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 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT06753994
Eligibility Criteria:
Adults ≥ 18 years old.
* A T1D diagnosis for at least one year, as per their treating physician in agreement with the investigator's judgment (confirmatory C-peptide and antibodies will not be required).
* HbA1c level of \< 11% within the last six months.
* Current use of intensive insulin therapy, either multi-daily injection or closed-loop insulin pump therapy, with no plan to change during the study.
* Current use of CGM, either real-time or intermittent.
* Active avoidance of pregnancy during the trial, which includes effective contraception for any individuals of childbearing potential, who are sexually active.
* Ability to consume an average of more than 50 g of carbohydrates per day.
* Use of a compatible phone to allow for download of the CKM sensor application.
Exclusion Criteria:
* DKA or severe hypoglycemia within the last six months.
* Current or recent use of any anti-hyperglycemic agent other than insulin (≤ one month for GLP1-RA, ≤ one week for all others).
* Current or ≤ one-month use of supraphysiological doses of glucocorticoids.
* Body mass index \< 20 kg/m2.
* Glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2 as per CKD-EPI formula with creatinine levels measured within the last two months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06753994
Study Brief:
Protocol Section:
NCT06753994