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BMJ. 2018 Apr 18;361:k1310. doi: 10.1136/bmj.k1310.

Artificial pancreas treatment for outpatients with type 1 diabetes: systematic review and meta-analysis.

Author information

1
Clinical Research and Evidence Based Medicine Unit, Aristotle University of Thessaloniki, 54642 Thessaloniki, Greece.
2
Diabetes Centre, Second Medical Department, Aristotle University of Thessaloniki, Thessaloniki, Greece.
3
Wellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.
4
Department of Hygiene and Epidemiology, Medical School, Aristotle University of Thessaloniki, Thessaloniki, Greece.
5
Clinical Research and Evidence Based Medicine Unit, Aristotle University of Thessaloniki, 54642 Thessaloniki, Greece atsapas@auth.gr.
6
Harris Manchester College, University of Oxford, Oxford, UK.

Abstract

OBJECTIVE:

To evaluate the efficacy and safety of artificial pancreas treatment in non-pregnant outpatients with type 1 diabetes.

DESIGN:

Systematic review and meta-analysis of randomised controlled trials.

DATA SOURCES:

Medline, Embase, Cochrane Library, and grey literature up to 2 February 2018.

ELIGIBILITY CRITERIA FOR SELECTING STUDIES:

Randomised controlled trials in non-pregnant outpatients with type 1 diabetes that compared the use of any artificial pancreas system with any type of insulin based treatment. Primary outcome was proportion (%) of time that sensor glucose level was within the near normoglycaemic range (3.9-10 mmol/L). Secondary outcomes included proportion (%) of time that sensor glucose level was above 10 mmol/L or below 3.9 mmol/L, low blood glucose index overnight, mean sensor glucose level, total daily insulin needs, and glycated haemoglobin. The Cochrane Collaboration risk of bias tool was used to assess study quality.

RESULTS:

40 studies (1027 participants with data for 44 comparisons) were included in the meta-analysis. 35 comparisons assessed a single hormone artificial pancreas system, whereas nine comparisons assessed a dual hormone system. Only nine studies were at low risk of bias. Proportion of time in the near normoglycaemic range (3.9-10.0 mmol/L) was significantly higher with artificial pancreas use, both overnight (weighted mean difference 15.15%, 95% confidence interval 12.21% to 18.09%) and over a 24 hour period (9.62%, 7.54% to 11.7%). Artificial pancreas systems had a favourable effect on the proportion of time with sensor glucose level above 10 mmol/L (-8.52%, -11.14% to -5.9%) or below 3.9 mmol/L (-1.49%, -1.86% to -1.11%) over 24 hours, compared with control treatment. Robustness of findings for the primary outcome was verified in sensitivity analyses, by including only trials at low risk of bias (11.64%, 9.1% to 14.18%) or trials under unsupervised, normal living conditions (10.42%, 8.63% to 12.2%). Results were consistent in a subgroup analysis both for single hormone and dual hormone artificial pancreas systems.

CONCLUSIONS:

Artificial pancreas systems are an efficacious and safe approach for treating outpatients with type 1 diabetes. The main limitations of current research evidence on artificial pancreas systems are related to inconsistency in outcome reporting, small sample size, and short follow-up duration of individual trials.

PMID:
29669716
PMCID:
PMC5902803
DOI:
10.1136/bmj.k1310
[Indexed for MEDLINE]
Free PMC Article

Conflict of interest statement

Competing interests: All authors have completed the ICMJE uniform disclosure at www.icmje.org/coi_disclosure.pdf and declare: support from the Aristotle University Research Committee, National Institute for Health Research Cambridge Biomedical Research Centre, and Wellcome Strategic Award for the submitted work; KK reports honorarium fees from Medtronic, Novo Nordisk, and Sanofi outside the submitted work; MT reports personal fees from Medtronic and Novo Nordisk outside the submitted work; RH reports personal fees from Eli Lilly, Novo Nordisk, BBraun, and Medtronic, grants from the National Institute for Health Research Cambridge Biomedical Research Centre, and Wellcome Strategic Award outside the submitted work, and reports patents and patent applications; AT reports honorarium fees from AstraZeneca, Boehringer Ingelheim, and Novo Nordisk outside the submitted work; no other relationships or activities that could appear to have influenced the submitted work.

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