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.
18 years or older
Clinical diagnosis of T2D ≥ one year
Using insulin for ≥ 6 months
Continued FreeStyle Libre® 2 isCGM device (isCGM cohort) as of the study start date
Have a prior history of rtCGM within 12 months of the index date
Recent or expectant change to antihyperglycemic medications or doses within 30 days of index date
Recent or expectant titration of insulin dose ≥ 20% within 30 days of index date
Are pregnant at the time of study enrollment or intending to become pregnant during the study
The study population will be adults, who are active patients with insulin-treated T2D at LMC, who switch from a FreeStyle Libre® 2 device to a Dexcom® G7 (rtCGM switch cohort) or initiated a FreeStyle Libre® 2 and maintain isCGM use (isCGM cohort) after December 2024
Cohort
Prospective
real-time continuous glucose monitor
DeviceIndividuals who switched from using isCGM to rtCGM
Change in Percent Time in Range (TIR)
evaluate change in percent TIR (3.9 to 10.0 mmol/L) at 3-6 months follow-up after switching from a second generation isCGM system to a rtCGM system compared with continued second generation isCGM cohort among propensity score matched cohorts of adults with insulin-treated T2D. Percent TIR will be reported from the patient's EMR or Clarity® and LibreView® platforms (last 14 days of available data closest to the index date or 6-month follow-up date, where percent sensor capture is ≥ 70%).
Change in Percent Time Below Range (TBR)
Evaluate change in percent TBR (\<3.9 mmol/L) at 3-6 months follow-up after switching from a second generation isCGM system to a rtCGM system compared with continued second generation isCGM cohort among propensity score matched cohorts of adults with insulin-treated T2D.
Change In Percent Time Below Range (TBR) in Level 2 Hypoglycemia
Evaluate change in percent TBR in level 2 hypoglycemia (\<3.0 mmol/L) at 3-6 months follow-up after switching from a second generation isCGM system to a rtCGM system compared with continued second generation isCGM cohort among propensity score matched cohorts of adults with insulin-treated T2D.
Change in Percent Time Above Target Glucose Range (TAR)
Evaluate change in percent TAR (\>10.0 mmol/L) at 3-6 months follow-up after switching from a second generation isCGM system to a rtCGM system compared with continued second generation isCGM cohort among propensity score matched cohorts of adults with insulin-treated T2D.
Change in Mean Glucose
Evaluate change in mean glucose (mmol/L) at 3-6 months follow-up after switching from a second generation isCGM system to a rtCGM system compared with continued second generation isCGM cohort among propensity score matched cohorts of adults with insulin-treated T2D.
Glucose Monitoring Device Satisfaction Scale (GMSS)
includes questions about device satisfaction, filled out only by the cohort switching from isCGM to rtCGM
Diabetes Distress Scale (DDS)
includes questions about psychological distress , filled out only by the cohort switching from isCGM to rtCGM
Protocol-Specific Dexcom Care Survey
includes protocol-specific questions about rtCGM device, filled out only by the cohort switching from isCGM to rtCGM
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LMC Diabetes & Endocrinology Ltd.
Lead sponsor
DexCom, Inc.
Collaborator
