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 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 12:37 AM
NCT ID:
NCT03489967
Eligibility Criteria:
Inclusion Criteria:
1. Males and females ≥ 18 years of old.
2. Clinical diagnosis of type 1 diabetes for at least one year.
3. Treatment with multiple daily insulin injections or insulin pump therapy and using insulin analogs (rapid, ultra-rapid and basal).
4. HbA1c ≤ 10%.
Exclusion Criteria:
1. Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially diagnosed gastroparesis) or severe proliferative retinopathy as judged by the investigator.
2. Recent (\< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
3. Known significant cardiac rhythm abnormality based on investigator judgment.
4. Abnormal blood panel and/or anemia (Hb \< 100g/L).
5. Ongoing pregnancy or breastfeeding.
6. Severe hypoglycemic episode within 1 month of screening.
7. Known uncorrected hypokalemia (potassium \< 3.5 mmol/L; available within the past 3 months).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03489967
Study Brief:
Protocol Section:
NCT03489967