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Completed

NCT Number: NCT04226378

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

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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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

LMC Healthcare

Toronto, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

MDI

Other

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

Primary outcomes

  1. Glycated hemoglobin (A1C)

    Time frame: Three to six months from baseline

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

Secondary outcomes

  1. Proportion of patients achieving A1C < 7.0%

    Time frame: Three to six months from baseline

    Proportion of patients achieving A1C < 7.0%

  2. Proportion of patients achieving A1C < 8.0%

    Time frame: Three to six months from baseline

    Proportion of patients achieving A1C < 8.0%

  3. Weight

    Time frame: Three to six months from baseline

    Change in weight (kg). Weight will be retrieved from the participants electronic medical records.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Other outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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%

  10. 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

Sponsors and collaborators

Lead sponsor

LMC Diabetes & Endocrinology Ltd.

Other

Collaborators

  • Insulet Corporation

Registry information

Official study title

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

Acronym: COPPER

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 13, 2020
Registry last updated
Feb 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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