SteadiSet Infusion Set for Type 1 Diabetes

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Tandem Diabetes Care, Inc.

Must be taking: Insulin

Must not be taking: Non-insulin glucose-lowering

Disqualifiers: Pregnancy, Severe hypoglycemia, DKA, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This feasibility study is a prospective, single center, multi-arm study evaluating possible enhancements to the SteadiSet extended wear infusion set.

Who Is on the Research Team?

Jordan Pinsker, MD

Principal Investigator

Tandem Diabetes Care

Are You a Good Fit for This Trial?

This trial is for people aged 18-80 with Type 1 Diabetes who are in good health and live in the US. They must have had diabetes for at least a year, use a Tandem pump and Dexcom CGM, have an HbA1c below 9% in the past six months, and be willing to follow study procedures using provided devices.

Inclusion Criteria

I am generally healthy and live in the U.S. with no plans to move abroad during the study.

My phone can run the Tandem Mobi Mobile App.

My HbA1c level has been below 9.0% in the past 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the SteadiSet insulin infusion set for 6 wear periods of up to 7 days each

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SteadiSet Infusion Set

Trial Overview

The study is testing potential improvements to the SteadiSet extended wear infusion set used by people with Type 1 Diabetes. Participants will try out different versions of this infusion set during their regular home routines.

How Is the Trial Designed?

Group I: t:slim X2 Users Experimental Treatment 1 Intervention

* t:slim X2 insulin pump with SteadiSet (43 inches) and an enhanced filling process (3 wear periods) * t:slim X2 with and SteadiSet (43 inches) with no side ports (3 wear periods)

Group II: Mobi Users Experimental Treatment 1 Intervention

* Mobi Insulin Pump with SteadiSet (5 inches) and an enhanced filling process (3 wear periods) * Mobi Insulin Pump and SteadiSet (5 inches) (3 wear periods)

Who Is Running the Clinical Trial?

Tandem Diabetes Care, Inc.

Lead Sponsor

Trials

43

Recruited

5,800+