Type 1 DiabetesNCT06144554
Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes
An observational study of Type 1 Diabetes, run by Insulet Corporation at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Omnipod 5
- Type of treatment
- Medical device
- How many people
- 2,200 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2023to Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- Child, Adult, Older adult
Study 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.
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Circuit Clinical
Buffalo, New York, 14203
Carmina VanHAll, 603-309-7690, cvanhall@circuitclinical.com
Ashok Subramanian, MD
About this study
Official title: Post Market Registry to Collect Real-World Safety and Effectiveness Data for the Omnipod 5 System in Children and Adults With Type 1 Diabetes
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.
Read the detailed 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.
A minimum of 2,200 Type 1 participants will be recruited to ensure a minimum of 1,650 participants completing 12 months of follow-up. The minimum number of completed participants is as follows:
- 150 participants aged 2-5
- 300 participants aged 6-13
- 300 participants aged 14-17
- 900 participants aged 18+
In addition to the enrollment targets above, a minimum of 1100 Omnipod-naïve users, 880 pump-naïve users, and 110 CGM-naïve users will be recruited.
Participants are expected to be followed for 12 months.
- Conditions
- Type 1 Diabetes
- Being tested
- Omnipod 5
- Keywords
- Type 1 Diabetes, Omnipod, Automated Insulin Delivery, Registry
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omnipod 5Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Omnipod User | 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. As part of the onboarding process, users will be invited to participate in this registry. Receives: Device: Omnipod 5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of severe hypoglycemia
Measures frequency of severe hypoglycemia
Measured: From baseline to study completion, up to 12 months.
Incidence rate of DKA
Measures frequency of DKA
Measured: From baseline to study completion, up to 12 months.
A1c at 3, 6, 9 and 12 months
Measures device effectiveness
Measured: Comparing the change in A1c at baseline compared to at 3, 6, 9 and 12 months
Percentage of time < 54 mg/dL
Glucose metric from study continuous glucose monitoring system
Measured: From baseline to study completion, up to 12 months
Percentage of time < 70 mg/dL
Glucose metric from study continuous glucose monitoring system
Measured: From baseline to study completion, up to 12 months
Percentage of time > 180 mg/dL
Glucose metric from study continuous glucose monitoring system
Measured: From baseline to study completion, up to 12 months
Percentage of time > 250 mg/dL
Glucose metric from study continuous glucose monitoring system
Measured: From baseline to study completion, up to 12 months
Percentage of time in range 70-180 mg/dL
Glucose metric from study continuous glucose monitoring system
Measured: From baseline to study completion, up to 12 months
Mean Glucose mg/dL
Glucose metric from study continuous glucose monitoring system
Measured: From baseline to study completion, up to 12 months
Standard deviation of glucose mg/dL
measure of the range of glucose readings
Measured: From baseline to study completion, about 12 months
Glucose management indicator %
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.
Measured: From baseline to study completion, up to 12 months
Percentage of participants achieving A1C < 7%
measurement of percentage of participants with A1c less than 7%
Measured: From baseline to study completion, up to 12 months
Percentage of participants with time in range > 70%
measurement of percentage of participants with time in range > 70%
Measured: From baseline to study completion, up to12 months
Percentage of participants with time below range (<70mg/dL) of < 4%
measurement of percentage of participants with time below range (<70mg/dL) of < 4%
Measured: From baseline to study completion, up to 12 months
Insulin Usage
Measure of insulin requirements
Measured: From baseline to study completion, up to 12 months
Body Mass Index (BMI) or BMI z-score
Changes in body mass index
Measured: at 6 months and at the end of registry participation, up to 12 months.
EQ-5D (inclusive of the Visual Analogue Scale (VAS))
Questionaire
Measured: at baseline, at 6 months and at the end of registry participation, up to 12 months.
Insulin Delivery Systems: Perceptions, Ideas, Reflections, and Expectations (INSPIRE)
Questionaire
Measured: at baseline, at 6 months and at the end of registry participation, up to 12 months
System Usability Scale (SUS)
Questionnaire
Measured: at baseline, at 6 months and at the end of registry participation, up to 12 months
Incidence rate of prolonged hyperglycemia (events per person months) during usage of Activity Feature
Measuring rate of prolonged high sugar while in activity feature
Measured: From baseline to study completion, up to 12 months
Incidence rate of prolonged hyperglycemia (events per person months)
Measuring the occurrence of prolonged hyperglycemia
Measured: From baseline to study completion, up to 12 months
Incidence rate of prolonged hyperglycemia (events per person months) during usage of a Target Glucose of 140 mg/dL or 150 mg/dL
Measuring the occurrence of prolonged hyperglycemia while at a set target glucose of 140mg/dL or 150mg/dL
Measured: From baseline to study completion, up to 12 months
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
Glucose metric from study CGM
Measured: From baseline to study completion, up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start25 Sep 2023
- Primary completionJun 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insulet Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06144554
- Sponsor's protocol ID
- Post-Market Registry
- Status last verified
- Jun 2026
- First submitted
- 10 Nov 2023
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Registry to Collect Real-World Safety and Effectiveness Data for the Omnipod 5 System in Children and Adults With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT06144554
- Acronym / sponsor ID
- Post-Market Registry
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 Diabetes, Omnipod, Automated Insulin Delivery, Registry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,200 participants (estimated)
- Lead sponsor
- Insulet CorporationIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 22 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
A minimum of 2,200 Type 1 participants will be recruited to ensure a minimum of 1,650 participants completing 12 months of follow-up. The minimum number of completed participants is as follows:
- 150 participants aged 2-5
- 300 participants aged 6-13
- 300 participants aged 14-17
- 900 participants aged 18+
In addition to the enrollment targets above, a minimum of 1100 Omnipod-naïve users, 880 pump-naïve users, and 110 CGM-naïve users will be recruited.
Participants are expected to be followed for 12 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Omnipod User | – | Device: Omnipod 5All 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. As part of the onboarding process, users will be invited to participate in this registry. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study 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.
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omnipod 5The 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. | Device | Omnipod User |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes, run by Insulet Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trang Ly, MBBS, PhD (978-600-7000, APClinical@insulet.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of severe hypoglycemia (time frame: From baseline to study completion, up to 12 months.). The study lists 23 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.