Evidence map›Paper›PMID 21610124›Full record

Trial reportDiabetes care2011

Long-term outcome of individuals treated with oral insulin: diabetes prevention trial-type 1 (DPT-1) oral insulin trial.

Kendra Vehik, David Cuthbertson, Holly Ruhlig, Desmond A Schatz, Mark Peakman, Jeffrey P Krischer, DPT-1 and TrialNet Study Groups

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Diabetes care, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 46 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
46citing papers in PubMed, 2 pooled it
8.0field-weighted citation impact, top 2% 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.

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

46 citing papers in PubMed, 2 syntheses or guidelines pooled it, 117 citations in OpenAlex.

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  8. Biomaterial Strategies for Selective Immune Tolerance: Advances and Gaps.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2023
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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

7 authors at 2 institutions in 1 country.

Kendra VehikUniversity of South Florida, Pediatrics Epidemiology Center, Tampa, Florida, USA. kendra.vehik@epi.usf.edu
David Cuthbertson
Holly Ruhlig
Desmond A Schatz
Mark Peakman
Jeffrey P Krischer
DPT-1 and TrialNet Study Groups
University of South Florida · USUniversity of Florida · US

Funding

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
Department of HealthNIDDK NIH HHS UC4 DK117009
6 · The paper itself

Abstract

objectiveTo evaluate the long-term intervention effects of oral insulin on the development of type 1 diabetes and to assess the rate of progression to type 1 diabetes before and after oral insulin treatment was stopped in the Diabetes Prevention Trial-Type 1 (DPT-1). RESEARCH DESIGN AND

methodsThe follow-up included subjects who participated in the early intervention of oral insulin (1994-2003) to prevent or delay type 1 diabetes. A telephone survey was conducted in 2009 to determine whether diabetes had been diagnosed and, if not, an oral glucose tolerance test (OGTT), hemoglobin A1c (HbA1c), and autoantibody levels were obtained on all subjects who agreed to participate.

resultsOf 372 subjects randomized, 97 developed type 1 diabetes before follow-up; 75% of the remaining 275 subjects were contacted. In the interim, 77 subjects had been diagnosed with type 1 diabetes and 54 of the remainder have had an OGTT; 10 of these were diagnosed with type 1 diabetes, subsequently. Among individuals meeting the original criteria for insulin autoantibodies (IAAs) (≥80 nU/mL), the overall benefit of oral insulin remained significant (P=0.05). However, the hazard rate in this group increased (from 6.4% [95% CI 4.5-9.1] to 10.0% [7.1-14.1]) after cessation of therapy, which approximated the rate of individuals treated with placebo (10.2% [7.1-14.6]).

conclusionsOverall, the oral insulin treatment effect in individuals with confirmed IAA≥80 nU/mL appeared to be maintained with additional follow-up; however, once therapy stopped, the rate of developing diabetes in the oral insulin group increased to a rate similar to that in the placebo group.

Indexed as

Administration, OralAdolescentAutoantibodiesChildDiabetes Mellitus, Type 1Family HealthFemaleGlucose Tolerance TestGlycated HemoglobinHumansHypoglycemic AgentsInsulinInsulin AntibodiesMalePlacebosSubstance Withdrawal SyndromeAutoantibodiesGlycated HemoglobinHypoglycemic AgentsInsulinInsulin AntibodiesPlacebos

Identifiers

PMID21610124
PMCPMC3120180
OpenAlexW2139394184

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.