No consensus guidelines exist for management of post-transplant glucocorticoid induced hyperglycemia, but most published reviews recommend insulin as first line therapy. A variety of insulin regimens have been proposed, including mealtime short-acting regular or analog insulin, once daily neutral protamine hagedorn (NPH) insulin, pre-mixed insulin, or basal insulin alone such as glargine or detemir. However, no randomized trial has ever examined different insulin regimens to determine which most effectively controls post-transplant steroid-induced hyperglycemia. Consequently, the proposed study intends to examine three commonly used insulin regimens used for managing post-transplant once-daily glucocorticoid-induced hyperglycemia to determine which is most effective: * Group 1: Intermediate-acting (NPH) insulin at breakfast * Group 2: Short-acting insulin (regular or aspart) before meals * Group 3: Insulin glargine at breakfast Question/Hypothesis: Among three commonly used insulin regimens, which is most effective for managing post-transplant once-daily glucocorticoid-induced hyperglycemia?
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Vancouver General Hospital - Jim Pattison Pavilion
Vancouver, British Columbia, Canada
Blood glucose - inpatient
Mean time from baseline to achieve at least 80% of pre-meal capillary blood glucose values within 5.0 - 7.8 mmol/L over a 48 hour period during hospitalization
Time frame: Time (days) from enrollment to described treatment range, an expected average of 7 days
Blood glucose - inpatient
Mean inpatient capillary blood glucose (mmol/L) from enrollment to discharge from hospital
Time frame: Subjects will be followed from enrollment for the remainder of hospital stay (days), an expected average of 21 days
Post prandial blood glucose - inpatient
Mean inpatient two-hour post-lunch capillary blood glucose (mmol/L) from enrollment to discharge from hospital
Time frame: Subjects will be followed from enrollment for the remainder of hospital stay (days), an expected average of 21 days
Length of inpatient hospital stay
Length of stay in hospital (days) from enrollment to discharge from hospital
Time frame: Subjects will be followed from enrollment for the remainder of hospital stay (days), an expected average of 21 days
Blood glucose
Mean fasting blood glucose (mmol/L) from enrollment to 3 months
Time frame: Enrollment to 3 months
Hemoglobin A1C
Mean hemoglobin A1C (%) from enrollment to 3 months
Time frame: Enrollment to 3 months
Post prandial blood glucose
Mean two-hour post-lunch capillary blood glucose (mmol/L) from enrollment to 3 months
Time frame: Enrollment to 3 months
Hypoglycemic episodes
Hypoglycemic episodes defined as: (1) Mild - any measured CBG 3.0-4.0 mmol/L; (2) Severe - any episode of hypoglycemia with a measured CBG \< 3.0 mmol/L, OR which the subject is not able to recognize and treat without the direct (substantial) intervention of a professional caregiver, nurse or physician (e.g. intravenous dextrose or intramuscular glucagon)
Time frame: Enrollment to 3 months
Glycemic treatment failure
Hypoglycemic treatment failure: subject experiences ≥3 hypoglycemic episodes (≤ 4.0 mmol/L) over any 5 day period or a single severe hypoglycemic event (as previously defined), they will be withdrawn from study and managed at discretion of attending physician, or hospital endocrine consult service. Hyperglycemic treatment failure: Severe hyperglycemia defined as CBG \>20 mmol/L. If subject experiences ≥3 severe hyperglycemic measures over the course of 48 hours they will be withdrawn from the study and managed at discretion of attending physician, or hospital endocrine consult service.
Time frame: Enrollment to 3 months
Cardiovascular events
New cardiovascular events defined as: myocardial infarction, new or worsened congestive heart failure, stroke, and cardiac arrhythmia.
Time frame: Enrollment to 3 months
Post-transplant infections or new antibiotic use
Post-transplant infections or new antibiotic use from enrollment to 3 months.
Time frame: Enrollment to 3 months
Transplant graft failure
Transplant graft failure (as specified by subject's medical transplant physician) from enrollment to 3 months.
Time frame: Enrollment to 3 months
New acute renal failure
New acute renal failure is defined according to Acute Kidney Network Guidelines: rapid time course and decreased kidney function according to an absolute Creatinine (Cr) rise greater than 26 μmol/L, greater than 2-fold increase in serum Cr from baseline, or urine output less than 0.5 mL/kg/hr for greater than 6 hours
Time frame: Enrollment to 3 months
Mortality
Overall subject mortality from baseline to 3 months.
Time frame: Enrollment to 3 months
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