CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 85 enrolled
Drug / intervention
NPH +1 moredrug
Likely dose
Correction Factor 2 unitsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01970241
NCT01970241Phase 4Completed

Inpatient Diabetes on Corticosteroids

Hennepin Healthcare Research Institute·interventional·Posted Oct 28, 2013·Updated Oct 1, 2019

In Brief

A Phase 4 clinical trial evaluating NPH and Correction Factor for Diabetes Mellitus. Completed, enrolled 85 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 28, 2013
Enrollment StartJul 1, 2014
Primary CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 12.7 years ago

Interventions

NPHdrug

NPH given per study table based on steroid dose and patient weight in kg.

Correction Factordrug

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.