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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

286 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-20

Study Completion Date

2020-02-09

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.

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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.

Conditions

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Diabetes Mellitus, Type 1

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Omnipod cohort

Adults with T1D who switch from MDI therapy to insulin pump therapy with Omnipod.

Omnipod

Intervention Type DEVICE

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.

MDI cohort

Adults with T1D who continue MDI therapy.

MDI

Intervention Type OTHER

Continued use of MDI therapy (traditional basal/bolus insulin regimen).

Interventions

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Omnipod

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.

Intervention Type DEVICE

MDI

Continued use of MDI therapy (traditional basal/bolus insulin regimen).

Intervention Type OTHER

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