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 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT06420518
Eligibility Criteria:
Inclusion Criteria:
1. Adults ≥ 18 years of age.
2. A clinical diagnosis of type 1 diabetes (T1D) for at least one year, as per their treating diabetes physician in agreement with the primary investigator's clinical judgment (confirmatory C-peptide and antibodies will not be required).
3. On stable, commercial closed-loop pump therapy for the past 30 days.
4. Stable use of continuous glucose monitor system for the past 30 days.
5. Cellular phone with Android OS operating system 8.1 and above or iOS11 and above operating system, for data compatibility with continuous ketone monitor mobile app (SiCKM app).
6. Able to perform study related tasks.
Exclusion Criteria:
1. Current or ≤ 2 weeks use of sodium-glucose cotransporter-2 (SGLT2) inhibitor medication (e.g. empagliflozin).
2. Current use of ascorbic acid (Vitamin C) as it may impair accuracy of the sensor.
3. Severe hypoglycemic episode within one month of admission, defined as an event where glucose was \<4 mmol/L resulting in seizure, loss of consciousness, needing third party assistance, or need to present to the emergency department.
4. Diabetic ketoacidosis episode requiring medical attention or intravenous insulin within one month.
5. Planned or ongoing pregnancy or breastfeeding individuals.
6. Any serious medical or psychiatric illness likely to interfere with ability to complete the trial, as per judgement of investigators.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06420518
Study Brief:
Protocol Section:
NCT06420518