Canadian Real-World Outcomes of Omnipod Initiation in People With T1D: Evidence From the LMC Diabetes Registry: The COPPER Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 286
- Locations
- 1
- Primary Endpoint
- Glycated hemoglobin (A1C)
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Clinical diagnosis of T1D ≥ 12 months prior to initiating the Omnipod
- •Age ≥ 18 years
- •Switched from MDI to Omnipod (Omnipod cohort)
- •Persistent with OmniPod treatment for ≥ six months
- •No change in basal insulin type or bolus insulin type between baseline and follow up (matched MDI cohort)
- •≥ one A1C measurement during the baseline and follow-up period
Exclusion Criteria
- •Switched from traditional CSII to OmniPod
- •Use of non-insulin diabetes therapies
Outcomes
Primary Outcomes
Glycated hemoglobin (A1C)
Time Frame: Three to six months from baseline
Change in A1C (%). A1C will be retrieved from the participants electronic medical records.
Secondary Outcomes
- Proportion of patients achieving A1C < 8.0%(Three to six months from baseline)
- Proportion of patients achieving A1C < 7.0%(Three to six months from baseline)
- Weight(Three to six months from baseline)
- Body mass index (BMI)(Three to six months from baseline)
- Total daily dose (TDD) of insulin(Three to six months from baseline)
- Weekly incidence of hypoglycemia(Three to six months from baseline)
- Annual incidence of severe hypoglycemia(Three to six months from baseline)