Evidence map›Paper›PMID 22226252›Full record

SynthesisJournal of diabetes science and technology2011

Meta-analysis of overnight closed-loop randomized studies in children and adults with type 1 diabetes: the Cambridge cohort.

Kavita Kumareswaran, Daniela Elleri, Janet M Allen, Julie Harris, Dongyuan Xing, Craig Kollman, Marianna Nodale, Helen R Murphy, Stephanie A Amiel, Simon R Heller and 5 more

3 registry-linked trialsOpen access · bronzeAbstract readMeta-Analysis
In one paragraph

Synthesis in Journal of diabetes science and technology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
2.7field-weighted citation impact, top 10% 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.

NCT01778348 phase2completednot on this mapstarted 2013, after this paper: background citation

An Open-label, Three-centre, Randomised, Two-period, Crossover Study to Assess the Efficacy, Safety and Utility of Overnight Closed-loop in Comparison With CGM Alone in the Home Setting in Children and Adolescents With Type 1 Diabetes

TypeinterventionalSponsorUniversity of CambridgeRan2013 to 2015Enrolled29ConditionsDiabetes Mellitus, Diabetes Mellitus, Type 1, Glucose Metabolism Disorders, Endocrine System DiseasesArmsOvernight closed-loop, Real-time CGM alone
NCT01873066 nacompletednot on this mapstarted 2014, after this paper: background citation

An Open-label, Single-centre, Randomised, Two-period Crossover Study to Assess the Efficacy, Safety and Utility of Automated Closed-loop Glucose Control, Day and Night Over 7 Days (Phase 1) and 21 Days (Phase 2) in Comparison With Continuous Subcutaneous Insulin Infusion Combined With Continuous Glucose Monitoring in the Home Setting in Children and Adolescents T1D

TypeinterventionalSponsorUniversity of CambridgeRan2014 to 2016Enrolled24ConditionsDiabetes Mellitus, Diabetes Mellitus, Type 1, Glucose Metabolism Disorders, Endocrine System DiseasesArmsClosed-loop system, real-time CGM
NCT02129868 nacompletednot on this mapstarted 2014, after this paper: background citation

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

8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 26 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Review
  6. Review
  7. Article
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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

15 authors at 4 institutions in 2 countries.

Kavita KumareswaranInstitute of Metabolic Science, University of Cambridge, Cambridge, United Kingdom.
Daniela Elleri
Janet M Allen
Julie Harris
Dongyuan Xing
Craig Kollman
Marianna Nodale
Helen R Murphy
Stephanie A Amiel
Simon R Heller
Malgorzata E Wilinska
Carlo L Acerini
Mark L Evans
David B Dunger
Roman Hovorka
University of Cambridge · GBJaeb Center for Health Research · USKing's College London · GBNorthern General Hospital · GB

Funding

Department of Health PDF/01/036Medical Research Council G0600717
6 · The paper itself

Abstract

aimWe reviewed the safety and efficacy of overnight closed-loop insulin delivery compared with conventional continuous subcutaneous insulin infusion (CSII) in two distinct age groups with type 1 diabetes mellitus (T1DM), young people aged 5 to 18 years and adults, combining data of previously published randomized studies.

methodsWe evaluated four randomized crossover studies in 17 children and adolescents [13.4 ± 3.6 years; mean ± standard deviation (SD)] and 24 adults (37.5 ± 9.1 years) on 45 closed-loop (intervention) and 45 CSII (control) visits. Each subject attended for two overnight study visits, using either closed-loop or conventional pump therapy, in random order. In each age group, studies were designed to mimic realistic likely scenarios. In the children and adolescent studies, closed loop was used following a standard evening meal and following 40 min of moderate-intensity exercise. In the adult studies, closed loop was commenced following a 60 g carbohydrate meal or a 100 g carbohydrate meal accompanied by alcohol. The primary outcome measure was time for which plasma glucose was within target range (3.91-8.0 mmol/liter).

resultsOvernight closed loop increased the time in target plasma glucose in both young (from 40% to 60%, p = .002) and adults (from 50% to 76%, p < .001) compared with conventional CSII. Combined analysis showed an increase from 43% to 71% with closed loop (p < .001). Additionally, closed loop reduced the time spent below 3.91 mmol/liter and above 8.0 mmol/liter, from 4.1% to 2.1% (p = .01) and 33% to 20% (p = .03), respectively. Glycemic variability, as measured by the SD of plasma glucose, was lower during closed loop compared with CSII (1.5 versus 2.1 mmol/liter, p = .007).

conclusionsOvernight closed loop may improve glycemic control and reduce nocturnal hypoglycemia in both young people and adults with T1DM.

Indexed as

Randomized Controlled Trials as TopicAdolescentAdultAlgorithmsBlood GlucoseChildCohort StudiesCross-Over StudiesDiabetes Mellitus, Type 1FemaleHumansHypoglycemic AgentsInsulinInsulin Infusion SystemsMaleBlood GlucoseHypoglycemic AgentsInsulin

Identifiers

PMID22226252
PMCPMC3262701
OpenAlexW2030104754

What OpenQuestion holds

Textmetadata
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.