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

February 19, 2020 updated by: LMC Diabetes & Endocrinology Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

286

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Toronto, Canada
        • LMC Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Omnipod cohort
Adults with T1D who switch from MDI therapy to insulin pump therapy with Omnipod.
Device: 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.
MDI cohort
Adults with T1D who continue MDI therapy.
Other: MDI
Continued use of MDI therapy (traditional basal/bolus insulin regimen).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycated hemoglobin (A1C)
Time Frame: Three to six months from baseline
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%
Time Frame: Three to six months from baseline
Proportion of patients achieving A1C < 7.0%
Three to six months from baseline
Proportion of patients achieving A1C < 8.0%
Time Frame: Three to six months from baseline
Proportion of patients achieving A1C < 8.0%
Three to six months from baseline
Weight
Time Frame: Three to six months from baseline
Change in weight (kg). Weight will be retrieved from the participants electronic medical records.
Three to six months from baseline
Body mass index (BMI)
Time Frame: Three to six months from baseline
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
Time Frame: 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.
Three to six months from baseline
Weekly incidence of hypoglycemia
Time Frame: 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.
Three to six months from baseline
Annual incidence of severe hypoglycemia
Time Frame: 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.
Three to six months from baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-measured blood glucose (SMBG) testing frequency
Time Frame: Pre- and post Omnipod initiation
The last 7 to 14 days of SMBG data during the baseline and follow-up period will be recorded from the participants electronic medical records, in a subset of participants with available SMBG data.
Pre- and post Omnipod initiation
Change in A1C in at 12, 18, 24 and 36 months
Time Frame: 12 months, 18 months, 24 months and 36 months
Change in A1C will be retrieved from the participants electronic medical records, in subsets of participants who have available A1C data at 12, 18, 24 and 36 months
12 months, 18 months, 24 months and 36 months
Continuous glucose monitor (CGM) glucose
Time Frame: Three to six months from baseline
Change in CGM glucose pre and post-Omnipod initiation will be reported in a subset of patients using a CGM device, who have 14 to 90 days of CGM data available within the baseline observation period and during the follow-up period.
Three to six months from baseline
CGM standard deviation (SD)
Time Frame: Three to six months from baseline
Change in CGM SD pre and post-Omnipod initiation will be reported in a subset of patients using a CGM device, who have 14 to 90 days of CGM data available within the baseline observation period and during the follow-up period.
Three to six months from baseline
CGM Co-efficient of variation (CV)
Time Frame: Three to six months from baseline
Proportion of patients with CGM CV ≤36% and >36% pre and post-Omnipod initiation will be reported in a subset of patients using a CGM device, who have 14 to 90 days of CGM data available within the baseline observation period and during the follow-up period.
Three to six months from baseline
Percent time in range
Time Frame: Three to six months from baseline
Change in percent time in range (glucose 3.9 to 10.0 mmol/L) pre and post-Omnipod initiation will be reported in a subset of patients using a CGM device, who have 14 to 90 days of CGM data available within the baseline observation period and during the follow-up period.
Three to six months from baseline
Percent time below range
Time Frame: Three to six months from baseline
Change in percentage time below range (glucose (<3.9 mmol/L) pre and post-Omnipod initiation will be reported in a subset of patients using a CGM device, who have 14 to 90 days of CGM data available within the baseline observation period and during the follow-up period.
Three to six months from baseline
Percent time above range
Time Frame: Three to six months from baseline
Change in percentage time above range (glucose (>10.0 mmol/L) pre and post-Omnipod initiation will be reported in a subset of patients using a CGM device, who have 14 to 90 days of CGM data available within the baseline observation period and during the follow-up period.
Three to six months from baseline
A1C stratified by baseline A1C
Time Frame: Three to six months from baseline
A1C outcomes will be assessed separately in patients with baseline A1C <9.0% and ≥9.0%
Three to six months from baseline
A1C stratified by age cohort
Time Frame: Three to six months from baseline
A1C outcomes will be assessed separately in three pre-defined age cohorts: 18 to 25 years, 26 to 49 years, and ≥ 50 years
Three to six months from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LMC Diabetes & Endocrinology Ltd.

Collaborators

Insulet Corporation

Investigators

  • Principal Investigator: Ronnie Aronson, LMC Healthcare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2020

Primary Completion (Actual)

February 9, 2020

Study Completion (Actual)

February 9, 2020

Study Registration Dates

First Submitted

January 9, 2020

First Submitted That Met QC Criteria

January 9, 2020

First Posted (Actual)

January 13, 2020

Study Record Updates

Last Update Posted (Actual)

February 21, 2020

Last Update Submitted That Met QC Criteria

February 19, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COPPER

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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