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:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2025-12-24 @ 5:44 PM
NCT ID:
NCT03877068
Eligibility Criteria:
Inclusion Criteria:
1. Males and females ≥ 18 years admitted to a general medicine or surgical services.
2. History of T1D or T2D receiving insulin therapy during hospital admission.
3. Subjects must have a randomization BG \<400 mg/dL without laboratory evidence of diabetic ketoacidosis (bicarbonate \< 18 milliequivalents per litre (mEq/L), potential of hydrogen (pH) \< 7.30, or positive serum or urinary ketones).
4. Patients with expected hospital length-of-stay of 2 or more day
Exclusion Criteria:
1. Patients with acute illness admitted to the ICU or expected to require admission to the ICU.
2. Patients expected to require MRI procedures during hospitalization.
3. Patients with clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension), corticosteroid therapy, end-stage renal disease (dialysis), or anasarca (massive peripheral edema).
4. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
5. Female subjects who are pregnant or breast-feeding at time of enrollment into the study.
6. Coronavirus Disease 2019 (COVID-19) infection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03877068
Study Brief:
Protocol Section:
NCT03877068