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 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT01648218
Eligibility Criteria:
Inclusion Criteria:
1. Have undergone bone marrow, liver, lung, or renal transplant.
2. Be using once daily oral glucocorticoid therapy (total daily dose of Prednisone ≥10 mg, Hydrocortisone ≥40 mg, Dexamethasone ≥1.5 mg) administered in the morning and expected to continue for at least 2 weeks.
3. Have pre-existing or newly diagnosed diabetes mellitus established by any of the criteria listed below:
1. Fasting plasma glucose ≥7.0 mmol/L (repeated x 1)
2. Any plasma glucose ≥11.0 mmol/L
4. Have at least three pre-meal inpatient capillary blood glucose (CBG) readings ≥ 7.8 mmol/L
5. Be eating meals by mouth
Exclusion Criteria:
1. Heart, Pancreas, Islet cell transplant recipients
2. Previous use of Basal-Bolus or Pre-Mixed Insulin regimen
3. Diabetes mellitus type I
4. NPO (not eating meals by mouth)
5. Receiving enteral (tube feeds) or parenteral (TPN) nutrition
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01648218
Study Brief:
Protocol Section:
NCT01648218