Evidence map›Paper›PMID 27837162›Full record

Trial reportJournal of diabetes science and technology2017

Sensor Life and Overnight Closed Loop: A Randomized Clinical Trial.

Martin Tauschmann, Janet M Allen, Malgorzata E Wilinska, Yue Ruan, Hood Thabit, Carlo L Acerini, David B Dunger, Roman Hovorka

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of diabetes science and technology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02129868 (An Open-label, Single-centre, Randomised, 2-period Cross-over Study to Assess the Efficacy and Safety of a Novel Automated Overnight Closed-loop Glucose Control System on Day 1 of Continuous Glucose Monitoring Sensor Insertion in Comparison to Day 3 to 4 After Sensor Insertion in Children and Adolescents With Type 1 Diabetes), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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.

NCT02129868 nacompletednot on this map

An Open-label, Single-centre, Randomised, 2-period Cross-over Study to Assess the Efficacy and Safety of a Novel Automated Overnight Closed-loop Glucose Control System on Day 1 of Continuous Glucose Monitoring Sensor Insertion in Comparison to Day 3 to 4 After Sensor Insertion in Children and Adolescents With Type 1 Diabetes

TypeinterventionalSponsorUniversity of CambridgeRan2014 to 2015Enrolled13ConditionsDiabetes Mellitus, Diabetes Mellitus, Type 1, Glucose Metabolism Disorders, Endocrine System DiseasesArmsClosed-loop (Android Closed-Loop platform)
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Martin Tauschmann1 Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.
Janet M Allen1 Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.
Malgorzata E Wilinska1 Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.
Yue Ruan1 Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.
Hood Thabit1 Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.
Carlo L Acerini2 Department of Paediatrics, University of Cambridge, Cambridge, UK.
David B Dunger1 Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.
Roman Hovorka1 Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.

Funding

Medical Research Council G0600717Wellcome TrustWellcome Trust 100574/Z/12/Z
6 · The paper itself

Abstract

backgroundClosed-loop (CL) systems direct insulin delivery based on continuous glucose monitor (CGM) sensor values. CGM accuracy varies with sensor life, being least accurate on day 1 of sensor insertion. We evaluated the effect of sensor life (enhanced Enlite, Medtronic MiniMed, Northridge, CA) on overnight CL.

methodsIn an open-label, randomized, 2-period, inpatient crossover pilot study, 12 adolescents on insulin pump (age 16.7 ± 1.9 years; HbA1c 66 ± 10 mmol/mol) attended a clinical research facility on 2 overnight occasions. In random order, participants received CL on day 1 or on day 3-4 after sensor insertion. During both periods, glucose was automatically controlled by a model predictive control algorithm informed by sensor glucose. Plasma glucose was measured every 30 to 60 min.

resultsDuring overnight CL (22:30 to 07:30), the proportion of time with plasma glucose readings in the target range (3.9-8.0 mmol/l, primary endpoint) when initiated on day 1 of sensor insertion vs day 3-4 were comparable (58 ± 32% day 1 vs 56 ± 36% day 3-4; P = .34), and there were no significant differences between interventions in terms of mean plasma glucose ( P = .26), percentage time above 8.0 mmol/l ( P = .49), and time spent below 3.9 mmol/l ( P = .93). Sensor accuracy varied with sensor life (mean absolute relative difference 19.8 ± 15.0% on day 1 and 13.7 ± 10.2% on day 3 to 4). Sensor glucose tended to under-read plasma glucose inflating benefits of CL on glucose control.

conclusionsIn spite of differences in sensor accuracy, overnight CL glucose control informed by sensor glucose on day 1 or day 3-4 after sensor insertion was comparable. The model predictive controller appears to mitigate against sensor inaccuracies.

Indexed as

Insulin Infusion SystemsAdolescentAlgorithmsBlood GlucoseBlood Glucose Self-MonitoringCross-Over StudiesDiabetes Mellitus, Type 1FemaleHumansHypoglycemic AgentsInsulinMalePilot ProjectsBlood GlucoseHypoglycemic AgentsInsulinartificial pancreasclosed loopcontinuous glucose monitoringsensor accuracysensor life

Identifiers

PMID27837162
PMCPMC5505426

What Socratic holds

Textmetadata
LicenceCC BY
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 Socratic graph.