Omnipod-5 A French Prospective Multicentric Study in Real World (Optimal-B)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2+
SponsorInsulet Corporation
About this trial
The purpose of this postmarket clinical investigation is to evaluate the levels of glycemic control, quality of life, and satisfaction, as well as the patient experience, and acute diabetes complication rates provided by the Omnipod 5 Automated Insulin Delivery System (referred to as the Omnipod 5 System) in a real-world setting.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient with T1D aged ≥ 2 years.
Patient prescribed, less than a year ago, a commercially available confi guration of the Omnipod 5 System using a FreeStyle Libre 2 Plus sensor.
Patient has never used the Omnipod 5 System prior to inclusion.
Patient has not objected to the use of their personal data for this study.
Disqualifiers
Patient is currently pregnant.
Patient presents an allergy to the materials of the Omnipod 5 System (patch, cannula, CGM).
Patient is unable to be followed by the same investigation site for the duration of the study or is unwilling or unable to maintain contact with the healthcare professional.
Patient is already participating in a clinical trial or in another study precluding their participation in other studies.
Trial population
The study population contains patients (age ≥ 2 years) with T1DM initiating a commercially available configuration of the Omnipod 5 System using a FreeStyle Libre 2Plus in France.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Omnipod 5
DeviceThe Omnipod 5 Automated Insulin Delivery System (Omnipod 5 System) is a tubeless insulin pump with a mono-hormonal insulin delivery system designed to deliver U-100 insulin subcutaneously for the management of type 1 diabetes in people aged 2 years and older who require insulin. The Omnipod 5 System is intended to function as an automated insulin delivery system when used with compatible Continuous Glucose Monitoring (CGM) systems.
Treatment groups
152 Participants
are divided into 1 treatment groupGroup A: Omnipod 5 User1 intervention
Trial outcomes
Primary outcomes
1
Change in the percentage of time in the 70 - 180 mg/dL range
Glucose metric from continuous glucose monitoring system to assess glucose control
Time frame
Change in percentage of time in specified range between Baseline and 12-months following first initiation of automated modeSecondary outcomes
1
Percentage of time in the 70 - 180 mg/dL range
Glucose metric from continuous glucose monitoring system to assess glucose control
Time frame
Up to 12-months following first initiation of automated mode2
Percentage of time in the 70 - 140 mg/dL range
Glucose metric from continuous glucose monitoring system to assess glucose control
Time frame
Up to 12-months following first initiation of automated mode3
Percentage of time below 54 mg/dL
Glucose metric from continuous glucose monitoring system to assess glucose control
Time frame
Up to 12-months following first initiation of automated mode4
Percentage of time below 70 mg/dL
Glucose metric from continuous glucose monitoring system to assess glucose control
Time frame
Up to 12-months following first initiation of automated modeSponsors and contacts
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Source ClinicalTrials.gov