Inpatient Diabetes on Corticosteroids

Study Overview
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Brief Summary
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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.

Detailed Description
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As above.

Official Title
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Inpatient Diabetes on Corticosteroids

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Drug: NPH
* Drug: Correction Factor


Participation Criteria
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Eligibility Criteria
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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: Renal failure with GFR (glomerular filtration rate) < 30 ml/min/1.73m2 ALT (alanine aminotransferase) > 2 times upper normal for laboratory

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NPH with steroid dose<br>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 | Drug: NPH<br>* NPH given per study table based on steroid dose and patient weight in kg.<br>* Other names: NPH Lilly Insulin;Drug: Correction Factor<br>* Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.<br>* Other names: Rapid acting regular insulin;|
| Active Comparator: Control - Background and correction insulin<br>Receive usual care with background insulin and correction factor for duration of study (2-5 days) | Drug: Correction Factor<br>* Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.<br>* Other names: Rapid acting regular insulin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean POC Glucose Level Between Groups | 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. | Assessed from enrollment to discharge or enrollment to day five. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Episodes of Hypoglycemia Between NPH and Control Groups | Hypoglycemia was defined as point of care glucose less than 70 mg/dL. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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corticosteroid, diabetes, insulin