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 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT01101867
Eligibility Criteria:
Inclusion Criteria:
* general medical or minor surgical hospitalized patients
* type 2 diabetes
* blood glucose 150-400 on at least 2 occasions within 24 hours or requiring at least 20 units of insulin/day in the 24 hours prior to enrollment
Exclusion Criteria:
* • Major surgery, occurring within the previous 2 weeks or planned within 72 hours of study entry, including cardiothoracic, neurosurgical, and open intra-abdominal procedures (in particular, any surgery lasting over 2 hours).
* Patients receiving glucocorticoids, total parental nutrition (TPN), or tube feeds.
* Pregnancy (glucose targets differ in pregnancy). Premenopausal women not on pharmacologic contraceptives, inrauterine device (IUD), or surgical menopause will undergo pregnancy testing.
* Patients currently on IV insulin (must wait to enroll) or with planned surgical procedures in the next 72 hours for whom intravenous insulin will be likely
* Prolonged (\>24 hour) strict nil per os (NPO-nothing by mouth) status (eg. small bowl obstruction). Liquid or modified consistency diets are acceptable.
* Patients for whom expected length of stay will be less than 48 hours
* Patients using subcutaneous insulin pumps
* Diabetic ketoacidosis
* End-stage renal disease on dialysis
* End-stage liver disease with cirrhosis
* Mental conditions precluding informed consent
* Potentially sensitive admissions: prisoners, HIV, suicidality
* Unable to give consent in English
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01101867
Study Brief:
Protocol Section:
NCT01101867