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

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.

• Authors: Hood Thabit, Sara Hartnell, Janet M Allen, Andrea Lake, Malgorzata E Wilinska, Yue Ruan, Mark L Evans, Anthony P Coll, Roman Hovorka
• Journal: The lancet. Diabetes & endocrinology (Lancet Diabetes Endocrinol) Vol. 5 Issue 2 Pg. 117-124 (02 2017) ISSN: 2213-8595 [Electronic] England
• PMID: 27836235 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2017 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY license. Published by Elsevier Ltd.. All rights reserved.

Chemical References

• Blood Glucose
• Insulin

Topics

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