Evidence map›Paper›PMID 32250536›Full record

ArticleDiabetes, obesity & metabolism2020

Risk of severe hypoglycaemia and its impact in type 2 diabetes in DEVOTE.

Simon Heller, Ildiko Lingvay, Steven P Marso, Athena Philis-Tsimikas, Thomas R Pieber, Neil R Poulter, Richard E Pratley, Elise Hachmann-Nielsen, Kajsa Kvist, Martin Lange and 4 more

Open access · bronzeAbstract read
In one paragraph

Article in Diabetes, obesity & metabolism, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
1.3field-weighted citation impact, top 19% 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.

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

10 citing papers in PubMed, 14 citations in OpenAlex.

  1. Trial
  2. Additive Effects of Quercetin-RichPharmaceuticals (Basel, Switzerland) · 2026
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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

14 authors at 9 institutions in 4 countries.

Simon HellerDepartment of Oncology and Metabolism, University of Sheffield, Sheffield, UK.ORCID 0000-0002-2425-9565
Ildiko LingvayDepartment of Internal Medicine and Department of Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas, Texas, USA.ORCID 0000-0001-7006-7401
Steven P MarsoHCA Midwest Health Heart and Vascular Institute, Overland Park, Kansas, USA.
Athena Philis-TsimikasScripps Whittier Diabetes Institute, San Diego, California, USA.
Thomas R PieberDepartment of Internal Medicine, Medical University of Graz, Graz, Austria.ORCID 0000-0003-3554-0405
Neil R PoulterImperial Clinical Trials Unit, National Heart and Lung Institute, Imperial College London, London, UK.
Richard E PratleyAdventHealth Translational Research Institute, Orlando, Florida, USA.
Elise Hachmann-NielsenNovo Nordisk A/S, Søborg, Denmark.
Kajsa KvistNovo Nordisk A/S, Søborg, Denmark.
Martin LangeNovo Nordisk A/S, Søborg, Denmark.
Alan C MosesNovo Nordisk A/S, Søborg, Denmark.
Marie Trock AndresenNovo Nordisk A/S, Søborg, Denmark.
John B BuseUniversity of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.
DEVOTE Study Group
Novo Nordisk (Denmark) · DKLung Institute · USMedical University of Graz · ATScripps Whittier Diabetes Institute · USThe University of Texas Southwestern Medical Center · USTranslational Research Institute for Metabolism and Diabetes · USUniversity of North Carolina at Chapel Hill · USUniversity of Sheffield · GBWest Health · US

Funding

Glycemia Reduction Approaches in Diabetes: A comparative effectiveness studyU01DK098246 · NIDDK · GEORGE WASHINGTON UNIVERSITY · PI KRAUSE-STEINRAUF, HEIDI, LACHIN, JOHN M · 2012 to 2022
$238.9M
Re-Entry Supplement: Investigation of Oral Microbial Enzymes for the Detection and Treatment of Periodontal DiseaseUL1TR002489 · NCATS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BUSE, JOHN BERNARD, SHAHEEN, NICHOLAS J · 2018 to 2022
$48.6M
Final clinical studies for submission of a pre-market approval application to the FDA for a Bionic Pancreas that automates type 1 diabetes managementUC4DK108612 · NIDDK · BOSTON UNIVERSITY (CHARLES RIVER CAMPUS) · PI BECK, ROY W., DAMIANO, EDWARD · 2015 to 2016
$13.5M
Pilot & Feasibility ProgramP30DK124723 · NIDDK · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI Morgana Lee Mongraw-Chaffin · 2020 to 2026
$11.0M
New York Regional Center for Diabetes Translation Research - Translational Intervention Methodology CoreP30DK111022 · NIDDK · ALBERT EINSTEIN COLLEGE OF MEDICINE, INC · PI JEFFREY GONZALEZ · 2016 to 2026
$7.8M
Dulce Digital-Me: An Adaptive mHealth Intervention for Underserved Hispanics with DiabetesR01DK112322 · NIDDK · SCRIPPS HEALTH · PI GALLO, LINDA C, PHILIS-TSIMIKAS, ATHENA · 2016 to 2020
$3.2M
Mi Puente: My Bridge to Better Cardiometabolic Health and Well-beingR01NR015754 · NINR · SCRIPPS HEALTH · PI GALLO, LINDA C, PHILIS-TSIMIKAS, ATHENA · 2015 to 2019
$2.4M
Medical Assistant Health Coaching for Diabetes in Diverse Primary Care SettingsR18DK104250 · NIDDK · SCRIPPS HEALTH · PI GALLO, LINDA C, PHILIS-TSIMIKAS, ATHENA · 2015 to 2019
$2.3M
DEVOTE and this secondary analysis were sponsored and funded by Novo Nordisk (Bagsvaerd, Denmark)NCATS NIH HHS UL1 TR002489NIDDK NIH HHS P30 DK111022NIDDK NIH HHS P30 DK124723NIDDK NIH HHS R01 DK112322NIDDK NIH HHS R18 DK104250NIDDK NIH HHS U01 DK098246NIDDK NIH HHS UC4 DK108612NINR NIH HHS R01 NR015754
6 · The paper itself

Abstract

aimsTo undertake a post-hoc analysis, utilizing a hypoglycaemia risk score based on DEVOTE trial data, to investigate if a high risk of severe hypoglycaemia was associated with an increased risk of cardiovascular events, and whether reduced rates of severe hypoglycaemia in patients identified as having the highest risk affected the risk of cardiovascular outcomes. MATERIALS AND

methodsThe DEVOTE population was divided into quartiles according to patients' individual hypoglycaemia risk scores. For each quartile, the observed incidence and rate of severe hypoglycaemia, major adverse cardiovascular event (MACE) and all-cause mortality were determined to investigate whether those with the highest risk of hypoglycaemia were also at the greatest risk of MACE and all-cause mortality. In addition, treatment differences within each risk quartile [insulin degludec (degludec) vs. insulin glargine 100 units/mL (glargine U100)] in terms of severe hypoglycaemia, MACE and all-cause mortality were investigated.

resultsPatients with the highest risk scores had the highest rates of severe hypoglycaemia, MACE and all-cause mortality. Treatment ratios between degludec and glargine U100 in the highest risk quartile were 95% confidence interval (CI) 0.56 (0.39; 0.80) (severe hypoglycaemia), 95% CI 0.76 (0.58; 0.99) (MACE) and 95% CI 0.77 (0.55; 1.07) (all-cause mortality).

conclusionsThe risk score demonstrated that a high risk of severe hypoglycaemia was associated with a high incidence of MACE and all-cause mortality and that, in this high-risk group, those treated with degludec had a lower incidence of MACE. These observations support the hypothesis that hypoglycaemia is a risk factor for cardiovascular events.

Indexed as

Diabetes Mellitus, Type 2HypoglycemiaHumansHypoglycemic AgentsInsulin GlargineInsulin, Long-ActingHypoglycemic AgentsInsulin GlargineInsulin, Long-Actingall-cause mortalityMACEsevere hypoglycaemiatype 2 diabetes

Identifiers

PMID32250536
PMCPMC7754351
OpenAlexW3014758643

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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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.