Evidence map›Paper›PMID 29661916›Full record

Trial reportDiabetes care2018

Sustained Reduction in Severe Hypoglycemia in Adults With Type 1 Diabetes Complicated by Impaired Awareness of Hypoglycemia: Two-Year Follow-up in the HypoCOMPaSS Randomized Clinical Trial.

Stuart A Little, Jane Speight, Lalantha Leelarathna, Emma Walkinshaw, Horng Kai Tan, Anita Bowes, Alexandra Lubina-Solomon, Thomas J Chadwick, Deborah D Stocken, Catherine Brennand and 7 more

Abstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Diabetes care, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 38 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 2 pooled it
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

38 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors.

Stuart A LittleInstitute of Cellular Medicine, Newcastle University, Newcastle, U.K.
Jane SpeightSchool of Psychology, Deakin University, Geelong, Victoria, Australia.
Lalantha LeelarathnaWellcome Trust-MRC Institute of Metabolic Science Metabolic Research Laboratories, University of Cambridge, Cambridge, U.K.
Emma WalkinshawSchool of Medicine and Biomedical Sciences, Sheffield University, Sheffield, U.K.
Horng Kai TanPeninsula College of Medicine and Dentistry, Plymouth, U.K.ORCID 0000-0003-1485-2514
Anita BowesCentre for Postgraduate Medical Research and Education, Bournemouth University, Poole, U.K.
Alexandra Lubina-SolomonSchool of Medicine and Biomedical Sciences, Sheffield University, Sheffield, U.K.
Thomas J ChadwickInstitute of Health and Society, Newcastle University, Newcastle, U.K.
Deborah D StockenInstitute of Health and Society, Newcastle University, Newcastle, U.K.
Catherine BrennandNewcastle Clinical Trials Unit, Faculty of Medical Sciences, Newcastle University, Newcastle, U.K.
Sally M MarshallInstitute of Cellular Medicine, Newcastle University, Newcastle, U.K.
Ruth WoodNewcastle Clinical Trials Unit, Faculty of Medical Sciences, Newcastle University, Newcastle, U.K.
David KerrCentre for Postgraduate Medical Research and Education, Bournemouth University, Poole, U.K.
Daniel FlanaganPeninsula College of Medicine and Dentistry, Plymouth, U.K.
Simon R HellerSchool of Medicine and Biomedical Sciences, Sheffield University, Sheffield, U.K.ORCID 0000-0002-2425-9565
Mark L EvansWellcome Trust-MRC Institute of Metabolic Science Metabolic Research Laboratories, University of Cambridge, Cambridge, U.K.
James A M ShawInstitute of Cellular Medicine, Newcastle University, Newcastle, U.K. jim.shaw@ncl.ac.uk.ORCID 0000-0002-2893-3211

Funding

Diabetes UK 07/0003556
6 · The paper itself

Abstract

objectiveSevere hypoglycemia is a feared complication of type 1 diabetes; yet, few trials have targeted prevention using optimized self-management (educational, therapeutic, and technological support). We aimed to investigate whether improved awareness and reduced severe hypoglycemia, achieved during an intensive randomized clinical trial (RCT), were sustained after return to routine care. RESEARCH DESIGN AND

methodsNinety-six adults with type 1 diabetes (29 ± 12 years' duration) and impaired awareness of hypoglycemia at five U.K. tertiary referral diabetes centers were recruited into a 24-week 2 × 2 factorial RCT (HypoCOMPaSS). Participants were randomized to pump (continuous subcutaneous insulin infusion [CSII]) or multiple daily injections (MDIs) and real-time continuous glucose monitoring (RT-CGM) or self-monitoring of blood glucose (SMBG), with equal education/attention to all groups. At 24 weeks, participants returned to routine care with follow-up until 24 months, including free choice of MDI/CSII; RT-CGM vs. SMBG comparison continued to 24 months. Primary outcome was mean difference (baseline to 24 months [between groups]) in hypoglycemia awareness.

resultsImprovement in hypoglycemia awareness was sustained (Gold score at baseline 5.1 ± 1.1 vs. 24 months 3.7 ± 1.9;

conclusionsOptimized insulin replacement and glucose monitoring underpinned by hypoglycemia-focused structured education should be provided to all with type 1 diabetes complicated by impaired awareness of hypoglycemia.

Indexed as

AwarenessAdultBlood GlucoseBlood Glucose Self-MonitoringDiabetes Mellitus, Type 1FemaleFollow-Up StudiesGlycated HemoglobinHumansHypoglycemiaInjectionsInsulinInsulin Infusion SystemsMaleMiddle AgedSeverity of Illness IndexBlood GlucoseGlycated HemoglobinInsulin

Identifiers

PMID29661916

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.