Evidence map›Paper›PMID 34819298›Full record

Trial reportBMJ open diabetes research & care2021

Hemoglobin glycation index, calculated from a single fasting glucose value, as a prediction tool for severe hypoglycemia and major adverse cardiovascular events in DEVOTE.

Klara R Klein, Edward Franek, Steven Marso, Thomas R Pieber, Richard E Pratley, Amoolya Gowda, Kajsa Kvist, John B Buse

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMJ open diabetes research & care, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01959529 (A Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Subjects With Type 2 Diabetes at High Risk of Cardiovascular Events), which is not on this map. Cited by 39 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 1 pooled it
2.6field-weighted citation impact, top 9% 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.

NCT01959529 phase3completednot on this map

A Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Subjects With Type 2 Diabetes at High Risk of Cardiovascular Events

TypeinterventionalSponsorNovo Nordisk A/SRan2013 to 2016Enrolled7,637ConditionsDiabetes, Diabetes Mellitus, Type 2Armsinsulin degludec, insulin glargine
3 · Its place in the literature

Who cites it

39 citing papers in PubMed, 1 synthesis or guideline pooled it, 44 citations in OpenAlex.

  1. Pooled it
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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

8 authors at 5 institutions in 4 countries.

Klara R KleinDivision of Endocrinology and Metabolism, Department of Medicine, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina, USA klara_klein@med.unc.edu.ORCID 0000-0002-5894-9054
Edward FranekMossakowski Medical Research Centre, Polish Academy of Sciences, Central Clinical Hospital MSW, Warsaw, Poland.
Steven MarsoHCA Midwest Health Heart and Vascular Institute, Overland Park, Kansas, USA.
Thomas R PieberDivision of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Graz, Austria.
Richard E PratleyAdventHealth Translational Research Institute, Orlando, Florida, USA.ORCID 0000-0002-2912-1389
Amoolya GowdaNovo Nordisk A/S, Søborg, Denmark.
Kajsa KvistNovo Nordisk A/S, Søborg, Denmark.
John B BuseDivision of Endocrinology and Metabolism, Department of Medicine, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina, USA.
Novo Nordisk (Denmark) · DKUniversity of North Carolina at Chapel Hill · USCentral Clinical Hospital · PLMedical University of Graz · ATTranslational Research Institute for Metabolism and Diabetes · US

Funding

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
North Carolina Translational & Clinical Sciences Institute (NC TraCS)UL1TR001111 · NCATS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BUSE, JOHN BERNARD, CAREY, TIMOTHY S · 2013 to 2017
$43.9M
NCATS NIH HHS UL1 TR001111NCATS NIH HHS UL1 TR002489
6 · The paper itself

Abstract

introductionHemoglobin glycation index (HGI) is the difference between observed and predicted glycated hemoglobin A1c (HbA RESEARCH DESIGN AND

methodsIn DEVOTE, a randomized, double-blind, cardiovascular outcomes trial, people with type 2 diabetes received once per day insulin degludec or insulin glargine 100 units/mL. The primary outcome was time to first occurrence of a major adverse cardiovascular event (MACE), comprising cardiovascular death, myocardial infarction or stroke; severe hypoglycemia was a secondary outcome. In these analyses, predicted HbA

resultsChanges in HGI were observed at 12 months after insulin initiation and stabilized by 24 months for the whole cohort and insulin-naive patients. There were significant differences in MACE risk between baseline HGI tertiles; participants with high HGI were at highest risk (low vs high, HR: 0.73 (0.61 to 0.87)

conclusionsHigh HGI was associated with a higher risk of MACE; this finding is of uncertain significance given the association of HGI with insulin initiation and HbA TRIAL REGISTRATION NUMBER: NCT01959529.

Indexed as

Diabetes Mellitus, Type 2HypoglycemiaMyocardial InfarctionFastingGlucoseHemoglobinsHumansHypoglycemic AgentsGlucoseHemoglobinsHypoglycemic Agentsdiabetes mellitustype 2

Identifiers

PMID34819298
PMCPMC8614152
OpenAlexW3217192453

What Socratic holds

Textmetadata
LicenceCC BY-NC
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.