Evidence map›Paper›PMID 34551936›Full record

Trial reportDiabetes2021

The Deterrence of Rapid Metabolic Decline Within 3 Months After Teplizumab Treatment in Individuals at High Risk for Type 1 Diabetes.

Emily K Sims, David Cuthbertson, Kevan C Herold, Jay M Sosenko

Abstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Diabetes, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
–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

13 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Trial
  4. Review
  5. Article
  6. Review
  7. Article
  8. Article
  9. Screening and Prevention of Type 1 Diabetes: Where Are We?The Journal of clinical endocrinology and metabolism · 2023
    Review
  10. Review
  11. Review
  12. Article
  13. Article
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

4 authors.

Emily K SimsDepartment of Pediatrics, Indiana University School of Medicine, Indianapolis, IN eksims@iu.edu.ORCID 0000-0002-4393-954X
David CuthbertsonDepartment of Pediatrics, Pediatrics Epidemiology Center, Morsani College of Medicine, University of South Florida, Tampa, FL.
Kevan C HeroldDepartments of Immunobiology and Internal Medicine, Yale University, New Haven, CT.
Jay M SosenkoDepartment of Medicine, University of Miami Miller School of Medicine, Miami, FL.ORCID 0000-0002-7204-8367

Funding

Revision to the Coordinating Center for Type 1 Diabetes TrialNetU01DK106993 · NIDDK · UNIVERSITY OF SOUTH FLORIDA · PI JEFFREY P KRISCHER, SAMUEL S WU · 2019 to 2026
$181.3M
University of Pittsburgh Clinical and Translational Science InstituteUL1TR001857 · NCATS · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI REIS, STEVEN E · 2016 to 2025
$129.3M
Clinical and Translational Science InstituteUL1TR001872 · NCATS · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI COLLARD, HAROLD R, JACOBY, VANESSA · 2016 to 2025
$112.1M
Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Colorado Clinical and Translational Sciences InstituteUL1TR001082 · NCATS · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 2013 to 2017
$48.0M
NIDDK Type 1 Diabetes TrialNet Data Coordinating CenterUC4DK097835 · NIDDK · UNIVERSITY OF SOUTH FLORIDA · PI KRISCHER, JEFFREY P · 2012 to 2012
$45.0M
RADx-UP: Improving the Response of Local Urban and Rural Communities to Disparities in Covid-19 TestingUL1TR002366 · NCATS · UNIVERSITY OF KANSAS MEDICAL CENTER · PI Mario Castro, JAMES STEVEN LEEDER · 2017 to 2026
$44.3M
The Vanderbilt Institute for Clinical and Translational Research (VICTR)UL1TR000445 · NCATS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI BERNARD, GORDON RAPHAEL · 2012 to 2016
$41.4M
NIDDK Type 1 Diabetes TrialNet Data Coordinating CenterUC4DK106993 · NIDDK · UNIVERSITY OF SOUTH FLORIDA · PI KRISCHER, JEFFREY P · 2015 to 2015
$36.6M
University of Minnesota Clinical and Translational Science Institute (UMN CTSI)UL1TR000114 · NCATS · UNIVERSITY OF MINNESOTA · PI BLAZAR, BRUCE R · 2012 to 2015
$35.0M
Yale University Clinical and Translational Science Award ProgramUL1TR000142 · NCATS · YALE UNIVERSITY · PI SHERWIN, ROBERT S · 2012 to 2015
$31.8M
Quality Assurance and Quality Control Project Management: Improving Submissions and Study Conduct in the Human Subjects Research Prior Approval ProcessUL1TR002529 · NCATS · INDIANA UNIVERSITY INDIANAPOLIS · PI MOE, SHARON M, WIEHE, SARAH ELIZABETH · 2018 to 2022
$27.2M
NCATS NIH HHS UL1 TR000064NCATS NIH HHS UL1 TR000114NCATS NIH HHS UL1 TR000142NCATS NIH HHS UL1 TR000445NCATS NIH HHS UL1 TR001082NCATS NIH HHS UL1 TR001857NCATS NIH HHS UL1 TR001863NCATS NIH HHS UL1 TR001872NCATS NIH HHS UL1 TR002366NCATS NIH HHS UL1 TR002529NCATS NIH HHS UL1 TR002537NIAID NIH HHS F31 AI009565NIDDK NIH HHS R01 DK121929NIDDK NIH HHS R01 DK133881NIDDK NIH HHS R03 DK117253NIDDK NIH HHS U01 DK061010NIDDK NIH HHS U01 DK061034NIDDK NIH HHS U01 DK061042NIDDK NIH HHS U01 DK061058NIDDK NIH HHS U01 DK085453NIDDK NIH HHS U01 DK085461NIDDK NIH HHS U01 DK085465NIDDK NIH HHS U01 DK085466NIDDK NIH HHS U01 DK085476NIDDK NIH HHS U01 DK085499NIDDK NIH HHS U01 DK085504NIDDK NIH HHS U01 DK085509NIDDK NIH HHS U01 DK103153NIDDK NIH HHS U01 DK103180NIDDK NIH HHS U01 DK103266NIDDK NIH HHS U01 DK103282NIDDK NIH HHS U01 DK106984NIDDK NIH HHS U01 DK106993NIDDK NIH HHS U01 DK107013NIDDK NIH HHS U01 DK107014NIDDK NIH HHS U01 DK127786NIDDK NIH HHS UC4 DK097835NIDDK NIH HHS UC4 DK106993
6 · The paper itself

Abstract

End points that provide an early identification of treatment effects are needed to implement type 1 diabetes prevention trials more efficiently. To this end, we assessed whether metabolic end points can be used to detect a teplizumab effect on rapid β-cell decline within 3 months after treatment in high-risk individuals in the TrialNet teplizumab trial. Glucose and C-peptide response curves (GCRCs) were constructed by plotting mean glucose and C-peptide values from 2-h oral glucose tolerance tests on a two-dimensional grid. Groups were compared visually for changes in GCRC shape and movement. GCRC changes reflected marked metabolic deterioration in the placebo group within 3 months of randomization. By 6 months, GCRCs resembled typical GCRCs at diagnosis. In contrast, GCRC changes in the teplizumab group suggested metabolic improvement. Quantitative comparisons, including two novel metabolic end points that indicate GCRC changes, the within-quadrant end point and the ordinal directional end point, were consistent with visual impressions of an appreciable treatment effect at the 3- and 6-month time points. In conclusion, an analytic approach combining visual evidence with novel end points demonstrated that teplizumab delays rapid metabolic decline and improves the metabolic state within 3 months after treatment; this effect extends for at least 6 months.

Indexed as

Antibodies, Monoclonal, HumanizedBlood GlucoseDiabetes Mellitus, Type 1Double-Blind MethodEnergy MetabolismFemaleGlucose Tolerance TestHumansInsulinInsulin-Secreting CellsMalePrediabetic StateRisk FactorsTime FactorsTreatment OutcomeAntibodies, Monoclonal, HumanizedBlood GlucoseInsulinteplizumab

Identifiers

PMID34551936
PMCPMC8660991

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.