Actively Recruiting
Feasibility Study of Extended Wear Insulin Infusion Set Options During Home Use in People With Type 1 Diabetes
Led by Tandem Diabetes Care, Inc. · Updated on 2026-03-05
20
Participants Needed
1
Research Sites
53 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This feasibility study is a prospective, single center, multi-arm study evaluating possible enhancements to the SteadiSet extended wear infusion set.
CONDITIONS
Official Title
Feasibility Study of Extended Wear Insulin Infusion Set Options During Home Use in People With Type 1 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 during the study
- Diagnosis of Type 1 Diabetes for at least 12 months
- Currently using a Tandem insulin pump
- Current Dexcom continuous glucose monitor user
- HbA1c less than 9.0% in the last 6 months
- Willing to follow pump alert and alarm settings on study-provided pump
- Willing to wear each infusion set for up to 7 days during each wear period
- Willing to perform blood ketone and blood glucose measurements using provided meters and strips
- If using Tandem Mobi, has a compatible cellular phone for the Tandem Mobi Mobile App
- Body mass index between 18 and 35 kg/m2 inclusive
- Currently using Humalog (or generic insulin lispro) or NovoLog (or generic insulin aspart) with no expected changes
- Willing to change insulin cartridge every 48-72 hours as recommended
- Able to understand and comply with study procedures and provide informed consent
You will not qualify if you...
- Using any non-insulin glucose-lowering agents other than metformin (e.g., GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas)
- Female who is pregnant, planning pregnancy, or not using adequate contraception
- Experienced severe hypoglycemia in last 6 months requiring medical assistance, loss of consciousness, or seizures
- Had one or more diabetic ketoacidosis episodes in last 6 months requiring hospitalization
- Currently on or planning to start ketogenic or low-carbohydrate diet under 60 grams per day
- History of Cushing's Disease, adrenal insufficiency, pancreatic islet cell tumor, insulinoma, lipodystrophy, or extensive lipohypertrophy
- Receiving systemic oral or intravenous corticosteroids currently or within 8 weeks prior to screening (inhaled glucocorticoids allowed)
- Significant history of alcoholism or drug abuse
- Significant acute or chronic illness that may affect safety or study results
- Currently participating in another clinical drug or device study
- Immediate family member who is study site personnel or Tandem Diabetes Care employee
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Stanford University
Stanford, California, United States, 94305
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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