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Feasibility Study of Extended Wear Insulin Infusion Sets for Type 1 Diabetes

This study is looking at how well different versions of the SteadiSet insulin infusion set work for people with type 1 diabetes. Researchers are comparing the standard SteadiSet with an enhanced version that has a special filling process. You could be eligible if you are 18 to 80 years old, have had type 1 diabetes for at least a year, use a Tandem insulin pump and Dexcom continuous glucose monitor (CGM), and have an HbA1c (a measure of average blood sugar) below 9.0% in the last six months. The main goal is to see how many of these infusion sets last for 7 days. This study plans to enroll 20 participants, but its current recruitment status is unclear.

Study design
This is a single-center study involving 20 participants. It compares two different ways of using the SteadiSet infusion set.
What's involved
Participants will use the SteadiSet insulin infusion set for six periods, each lasting up to 7 days.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome measure is taken at 6 weeks.

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NCT07325461

Feasibility Study of Extended Wear Insulin Infusion Set Options During Home Use in People With Type 1 Diabetes

Completed
NAAges 18–80InterventionalTreatment
Tandem Diabetes Care, Inc.
~20 participants
Updated 2026-08-31 on ClinicalTrials.gov
What's tested:SteadiSet Infusion Set

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
7 Day Survival of Infusion Set for Primary Outcome Measure
Measured over 6 weeks

Conditions

Diabetes Mellitus, Type 1

Explore related trials

Type 1 Diabetes Mellitus

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Jordan Pinsker, MD · STUDY_DIRECTOR · Tandem Diabetes Care

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age 18 to 80 years old inclusive
Generally in good health, as determined by the investigator
Living in the United States with no plans to move outside the United States during the study
Diagnosis of T1D for at least 12 months
Currently using a Tandem pump
Current Dexcom CGM user
HbA1c \<9.0% in the last 6 months.
Willing to implement and adhere to pump alert/alarm settings on a study-provided pump as instructed during the study
Willing to wear each investigational infusion set for up to 7 days during each of the wear periods in the study
Willing to perform blood ketone and blood glucose (fingerstick) measurements as directed using provided ketone and blood glucose meters and strips
If using Tandem Mobi, has a compatible cellular phone that can run the Tandem Mobi Mobile App
BMI in the range 18-35 kg/m2, both inclusive
Currently using one of the following insulins with no expectation of a need to change insulin type during the study:
Willing to change insulin cartridge every 48-72 hours, as recommended by patient's healthcare provider during the study
Has the ability to understand and comply with protocol procedures and to provide informed consent

Exclusion

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
Episodes of severe hypoglycemia in the last 6 months resulting in:
One or more episodes of diabetic ketoacidosis (DKA) in the last 6 months requiring hospitalization
Currently on a ketogenic or low-carbohydrate diet of less than 60 grams of carbohydrates per day, or intending to begin one during the study period
Known history of any of the following conditions:
Undergoing treatment with systemic oral or intravenous corticosteroids, at or within the last 8 weeks from screening. Inhaled glucocorticoids are allowed.
Significant history of any of the following, that in the opinion of the investigator would compromise safety or successful study participation:
Significant acute or chronic illness, that in the opinion of the investigator might interfere with safety or integrity of study results
Current participation in another clinical drug or device study
Immediate family member (spouse, biological or legal guardian, child, sibling, parent) who is a study site personnel directly affiliated with this study or who is an employee of Tandem Diabetes Care

What this trial measures

  • 7 Day Survival of Infusion Set for Primary Outcome Measure6 weeks

    7-day infusion set survival for primary outcome reasons as defined in the protocol (Hyperglycemia and failure to respond to boluses, Hyperglycemia with ketones \>1.0 mmol/L, or Investigator advised)