Clinical trial NCT04226378: Canadian Real-World Outcomes of Omnipod Initiation in People With T1D
Official title: Canadian Real-World Outcomes of Omnipod Initiation in People With T1D: Evidence From the LMC Diabetes Registry: The COPPER Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 1
Keywords: Diabetes
Observational study
Glycemic control
Insulin pumps
Lead sponsor: LMC Diabetes & Endocrinology Ltd.
Sponsor class: OTHER
Collaborators: name: Insulet Corporation
First posted: 2020-01-13
Enrollment: 286
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with T1D initiating Omnipod between January 2011 and December 2018, and a matched cohort of MDI users who have available data during the same time frame.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Glycated hemoglobin (A1C)
timeFrame: Three to six months from baseline
Secondary outcomes:
measure: Proportion of patients achieving A1C < 7.0%
timeFrame: Three to six months from baseline
measure: Proportion of patients achieving A1C < 8.0%
timeFrame: Three to six months from baseline
measure: Weight
timeFrame: Three to six months from baseline
measure: Body mass index (BMI)
timeFrame: Three to six months from baseline
measure: Total daily dose (TDD) of insulin
timeFrame: Three to six months from baseline
measure: Weekly incidence of hypoglycemia
timeFrame: Three to six months from baseline
measure: Annual incidence of severe hypoglycemia
timeFrame: Three to six months from baseline
Other outcomes:
measure: Self-measured blood glucose (SMBG) testing frequency
timeFrame: Pre- and post Omnipod initiation
measure: Change in A1C in at 12, 18, 24 and 36 months
timeFrame: 12 months, 18 months, 24 months and 36 months
measure: Continuous glucose monitor (CGM) glucose
timeFrame: Three to six months from baseline
measure: CGM standard deviation (SD)
timeFrame: Three to six months from baseline
measure: CGM Co-efficient of variation (CV)
timeFrame: Three to six months from baseline
measure: Percent time in range
timeFrame: Three to six months from baseline
measure: Percent time below range
timeFrame: Three to six months from baseline
measure: Percent time above range
timeFrame: Three to six months from baseline
measure: A1C stratified by baseline A1C
timeFrame: Three to six months from baseline
measure: A1C stratified by age cohort
timeFrame: Three to six months from baseline
Locations:
city: Toronto
country: Canada
facility: LMC Healthcare
Study officials:
affiliation: LMC Healthcare
name: Ronnie Aronson
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brown RE, Vienneau T, Aronson R. Canadian Real-World Outcomes of Omnipod Initiation in People with Type 1 Diabetes (COPPER study): Evidence from the LMC Diabetes Registry. Diabet Med. 2021 Jun;38(6):e14420. doi: 10.1111/dme.14420. Epub 2020 Oct 22.