Evidence map›Paper›PMID 34320286›Full record

ArticleThe New England journal of medicine2021

Long-Term Complications in Youth-Onset Type 2 Diabetes.

TODAY Study Group, Petter Bjornstad, Kimberly L Drews, Sonia Caprio, Rose Gubitosi-Klug, David M Nathan, Bereket Tesfaldet, Jeanie Tryggestad, Neil H White, Philip Zeitler

4 registry-linked trialsOpen access · bronzeAbstract readMulticenter Study
In one paragraph

Article in The New England journal of medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 277 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
277citing papers in PubMed, 6 pooled it
50.2field-weighted citation impact, top 1% 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.

NCT01364350 completednot on this map

TODAY2 Phase 1 Immediate Post-Intervention Observational Follow-up Study of the TODAY Clinical Trial Cohort

TypeobservationalSponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Ran2011 to 2014Enrolled550ConditionsDiabetes Mellitus Type 2 in ObeseArmsstandard of care in general clinical practice
NCT02310724 completednot on this map

Long-term Post-Intervention Follow-up of the TODAY Cohort (Treatment Options for Type 2 Diabetes in Youth and Adolescents)

TypeobservationalSponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Ran2014 to 2020Enrolled517ConditionsType 2 DiabetesArmsTODAY cohort
NCT06089070 naactive not recruitingnot on this mapstarted 2024, after this paper: background citation

Feasibility of the FreeStyle Libre Continuous Glucose Monitoring System in Youth With Type 2 Diabetes (FREE CGM)

TypeinterventionalSponsorUniversity of California, San FranciscoRan2024 to 2027Enrolled20ConditionsType 2 DiabetesArmsFreeStyle Libre Continuous Glucose Monitor System
NCT06837181 recruitingnot on this mapstarted 2025, after this paper: background citation

Studying the Presence of CFRD Complications With Thoughtful Recruitment (SPeCTRuM)

TypeobservationalSponsorJaeb Center for Health ResearchRan2025 to 2028Enrolled200ConditionsCystic Fibrosis (CF), Cystic Fibrosis-related Diabetes, Diabetes, RetinopathyArmsobservational study
3 · Its place in the literature

Who cites it

277 citing papers in PubMed, 6 syntheses or guidelines pooled it, 480 citations in OpenAlex.

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217 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors.

