What side effects are associated with this type of intervention?

The most common treatments for Type 1 Diabetes, such as Continuous Subcutaneous Insulin Infusion (CSII), are associated with several side effects. Skin problems, including irritation and infections at the infusion site, are frequently reported. These skin issues can also lead to increased emotional distress among patients. Other general side effects of insulin therapy include hypoglycemia, weight gain, and potential allergic reactions at the injection site. It is important for patients to monitor these side effects and discuss them with their healthcare provider to manage and mitigate any adverse effects effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for Type 1 Diabetes that involve continuous subcutaneous insulin infusion (CSII). These include standalone insulin pumps, sensor-augmented pumps, and hybrid closed-loop (HCL) systems. HCL systems, which automatically adjust insulin delivery based on real-time glucose readings, have shown modest improvements in glycemic control and quality of life. Additionally, adjunctive therapies like pramlintide have been studied, although their safety and efficacy in children are not well established. The Extended Wear Infusion Set (EWIS) is an investigational device aimed at extending the wear time of insulin infusion sets to seven days, potentially improving convenience and adherence for patients using CSII.

What other types of research exist?

Promising alternatives to the Extended Wear Infusion Set for Type 1 Diabetes patients include: 1) Hybrid Closed-Loop (HCL) systems, which combine continuous glucose monitoring with automated insulin delivery based on real-time glucose levels, offering improved glycemic control and patient satisfaction. 2) Sensor-Augmented Pump (SAP) therapy, which integrates CGM with insulin pumps to provide more precise insulin dosing. Both options require extensive training and commitment but have shown to modestly improve glycemic outcomes and quality of life.

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Insulin Delivery Device

Extended Wear Insulin Infusion Set for Type 1 Diabetes

N/A

Waitlist Available

Research Sponsored by Tandem Diabetes Care, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Using Tandem t:slim X2 insulin pump with Control-IQ technology for a minimum of 1 month at the time of enrollment

Using insulin lispro or aspart for a minimum of 3 months at the time of enrollment

Must not have

Concurrent use of any non-insulin glucose-lowering agent, other than metformin (for example, GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas)

Female subject is pregnant, planning to become pregnant, or not using adequate method of contraception

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 168 hours

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new device called the Extended Wear Infusion Set (EWIS) that helps deliver insulin for a longer period. It is aimed at adults with Type 1 diabetes who use an insulin pump. The device could make managing diabetes easier by reducing how often they need to change their infusion set. The Extended Wear Infusion Set (EWIS) is designed to improve convenience and quality of life for insulin pump users by allowing longer use compared to the standard duration.

Who is the study for?

This trial is for people with Type 1 Diabetes who are interested in trying a new insulin infusion set designed to be worn for up to 7 days. Participants will need to wear the device over 12 consecutive periods and monitor their blood glucose, especially if it rises above certain levels.

What is being tested?

The study is testing the SteadiSet Extended Wear Infusion Set's performance when worn continuously for one week. It aims to collect data on its safety and effectiveness during this extended wear time compared to standard infusion sets.

What are the potential side effects?

Potential side effects may include skin irritation at the site of infusion, risk of infection, or issues with insulin delivery such as blockage that could affect blood sugar control.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been using the Tandem t:slim X2 insulin pump with Control-IQ for at least 1 month.

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I have been using insulin lispro or aspart for at least 3 months.

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I am between 18 and 80 years old.

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I have been diagnosed with Type 1 Diabetes for over a year.

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I am currently using Humalog or NovoLog insulin and don't plan to change.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not taking any diabetes medication other than metformin.

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I am pregnant, planning to become pregnant, or not using birth control.

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I've had severe low blood sugar or DKA needing medical help in the last 6 months.

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I have a history of specific conditions like Cushing's Disease or insulinoma.

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I am not currently on steroids but may be taking stable thyroid medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 168 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~168 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 168 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Measure

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: SteadiSet Extended Wear Infusion SetExperimental Treatment1 Intervention

Each participant will be asked to wear the Investigational Extended Wear Infusion Set for up to 168 hours for 12 consecutive wear periods with the Tandem t:slim X2 insulin pump with Control-IQ technology, and wearing the Dexcom G6 or G7 sensor.

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The primary treatment for Type 1 Diabetes is insulin therapy, which compensates for the body's inability to produce insulin. Continuous Subcutaneous Insulin Infusion (CSII) systems, such as insulin pumps, deliver insulin continuously through a small catheter placed under the skin. This method mimics the body's natural insulin release more closely than multiple daily injections (MDI), providing better glycemic control and flexibility. The Extended Wear Infusion Set, which allows for longer wear times, aims to improve convenience and adherence, reducing the frequency of set changes and potentially enhancing the quality of life for patients. Effective insulin delivery is crucial for managing blood glucose levels, preventing complications, and maintaining overall health in Type 1 Diabetes patients.