI therapy). rtCGM switch participants will be enrolled at an LMC location and asked to complete PROs at baseline and 3-6 month follow-up. Continued isCGM participants will not be asked to complete PROs.