Evidence map›Paper›PMID 35484164›Full record

Observational studyNature communications2022

Glycaemic control is associated with SARS-CoV-2 breakthrough infections in vaccinated patients with type 2 diabetes.

Raffaele Marfella, Celestino Sardu, Nunzia D'Onofrio, Francesco Prattichizzo, Lucia Scisciola, Vincenzo Messina, Rosalba La Grotta, Maria Luisa Balestrieri, Paolo Maggi, Claudio Napoli and 2 more

Open access · goldAbstract readObservational Study
In one paragraph

Observational study in Nature communications, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 47 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
47citing papers in PubMed, 2 pooled it
7.0field-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

47 citing papers in PubMed, 2 syntheses or guidelines pooled it, 71 citations in OpenAlex.

  1. Pooled it
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  13. Editorial: Mucosal immunity after vaccination.Frontiers in immunology · 2025
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  16. How does geographical diversity shape vaccine efficacy?Clinical and experimental vaccine research · 2024
    Review
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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

12 authors at 3 institutions in 1 country.

Raffaele MarfellaUniversità degli Studi della Campania "Luigi Vanvitelli", Piazza Luigi Miraglia 2, 80138, Naples, Italy. raffaele.marfella@unicampania.it.ORCID 0000-0003-3960-9270
Celestino SarduUniversità degli Studi della Campania "Luigi Vanvitelli", Piazza Luigi Miraglia 2, 80138, Naples, Italy.
Nunzia D'OnofrioUniversità degli Studi della Campania "Luigi Vanvitelli", Piazza Luigi Miraglia 2, 80138, Naples, Italy.
Francesco PrattichizzoIRCCS MultiMedica, Via Fantoli 16/15, 20138, Milan, Italy.ORCID 0000-0002-2959-2658
Lucia ScisciolaUniversità degli Studi della Campania "Luigi Vanvitelli", Piazza Luigi Miraglia 2, 80138, Naples, Italy.
Vincenzo MessinaSant'Anna Hospital, Caserta, Italy.
Rosalba La GrottaIRCCS MultiMedica, Via Fantoli 16/15, 20138, Milan, Italy.
Maria Luisa BalestrieriUniversità degli Studi della Campania "Luigi Vanvitelli", Piazza Luigi Miraglia 2, 80138, Naples, Italy.
Paolo MaggiUniversità degli Studi della Campania "Luigi Vanvitelli", Piazza Luigi Miraglia 2, 80138, Naples, Italy.
Claudio NapoliUniversità degli Studi della Campania "Luigi Vanvitelli", Piazza Luigi Miraglia 2, 80138, Naples, Italy.
Antonio CerielloIRCCS MultiMedica, Via Fantoli 16/15, 20138, Milan, Italy. antonio.ceriello@hotmail.com.
Giuseppe PaolissoUniversità degli Studi della Campania "Luigi Vanvitelli", Piazza Luigi Miraglia 2, 80138, Naples, Italy.
University of Campania "Luigi Vanvitelli" · ITMultiMedica · ITOspedale Sant'Anna · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Patients with type 2 diabetes (T2D) are characterized by blunted immune responses, which are affected by glycaemic control. Whether glycaemic control influences the response to COVID-19 vaccines and the incidence of SARS-CoV-2 breakthrough infections is unknown. Here we show that poor glycaemic control, assessed as mean HbA1c in the post-vaccination period, is associated with lower immune responses and an increased incidence of SARS-CoV-2 breakthrough infections in T2D patients vaccinated with mRNA-BNT162b2. We report data from a prospective observational study enroling healthcare and educator workers with T2D receiving the mRNA-BNT162b2 vaccine in Campania (Italy) and followed for one year (5 visits, follow-up 346 ± 49 days) after one full vaccination cycle. Considering the 494 subjects completing the study, patients with good glycaemic control (HbA1c one-year mean < 7%) show a higher virus-neutralizing antibody capacity and a better CD4 + T/cytokine response, compared with those with poor control (HbA1c one-year mean ≥ 7%). The one-year mean of HbA1c is linearly associated with the incidence of breakthrough infections (Beta = 0.068; 95% confidence interval [CI], 0.032-0.103; p < 0.001). The comparison of patients with poor and good glycaemic control through Cox regression also show an increased risk for patients with poor control (adjusted hazard ratio [HR], 0.261; 95% CI, 0.097-0.700; p = 0.008). Among other factors, only smoking (HR = 0.290, CI 0.146-0.576 for non-smokers; p < 0.001) and sex (HR = 0.105, CI 0.035-0.317 for females; p < 0.001) are significantly associated with the incidence of breakthrough infections.

Indexed as

COVID-19Diabetes Mellitus, Type 2BNT162 VaccineCOVID-19 VaccinesFemaleGlycated HemoglobinGlycemic ControlHumansRNA, MessengerSARS-CoV-2BNT162 VaccineCOVID-19 VaccinesGlycated HemoglobinRNA, Messenger

Identifiers

PMID35484164
PMCPMC9051134
OpenAlexW4224997315

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.