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

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Other: MDI; Device: Omnipod

• Registration Number: NCT04226378
• Lead Sponsor: LMC Diabetes & Endocrinology Ltd.

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 Timeline

• Study First Submitted: 2020-01-09
• Study First Submitted QC: 2020-01-09
• Study First Posted: 2020-01-13
• Study Start: 2020-01-20
• Status Verified: 2020-02
• Primary Completion: 2020-02-09
• Study Completion: 2020-02-09
• Last Update Submitted: 2020-02-19
• Last Update Posted: 2020-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 286

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MDI cohort	MDI	Adults with T1D who continue MDI therapy.
Omnipod cohort	Omnipod	Adults with T1D who switch from MDI therapy to insulin pump therapy with Omnipod.

Primary Outcome Measures

Name	Time	Method
Glycated hemoglobin (A1C)	Three to six months from baseline	Change in A1C (%). A1C will be retrieved from the participants electronic medical records.

Secondary Outcome Measures

Name	Time	Method
Proportion of patients achieving A1C < 7.0%	Three to six months from baseline	Proportion of patients achieving A1C \< 7.0%
Proportion of patients achieving A1C < 8.0%	Three to six months from baseline	Proportion of patients achieving A1C \< 8.0%
Weight	Three to six months from baseline	Change in weight (kg). Weight will be retrieved from the participants electronic medical records.
Body mass index (BMI)	Three to six months from baseline	Change in BMI (kg/m2). BMI will be retrieved from the participants electronic medical records.
Total daily dose (TDD) of insulin	Three to six months from baseline	Change in total daily dose (TDD) of insulin. TDD of insulin will be retrieved from the participants electronic medical records.
Weekly incidence of hypoglycemia	Three to six months from baseline	Change in self-reported weekly incidence of any hypoglycemia. Weekly incidence of hypoglycemia will be retrieved from the participants electronic medical records.
Annual incidence of severe hypoglycemia	Three to six months from baseline	Change in self-reported annual incidence of severe hypoglycemia. Severe hypoglycemia will be retrieved from the participants electronic medical records.

Trial Locations

Locations (1)

LMC Healthcare; 🇨🇦 Toronto, Canada