Validation of Insulin Protocol for Glucocorticoid-induced Hyperglycemia in Diabetic Oncology Patients
- Conditions
- LymphomaDiabetes Mellitus, Type 2Hyperglycemia
- Registration Number
- NCT02012465
- Lead Sponsor
- Washington University School of Medicine
- 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 (unpublished data) found a relationship between insulin requirements needed to maintain normal blood sugars, patient weight, and mg of steroid administered.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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- 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.
Trial Locations
- Locations (1)
Washington University in St. Louis
🇺🇸Saint Louis, Missouri, United States
Washington University in St. Louis🇺🇸Saint Louis, Missouri, United States