The current study aims to assess clinical outcomes in adults with type 1 diabetes (T1D) who have switched from traditional multiple daily injection (MDI) therapy to continuous subcutaneous insulin infusion (CSII) therapy with the Omnipod insulin system.
Poor glycemic control is associated with increased risk of diabetes-related complications in persons with type 1 diabetes (T1D). Despite advancements in insulin therapies and an increase in diabetes technology use, only 21% of adults with T1D are meeting their targeted glycated hemoglobin (A1C) levels. The Omnipod insulin system is a patch pump that consists of a handheld controller and disposable pod that delivers insulin. A retrospective analysis of medical records in the United States found that there was a significant reduction in A1C three months after initiating Omnipod in pediatric, adolescent and adult populations with T1D who switched from either MDI or traditional CSII. Currently, the real-world effectiveness of the Omnipod compared to MDI in adults with T1D on glycemic control, weight, and insulin dose, is not established. The Canadian Real-World Outcomes of Omnipod Initiation in People with T1D: Evidence from the LMC Diabetes Registry (COPPER) study is a retrospective, observational study using demographic and clinical data from the LMC Diabetes Registry, which consists of over 42,000 active patients with diabetes across 3 Canadian provinces. The overall objectives of this study are to assess clinical outcomes in adults with T1D who switch from MDI to CSII therapy with Omnipod, and to compare clinical outcomes in the Omnipod cohort to a matched cohort of MDI users.
Study Type
OBSERVATIONAL
Enrollment
286
LMC Healthcare
Toronto, Canada
Glycated hemoglobin (A1C)
Change in A1C (%). A1C will be retrieved from the participants electronic medical records.
Time frame: Three to six months from baseline
Proportion of patients achieving A1C < 7.0%
Proportion of patients achieving A1C \< 7.0%
Time frame: Three to six months from baseline
Proportion of patients achieving A1C < 8.0%
Proportion of patients achieving A1C \< 8.0%
Time frame: Three to six months from baseline
Weight
Change in weight (kg). Weight will be retrieved from the participants electronic medical records.
Time frame: Three to six months from baseline
Body mass index (BMI)
Change in BMI (kg/m2). BMI will be retrieved from the participants electronic medical records.
Time frame: Three to six months from baseline
Total daily dose (TDD) of insulin
Change in total daily dose (TDD) of insulin. TDD of insulin will be retrieved from the participants electronic medical records.
Time frame: Three to six months from baseline
Weekly incidence of hypoglycemia
Change in self-reported weekly incidence of any hypoglycemia. Weekly incidence of hypoglycemia will be retrieved from the participants electronic medical records.
Time frame: Three to six months from baseline
Annual incidence of severe hypoglycemia
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Change in self-reported annual incidence of severe hypoglycemia. Severe hypoglycemia will be retrieved from the participants electronic medical records.
Time frame: Three to six months from baseline