TODAY Study Group
Petter BjornstadFrom the University of Colorado Anschutz Medical Campus, Children's Hospital Colorado, Aurora (P.B., P.Z.); George Washington University, Rockville, MD (K.L.D., B.T.); Yale University, New Haven, CT (S.C.); Case Western Reserve University, Rainbow Babies and Children's Hospital, Cleveland (R.G.-K.); the Massachusetts General Hospital Diabetes Center, Harvard Medical School, Boston (D.M.N.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.T.); and Washington University School of Medicine, St. Louis (N.H.W.).
Kimberly L DrewsFrom the University of Colorado Anschutz Medical Campus, Children's Hospital Colorado, Aurora (P.B., P.Z.); George Washington University, Rockville, MD (K.L.D., B.T.); Yale University, New Haven, CT (S.C.); Case Western Reserve University, Rainbow Babies and Children's Hospital, Cleveland (R.G.-K.); the Massachusetts General Hospital Diabetes Center, Harvard Medical School, Boston (D.M.N.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.T.); and Washington University School of Medicine, St. Louis (N.H.W.).ORCID 0000-0001-9287-2540
Sonia CaprioFrom the University of Colorado Anschutz Medical Campus, Children's Hospital Colorado, Aurora (P.B., P.Z.); George Washington University, Rockville, MD (K.L.D., B.T.); Yale University, New Haven, CT (S.C.); Case Western Reserve University, Rainbow Babies and Children's Hospital, Cleveland (R.G.-K.); the Massachusetts General Hospital Diabetes Center, Harvard Medical School, Boston (D.M.N.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.T.); and Washington University School of Medicine, St. Louis (N.H.W.).
Rose Gubitosi-KlugFrom the University of Colorado Anschutz Medical Campus, Children's Hospital Colorado, Aurora (P.B., P.Z.); George Washington University, Rockville, MD (K.L.D., B.T.); Yale University, New Haven, CT (S.C.); Case Western Reserve University, Rainbow Babies and Children's Hospital, Cleveland (R.G.-K.); the Massachusetts General Hospital Diabetes Center, Harvard Medical School, Boston (D.M.N.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.T.); and Washington University School of Medicine, St. Louis (N.H.W.).
David M NathanFrom the University of Colorado Anschutz Medical Campus, Children's Hospital Colorado, Aurora (P.B., P.Z.); George Washington University, Rockville, MD (K.L.D., B.T.); Yale University, New Haven, CT (S.C.); Case Western Reserve University, Rainbow Babies and Children's Hospital, Cleveland (R.G.-K.); the Massachusetts General Hospital Diabetes Center, Harvard Medical School, Boston (D.M.N.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.T.); and Washington University School of Medicine, St. Louis (N.H.W.).
Bereket TesfaldetFrom the University of Colorado Anschutz Medical Campus, Children's Hospital Colorado, Aurora (P.B., P.Z.); George Washington University, Rockville, MD (K.L.D., B.T.); Yale University, New Haven, CT (S.C.); Case Western Reserve University, Rainbow Babies and Children's Hospital, Cleveland (R.G.-K.); the Massachusetts General Hospital Diabetes Center, Harvard Medical School, Boston (D.M.N.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.T.); and Washington University School of Medicine, St. Louis (N.H.W.).
Jeanie TryggestadFrom the University of Colorado Anschutz Medical Campus, Children's Hospital Colorado, Aurora (P.B., P.Z.); George Washington University, Rockville, MD (K.L.D., B.T.); Yale University, New Haven, CT (S.C.); Case Western Reserve University, Rainbow Babies and Children's Hospital, Cleveland (R.G.-K.); the Massachusetts General Hospital Diabetes Center, Harvard Medical School, Boston (D.M.N.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.T.); and Washington University School of Medicine, St. Louis (N.H.W.).
Neil H WhiteFrom the University of Colorado Anschutz Medical Campus, Children's Hospital Colorado, Aurora (P.B., P.Z.); George Washington University, Rockville, MD (K.L.D., B.T.); Yale University, New Haven, CT (S.C.); Case Western Reserve University, Rainbow Babies and Children's Hospital, Cleveland (R.G.-K.); the Massachusetts General Hospital Diabetes Center, Harvard Medical School, Boston (D.M.N.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.T.); and Washington University School of Medicine, St. Louis (N.H.W.).
Philip ZeitlerFrom the University of Colorado Anschutz Medical Campus, Children's Hospital Colorado, Aurora (P.B., P.Z.); George Washington University, Rockville, MD (K.L.D., B.T.); Yale University, New Haven, CT (S.C.); Case Western Reserve University, Rainbow Babies and Children's Hospital, Cleveland (R.G.-K.); the Massachusetts General Hospital Diabetes Center, Harvard Medical School, Boston (D.M.N.); the University of Oklahoma Health Sciences Center, Oklahoma City (J.T.); and Washington University School of Medicine, St. Louis (N.H.W.).

