Canadian Real-World Outcomes of Omnipod Initiation in People With T1D

Study Overview
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Brief Summary
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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
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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.

Official Title
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Canadian Real-World Outcomes of Omnipod Initiation in People With T1D: Evidence From the LMC Diabetes Registry: The COPPER Study

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Device: Omnipod
* Other: MDI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Omnipod cohort<br>Adults with T1D who switch from MDI therapy to insulin pump therapy with Omnipod. | Device: Omnipod<br>* Switch from MDI therapy to an Omnipod as part of usual clinical practice. An Omnipod is a patch pump that consists of a handheld controller and a disposable pod that delivers insulin.<br>|
| MDI cohort<br>Adults with T1D who continue MDI therapy. | Other: MDI<br>* Continued use of MDI therapy (traditional basal/bolus insulin regimen).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycated hemoglobin (A1C) | Change in A1C (%). A1C will be retrieved from the participants electronic medical records. | Three to six months from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients achieving A1C < 7.0% | Proportion of patients achieving A1C < 7.0% | Three to six months from baseline | 
| Proportion of patients achieving A1C < 8.0% | Proportion of patients achieving A1C < 8.0% | Three to six months from baseline | 
| Weight | Change in weight (kg). Weight will be retrieved from the participants electronic medical records. | 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. | 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. | 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. | Three to six months from baseline | 
| Annual incidence of severe hypoglycemia | Change in self-reported annual incidence of severe hypoglycemia. Severe hypoglycemia will be retrieved from the participants electronic medical records. | Three to six months from baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Observational study, Glycemic control, Insulin pumps