Evidence map›Paper›PMID 24943065›Full record

Trial reportThe lancet. Diabetes & endocrinology2014

Home use of closed-loop insulin delivery for overnight glucose control in adults with type 1 diabetes: a 4-week, multicentre, randomised crossover study.

Hood Thabit, Alexandra Lubina-Solomon, Marietta Stadler, Lalantha Leelarathna, Emma Walkinshaw, Andrew Pernet, Janet M Allen, Ahmed Iqbal, Pratik Choudhary, Kavita Kumareswaran and 9 more

2 registry-linked trialsOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The lancet. Diabetes & endocrinology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 62 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
62citing papers in PubMed, 3 pooled it
20.2field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01440140 phase2completednot on this map

An Open-label, Three-centre, Randomised, Two-period, Crossover Study to Assess the Efficacy, Safety and Utility of Real-time Continuous Subcutaneous Glucose Monitoring Combined With Overnight Closed-loop Glucose Control in the Home Setting in Comparison With Real-time Continuous Subcutaneous Glucose Monitoring Alone in Adults With Type 1 Diabetes on Subcutaneous Insulin Infusion Pump Therapy

TypeinterventionalSponsorUniversity of CambridgeRan2012 to 2014Enrolled24ConditionsType 1 Diabetes MellitusArmsClosed-loop, Conventional insulin pump delivery
NCT02523131 nacompletednot on this mapstarted 2016, after this paper: background citation

An Open-label, Multi-centre, Randomised, Single-period, Parallel Design Study to Assess the Efficacy, Safety, Utility and Psychosocial Effect of 12 Week Day and Night Automated Closed Loop Glucose Control Combined With Pump Suspend Feature Compared to Sensor Augmented Insulin Pump Therapy in Youth and Adults With Type 1 Diabetes With Sub-optimal Glucose Control Under Free Living Conditions

TypeinterventionalSponsorUniversity of CambridgeRan2016 to 2018Enrolled84ConditionsDiabetes Mellitus, Diabetes Mellitus, Type 1, Glucose Metabolism Disorders, Endocrine System DiseasesArmsFlorenceM, Medtronic insulin pump 640G
3 · Its place in the literature

Who cites it

62 citing papers in PubMed, 3 syntheses or guidelines pooled it, 148 citations in OpenAlex.

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  12. Psychosocial Impact of the Bionic Pancreas During Summer Camp.Journal of diabetes science and technology · 2016
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  14. Home Use of an Artificial Beta Cell in Type 1 Diabetes.The New England journal of medicine · 2015
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2 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors at 7 institutions in 1 country.

Hood ThabitWellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.
Alexandra Lubina-SolomonAcademic Unit of Diabetes, Endocrinology and Metabolism, Department of Human Metabolism, University of Sheffield, Sheffield, UK.
Marietta StadlerDiabetes Research Group, King's College London, London, UK.
Lalantha LeelarathnaWellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.
Emma WalkinshawAcademic Unit of Diabetes, Endocrinology and Metabolism, Department of Human Metabolism, University of Sheffield, Sheffield, UK.
Andrew PernetDiabetes Research Group, King's College London, London, UK.
Janet M AllenWellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.
Ahmed IqbalAcademic Unit of Diabetes, Endocrinology and Metabolism, Department of Human Metabolism, University of Sheffield, Sheffield, UK.
Pratik ChoudharyDiabetes Research Group, King's College London, London, UK.
Kavita KumareswaranWellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.
Marianna NodaleWellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.
Chloe NisbetAcademic Unit of Diabetes, Endocrinology and Metabolism, Department of Human Metabolism, University of Sheffield, Sheffield, UK.
Malgorzata E WilinskaWellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.
Katharine D BarnardHuman Development and Health Academic Unit, Faculty of Medicine, University of Southampton, Southampton, UK.
David B DungerWellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.
Simon R HellerAcademic Unit of Diabetes, Endocrinology and Metabolism, Department of Human Metabolism, University of Sheffield, Sheffield, UK.
Stephanie A AmielDiabetes Research Group, King's College London, London, UK.
Mark L EvansWellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK.
Roman HovorkaWellcome Trust-Medical Research Council Institute of Metabolic Science, University of Cambridge, Cambridge, UK. Electronic address: rh347@cam.ac.uk.
University of Sheffield · GBKing's College London · GBUniversity of Cambridge · GBWellcome/MRC Institute of Metabolic Science · GBMedical Research Council · GBUniversity of Southampton · GBWellcome Trust · GB

Funding

Home testing of 24/7 closed-loop control in children and adolescents with type 1R01DK085621 · NIDDK · UNIVERSITY OF CAMBRIDGE · PI HOVORKA, ROMAN · 2009 to 2010
$748k
Medical Research Council MR/J006742/1NIDDK NIH HHS 1R01DK085621NIDDK NIH HHS R01 DK085621Wellcome Trust 100574
6 · The paper itself

Abstract

backgroundClosed-loop insulin delivery is a promising option to improve glycaemic control and reduce the risk of hypoglycaemia. We aimed to assess whether overnight home use of automated closed-loop insulin delivery would improve glucose control.

methodsWe did this open-label, multicentre, randomised controlled, crossover study between Dec 1, 2012, and Dec 23, 2014, recruiting patients from three centres in the UK. Patients aged 18 years or older with type 1 diabetes were randomly assigned to receive 4 weeks of overnight closed-loop insulin delivery (using a model-predictive control algorithm to direct insulin delivery), then 4 weeks of insulin pump therapy (in which participants used real-time display of continuous glucose monitoring independent of their pumps as control), or vice versa. Allocation to initial treatment group was by computer-generated permuted block randomisation. Each treatment period was separated by a 3-4 week washout period. The primary outcome was time spent in the target glucose range of 3·9-8·0 mmol/L between 0000 h and 0700 h. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01440140.

findingsWe randomly assigned 25 participants to initial treatment in either the closed-loop group or the control group, patients were later crossed over into the other group; one patient from the closed-loop group withdrew consent after randomisation, and data for 24 patients were analysed. Closed loop was used over a median of 8·3 h (IQR 6·0-9·6) on 555 (86%) of 644 nights. The proportion of time when overnight glucose was in target range was significantly higher during the closed-loop period compared to during the control period (mean difference between groups 13·5%, 95% CI 7·3-19·7; p=0·0002). We noted no severe hypoglycaemic episodes during the control period compared with two episodes during the closed-loop period; these episodes were not related to closed-loop algorithm instructions.

interpretationUnsupervised overnight closed-loop insulin delivery at home is feasible and could improve glucose control in adults with type 1 diabetes.

fundingDiabetes UK.

Indexed as

Pancreas, ArtificialAdultAlgorithmsBlood GlucoseCross-Over StudiesDiabetes Mellitus, Type 1FemaleGlycated HemoglobinHumansHypoglycemiaHypoglycemic AgentsInsulinInsulin Infusion SystemsMaleMiddle AgedTreatment OutcomeBlood GlucoseGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsInsulin

Identifiers

PMID24943065
PMCPMC4165604
OpenAlexW2135887483

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.