Closed-loop insulin delivery in inpatients with type 2 diabetes: a randomised, parallel-group trial

Hood Thabit, Sara Hartnell, Janet M Allen, Andrea Lake, Malgorzata E Wilinska, Yue Ruan, Mark L Evans, Anthony P Coll, Roman Hovorka

Research output: Contribution to journalArticlepeer-review

Abstract

Background: We assessed whether fully closed-loop insulin delivery (the so-called artificial pancreas) is safe and effective compared with standard subcutaneous insulin therapy in patients with type 2 diabetes in the general ward.

Methods: For this single-centre, open-label, parallel-group, randomised controlled trial, we enrolled patients aged 18 years or older with type 2 diabetes who were receiving insulin therapy. Patients were recruited from general wards at Addenbrooke's Hospital, Cambridge, UK. Participants were randomly assigned (1:1) by a computer-generated minimisation method to receive closed-loop insulin delivery (using a model-predictive control algorithm to direct subcutaneous delivery of rapid-acting insulin analogue without meal-time insulin boluses) or conventional subcutaneous insulin delivery according to local clinical guidelines. The primary outcome was time spent in the target glucose concentration range of 5·6-10·0 mmol/L during the 72 h study period. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01774565.

Findings: Between Feb 20, 2015, and March 24, 2016, we enrolled 40 participants, of whom 20 were randomly assigned to the closed-loop intervention group and 20 to the control group. The proportion of time spent in the target glucose range was 59·8% (SD 18·7) in the closed-loop group and 38·1% (16·7) in the control group (difference 21·8% [95% CI 10·4-33·1]; p=0·0004). No episodes of severe hypoglycaemia or hyperglycaemia with ketonaemia occurred in either group. One adverse event unrelated to study devices occurred during the study (gastrointestinal bleed).

Interpretation: Closed-loop insulin delivery without meal-time boluses is effective and safe in insulin-treated adults with type 2 diabetes in the general ward.

Funding: Diabetes UK; European Foundation for the Study of Diabetes; JDRF; National Institute for Health Research Cambridge Biomedical Research Centre; Wellcome Trust.

Original languageEnglish
Pages (from-to)117-124
Number of pages8
JournalThe Lancet Diabetes and Endocrinology
Volume5
Issue number2
DOIs
Publication statusPublished - Feb 2017

Keywords

  • Aged
  • Aged, 80 and over
  • Blood Glucose/drug effects
  • Diabetes Mellitus, Type 2/blood
  • Female
  • Humans
  • Insulin/administration & dosage
  • Insulin Infusion Systems
  • Male
  • Middle Aged

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