NCT06144554 · Insulet Corporation
Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
Omnipod 5
The 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.
Primary outcome measures
Incidence rate of severe hypoglycemia
Time frame: From baseline to study completion, up to 12 months.
Measures frequency of severe hypoglycemia
Incidence rate of DKA
Time frame: From baseline to study completion, up to 12 months.
Measures frequency of DKA
A1c at 3, 6, 9 and 12 months
Time frame: Comparing the change in A1c at baseline compared to at 3, 6, 9 and 12 months
Measures device effectiveness
Percentage of time < 54 mg/dL
Time frame: From baseline to study completion, up to 12 months
Glucose metric from study continuous glucose monitoring system
Percentage of time < 70 mg/dL
Time frame: From baseline to study completion, up to 12 months
Glucose metric from study continuous glucose monitoring system
Percentage of time > 180 mg/dL
Time frame: From baseline to study completion, up to 12 months
Glucose metric from study continuous glucose monitoring system
Percentage of time > 250 mg/dL
Time frame: From baseline to study completion, up to 12 months
Glucose metric from study continuous glucose monitoring system
Percentage of time in range 70-180 mg/dL
Time frame: From baseline to study completion, up to 12 months
Glucose metric from study continuous glucose monitoring system
Mean Glucose mg/dL
Time frame: From baseline to study completion, up to 12 months
Glucose metric from study continuous glucose monitoring system
Standard deviation of glucose mg/dL
Time frame: From baseline to study completion, about 12 months
measure of the range of glucose readings
Glucose management indicator %
Time frame: From baseline to study completion, up to 12 months
MI tells you what your approximate A1C level is likely to be, based on the average glucose level from your CGM readings for 14 or more days.
Percentage of participants achieving A1C < 7%
Time frame: From baseline to study completion, up to 12 months
measurement of percentage of participants with A1c less than 7%
Percentage of participants with time in range > 70%
Time frame: From baseline to study completion, up to12 months
measurement of percentage of participants with time in range \> 70%
Percentage of participants with time below range (<70mg/dL) of < 4%
Time frame: From baseline to study completion, up to 12 months
measurement of percentage of participants with time below range (\<70mg/dL) of \< 4%
Insulin Usage
Time frame: From baseline to study completion, up to 12 months
Measure of insulin requirements
Body Mass Index (BMI) or BMI z-score
Time frame: at 6 months and at the end of registry participation, up to 12 months.
Changes in body mass index
EQ-5D (inclusive of the Visual Analogue Scale (VAS))
Time frame: at baseline, at 6 months and at the end of registry participation, up to 12 months.
Questionaire
Insulin Delivery Systems: Perceptions, Ideas, Reflections, and Expectations (INSPIRE)
Time frame: at baseline, at 6 months and at the end of registry participation, up to 12 months
Questionaire
System Usability Scale (SUS)
Time frame: at baseline, at 6 months and at the end of registry participation, up to 12 months
Questionnaire
Incidence rate of prolonged hyperglycemia (events per person months) during usage of Activity Feature
Time frame: From baseline to study completion, up to 12 months
Measuring rate of prolonged high sugar while in activity feature
Incidence rate of prolonged hyperglycemia (events per person months)
Time frame: From baseline to study completion, up to 12 months
Measuring the occurrence of prolonged hyperglycemia
Incidence rate of prolonged hyperglycemia (events per person months) during usage of a Target Glucose of 140 mg/dL or 150 mg/dL
Time frame: From baseline to study completion, up to 12 months
Measuring the occurrence of prolonged hyperglycemia while at a set target glucose of 140mg/dL or 150mg/dL
Glucose Outcomes during the 4-hour post-bolus period using the SmartBolus Calculator: o Percentage of time < 54 mg/dL o Percentage of time in range 70-180 mg/dL
Time frame: From baseline to study completion, up to 12 months
Glucose metric from study CGM
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- Willing to collect A1C samples using a provided home kit and send the samples to the registry specific core laboratory at baseline and 3, 6, 9 and 12 months
- Willing and able to complete registry assessments every two weeks
- Willing and able to complete registry outcome questionnaires at baseline, 6 months and end of study (or at withdrawal)
- Is not currently pregnant or planning to become pregnant in the next 12 months and is using a reliable form of birth control
- Access to internet via phone, tablet and/or computer to use the registry online platform
- Willing to provide CGM and insulin delivery data collected prior to using the Omnipod 5 System, if available (participants will not be excluded if data is not provided)
- Willing and able to provide informed consent (or assent) and/or has a parent/guardian willing and able to provide informed consent as applicable
Exclusion criteria
- 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
Where
- Buffalo, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 1, 2026 · Source of record for eligibility and locations