Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07325461
Eligibility 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07325461
Study Brief:
Protocol Section:
NCT07325461