Funding

Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) StudyU01DK061230 · NIDDK · GEORGE WASHINGTON UNIVERSITY · PI BRAFFETT, BARBARA HALINA, ZEITLER, PHILIP S. · 2001 to 2019
$231.8M
University of Pittsburgh Clinical and Translational Science InstituteUL1TR001857 · NCATS · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI REIS, STEVEN E · 2016 to 2025
$129.3M
Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
WU INSTITUTE OF CLINICAL AND TRANSLATIONAL SCIENCESUL1TR002345 · NCATS · WASHINGTON UNIVERSITY · PI William G. Powderly · 2017 to 2026
$97.8M
HARVARD CLINICAL AND TRANSLATIONAL SCIENCE CENTER (UL1)UL1RR025758 · NCRR · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2008 to 2011
$91.4M
ZOPOLRESTAT IN NORMOTENSIVE, TYPE 1 DIA WITH INCIPIENT NEPHROPATHYM01RR000043 · NCRR · UNIVERSITY OF SOUTHERN CALIFORNIA · PI ZAIA, JOHN A · 1985 to 2010
$76.4M
UNIVERSITY OF PITTSBURGH CLINICAL AND TRANSLATIONAL SCIENCE INSTITUTE: BPCAUL1RR024153 · NCRR · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI REIS, STEVEN E · 2006 to 2011
$73.9M
INSTITUTIONAL CLINICAL AND TRANSLATIONAL SCIENCE AWARDUL1RR024134 · NCRR · UNIVERSITY OF PENNSYLVANIA · PI FITZGERALD, GARRET A · 2006 to 2011
$70.4M
CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR025780 · NCRR · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 2008 to 2011
$61.3M
YALE UNIVERSITY CLINICAL AND TRANSLATIONAL SCIENCE AWARD PROGRAMUL1RR024139 · NCRR · YALE UNIVERSITY · PI SHERWIN, ROBERT S · 2006 to 2011
$56.8M
CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR024989 · NCRR · CASE WESTERN RESERVE UNIVERSITY · PI DAVIS, PAMELA B · 2007 to 2011
$53.7M
NIH Prior Approval Process ProfessionalUL1TR002535 · NCATS · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 2018 to 2022
$51.1M
NCATS NIH HHS UL1 TR000003NCATS NIH HHS UL1 TR001857NCATS NIH HHS UL1 TR001863NCATS NIH HHS UL1 TR002345NCATS NIH HHS UL1 TR002535NCATS NIH HHS UL1 TR002548NCRR NIH HHS M01 RR000036NCRR NIH HHS M01 RR000043NCRR NIH HHS M01 RR000069NCRR NIH HHS M01 RR000084NCRR NIH HHS M01 RR000125NCRR NIH HHS M01-RR00036NCRR NIH HHS M01-RR00043-45NCRR NIH HHS M01-RR00069NCRR NIH HHS M01-RR00084NCRR NIH HHS M01 RR001066NCRR NIH HHS M01-RR00125NCRR NIH HHS M01-RR01066NCRR NIH HHS M01 RR014467NCRR NIH HHS M01-RR14467NCRR NIH HHS UL1 RR024134NCRR NIH HHS UL1-RR024134NCRR NIH HHS UL1 RR024139NCRR NIH HHS UL1-RR024139NCRR NIH HHS UL1 RR024153NCRR NIH HHS UL1-RR024153NCRR NIH HHS UL1 RR024989NCRR NIH HHS UL1-RR024989NCRR NIH HHS UL1 RR024992NCRR NIH HHS UL1-RR024992NCRR NIH HHS UL1 RR025758NCRR NIH HHS UL1-RR025758NCRR NIH HHS UL1 RR025780NCRR NIH HHS UL1-RR025780NHLBI NIH HHS K24 HL145076NIDDK NIH HHS P30 DK048520NIDDK NIH HHS R01 DK111038NIDDK NIH HHS U01 DK061212NIDDK NIH HHS U01 DK061230NIDDK NIH HHS U01 DK061239NIDDK NIH HHS U01 DK061242NIDDK NIH HHS U01 DK061254NIDDK NIH HHS U01-DK61212NIDDK NIH HHS U01-DK61230NIDDK NIH HHS U01-DK61239NIDDK NIH HHS U01-DK61242NIDDK NIH HHS U01-DK61254
6 · The paper itself

Abstract

backgroundThe prevalence of type 2 diabetes in youth is increasing, but little is known regarding the occurrence of related complications as these youths transition to adulthood.

methodsWe previously conducted a multicenter clinical trial (from 2004 to 2011) to evaluate the effects of one of three treatments (metformin, metformin plus rosiglitazone, or metformin plus an intensive lifestyle intervention) on the time to loss of glycemic control in participants who had onset of type 2 diabetes in youth. After completion of the trial, participants were transitioned to metformin with or without insulin and were enrolled in an observational follow-up study (performed from 2011 to 2020), which was conducted in two phases; the results of this follow-up study are reported here. Assessments for diabetic kidney disease, hypertension, dyslipidemia, and nerve disease were performed annually, and assessments for retinal disease were performed twice. Complications related to diabetes identified outside the study were confirmed and adjudicated.

resultsAt the end of the second phase of the follow-up study (January 2020), the mean (±SD) age of the 500 participants who were included in the analyses was 26.4±2.8 years, and the mean time since the diagnosis of diabetes was 13.3±1.8 years. The cumulative incidence of hypertension was 67.5%, the incidence of dyslipidemia was 51.6%, the incidence of diabetic kidney disease was 54.8%, and the incidence of nerve disease was 32.4%. The prevalence of retinal disease, including more advanced stages, was 13.7% in the period from 2010 to 2011 and 51.0% in the period from 2017 to 2018. At least one complication occurred in 60.1% of the participants, and at least two complications occurred in 28.4%. Risk factors for the development of complications included minority race or ethnic group, hyperglycemia, hypertension, and dyslipidemia. No adverse events were recorded during follow-up.

conclusionsAmong participants who had onset of type 2 diabetes in youth, the risk of complications, including microvascular complications, increased steadily over time and affected most participants by the time of young adulthood. Complications were more common among participants of minority race and ethnic group and among those with hyperglycemia, hypertension, and dyslipidemia. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; ClinicalTrials.gov numbers, NCT01364350 and NCT02310724.).

Indexed as

AdolescentChildDiabetes ComplicationsDiabetes Mellitus, Type 2DyslipidemiasFemaleFollow-Up StudiesHumansHypertensionHypoglycemic AgentsMaleMetforminRisk FactorsHypoglycemic AgentsMetformin

Identifiers

PMID34320286
PMCPMC8697255
OpenAlexW3187052158

What OpenQuestion holds

Texttitle and abstract
LicenceTDM
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.