Washington University in St. Louis
St Louis, Missouri, 63108, United States
NCT Number: NCT02012465
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 (unpublished data) found a relationship between insulin requirements needed to maintain normal blood sugars, patient weight, and mg of steroid administered.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.
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Notify Me18 year and older
All sexes
Interventional
Early Phase 1
St Louis, Missouri, 63108, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
For diabetics enrolled on admission:
Inclusion criteria
Exclusion criteria
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
Within 24 hours of admission for diabetic participants, the inpatient oncology team will consult the endocrine team to apply the following part of the protocol, confirm NPH insulin dosing, and ensure that oral hypoglycemics are held.
The following basal-bolus protocol is standard of care for inpatient diabetics requiring insulin at Barnes Jewish Hospital. The alternative practice has been to use 60-80% of the home insulin regimen while patients are hospitalized. For patients using home insulin, the admitting oncology team will enact one of these methods while awaiting the endocrine service's formal recommendations.
Other names: NPH, Glargine, Lispro
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 year
Washington University School of Medicine
Other
Validation of Insulin Protocol for Prevention and Management of Hyperglycemia in Oncology Patients With Diabetes Receiving High Dose Glucocorticoid Therapy
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