Clinical trial NCT02012465: Validation of Insulin Protocol for Glucocorticoid-induced Hyperglycemia in Diabetic Oncology Patients
Official title: Validation of Insulin Protocol for Prevention and Management of Hyperglycemia in Oncology Patients With Diabetes Receiving High Dose Glucocorticoid Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Lymphoma
Diabetes Mellitus, Type 2
Hyperglycemia
Keywords: Steroid induced hyperglycemia
Glucocorticoid induced hyperglycemia
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2013-12-16
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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 (unpublished data) found a relationship between insulin requirements needed to maintain normal blood sugars, patient weight, and mg of steroid administered.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.


Eligibility criteria: 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)

Primary outcomes:
measure: Incidence of hyperglycemia
timeFrame: up to 5 days of hospital course
Secondary outcomes:
measure: Incidence of severe hyperglycemia
timeFrame: up to 5 days of hospital course
measure: Incidence of hypoglycemia
timeFrame: up to 5 days of hospital course
measure: Incidence of severe hypoglycemia
timeFrame: up to 5 days of hospital course
measure: Remission of primary oncologic diagnosis at one year
timeFrame: 1 year
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Garry Tobin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Anna Roshal, MD
role: PRINCIPAL_INVESTIGATOR
References: