Inpatient Diabetes on Corticosteroids

Completed · Phase 4

Conditions studied: Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT01970241

Run by

Hennepin Healthcare Research Institute

People needed

85

Starts

2014-07-01

Expected to finish

2016-06-01

Last updated by the study team

2019-10-01

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Hennepin County Medical Center — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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