New insulin set aims to last a full week – no more Every-Other-Day changes?
NCT ID NCT06273124
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tested a new insulin infusion set designed to be worn for up to 7 days instead of the usual 2-3 days. 260 adults with type 1 diabetes used the set at home for 12 wear periods. The goal was to see if the set could safely deliver insulin for a full week without causing high blood sugar or other problems.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SteadiSet Extended Wear Infusion Set (a device that delivers insulin continuously for up to 7 days)
- What this could lead to
- If successful, this could allow people with type 1 diabetes to change their insulin infusion set only once a week instead of every 2-3 days, making daily management easier.
- What could go wrong
- This is a completed study, but results are not yet published. The device may not last the full 7 days for everyone, and there is a risk of high blood sugar or ketones if it fails.
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
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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
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260 people
The number who actually took part.
- Started
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Mar 2024
- Finished
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Dec 2024
- Lead sponsor
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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
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide 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: * Inclusion Criteria: 1. Age 18 to 80 years old inclusive 2. Generally in good health, as determined by the investigator 3. Living in the United States with no plans to move outside the United States during the study 4. Diagnosis of T1D for at least 12 months 5. Minimum of 6 months of insulin pump experience and at least 3 months of current experience with a Tandem pump 6. Using Tandem t:slim X2 insulin pump with Control-IQ technology for a minimum of 1 month at the time of enrollment 7. Minimum of 14 days of Control-IQ data immediately preceding screening that demonstrate pump use compliance, including at least 85% of time with Control-IQ technology active 8. HbA1c \<9.0% in the last 6 months. 9. Willing to implement and adhere to pump alert/alarm settings on a study-provided pump as instructed during the study 10. Willing to wear each investigational infusion set for up to 7 days during each of the 12 consecutive wear periods in the study 11. Willing to perform blood ketone and blood glucose (fingerstick) measurements as directed using provided ketone and blood glucose meters and strips 12. Access to internet for required periodic uploads of study device data 13. BMI in the range 18-35 kg/m2, both inclusive 14. Currently using one of the following insulins with no expectation of a need to change insulin type during the study: 1. Humalog™\* (insulin lispro) 2. NovoLog™\* (insulin aspart) 15. Using Humalog™ insulin lispro or NovoLog™ insulin aspart for a minimum of 1 month at the time of enrollment 16. Willing to change insulin cartridge every 48-72 hours, as recommended by patient's healthcare provider during the study 17. Has routine access to a smart phone e.g., ability to receive text messages 18. Has the ability to understand and comply with protocol procedures and to provide informed consent (i.e., English proficient in both verbal and written communication) Exclusion Criteria: 1. 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) 2. Female subject is pregnant, planning to become pregnant, or not using adequate method of contraception 3. 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 4. One or more episodes of diabetic ketoacidosis (DKA) in the last 6 months requiring hospitalization 5. 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 6. Known cardiovascular disease considered to be clinically relevant by the investigator 7. Known history of any of the following conditions: 1. Cushing's Disease 2. Pancreatic islet cell tumor 3. Insulinoma 4. Lipodystrophy 5. Extensive lipohypertrophy, as assessed by the investigator 8. Currently undergoing treatment with: 1. Systemic oral or intravenous corticosteroids (current or within the last 8 weeks from screening), 2. Thyroid hormones, unless use has been stable during the past 3 months 9. 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 10. Significant acute or chronic illness, that in the opinion of the investigator might interfere with safety or integrity of study results 11. Current participation in another clinical drug or device study 12. 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 Capillary Biomedical
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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
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Barbara Davis Center
Aurora, Colorado, 80045, United States
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Endocrine Research Solutions
Roswell, Georgia, 30076, United States
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Henry Ford Health System
Detroit, Michigan, 48202, United States
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Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663, United States
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Icahn School of Medicine at Mt. Sinai
New York, New York, 10029, United States
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International Diabetes Center - HealthPartners Institute
Minneapolis, Minnesota, 55416, United States
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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Mayo Clinic
Rochester, Minnesota, 55905, United States
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Northwestern University
Evanston, Illinois, 60208, United States
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Rainier Clinical Research Center
Renton, Washington, 98057, United States
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Rocky Mountain Clinical Research
Idaho Falls, Idaho, 83404, United States
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SUNY Upstate Medical University
Syracuse, New York, 13210, United States
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Stanford University
Stanford, California, 94305, United States
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Texas Diabetes and Endocrinology
Austin, Texas, 78731, United States
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University of Washington
Seattle, Washington, 98109, United States
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