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Phase II study of tight glycaemic control in COPD patients with exacerbations admitted to the acute medical unit
  1. John R H Archer1,
  2. Shivani Misra1,
  3. Marcus Simmgen2,
  4. Paul W Jones3,
  5. Emma H Baker1
  1. 1Division of Biomedical Science, St George's, University of London, London, UK
  2. 2Acute Medical Unit, St George's Hospital, London, UK
  3. 3Division of Clinical Sciences, St George's, University of London, London, UK
  1. Correspondence to Emma Baker; ebaker{at}sgul.ac.uk

Abstract

Background Hyperglycaemia is associated with poor outcomes from exacerbations of chronic obstructive pulmonary disease (COPD). Glycaemic control could improve outcomes by reducing infection, inflammation and myopathy. Most patients with COPD are managed on the acute medical unit (AMU) outside intensive care (ICU).

Objective To determine the feasibility, safety and efficacy of tight glycaemic control in patients on an AMU.

Design Prospective, non-randomised, phase II, single-arm study of tight glycaemic control in COPD patients with acute exacerbations and hyperglycaemia admitted to the AMU. Participants received intravenous, then subcutaneous, insulin to control blood glucose to 4.4–6.5 mmol/l. Tight glycaemic control was evaluated: feasibility, protocol adherence; acceptability, patient questionnaire; safety, frequency of hypoglycaemia (capillary blood glucose (CBG) <2.2 mmol/l and 2.2–3.3 mmol/l); efficacy, median CBG, fasting CBG, proportion of measurements/time in target range, glycaemic variability. Results were compared with 25 published ICU studies.

Results 20 patients (10 females, age 71±9 years; forced expiratory volume in 1 s: 41±16% predicted) were recruited. Tight glycaemic control was feasible (78% CBG measurements and 89% of insulin-dose adjustments were adherent to protocol) and acceptable to patients. 0.2% CBG measurements were <2.2 mmol/l and 4.1% measurements 2.2–3.3 mmol/l. The study CBG and proportion of measurements/time in target range were similar to that of ICU studies, whereas the fasting CBG was lower, and the glycaemic variability was greater.

Conclusions Tight glycaemic control is feasible and has similar safety and efficacy on AMU to ICU. However, as more recent ICU studies have shown no benefit and possible harm from tight glycaemic control, alternative strategies for blood glucose control in COPD exacerbations should now be explored.

Trial registration number ISRCTN: 42412334. http://Clinical.Trials.gov NCT00764556.

  • Hyperglycaemia
  • insulin
  • hypoglycaemia
  • glycaemic variability
  • COPD
  • acute medical unit
  • Chronic airways disease
  • clinical pharmacology
  • medical education and training
  • respiratory infections
  • cystic fibrosis
  • other metabolic
  • iron
  • porphyria

This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/2.0/ and http://creativecommons.org/licenses/by-nc/2.0/legalcode.

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Footnotes

  • Funding This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors. Academic clinical fellows contributing to the study were funded by the National Institute for Health Research. Therefore, the study was adopted by the UKCLRN portfolio (5689).

  • Competing interests None.

  • Patient consent Obtained.

  • Ethics approval Regulatory approval was provided by the Medicines and Healthcare Regulatory Authority (UK) and National Research Ethics Committee.

  • Contributors JRHA: protocol design, regulatory approval, patient recruitment and assessment, data entry and analysis, drafting paper for publication, trial governance. SM: protocol design, regulatory approval, patient recruitment and assessment, data entry and analysis, reviewing drafts of paper. MS: protocol design, supervised patient recruitment and assessment, data analysis, reviewing drafts of paper. PWJ: study design, data analysis, contribution to writing paper. EHB: chief investigator with overall responsibility for the study; study and protocol design, regulatory approval, supervision of patient recruitment and assessment, data analysis, writing paper for publication. All authors approved the final submitted version of the manuscript.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement Consent for data-sharing was not obtained from study participants at the time of recruitment, but the presented data are held in an anonymised data set. Access to the data set is available from the corresponding author (ebaker{at}sgul.ac.uk) in SPSS format for clinical academic researchers interested in undertaking a formally agreed collaborative research project(s). Although the risk of individual patient identification is low, any research involving the release of the data set to other clinical academics would require approval by the National Research Ethics Committee.

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