Evidence map›Paper›PMID 26628417›Full record

Trial reportDiabetes care2016

Pregnancy Outcomes in Youth With Type 2 Diabetes: The TODAY Study Experience.

Georgeanna J Klingensmith, Laura Pyle, Kristen J Nadeau, Linda A Barbour, Robin S Goland, Steven M Willi, Barbara Linder, Neil H White, TODAY Study Group

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

Trial report in Diabetes care, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT00081328. Cited by 34 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 1 pooled it
7.1field-weighted citation impact, top 3% 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.

NCT00081328 phase3completed

Studies to Treat Or Prevent Pediatric Type 2 Diabetes (STOPP-T2D) Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Clinical Trial

Ran2004Enrolled699Registered outcomes11Posted comparisons0ConditionsDiabetes Mellitus, Type IIArmsLifestyle Program, Metformin, Rosiglitazone
Open the trial in the graph
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 1 synthesis or guideline pooled it, 74 citations in OpenAlex.

  1. Guideline
  2. Trial
  3. Trial
  4. Review
  5. Article
  6. Review
  7. Predictors of Composite Maternal and Fetal Outcomes among Pregnant Women with Early-Onset Type 2 Diabetes: A Cross-Sectional Study.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2025
    Article
  8. Article
  9. Article
  10. Review
  11. Review
  12. Article
  13. Article
  14. Observational
  15. Review
  16. Review
  17. Article
  18. Review
  19. Dysglycemia in Pregnancy and Maternal/Fetal Outcomes.Journal of women's health (2002) · 2021
    Article
  20. Pediatric Type 2 Diabetes: Not a Mini Version of Adult Type 2 Diabetes.Endocrinology and metabolism clinics of North America · 2020
    Review
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

9 authors at 6 institutions in 1 country.

Georgeanna J KlingensmithBarbara Davis Center for Diabetes and Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO.
Laura PyleThe Biostatistics Center, George Washington University, Rockville, MD laura.pyle@ucdenver.edu.
Kristen J NadeauDivision of Pediatric Endocrinology, Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO.
Linda A BarbourDepartment of Medicine, Division of Endocrinology, and Department of Obstetrics and Gynecology, Division of Maternal Fetal Medicine, University of Colorado School of Medicine, Aurora, CO.
Robin S GolandNaomi Berrie Diabetes Center, Columbia University, New York, NY.
Steven M WilliDepartment of Endocrinology and Diabetes, The Children's Hospital of Philadelphia, Philadelphia, PA.
Barbara LinderNational Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD.
Neil H WhiteDivision of Endocrinology & Diabetes, Department of Pediatrics, Washington University School of Medicine in St. Louis, St. Louis, MO.
TODAY Study Group
University of Colorado Denver · USChildren's Hospital of Philadelphia · USColumbia University · USGeorge Washington University · USNational Institute of Diabetes and Digestive and Kidney Diseases · USWashington University in St. Louis · US

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
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
Clinical and Translational Science Collaborative of ClevelandUL1TR000439 · NCATS · CASE WESTERN RESERVE UNIVERSITY · PI KONSTAN, MICHAEL W. · 2012 to 2016
$50.0M
Colorado Clinical and Translational Sciences InstituteUL1TR001082 · NCATS · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 2013 to 2017
$48.0M
Washington University Institute of Clinical and Translational Sciences (UL1)UL1RR024992 · NCRR · WASHINGTON UNIVERSITY · PI EVANOFF, BRADLEY A · 2007 to 2011
$45.4M
Washington University Institute of Clinical and Translational SciencesUL1TR000448 · NCATS · WASHINGTON UNIVERSITY · PI EVANOFF, BRADLEY A · 2012 to 2016
$41.4M
NCATS NIH HHS UL1 TR000439NCATS NIH HHS UL1 TR000448NCATS NIH HHS UL1 TR001082NCRR NIH HHS M01 RR000036NCRR NIH HHS M01 RR000043NCRR NIH HHS M01 RR000069NCRR NIH HHS M01 RR000084NCRR NIH HHS M01 RR000125NCRR NIH HHS M01-RR-00036NCRR 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-RR-024134NCRR NIH HHS UL1 RR024139NCRR NIH HHS UL1-RR-024139NCRR NIH HHS UL1 RR024153NCRR NIH HHS UL1-RR-024153NCRR NIH HHS UL1 RR024989NCRR NIH HHS UL1-RR-024989NCRR NIH HHS UL1 RR024992NCRR NIH HHS UL1-RR-024992NCRR NIH HHS UL1 RR025758NCRR NIH HHS UL1-RR-025758NCRR NIH HHS UL1 RR025780NCRR NIH HHS UL1-RR-025780NIDDK NIH HHS U01 DK061212NIDDK NIH HHS U01 DK061230NIDDK NIH HHS U01 DK061239NIDDK NIH HHS U01 DK061242NIDDK NIH HHS U01 DK061254NIDDK NIH HHS U01-DK-61212NIDDK NIH HHS U01-DK-61230NIDDK NIH HHS U01-DK-61239NIDDK NIH HHS U01-DK-61242NIDDK NIH HHS U01-DK-61254
6 · The paper itself

Abstract

objectiveWe evaluated pregnancy outcomes, maternal and fetal/neonatal, during the Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) study. RESEARCH DESIGN AND

methodsThe TODAY study was a randomized controlled trial comparing three treatment options for youth with type 2 diabetes. Informed consent included the requirement for contraception, including abstinence; this was reinforced at each visit. Following informed consent, self-reported data related to the mother's prenatal care and delivery and the infant's health were retrospectively collected. When permitted, maternal medical records and infant birth records were reviewed.

resultsOf the 452 enrolled female participants, 46 (10.2%) had 63 pregnancies. Despite continued emphasis on adequate contraception, only 4.8% of the pregnant participants reported using contraception prior to pregnancy. The mean age at first pregnancy was 18.4 years; the mean diabetes duration was 3.17 years. Seven pregnancies were electively terminated; three pregnancies had no data reported. Of the remaining 53 pregnancies, 5 (9.4%) resulted in early pregnancy loss, and 7 (13%) resulted in loss with inadequate pregnancy duration data. Two pregnancies ended in stillbirth, at 27 and 37 weeks, and 39 ended with a live-born infant. Of the live-born infants, six (15.4%) were preterm and eight (20.5%) had a major congenital anomaly.

conclusionsDespite diabetes-specific information recommending birth control and the avoidance of pregnancy, 10% of the study participants became pregnant. Pregnancies in youth with type 2 diabetes may be especially prone to result in congenital anomalies. Reasons for the high rate of congenital anomalies are uncertain, but may include poor metabolic control and extreme obesity.

Indexed as

Pregnancy OutcomeAdolescentDelivery, ObstetricDiabetes Mellitus, Type 2FemaleHumansInfant, NewbornPatient CompliancePregnancyPregnancy in DiabeticsPrenatal CareStillbirth

Identifiers

PMID26628417
PMCPMC4686849
OpenAlexW2185485830

What OpenQuestion holds

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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.