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:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-25 @ 2:18 AM
NCT ID:
NCT05204134
Eligibility Criteria:
Inclusion Criteria:
* Adult subjects ≥ age 18 years
* Clinical diagnosis of type 1 diabetes for at least one year
* Using a basal/bolus regimen by injection (MDI therapy)
* Total daily dose ≥10 units/day
* Willing to use only aspart (novolog) or lispro (humalog) U-100 insulin with the study pump.
* A1c ≥ 7.5% and ≤ 11% at screening
* Not pregnant or planning a pregnancy during the time period of the study.
* Has current glucagon product to treat severe hypoglycemia (injectable or nasal) at home (will provide prescription if they do not have one)
* Willingness to follow study procedures and a signed informed consent form
Exclusion Criteria:
* Two or more episodes of severe hypoglycemia (needing assistance) in the past 6 months
* Two or more episodes of diabetic ketoacidosis in the past 6 months
* Inpatient psychiatric treatment in the past 6 months
* History of drug abuse (defined as any illicit drug use) or history of alcohol abuse prior to screening or unwillingness to agree to abstain from illicit drugs throughout the study
* Significant chronic kidney disease or hemodialysis
* Significant liver disease
* History of adrenal insufficiency
* Hypothyroidism or hyperthyroidism that is not appropriately treated
* Other chronic disease/condition determined by investigator to interfere with participation in the study
* Use of glucocorticoids, beta blockers or other medications determined by investigator to interfere with study
* Use of long-acting insulin, inhaled insulin (Afrezza), or use of any non-insulin glucose lowering agents (i.e. SGLT-2 inhibitor) other than Metformin with the study pump
* Subject is pregnant or lactating or intending to become pregnant before or during participation in this study
* Investigator judgement that subject would not be able to complete the trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05204134
Study Brief:
Protocol Section:
NCT05204134