Insulin Therapy for Post-transplant Glucocorticoid Induced Hyperglycemia

• Status: Terminated
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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?

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vancouver General Hospital
• Treatments: Glucocorticoids; Insulin; Insulin Aspart; Insulin Glargine; Insulin, Globin Zinc; Insulin, Isophane; Isophane Insulin, Human; Protamines

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