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| Name | Class |
|---|---|
| DexCom, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| real-time continuous glucose monitoring switch group (rtCGM switch group) | adults with diabetes that switched from an isCGM to an rtCGM |
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| intermittently scanned continuous glucose monitoring group (isCGM group) | adults with diabetes that remained on an isCGM |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| real-time continuous glucose monitor | Device | Individuals who switched from using isCGM to rtCGM |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c at 6-12-month follow-up compared to baseline | 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 | from index date to 6- to-12-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c in the rtCGM switch cohort compared to a matched isCGM cohort | 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%. | from index date to 6- to-12-month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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The study population includes adults, who were active patients with type 1 diabetes or type 2 diabetes at LMC, who switched from intermittently scanned continuous glucose monitoring to real-time continuous glucose monitoring (rtCGM switch cohort) or initiated and maintained intermittently scanned continuous glucose monitoring use (isCGM cohort).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LMC Diabetes & Endocrinology Ltd. | Toronto | Ontario | M4G3E8 | Canada |
This is a real-world study using data retrieved from a national Diabetes Registry. IPD will not be shared.
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Change in percent time in target glucose range (TIR) at 6-12 months 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%. | from index date to 6- to-12-month follow-up |
| Change in percent time below target glucose range (TBR) | 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%. | from index date to 6- to-12-month follow-up |
| Change in percent time above target glucose range (TAR) | 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%. | from index date to 6- to-12-month follow-up |
| Change in mean glucose | 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%. | from index date to 6- to-12-month follow-up |
| Change in standard deviation (SD) of mean glucose | 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%. | from index date to 6- to-12-month follow-up |
| Change in coefficient of variation (CV) of mean glucose | 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%. | from index date to 6- to-12-month follow-up |
| Change in weight | 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%. | from index date to 6- to-12-month follow-up |
| Proportion of patients who achieve HbA1c ≤7.0% | 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. | evaluated at 6- to-12-month follow-up |
| Weekly incidence of self-reported hypoglycemia | 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%. | evaluated at 6- to-12-month follow-up |
| Proportion of patients with ≥ 1 self-reported hypoglycemic event | 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%. | evaluated at 6- to-12-month follow-up |
| Change in total daily dose (TDD) of insulin | 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%. | from index date to 6- to-12-month follow-up |
| Proportion of patients using a Tandem® insulin pump in the rtCGM switch cohort | 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. | from index date to 6- to-12-month follow-up |