COPPER: Canadian Real-World Outcomes of Omnipod Initiation in People With T1D
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Arms and Interventions
| Arm | 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).
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Other Outcome Measures
- Self-measured blood glucose (SMBG) testing frequency [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.
- Change in A1C in at 12, 18, 24 and 36 months [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
- Continuous glucose monitor (CGM) glucose [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.
- CGM standard deviation (SD) [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.
- CGM Co-efficient of variation (CV) [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.
- Percent time in range [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.
- Percent time below range [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.
- Percent time above range [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.
- A1C stratified by baseline A1C [Three to six months from baseline]
A1C outcomes will be assessed separately in patients with baseline A1C <9.0% and ≥9.0%
- A1C stratified by age cohort [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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Clinical diagnosis of T1D ≥ 12 months prior to initiating the Omnipod
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Age ≥ 18 years
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Switched from MDI to Omnipod (Omnipod cohort)
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Persistent with OmniPod treatment for ≥ six months
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No change in basal insulin type or bolus insulin type between baseline and follow up (matched MDI cohort)
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≥ one A1C measurement during the baseline and follow-up period
Exclusion Criteria:
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Switched from traditional CSII to OmniPod
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Use of non-insulin diabetes therapies
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | LMC Healthcare | Toronto | Canada |
Sponsors and Collaborators
- LMC Diabetes & Endocrinology Ltd.
- Insulet Corporation
Investigators
- Principal Investigator: Ronnie Aronson, LMC Healthcare
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- COPPER