Trying extended-wear SteadiSet insulin infusion sets with Tandem pumps at home
Feasibility Study of Extended Wear Insulin Infusion Set Options During Home Use in People With Type 1 Diabetes
This trial tests whether extended-wear SteadiSet infusion sets with different filling and port options work well and are safe for adults with type 1 diabetes who use Tandem t:slim X2 or Mobi pumps and Dexcom CGM.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Tandem Diabetes Care, Inc. Industry-sponsored |
| Locations | 1 site (Stanford, California) |
| Trial ID | NCT07325461 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-center, multi-arm feasibility study conducted at Stanford University where participants will complete six infusion-set wear periods of up to seven days each using the SteadiSet. Participants are grouped by current pump type (t:slim X2 or Mobi) and will try both a version with an enhanced filling process and a version without side ports across sequential wear periods. The study collects device performance, tolerability, blood glucose and blood ketone measurements, and adherence to pump alert settings during home use. The primary focus is feasibility and user experience with the SteadiSet modifications rather than long-term clinical outcomes.
Who should consider this trial
Good fit: Adults aged 18–80 with type 1 diabetes for at least 12 months who currently use a Tandem pump, use Dexcom CGM, have HbA1c under 9.0%, BMI 18–35 kg/m2, live in the United States, and are willing to perform fingerstick and ketone testing are ideal candidates.
Not a fit: People who do not use Tandem pumps or Dexcom CGM, have BMI or HbA1c outside the listed ranges, cannot remain in the U.S. for the study, or are unwilling to perform required monitoring may not benefit or be eligible.
Why it matters
Potential benefit: If successful, the enhanced SteadiSet options could allow longer infusion-set wear and reduce how often users need to change sets, improving convenience.
How similar studies have performed: Other studies of extended-wear infusion sets have shown promise for longer wear and user convenience, but these specific SteadiSet filling and port modifications are novel and primarily being tested for feasibility in home use.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Stanford, California
- Stanford University — Stanford, California, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.