Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes
ConditionType 1 Diabetes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2+
SponsorInsulet Corporation
About this trial
This is a decentralized observational clinical registry to collect real-world evidence related to the safety and effectiveness of the Omnipod 5 system in children and adults with Type 1 Diabetes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Self-reported type 1 diabetes
Prescribed, obtained, and have been using the Omnipod 5 System for no more than two weeks or plan to start using the system within the next two weeks
Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, or Admelog
Able to read and speak English or Spanish (when available) fluently and reside full time in the United States
Disqualifiers
Diagnosed with sickle cell anemia and/or hemoglobinopathy
Planned blood transfusions over the course of the study or has received a blood transfusion within 3 months prior to starting on Omnipod 5
Adults that are unable to provide informed consent
Trial population
All new users for the Omnipod 5 System will be required to register with Insulet's Podder Central. Users already in Podder Central will be required to log into their account before logging into the Omnipod 5 Controller if transitioning to the Omnipod 5 System. A minimum of 2,200 Type 1 participants will be recruited.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Omnipod 5
DeviceThe Omnipod 5 System consists of a tubeless insulin Pod and the Omnipod® 5 App, installed on a designated Controller or compatible Android smartphone. The Omnipod 5 System works with the Dexcom G6® Continuous Glucose Monitoring System to continuously adapt and automatically deliver insulin according to personal needs. Every two weeks while on the Omnipod 5 system, participants will receive a push notification to complete assessments including any severe hypoglycemia or diabetic ketoacidosis events experienced since the prior assessment.
Treatment groups
2,200 Participants
are divided into 1 treatment groupGroup A: Omnipod User1 intervention
Trial outcomes
Primary outcomes
1
Incidence rate of severe hypoglycemia
Measures frequency of severe hypoglycemia
Time frame
From baseline to study completion, up to 12 months.2
Incidence rate of DKA
Measures frequency of DKA
Time frame
From baseline to study completion, up to 12 months.3
A1c at 3, 6, 9 and 12 months
Measures device effectiveness
Time frame
Comparing the change in A1c at baseline compared to at 3, 6, 9 and 12 months4
Percentage of time < 54 mg/dL
Glucose metric from study continuous glucose monitoring system
Time frame
From baseline to study completion, up to 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov