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Impact of Insulin Degludec in Hospitalized Patients With and Without Type 2 Diabetes Requiring Parenteral/Enteral Nutrition: An Observational Study

Abstract

Introduction

Hyperglycemia in inpatients is a major problem, especially when nutritional support is required. This study aims to assess the impact of treatment with insulin degludec (IDeg) on mean blood glucose (BG) and glycemic variability in noncritical hospitalized patients with and without type 2 diabetes (T2DM) receiving enteral and/or parenteral nutrition (EN, PN).

Methods

Mean BG and glycemic variability from admission up to 7 days of hospitalization were evaluated in consecutive cases with and without T2DM. Percentage of coefficient of variation (CV) for glucose was used to express glycemic variability.

Results

Overall, 26 patients (13 with and 13 without T2DM) were admitted to the hospital for any cause. Subjects were 65.4% men and they were mainly elderly (mean age 66.3 ± 13.4 years). PN was administered in 88.5% of patients and EN in 19.2%. At admission, mean HbA1c level was 5.9 ± 0.7% in patients without diabetes and 9.1 ± 2.5% in patients with T2DM. During hospitalization, mean daily BG levels changed from 151 ± 47.3 mg/dl (day 1) to 157 ± 66.7 mg/dl (day 7) in patients without diabetes and from 210 ± 66.5 mg/dl to 192 ± 48.6 mg/dl in patients with T2DM. CV decreased from 14% (day 1) to 11% (day 7) in patients without diabetes and from 20% (day 1) to 9% (day 7) in patients with T2DM. No symptomatic or severe hypoglycemia occurred.

Conclusions

Despite the small sample size and the lack of control group, this study represents the first proof-of-concept that IDeg in hospitalized patients with or without T2DM who require nutritional support has the potential to maintain stable levels of BG and reduce glycemic variability.

Funding

Novo Nordisk S.p.A. grant.

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Acknowledgements

We thank the participants of the study.

Funding

Data collection for this study was performed by investigators as part of the routine clinical practice, no external funding was provided. Article processing charges were funded by Airon Communication, via an unconditional grant from Novo Nordisk S.p.A. The authors of the publication are fully responsible for its contents and conclusions. Novo Nordisk S.p.A. did not influence and has not been involved in the data interpretation and statistical analysis presented in the manuscript. All authors had full access to all of the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis.

Medical Writing, Editorial, and Other Assistance

The agency Airon Communication supported the clinicians with editorial assistance. This assistance included medical writing services (provided by CORESEARCH) and article processing charges. These services were funded through an unconditional grant from Novo Nordisk S.p.A.

Authorship

All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this manuscript, take responsibility for the integrity of the work as a whole, and gave their final approval of the version to be published.

Authorship Contributions

The authors of the publication Giuseppe Fatati, Agnese Di Donato, Ileana Grandone, Pina Menicocci, Eva Mirri, and Mariangela Palazzi researched data; Maria Chiara Rossi, Marco Scardapane, and Giuseppe Prosperini analyzed data; Giuseppe Fatati and Maria Chiara Rossi wrote the manuscript; all other authors reviewed/edited the manuscript and contributed to discussions.

Disclosures

Giuseppe Fatati received research support from Sanofi, Novo Nordisk, AstraZeneca, Lilly and Boehringer Ingelheim.

Ileana Grandone received research support from Sanofi, Novo Nordisk, AstraZeneca, Lilly and Boehringer Ingelheim.

Eva Mirri received research support from Sanofi, Novo Nordisk, AstraZeneca, Lilly and Boehringer Ingelheim.

Maria Chiara Rossi received research support from ForaCare, Artsana, Sanofi, Novo Nordisk, Dexcom, Medtronic, AstraZeneca.

Mariangela Palazzi received research support from Sanofi, Novo Nordisk, AstraZeneca, Lilly and Boehringer Ingelheim.

Agnese Di Donato, Pina Menicocci, Giuseppe Prosperini and Marco Scardapane have nothing to disclose.

Compliance with Ethics Guidelines

All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1964, as revised in 2013. The study protocol was approved by the local Ethics Committee and the informed consent was signed by all patients included in the analysis.

Data Availability

The datasets generated and/or analyzed during the current study are not publicly available due to restrictions imposed by Italian law, but they are available from the corresponding author on reasonable request.

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Correspondence to Maria Chiara Rossi.

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Fatati, G., Di Donato, A., Grandone, I. et al. Impact of Insulin Degludec in Hospitalized Patients With and Without Type 2 Diabetes Requiring Parenteral/Enteral Nutrition: An Observational Study. Adv Ther 35, 809–816 (2018). https://doi.org/10.1007/s12325-018-0709-x

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Keywords

  • Diabetes
  • Enteral nutrition
  • Glycemic variability
  • Hospitalized patients
  • Insulin degludec
  • Parenteral nutrition