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

Recruitment & Eligibility

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:

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)

Study & Design

Arm && Interventions

Group	Intervention	Description
Insulin protocol	Insulin protocol	For diabetic patients, as part of the initial chemotherapy orders on admission, the following will be calculated by the primary oncologist to determine the amount of neutral protamine Hagedorn (NPH) insulin needed to cover steroid use in prednisone equivalents (all insulin in this study is to be administered subcutaneously): * Use 0.1 (mg of prednisone equivalent - 20)/20 x weight (kg) to estimate total insulin in 24 hours (Total daily dose (TDD)) * Total daily NPH dose will be divided equally based on the frequency of steroid administration, and given with each steroid dose. For nondiabetic participants with hyperglycemia recruited during admission, the inpatient oncology team will consult the endocrine team within 24 hours of eligibility for NPH dosing as above.

Primary Outcome Measures

Name	Time	Method
Incidence of hyperglycemia	up to 5 days of hospital course	Defined as blood glucose \> 180 mg/dL. This will be measured as the % of patient-days with a blood sugar \> 180 mg/dL.

Secondary Outcome Measures

Name	Time	Method
Incidence of hypoglycemia	up to 5 days of hospital course	Defined as blood glucose \< 70 mg/dL. This will be measured as the % of patient-days with a blood sugar \< 70 mg/dL.
Incidence of severe hypoglycemia	up to 5 days of hospital course	Defined as blood glucose \< 40 mg/dL. This will be measured as the % of patient-days with a blood sugar \< 40 mg/dL.
Remission of primary oncologic diagnosis at one year	1 year
Incidence of severe hyperglycemia	up to 5 days of hospital course	Defined as blood glucose \> 299 mg/dL. This will be measured as the % of patient-days with a blood sugar \> 299 mg/dL.

Recruitment & Eligibility