Inpatient Diabetes on Corticosteroids

Phase 4

Completed

Brief Summary: Despite a significant problem with out-of-control glucose levels in patients with diabetes receiving corticosteroids for a variety of illnesses, there are no published protocols addressing how to adequately treat corticosteroid-induced hyperglycemia. Investigators propose to test a protocol using scheduled dosing of NPH (Neutral protamine Hagedorn) insulin for inpatients with diabetes receiving corticosteroids. NPH insulin action is ideally timed to counteract corticosteroid-induced hyperglycemia, and the dose is added to the patient's usual insulin regimen and timed to correspond to the corticosteroid dosing regimen. Investigators will prospectively enroll eligible consented patients with diabetes who are receiving corticosteroids as part of their treatment in a large county hospital, will randomize them to intervention or control groups, and will monitor their glucose levels during their inpatient stay. The protocol will demonstrate improved control of glucose levels with minimal risk of hypoglycemia, and will provide a practical and readily implementable protocol using NPH insulin as therapy for corticosteroid-induced diabetes.

Recruitment & Eligibility

Inclusion Criteria

Prior history of diabetes
Able to provide informed consent
Receiving corticosteroids while hospitalized of greater than 10 mg/d prednisone or the equivalent of dexamethasone or methylprednisolone
Expect to be hospitalized for 48 hours

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
NPH with steroid dose	NPH	Receive NPH with each corticosteroid dose during the study duration (2-5 days). Low dose corticosteroids High dose corticosteroids Eating and 6a-8p 0.15 units NPH/kg 0.3 units NPH/kg NPO(nothing by mouth) or 8p-6a 0.1 units NPH/kg 0.2 units NPH/kg
NPH with steroid dose	Correction Factor	Receive NPH with each corticosteroid dose during the study duration (2-5 days). Low dose corticosteroids High dose corticosteroids Eating and 6a-8p 0.15 units NPH/kg 0.3 units NPH/kg NPO(nothing by mouth) or 8p-6a 0.1 units NPH/kg 0.2 units NPH/kg
Control - Background and correction insulin	Correction Factor	Receive usual care with background insulin and correction factor for duration of study (2-5 days)

Primary Outcome Measures

Name	Time	Method
Mean POC Glucose Level Between Groups	Assessed from enrollment to discharge or enrollment to day five.	Primary outcome measure was mean blood glucose levels measured pre-meal and at bedtime in study patients and controls for the duration of the intervention. Values shown are the overall mean point of care blood glucose.

Secondary Outcome Measures

Name	Time	Method
Episodes of Hypoglycemia Between NPH and Control Groups	Glucose levels measured pre-meal, at bedtime, and during symptoms of hypoglycemia in study patients and controls for the duration of the intervention. Values shown represent cumulative episodes of hypoglycemia per group.	Hypoglycemia was defined as point of care glucose less than 70 mg/dL.