Diabetes Mellitus
Conditions
Brief summary
The objective of this retrospective, observational study, is to better understand the real-world glycemic effectiveness of switching to real time continuous glucose monitoring (rtCGM) from intermittently scanned continuous glucose monitoring (isCGM) among adults with type 1 diabetes or type 2 diabetes in Canada.
Interventions
Individuals who switched from using isCGM to rtCGM
Sponsors
DexCom, Inc.
LMC Diabetes & Endocrinology Ltd.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older as of the index date * Clinical diagnosis of T1D or T2D ≥ one year * Using either MDI or CSII therapy * Initiated a FreeStyle Libre® isCGM device between January 1, 2018 and July 31, 2023 (isCGM cohort) * Switched from a FreeStyle Libre® 1 or Libre 2® isCGM device to a Dexcom® G5 or G6 CGM device between April 1, 2018 and July 31, 2023 (rtCGM cohort) * Baseline HbA1c ≥7.0% for primary objective with rtCGM cohort * Baseline HbA1c ≥8.0% for key secondary objective comparing rtCGM cohort to isCGM cohort * Known rtCGM/isCGM start date (month and year) * Exclusive use of isCGM for ≥ 3 months * ≥ one HbA1c value up to 6 months (± 6 weeks) prior to index date (HbA1c value must be after isCGM initiation and no more than 6 weeks after the index date) * ≥ one HbA1c value 6-12 months (± 6 weeks) following the index date * Informed consent for their medical record data to be used for research purposes
Exclusion criteria
* Have a prior history of rtCGM within 12 months of the index date * Are pregnant at the time of isCGM initiation or time of switch to rtCGM * Used the isCGM or rtCGM for \< 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c at 6-12-month follow-up compared to baseline | from index date to 6- to-12-month follow-up | To evaluate change in HbA1c at 6-12-month follow-up compared to baseline after switching from an isCGM system to a rtCGM system in adults with type 1 diabetes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in percent time in target glucose range (TIR) at 6-12 months follow-up | from index date to 6- to-12-month follow-up | To evaluate change in percent TIR at 6-12 months follow-up compared to baseline in the rtCGM switch cohort, and between the rtCGM switch cohort with HbA1c ≥ 7.5% and propensity score matched isCGM cohort with HbA1c ≥ 7.5%. |
| Change in percent time below target glucose range (TBR) | from index date to 6- to-12-month follow-up | To evaluate change in percent TBR at 6-12 months follow-up compared to baseline in the rtCGM switch cohort, and between the rtCGM switch cohort with HbA1c ≥ 7.5% and propensity score matched isCGM cohort with HbA1c ≥ 7.5%. |
| Change in percent time above target glucose range (TAR) | from index date to 6- to-12-month follow-up | To evaluate change in percent TAR at 6-12 months follow-up compared to baseline in the rtCGM switch cohort, and between the rtCGM switch cohort with HbA1c ≥ 7.5% and propensity score matched isCGM cohort with HbA1c ≥ 7.5%. |
| Change in mean glucose | from index date to 6- to-12-month follow-up | To evaluate change in mean glucose at 6-12 months follow-up compared to baseline in the rtCGM switch cohort, and between the rtCGM switch cohort with HbA1c ≥ 7.5% and propensity score matched isCGM cohort with HbA1c ≥ 7.5%. |
| Change in standard deviation (SD) of mean glucose | from index date to 6- to-12-month follow-up | To evaluate change in SD of mean glucose at 6-12 months follow-up compared to baseline in the rtCGM switch cohort, and between the rtCGM switch cohort with HbA1c ≥ 7.5% and propensity score matched isCGM cohort with HbA1c ≥ 7.5%. |
| Change in coefficient of variation (CV) of mean glucose | from index date to 6- to-12-month follow-up | To evaluate change in CV of mean glucose at 6-12 months follow-up compared to baseline in the rtCGM switch cohort, and between the rtCGM switch cohort with HbA1c ≥ 7.5% and propensity score matched isCGM cohort with HbA1c ≥ 7.5%. |
| Change in HbA1c in the rtCGM switch cohort compared to a matched isCGM cohort | from index date to 6- to-12-month follow-up | To compare 6-12 month change in HbA1c in the rtCGM switch cohort, who switched from isCGM to rtCGM, compared to a propensity score matched isCGM cohort, who maintained isCGM use, among a subgroup of patients with T1D and HbA1c ≥ 7.5%. |
| Proportion of patients who achieve HbA1c ≤7.0% | evaluated at 6- to-12-month follow-up | To evaluate the proportion of patients who achieve HbA1c ≤7.0% at 6-12 months follow-up in the rtCGM switch cohort, and between the rtCGM switch cohort with HbA1c ≥ 7.5% at baseline and propensity score matched isCGM cohort with HbA1c ≥ 7.5% at baseline. |
| Weekly incidence of self-reported hypoglycemia | evaluated at 6- to-12-month follow-up | To evaluate weekly incidence of self-reported hypoglycemia at 6-12 months in the rtCGM switch cohort, and between the rtCGM switch cohort with HbA1c ≥ 7.5% and propensity score matched isCGM cohort with HbA1c ≥ 7.5%. |
| Proportion of patients with ≥ 1 self-reported hypoglycemic event | evaluated at 6- to-12-month follow-up | To evaluate proportion of patients with ≥ 1 self-reported hypoglycemic event at 6-12 months in the rtCGM switch cohort, and between the rtCGM switch cohort with HbA1c ≥ 7.5% and propensity score matched isCGM cohort with HbA1c ≥ 7.5%. |
| Change in total daily dose (TDD) of insulin | from index date to 6- to-12-month follow-up | To evaluate change in TDD of insulin at 6-12 months follow-up compared to baseline in the rtCGM switch cohort, and between the rtCGM switch cohort with HbA1c ≥ 7.5% and propensity score matched isCGM cohort with HbA1c ≥ 7.5%. |
| Proportion of patients using a Tandem® insulin pump in the rtCGM switch cohort | from index date to 6- to-12-month follow-up | To evaluate proportion of patients using a Tandem® insulin pump in the rtCGM switch cohort during the study period from baseline to 6-12 months follow-up. |
| Change in weight | from index date to 6- to-12-month follow-up | To evaluate change in weight at 6-12 months follow-up compared to baseline in the rtCGM switch cohort, and between the rtCGM switch cohort with HbA1c ≥ 7.5% and propensity score matched isCGM cohort with HbA1c ≥ 7.5%. |
Countries
Canada
Outcome results
None listed