Evidence map›Paper›PMID 42283716›Full record

ArticleDiabetes care2026

Extended Follow-up of Type 1 Diabetes Immunotherapy Trial Participants Suggests Benign Side Effect Profile.

Laura M Jacobsen, Dave Cuthbertson, Jamie Felton, Jennifer L Sherr, Kimber M Simmons, Jennifer Hosford, Heba M Ismail, Carla J Greenbaum, Diane K Wherrett, Ashley Pinckney and 4 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Diabetes care, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Laura M JacobsenDepartments of Pediatrics and Pathology, Diabetes Institute, College of Medicine, University of Florida, Gainesville, FL.ORCID 0000-0002-5144-7836
Dave CuthbertsonHealth Informatics Institute, University of South Florida, Tampa, FL.
Jamie FeltonDepartment of Pediatrics and the IU Center for Diabetes and Metabolic Disease, Indiana University School of Medicine, Indianapolis, IN.
Jennifer L SherrDepartment of Pediatrics, Yale School of Medicine, New Haven, CT.
Kimber M SimmonsBarbara Davis Center, University of Colorado School of Medicine, Aurora, CO.
Jennifer HosfordDepartments of Pediatrics and Pathology, Diabetes Institute, College of Medicine, University of Florida, Gainesville, FL.
Heba M IsmailDepartment of Pediatrics and the IU Center for Diabetes and Metabolic Disease, Indiana University School of Medicine, Indianapolis, IN.
Carla J GreenbaumBenaroya Research Institute, Seattle, WA.
Diane K WherrettDepartment of Pediatrics, Hospital for Sick Children and University of Toronto, Toronto, Ontario, Canada.
Ashley PinckneyRho, Durham, NC.
Srinath SandaImmune Tolerance Network, San Francisco, CA.
Linda A DiMeglioDepartment of Pediatrics and the IU Center for Diabetes and Metabolic Disease, Indiana University School of Medicine, Indianapolis, IN.
Lauren E HigdonImmune Tolerance Network, San Francisco, CA.
Carmella Evans-MolinaDepartment of Pediatrics and the IU Center for Diabetes and Metabolic Disease, Indiana University School of Medicine, Indianapolis, IN.

Funding

Immune Tolerance Network UM1 2023 SupplementUM1AI109565 · NIAID · BENAROYA RESEARCH INST AT VIRGINIA MASON · PI Mark S Anderson, Jane Hoyt Buckner · 2014 to 2026
$451.6M
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
Data Coordinating Center for Type 1 Diabetes TrialNet (UC4)USF: TrialNet UC4-3UC4DK117009 · NIDDK · UNIVERSITY OF SOUTH FLORIDA · PI KRISCHER, JEFFREY P · 2017 to 2019
$49.6M
NIDDK Type 1 Diabetes TrialNet Data Coordinating CenterUC4DK106993 · NIDDK · UNIVERSITY OF SOUTH FLORIDA · PI KRISCHER, JEFFREY P · 2015 to 2015
$36.6M
IPP: AUTOIMMUNE DISEASES STATISTICAL AND CLINICAL COORDINATING CENTER (ADSCCC)75N93022C00003 · NIAID · RHO FEDERAL SYSTEMS DIVISION, INC. · PI MILLIN, CHRISTINA · 2022 to 2025
$32.1M
Type 1 Diabetes TrialNet Clinical Network HubU01DK103282 · NIDDK · BENAROYA RESEARCH INST AT VIRGINIA MASON · PI CARLA J GREENBAUM, KURT J GRIFFIN · 2014 to 2026
$14.2M
Northwest Clinical Center for Type 1 Diabetes - TrialNetU01DK061034 · NIDDK · BENAROYA RESEARCH INST AT VIRGINIA MASON · PI GREENBAUM, CARLA J · 2001 to 2018
$10.3M
Type I Diabetes Trialnet at StsnfordU01DK061042 · NIDDK · STANFORD UNIVERSITY · PI WILSON, DARRELL M · 2001 to 2018
$8.5M
UCSF Trialnet: A Phase II Trial of Imatimib in New Onset Type I DiabetesU01DK061010 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI GITELMAN, STEPHEN E · 2001 to 2018
$8.1M
Type 1 Diabetes-A Proposal for Prevention & InterventionU01DK085476 · NIDDK · UNIVERSITY OF MINNESOTA · PI MORAN, ANTOINETTE M. · 2009 to 2018
$7.1M
Prediction and Prevention of Type I DiabetesU01DK061058 · NIDDK · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI BECKER, DOROTHY J · 2001 to 2018
$6.5M
TrialNet: University of Florida Clinical Center and NetworkU01DK085461 · NIDDK · UNIVERSITY OF FLORIDA · PI HALLER, MICHAEL JAMES · 2009 to 2018
$5.9M
National Institute of Allergy and Infectious Diseases UM1AI109565NIAID NIH HHS UM1 AI109565NIDDK NIH HHS U01 DK061010NIDDK NIH HHS U01 DK061010, U01 DK061034, U01 DK061042, U01 DK06NIDDK NIH HHS U01 DK061034NIDDK NIH HHS U01 DK061042NIDDK NIH HHS U01 DK061058NIDDK NIH HHS U01 DK085461NIDDK NIH HHS U01 DK085465NIDDK NIH HHS U01 DK085466NIDDK NIH HHS U01 DK085476NIDDK NIH HHS U01 DK085499NIDDK 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 DK106994NIDDK NIH HHS U01 DK107013NIDDK NIH HHS U01 DK107014NIDDK NIH HHS UC4 DK106993NIDDK NIH HHS UC4 DK117009NIH HHS 75N93022C00003
6 · The paper itself

Abstract

objectiveLong-term side effect surveillance after immunotherapy clinical trial participation in individuals with or at risk of type 1 diabetes is needed. RESEARCH DESIGN AND

methodsParticipants from 14 randomized controlled trials (47%) joined the Long-term Investigative Follow-up in Type 1 Diabetes TrialNet or Immune Tolerance Network Type 1 Diabetes Extension Study, and 98% answered at least one health-related outcomes question.

resultsParticipants were observed for a median of 1.78 (interquartile range 0.89-4.04) years after original trial completion and, in some, up to 18 years. There were no differences in the frequency of self-reported health outcomes, including moderate to severe hypoglycemia events, hospitalizations, serious infections (including COVID-19 infection), new allergic reactions, autoimmune disease, and cancer incidence, between those receiving active and placebo therapy (n = 209-473 responses per question; P > 0.05 for all).

conclusionsWe observed no differences in self-reported health outcomes between those who received active immunotherapy versus placebo. Continued long-term follow-up of immunotherapy trial participants is essential.

Indexed as

Diabetes Mellitus, Type 1ImmunotherapyAdultFemaleFollow-Up StudiesHumansHypoglycemiaMale

Identifiers

PMID42283716
PMCPMC13385935

What OpenQuestion holds

Textmetadata
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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.