Comparison of Insulin Therapy in Treating Post-Transplant Diabetes

A large percentage of organ transplant recipients develop de novo diabetes mellitus after
transplantation, also called "New Onset Diabetes After Transplant" or NODAT. The cause of the
diabetes appears to be commonly used anti-rejection medications, particularly calcineurin
inhibitors and glucocorticoids.

Management of glucose levels in NODAT often requires insulin therapy. Standard practice is to
start long-acting insulin. However, patients with NODAT often exhibit fasting morning glucose
levels that are relatively low compared to pre-lunch and pre-dinner glucose levels. This
seems to make NODAT patients more susceptible to fasting, or morning, hypoglycemia on
long-acting insulin analogues than non-transplant patients with type II diabetes. This
phenomenon of morning hypoglycemia in NODAT often limits the up-titration of basal insulin
resulting in suboptimal treatment of hyperglycemia later in the day. Because of this pattern,
transplant patients may respond better to morning insulin isophane (intermediate acting) than
to long-acting insulin glargine preparations.

Our trial is designed to compare morning NPH insulin (isophane insulin) with conventional
therapy of basal glargine insulin on both continuous blood glucose levels and hemoglobin A1c
(glycosylated hemoglobin).

Inclusion Criteria:

1. Must be followed by the Inova Fairfax Hospital transplantation program for
post-transplant care

2. Diabetes mellitus inadequately responsive to lifestyle modification and non-insulin
hypoglycemic medication

3. Need for subcutaneous insulin therapy (after discontinuation of IV insulin therapy, if
it was required)

4. Ability to read consent form and give consent in English.

Exclusion Criteria:

1. Use of insulin or non-insulin hypoglycemic medication before transplantation

2. Cystic fibrosis patients

3. Age < 18 years of age

4. Pregnancy

5. Non-English speaking subjects