Omnipod Systems for Type 1 Diabetes

(STRIVE Trial)

Not currently recruiting at 10 trial locations

Overseen By Bonnie Dumais, RN

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Insulet Corporation

Must be taking: U-100 insulin

Must not be taking: Hydroxyurea, Non-insulin anti-hyperglycemics

Disqualifiers: Severe hypoglycemia, DKA, Blood disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the safety and effectiveness of the Omnipod 5 SmartAdjust 2.0 System, an insulin delivery device, for individuals with type 1 or type 2 diabetes. Participants will use two different systems sequentially to help researchers assess how well each manages blood sugar levels. The study involves using the device during regular daily routines and limits the frequency of extra insulin doses for meals. It is suitable for those with a history of type 1 diabetes who are already familiar with using an Omnipod system with specific types of insulin. As an unphased trial, this study offers a unique opportunity to contribute to diabetes research and potentially enhance daily insulin management.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you must use only certain types of U-100 insulin during the study. If you are taking non-insulin diabetes medications, you should remain on a steady dose of metformin or GLP1 if applicable.

What prior data suggests that the Omnipod Systems are safe for individuals with diabetes?

Research has shown that the Omnipod 5 SmartAdjust 2.0 System is generally safe and effective for people with type 1 diabetes. In earlier studies, this automated insulin delivery system improved blood sugar levels and reduced episodes of low blood sugar, a common concern in insulin management. Additionally, a real-world study of over 37,000 users found that most people controlled their blood sugar effectively without major issues. Overall, these studies suggest that the system is safe for managing diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Omnipod 5 SmartAdjust 2.0 System for Type 1 Diabetes because it introduces a new level of automation in insulin delivery. Unlike traditional insulin pumps or manual injections, this system can automatically adjust insulin delivery based on continuous glucose monitoring, potentially improving blood sugar control and reducing the burden on users. This means fewer manual adjustments and more personalized insulin delivery, which could lead to better overall management of diabetes.

What evidence suggests that the Omnipod 5 SmartAdjust 2.0 System is effective for diabetes?

Research has shown that the Omnipod 5 SmartAdjust 2.0 System, which participants in this trial may use, can help people with diabetes better control their blood sugar. One study found that this system increased the time when blood sugar levels were in a healthy range by 9.3% for adults and teens, and by 15.6% for children. Other research indicates that the system improves blood sugar levels and enhances quality of life for those with type 2 diabetes. The system automatically adjusts insulin delivery based on blood sugar levels, which contributes to its expected effectiveness. ^{1 2 6 7 8}

Who Is on the Research Team?

Gregory Forlenza, MD

Principal Investigator

Barbara Davis Center

Are You a Good Fit for This Trial?

This trial is for individuals with Type 1 Diabetes, including those with diabetic retinopathy. Participants will use the Omnipod insulin management systems and must be willing to attend about 5 in-person visits. Specific inclusion or exclusion criteria are not provided.

Inclusion Criteria

If of childbearing potential, willing and able to have pregnancy testing

Investigator has confidence that the participant and/or caregiver can safely operate all study devices and can adhere to the protocol

Willing to wear the system continuously throughout the study

Exclusion Criteria

Any medical condition, which in the opinion of the investigator, would put the participant at an unacceptable safety risk

History of severe hypoglycemia in the past 6 months. Severe hypoglycemia is defined as an event that requires the assistance of another person due to altered mental and/or physical status, and requires another person to actively administer carbohydrate, glucagon, or other resuscitative actions

Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Period 1

Participants use either the Omnipod 5 SmartAdjust 2.0 System or the Omnipod 5 System

4 weeks

Approximately 2 visits (in-person)

Treatment Period 2

Participants switch to the opposite system from Period 1

4 weeks

Approximately 2 visits (in-person)

Treatment Period 3

All participants use the Omnipod 5 SmartAdjust 2.0 System with a goal of no more than 3 meal or snack boluses per day

4-6 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Omnipod 5 SmartAdjust 2.0 System
• Omnipod 5 System

Trial Overview The study compares two insulin delivery systems: the new Omnipod 5 SmartAdjust 2.0 System versus the existing Omnipod 5 System. It's a cross-over study where participants switch between systems after four weeks and everyone uses the new system in the final period.

How Is the Trial Designed?

Group I: Omnipod 5 SmartAdjust 2.0 System Experimental Treatment 2 Interventions

A subset of participants will begin the study using the Omnipod 5 SmartAdjust 2.0 System then switch to the comparator, and back again to the experimental system.

