Validation of Insulin Protocol for Glucocorticoid-induced Hyperglycemia in Diabetic Oncology Patients



Status:Completed
Conditions:Lymphoma, Diabetes, Diabetes, Diabetes
Therapuetic Areas:Endocrinology, Oncology
Healthy:No
Age Range:18 - Any
Updated:5/9/2018
Start Date:September 2013
End Date:May 2015

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Validation of Insulin Protocol for Prevention and Management of Hyperglycemia in Oncology Patients With Diabetes Receiving High Dose Glucocorticoid Therapy

There are no guidelines for the management of glucocorticoid- (henceforth steroid) induced
elevated blood sugars (henceforth hyperglycemia). Oncology ward patients have particularly
high rates of hyperglycemia and are frequently exposed to high dose steroid therapy. A prior
study by Muthala et al. (unpublished data) found a relationship between insulin requirements
needed to maintain normal blood sugars, patient weight, and mg of steroid administered. In
this pilot study, through an endocrine consult team, a weight-based, steroid dose-based
insulin protocol will be implemented for the management of hyperglycemia in lymphoma patients
requiring high dose steroid therapy, with the goal of reducing hyperglycemia incidence.


For diabetics enrolled on admission:

Inclusion Criteria:

- Age ≥ 18 years old

- Type 2 diabetes mellitus treated with insulin secretagogues or insulin prior to
hospitalization

- Diagnosis of lymphoma

- Plan to treat with steroids of minimum equivalent of 20 mg prednisone per day

- Hospitalized for at least 48 hours

- Decision-making capacity to provide own consent

Exclusion Criteria:

- Type 1 diabetes

- Any contraindication to insulin therapy

- Patients only on single agent therapy such as metformin, thiazolidinediones (TZDs),
Dipeptidyl peptidase-4 (DPP4) inhibitors, or Exenatide®, for safety concerns

- Insulin requirement of >1.5 units of insulin/kg

- If a patient required ICU stay during the hospitalization, data from 12 hours before,
during, and 12 hours after ICU stay will be omitted to avoid confounding of the effect
of critical illness on glycemic control

- Pregnancy, confirmed with a urine b-human chorionic gonadotropin (HCG) (for all women
between the age of 18 and 60 years old)

Patients who develop a blood glucose > 235 mg/dL after admission will be eligible for study
enrollment based on the following:

Inclusion criteria:

- Age ≥ 18 years old

- Diagnosis of lymphoma

- Plan to treat with steroids of minimum equivalent of 20 mg prednisone per day

- Will be hospitalized for at least an additional 48 hours

- Decision-making capacity to provide own consent

Exclusion criteria:

- Any contraindication to insulin therapy

- If a patient required ICU stay during the hospitalization, data from 12 hours before,
during, and 12 hours after ICU stay will be omitted to avoid confounding of the effect
of critical illness on glycemic control

- Pregnancy, confirmed with a urine b-HCG (for all women between the age of 18 and 60
years old)
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