Omnipod Systems for Type 1 Diabetes

(STRIVE Trial)

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

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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 with type 1 or type 2 diabetes. Study participants will complete about 5 in-person visits and be expected to treat their diabetes per their usual routine using the system at the lowest available target setting. Each participant will begin the study using either the Omnipod 5 SmartAdjust 2.0 System or the Omnipod 5 System for 4 weeks (Period 1) then switch to the opposite system for the next 4 weeks (Period 2). Everyone will use the Omnipod 5 SmartAdjust 2.0 System for the last 4-6 weeks (Period 3). During Period 3, participants will have a goal of administering no more than 3 meal or snack boluses per day.

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.

Is the Omnipod 5 System safe for use in people with type 1 diabetes?

The Omnipod 5 System has been shown to be safe for use in people with type 1 diabetes, with no serious device-related adverse events reported in a 14-day study and only one episode of diabetic ketoacidosis and seven episodes of severe hypoglycemia over a two-year period. ^{1 2 3 4 5}

How is the Omnipod 5 SmartAdjust 2.0 System different from other treatments for type 1 diabetes?

The Omnipod 5 SmartAdjust 2.0 System is unique because it is a tubeless automated insulin delivery system that allows for customizable glucose targets, providing flexibility and ease of use for people with type 1 diabetes. It maintains long-term improvements in blood sugar control and reduces the need for frequent manual insulin adjustments. ^{1 2 3 4 6}

What data supports the effectiveness of the Omnipod 5 SmartAdjust 2.0 System and Omnipod 5 System treatment for type 1 diabetes?

Research shows that the Omnipod 5 System helps people with type 1 diabetes improve their blood sugar control. In a study, children and adults using the system for up to 2 years had better blood sugar levels and spent more time in the target range, which means their blood sugar was neither too high nor too low. ^{2 3 4 5 7}

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

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]

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 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. Ireland pubmed.ncbi.nlm.nih.gov

Improved glycemic control in 3,592 adults with type 2 diabetes mellitus initiating a tubeless insulin management system. [2021]

2. United States 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. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Real-World Glycemic Outcomes with Early Omnipod 5 Use in Youth with Type 1 Diabetes. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Canadian Real-World Outcomes of Omnipod Initiation in People with Type 1 Diabetes (COPPER study): Evidence from the LMC Diabetes Registry. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Patient perceptions of using the OmniPod system compared with conventional insulin pumps in young adults with type 1 diabetes. [2022]

6. United States 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. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Review of the Omnipod® 5 Automated Glucose Control System Powered by Horizon™ for the treatment of Type 1 diabetes. [2021]