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Phase 4 Completed N=85 Randomized Treatment

Inpatient Diabetes on Corticosteroids

Source: ClinicalTrials.gov NCT01970241 ↗
Enrolled (actual)
85
Serious AEs
10.0%
Results posted
Oct 2019
Primary outcomePrimary: Mean POC Glucose Level Between Groups — 225; 266 mg/dl
◆ Published Evidence
Established ▲ Trending
25citations · ~3 / year
Glycemic Control in Hospitalized Patients with Diabetes Receiving Corticosteroids Using a Neutral Protamine Hagedorn Insulin Protocol: A Randomized Clinical Trial.
Diabetes therapy : research, treatment and education of diabetes and related disorders · 2018 · Open access · Likely link

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.

Linked Publications

  • Glycemic Control in Hospitalized Patients with Diabetes Receiving Corticosteroids Using a Neutral Protamine Hagedorn Insulin Protocol: A Randomized Clinical Trial.
    Diabetes therapy : research, treatment and education of diabetes and related disorders · 2018 · 25 citations · Open access · Likely link

Outcome Measures

OutcomeResultp-value
PRIMARY
Mean POC Glucose Level Between Groups
225; 266
SECONDARY
Episodes of Hypoglycemia Between NPH and Control Groups
6; 0

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01970241) and the linked publication. 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. Informational only — not medical advice.

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