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

Diabetes Mellitus, Type 1 Clinical Trial

— COPPER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04226378
• Other study ID #: COPPER
• Status: Completed
• Start date: January 20, 2020
• Est. completion date: February 9, 2020

Study information

• Verified date: February 2020
• Source: LMC Diabetes & Endocrinology Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 286
• Est. completion date: February 9, 2020
• Est. primary completion date: February 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1

Intervention

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.

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

Locations

Country	Name	City	State
Canada	LMC Healthcare	Toronto

Sponsors (2)

Lead Sponsor	Collaborator
LMC Diabetes & Endocrinology Ltd.	Insulet Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Change in A1C in at 12, 18, 24 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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	Glycated hemoglobin (A1C)	Change in A1C (%). A1C will be retrieved from the participants electronic medical records.	Three to six months from baseline
Secondary	Proportion of patients achieving A1C < 7.0%	Proportion of patients achieving A1C < 7.0%	Three to six months from baseline
Secondary	Proportion of patients achieving A1C < 8.0%	Proportion of patients achieving A1C < 8.0%	Three to six months from baseline
Secondary	Weight	Change in weight (kg). Weight will be retrieved from the participants electronic medical records.	Three to six months from baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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