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

May 28, 2026 updated by: Tandem Diabetes Care, Inc.
This feasibility study is a prospective, single center, multi-arm study evaluating possible enhancements to the SteadiSet extended wear infusion set.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

All participants will use the SteadiSet insulin infusion set for 6 wear periods of up to 7 days each.

The 2 treatment arms are:

Existing t:slim X2 Users:

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

Existing Mobi Users:

  • 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)

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: t:slim X2 Users
  • 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)
Device: SteadiSet Infusion Set
Participants will use the SteadiSet Infusion set with an enhanced filling process for three wear periods and the Steadiset Infusion Set only for three wear periods.
Experimental: Mobi Users
  • 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)
Device: SteadiSet Infusion Set
Participants will use the SteadiSet Infusion set with an enhanced filling process for three wear periods and the Steadiset Infusion Set only for three wear periods.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
7 Day Survival of Infusion Set for Primary Outcome Measure
Time Frame: 6 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)
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tandem Diabetes Care, Inc.

Investigators

  • Study Director: Jordan Pinsker, MD, Tandem Diabetes Care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 18, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

January 6, 2026

First Submitted That Met QC Criteria

January 6, 2026

First Posted (Actual)

January 8, 2026

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TP-0023728

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 1

Clinical Trials on SteadiSet Infusion Set

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in France

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe