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New insulin set aims to last a full week for type 1 diabetes

NCT ID NCT07325461

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 01, 2026 · Updated 3 times

Summary

This study tests a new insulin infusion set designed to last up to 7 days for people with type 1 diabetes. Twenty adults currently using a Tandem insulin pump and Dexcom CGM will try the SteadiSet at home. The goal is to see if the set can survive a full week without causing high blood sugar or other issues.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SteadiSet Infusion Set (device)
What this could lead to
If successful, this could lead to longer-lasting insulin infusion sets, reducing the need for frequent changes and improving diabetes management.
What could go wrong
This is a small, early feasibility study with only 20 participants. The device may not last the full 7 days for everyone, and results may not apply to all people with type 1 diabetes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

20 people

The number who actually took part.

Started

Feb 2026

Finished

Jun 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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: 1. Humalog™ (or generic insulin lispro) 2. NovoLog™ (or generic insulin aspart) * 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 Criteria: * 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: 1. Medical Assistance (i.e., paramedics, hospital evaluation or hospitalization) 2. Loss of consciousness 3. Seizures * 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: 1. Cushing's Disease 2. Adrenal insufficiency 3. Pancreatic islet cell tumor 4. Insulinoma 5. Lipodystrophy 6. Extensive lipohypertrophy, as assessed by the investigator * 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: 1. Alcoholism 2. Drug abuse * 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Stanford University

    Stanford, California, 94305, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.