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| Name | Class |
|---|---|
| Insulet Corporation | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omnipod cohort | Adults with T1D who switch from MDI therapy to insulin pump therapy with Omnipod. |
| |
| MDI cohort | Adults with T1D who continue MDI therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Glycated hemoglobin (A1C) | Change in A1C (%). A1C will be retrieved from the participants electronic medical records. | Three to six months from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients achieving A1C < 7.0% | Proportion of patients achieving A1C < 7.0% | Three to six months from baseline |
| Proportion of patients achieving A1C < 8.0% | Proportion of patients achieving A1C < 8.0% |
| Measure | Description | Time Frame |
|---|---|---|
| Self-measured blood glucose (SMBG) testing frequency | 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 |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Ronnie Aronson | LMC Healthcare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LMC Healthcare | Toronto | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33040383 | Derived | 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. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| MDI | Other | Continued use of MDI therapy (traditional basal/bolus insulin regimen). |
|
| Three to six months from baseline |
| Weight | Change in weight (kg). Weight will be retrieved from the participants electronic medical records. | Three to six months from baseline |
| Body mass index (BMI) | 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 | 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 | 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 | 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 |
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 | 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) | 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) | 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 | 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 | 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 | 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 | 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 | 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 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |