Type 1 Diabetes
Conditions
Keywords
Type 1 Diabetes, Omnipod, Automated Insulin Delivery, Registry
Brief 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.
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.
Interventions
DEVICEOmnipod 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.
Sponsors
Insulet Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Inclusion criteria
1. Self-reported type 1 diabetes 2. 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 3. Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, or Admelog 4. Able to read and speak English or Spanish (when available) fluently and reside full time in the United States 5. 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 6. Willing and able to complete registry assessments every two weeks 7. Willing and able to complete registry outcome questionnaires at baseline, 6 months and end of study (or at withdrawal) 8. Is not currently pregnant or planning to become pregnant in the next 12 months and is using a reliable form of birth control 9. Access to internet via phone, tablet and/or computer to use the registry online platform 10. 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) 11. 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
1. Diagnosed with sickle cell anemia and/or hemoglobinopathy 2. Planned blood transfusions over the course of the study or has received a blood transfusion within 3 months prior to starting on Omnipod 5 3. Adults that are unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence rate of severe hypoglycemia | From baseline to study completion, up to 12 months. | Measures frequency of severe hypoglycemia |
| Incidence rate of DKA | From baseline to study completion, up to 12 months. | Measures frequency of DKA |
| A1c at 3, 6, 9 and 12 months | 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 | From baseline to study completion, up to 12 months | Glucose metric from study continuous glucose monitoring system |
| Percentage of time < 70 mg/dL | From baseline to study completion, up to 12 months | Glucose metric from study continuous glucose monitoring system |
| Percentage of time > 180 mg/dL | From baseline to study completion, up to 12 months | Glucose metric from study continuous glucose monitoring system |
| Percentage of time > 250 mg/dL | 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 | From baseline to study completion, up to 12 months | Glucose metric from study continuous glucose monitoring system |
| Mean Glucose mg/dL | From baseline to study completion, up to 12 months | Glucose metric from study continuous glucose monitoring system |
| Standard deviation of glucose mg/dL | From baseline to study completion, about 12 months | measure of the range of glucose readings |
| Glucose management indicator % | 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% | 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% | 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% | From baseline to study completion, up to 12 months | measurement of percentage of participants with time below range (\<70mg/dL) of \< 4% |
| Insulin Usage | From baseline to study completion, up to 12 months | Measure of insulin requirements |
| Body Mass Index (BMI) or BMI z-score | 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)) | 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) | at baseline, at 6 months and at the end of registry participation, up to 12 months | Questionaire |
| System Usability Scale (SUS) | 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 | 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) | 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 | 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 | From baseline to study completion, up to 12 months | Glucose metric from study CGM |
Countries
United States
Contacts
Primary ContactTrang Ly, MBBS, PhD
Backup ContactJulie Perkins
Outcome results
None listed