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

NCT04226378 | Completed FDA Device

• 1 other identifier: COPPER
• Study Type: observational
• Target: 286
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 1

Keywords

Diabetes; Observational study; Glycemic control; Insulin pumps

Outcome Measures

Primary Outcomes (1)

• Glycated hemoglobin (A1C)

  Change in A1C (%). A1C will be retrieved from the participants electronic medical records.

  Three to six months from baseline

Secondary Outcomes (7)

• Proportion of patients achieving A1C < 7.0%

  Three to six months from baseline

• Proportion of patients achieving A1C < 8.0%

  Three to six months from baseline

• Weight

  Three to six months from baseline

• Body mass index (BMI)

  Three to six months from baseline

• Total daily dose (TDD) of insulin

  Three to six months from baseline

Other Outcomes (10)

• Self-measured blood glucose (SMBG) testing frequency

  Pre- and post Omnipod initiation

• Change in A1C in at 12, 18, 24 and 36 months

  12 months, 18 months, 24 months and 36 months

• Continuous glucose monitor (CGM) glucose

  Three to six months from baseline

Study Arms (2)

Omnipod cohort

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

Device: Omnipod

MDI cohort

Adults with T1D who continue MDI therapy.

Other: MDI

Interventions

Omnipod 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.

Omnipod cohort

MDI OTHER

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

MDI cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Switched from traditional CSII to OmniPod
• Use of non-insulin diabetes therapies

Sponsors & Collaborators

• LMC Diabetes & Endocrinology Ltd.: lead
• Insulet Corporation: collaborator

Study Sites (1)

LMC Healthcare

Toronto, Canada

Location

Related Publications (1)

• 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.

  PMID: 33040383 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Ronnie Aronson

  LMC Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: January 13, 2020
• Study Start: January 20, 2020
• Primary Completion: February 9, 2020
• Study Completion: February 9, 2020
• Last Updated: February 21, 2020

Record last verified: 2020-02

Locations

CA (1)