Phase 4
N=85
Inpatient Diabetes on Corticosteroids
Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT01970241 ↗Enrolled (actual)
85
Serious AEs
10.0%
Results posted
Oct 2019
Primary outcome: Primary: Mean POC Glucose Level Between Groups — 225; 266 mg/dl
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- NPH (Drug); Correction Factor (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hennepin Healthcare Research Institute
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean POC Glucose Level Between Groups |
225; 266 | — |
| SECONDARY Episodes of Hypoglycemia Between NPH and Control Groups |
6; 0 | — |
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.
Eligibility Criteria
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) 2 times upper normal for laboratory
Data sourced from ClinicalTrials.gov (NCT01970241). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.