NCT07325461

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
10mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress21%
Feb 2026Mar 2027

First Submitted

Initial submission to the registry

January 6, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 8, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

February 18, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

January 6, 2026

Last Update Submit

March 3, 2026

Conditions

Diabetes Mellitus, Type 1

Keywords

type 1 diabetesT1DTandemt:slim X2Tandem Mobiautomated insulin deliverySteadiSet

Outcome Measures

Primary Outcomes (1)

  • 7 Day Survival of Infusion Set for Primary Outcome Measure

    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

Study Arms (2)

t:slim X2 Users

EXPERIMENTAL

* 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

Mobi Users

EXPERIMENTAL

* 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

Interventions

SteadiSet Infusion SetDEVICE

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.

Mobi Userst:slim X2 Users

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • Humalog™ (or generic insulin lispro)
  • NovoLog™ (or generic insulin aspart)
  • +2 more criteria

You may not qualify if:

  • 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:
  • Medical Assistance (i.e., paramedics, hospital evaluation or hospitalization)
  • Loss of consciousness
  • 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:
  • Cushing's Disease
  • Adrenal insufficiency
  • Pancreatic islet cell tumor
  • Insulinoma
  • Lipodystrophy
  • Extensive lipohypertrophy, as assessed by the investigator
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Jordan Pinsker, MD

    Tandem Diabetes Care

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2026

First Posted

January 8, 2026

Study Start

February 18, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

March 5, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)