Group II: Omnipod 5 System Active Control 2 Interventions

A subset of participants will begin the study using the Omnipod 5 System then switch to the experimental system for the remainder of the study.

Who Is Running the Clinical Trial?

Insulet Corporation

Lead Sponsor

Trials

23

Recruited

19,600+

Published Research Related to This Trial

In a study of 29 young adults with type 1 diabetes, the wireless OmniPod™ Insulin Management System was found to be well-received, with 76% of participants preferring its automated cannula insertion over conventional insulin pumps.

The OmniPod system led to a greater reduction in HbA1c levels compared to conventional insulin pumps, indicating it may provide better glycemic control for users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient perceptions of using the OmniPod system compared with conventional insulin pumps in young adults with type 1 diabetes. Lebenthal, Y., Lazar, L., Benzaquen, H., et al.[2022]

The Omnipod® 5 Automated Insulin Delivery System demonstrated long-term safety and effectiveness in managing type 1 diabetes, maintaining significant reductions in HbA1c levels over up to 2 years of use among 224 participants.

Participants experienced an increase in time spent within the target glucose range, with minimal severe hypoglycemia incidents, indicating that the system effectively supports glycemic control while being safe for extended use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two Years with a Tubeless Automated Insulin Delivery System: A Single-Arm Multicenter Trial in Children, Adolescents, and Adults with Type 1 Diabetes. Criego, AB., Carlson, AL., Brown, SA., et al.[2023]

The Omnipod 5 automated insulin delivery system significantly improved time in range (TIR) for both children and adults with type 1 diabetes, achieving higher TIR percentages during the hybrid closed-loop phase compared to standard therapy, indicating its effectiveness in managing blood glucose levels.

The study demonstrated that the Omnipod 5 was safe, with no serious device-related adverse events, severe hypoglycemia, or diabetic ketoacidosis reported during the 14-day home use period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First Outpatient Evaluation of a Tubeless Automated Insulin Delivery System with Customizable Glucose Targets in Children and Adults with Type 1 Diabetes. Forlenza, GP., Buckingham, BA., Brown, SA., et al.[2022]

Citations

1. omnipod.com omnipod.com/hcp/c/outcomes

Omnipod® 5 Clinical Outcomes Retrospective analysis of real-world data from 37,640 users with type 1 diabetes using Omnipod 5 who utilized the 6.1 mmol/L or 110 mg/dL glucose target of ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06865989

Study Details | NCT06865989 | Omnipod® SmartAdjust 2.0 ... The goal of this multi-center, randomized, cross-over study is to evaluate the safety and effectiveness of the Omnipod 5 SmartAdjust 2.0 System in individuals ...

3. omnipod.com omnipod.com/hcp/blog/clinical-studies/forlenza-24-summary

Real-World Evidence of Omnipod® 5 Shows Glycemic ... In one trial, Omnipod 5 improved time in range (TIR) by 9.3% in adults/adolescents and by 15.6% in children. ... In another, it improved TIR of ...

4. appliedclinicaltrialsonline.com appliedclinicaltrialsonline.com/view/trial-results-efficacy-automated-insulin-delivery-treatment-diabetes

SECURE-T2D Trial Results Show Efficacy of Automated ... Omnipod 5 Automated Insulin Delivery System shows improvements in blood glucose outcomes and overall quality of life among patients with type 2 diabetes.

5. trialx.com trialx.com/clinical-trials/listings/296724/omnipod-smartadjust-20-system-compared-to-the-omnipod-5-system-in-individuals-with-type-1-or-type-2-diabetes/

Omnipod® SmartAdjust 2.0 System Compared to the ... The goal of this multi-center, randomized, cross-over study is to evaluate the safety and effectiveness of the Omnipod 5 SmartAdjust 2.0 System ...

6. omnipod.com omnipod.com/sites/default/files/omnipod-5_safety-glycemic-outcomes_ca-english.pdf

Safety and Glycemic Outcomes With a Tubeless Automated ... Delivery (AID) System, the first tubeless, on-body. AID system with customizable glycemic targets, in very young children with type 1 diabetes. ○ Primary ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9346983/

Safety and Glycemic Outcomes With a Tubeless Automated ... Use of the automated insulin delivery system was safe, and participants experienced improved glycemic measures and reduced hypoglycemia during the study phase.

8. omnipod.com omnipod.com/en-gb/hcp/omnipod-case-studies

Omnipod® Case Studies Real-World Glycaemic Outcomes of 36,634 Adults with Type 1 Diabetes Using the Omnipod® 5 Automated Insulin Delivery System with Cloud-Based Data Management.