Glycemic Control in Hospitalized Patients with Diabetes Receiving Corticosteroids Using a Neutral Protamine Hagedorn Insulin Protocol: A Randomized Clinical Trial

Ameer Khowaja, Jamil B Alkhaddo, Zaighum Rana, Lisa Fish, Ameer Khowaja, Jamil B Alkhaddo, Zaighum Rana, Lisa Fish

Abstract

Introduction: Hospitalized patients with diabetes receiving corticosteroids are at risk of developing hyperglycemia and related complications. This study evaluated a neutral protamine Hagedorn (NPH) insulin-based protocol in improving glycemic control in hospitalized patients receiving corticosteroids.

Methods: This was a randomized, prospective, non-blinded study in an inpatient setting involving patients with diabetes who were hospitalized and receiving prednisone ≥ 10 mg per day or equivalent. High dose corticosteroids group (prednisone > 40 mg/day or equivalent) received NPH insulin 0.3 U/kg between 0600 and 2000 hours if eating or 0.2 U/kg between 2000 and 0600 hours if not eating. Low dose corticosteroids group (prednisone 10-40 mg/day or equivalent) received 0.15 U/kg between 0600 and 2000 hours if eating or 0.1 U/kg between 2000 and 0600 hours if not eating. Primary outcome measure was mean blood glucose level measured pre-meal and at bedtime for days 1-5.

Results: Mean blood glucose level was lower in the intervention (n = 29) than in the usual care (n = 31) group [226.12 vs. 268.57 mg/dL, respectively, (95% CI for difference - 63.195 to - 21.695), p < 0.0001]. Significant differences in mean glucose level were noted at fasting [170.96 vs. 221.13 mg/dL, respectively, (95% CI for difference - 72.70 to - 27.63), p < 0.0001] and pre-lunch [208 vs. 266.48 mg/dL, respectively, (95% CI for difference - 86.61 to - 30.36), p < 0.0001].

Conclusion: In hospitalized patients with diabetes receiving corticosteroids, an NPH insulin-based protocol improves glycemic control.

Trial registration: ClinicalTrials.gov Identifier: NCT01970241.

Funding: Eli Lilly and Company.

Keywords: DM; Diabetes mellitus; NPH; Neutral protamine Hagedorn insulin; Steroids.

Figures

Fig. 1
Fig. 1
CONSORT diagram showing the flow of participants
Fig. 2
Fig. 2
Mean POC glucose at fasting, pre-meals, and bedtime

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