Insulin Dosing with Omnipod M System for Type 2 Diabetes

(SIMPLEUSE Trial)

Recruiting at 5 trial locations

Overseen By Bonnie Dumais, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Insulet Corporation

Must be taking: Insulin

Must not be taking: Steroids, Hydroxyurea

Disqualifiers: AID pump use, Cardiac disease, others

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

Compensation: Varies

Number of Visits: Unknown

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Omnipod M System for managing type 2 diabetes. Researchers aim to determine the safety and tolerability of different starting doses of insulin with this system. The Omnipod M System includes a small wearable pod and a controller, working alongside a continuous glucose monitor to help manage blood sugar levels. Individuals who have used insulin for at least three months and are open to trying a new device may be suitable for this study. Participants will use this system in an automated mode to manage their diabetes throughout the trial. As an unphased trial, this study offers a unique opportunity to explore innovative diabetes management technology.

Do I need to stop taking my current medications to join the trial?

The trial does not specify that you need to stop taking your current medications. However, your doses of other glucose-lowering and weight loss medications should be stable for at least 4 weeks before the study and remain stable during the study, unless adjusted by the investigator.

What prior data suggests that the Omnipod M System is safe for managing type 2 diabetes?

Research has shown that the Omnipod M System, when used with insulin, is generally safe for people with diabetes. Studies on similar systems, like the Omnipod 5, have found that adults with type 2 diabetes tolerate it well. Participants in these studies reported few serious side effects, with most issues being mild and related to insulin, such as low blood sugar.

The Omnipod M System includes safety checks to monitor insulin delivery, reducing risks while managing diabetes. Overall, testing has shown the system to be safe for people, with only minor side effects usually reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Omnipod M System for Type 2 Diabetes because it offers a novel approach to insulin delivery compared to traditional methods like multiple daily injections or insulin pens. Unlike these standard options, the Omnipod M System is a tubeless, wearable insulin pump that allows for continuous insulin delivery, which can improve blood glucose management and provide more flexibility and convenience for users. The trial is exploring different starting doses with this system, which could further optimize insulin therapy for individuals with Type 2 Diabetes, potentially enhancing treatment efficacy and patient satisfaction.

What evidence suggests that the Omnipod M System is effective for managing type 2 diabetes?

Research has shown that the Omnipod M System can help people with type 2 diabetes manage their blood sugar effectively. One study found that this system lowered HbA1c levels, indicating better blood sugar control. Another study demonstrated improvements in daily quality of life. The system automatically delivers insulin, simplifying the maintenance of healthy blood sugar levels. In this trial, participants will receive the Omnipod M System with either a higher or lower starting dose of insulin. For those with type 2 diabetes, the Omnipod M System appears promising for better overall diabetes management. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults with type 2 diabetes who can manage their condition using the Omnipod M System and a continuous glucose monitoring sensor. Participants must be able to complete up to 18 weeks in the study, including an optional extension phase.

Inclusion Criteria

I am between 18 and 75 years old.

I use insulin and my A1c is within the required range for my treatment type.

I have type 2 diabetes and have been on insulin for at least 3 months.

Exclusion Criteria

Arrhythmias or other cardiac conditions confirmed by ECG (within past 30 days) which in the opinion of the Investigator, would put the participant at an unacceptable safety risk

My heart condition is stable and I haven't had a heart attack or surgery in the last year.

Unable to tolerate adhesive tape or has any unresolved skin condition that could impact sensor or pump placement

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Precursory Evaluation

Participants undergo a precursory evaluation using the Omnipod M System in Automated Mode

12 weeks

Randomized Trial

Participants manage their diabetes using the Omnipod M System with different starting doses of insulin

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label Extension (optional)

Participants may opt into continued use of the Omnipod M System

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Omnipod M System

Trial Overview The study tests two different starting doses of insulin delivered by the Omnipod M System. It aims to see which dose is safer and more tolerable for managing type 2 diabetes over a period that includes a precursory evaluation and randomized trial phases.

How Is the Trial Designed?

Group I: Omnipod M System with higher starting dose Active Control 1 Intervention

Group II: Omnipod M System with lower starting dose Active Control 1 Intervention

Who Is Running the Clinical Trial?

Insulet Corporation

Lead Sponsor

Trials

23

Recruited

19,600+

Citations

1. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2830238

Automated Insulin Delivery in Adults With Type 2 Diabetes The feasibility trial of the Omnipod 5 System used in this study showed similar glycemic improvements in 24 adults with type 2 diabetes. Two ...

2. omnipod.com omnipod.com/hcp/c/outcomes

Omnipod® 5 Clinical Outcomes The SECURE-T2D trial, the first and most racially diverse type 2 diabetes pivotal study4, demonstrated improved clinical outcomes and quality of life in this ...

3. diabetesjournals.org diabetesjournals.org/diabetes/article/74/Supplement_1/314-OR/159778/314-OR-Improved-Outcomes-across-Baseline-Time-in

314-OR: Improved Outcomes across Baseline Time-in-Range ... Conclusion: These results demonstrate the efficacy of the Omnipod 5 System compared with MDI in people with T1D across all baseline levels ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39951268/

Automated Insulin Delivery in Adults With Type 2 Diabetes In this nonrandomized clinical trial, HbA1c levels were lower in a diverse cohort of adults with type 2 diabetes following AID initiation.

5. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/full/10.1111/dom.15993

Glycaemic outcomes in adults with type 2 diabetes over 34 ... These longer-term findings of Omnipod 5 AID System use demonstrate the potential value of AID in helping people with type 2 diabetes reach glycaemic targets.

6. omnipod.com omnipod.com/safety

Important Safety Information | Insulin Pump Therapy Safety Features​​ The Omnipod DASH System also performs safety checks on the Personal Diabetes Manager (PDM) whenever the PDM is awake. If it detects any ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10090930/

Safety and Efficacy of the Omnipod 5 Automated Insulin ... We tested the feasibility of using AID for type 2 diabetes with the Omnipod 5 System in a multicenter outpatient trial.

8. omnipod.com omnipod.com/sites/default/files/omnipod-5_summary-of-safety-and-clinical-performance_healthcare-providers_uk-english.pdf

Summary of Safety and Clinical Performance This feasibility study evaluated the feasibility, safety, and efficacy of the Omnipod 5 System in 16 people with type 1 and type 2 diabetes in ...

9. omnipod.com omnipod.com/sites/default/files/omnipod-5_important-safety-information-guide_us-english.pdf

Important Safety Information The goal of this U.S.-based pivotal study was to assess the safety and efficacy of the Omnipod 5 System in adults with type 2 diabetes aged 18 to 75 years. This ...