Evidence map›Paper›PMID 39971752›Full record

Observational studyDiabetologia2025

Pregnancy and neonatal outcomes in women with GCK-MODY: an observational study based on standardised insulin modalities.

Cécile Ciangura, Aurélien Seco, Cécile Saint-Martin, Pierre-Yves Ancel, Delphine Bouvet, Sophie Jacqueminet, Agnès Hartemann, Jacques Lepercq, Jacky Nizard, José Timsit and 2 more

Registry-linked trialAbstract readObservational Study
PubMed Publisher
In one paragraph

Observational study in Diabetologia, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02556840 (Impact of Two Standardized Clinical Care Protocols on Pregnancy Outcomes in Women With Monogenic Diabetes MODY2), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–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.

NCT02556840 nacompletednot on this map

Impact of Two Standardized Clinical Care Protocols on Pregnancy Outcomes in Women With Monogenic Diabetes MODY2

TypeinterventionalSponsorAssistance Publique - Hôpitaux de ParisRan2016 to 2020Enrolled46ConditionsMaturity-Onset Diabetes of the YoungArmsinsulin therapy
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. 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

12 authors.

Cécile CianguraDepartment of Diabetology, Pitié-Salpêtrière Hospital, Sorbonne University, AP-HP, Paris, France. cecile.ciangura@aphp.fr.ORCID http://orcid.org/0000-0003-1960-9919
Aurélien SecoClinical Research Unit Necker Cochin, AP-HP, Paris, France.ORCID http://orcid.org/0000-0003-1462-1193
Cécile Saint-MartinNational Reference Center for Rare Diseases of Insulin Secretion and Insulin Sensitivity (PRISIS), Paris, France.ORCID http://orcid.org/0000-0002-9534-0969
Pierre-Yves AncelClinical Research Unit Necker Cochin, AP-HP, Paris, France.
Delphine BouvetNational Reference Center for Rare Diseases of Insulin Secretion and Insulin Sensitivity (PRISIS), Paris, France.ORCID http://orcid.org/0009-0003-9474-1693
Sophie JacqueminetDepartment of Diabetology, Pitié-Salpêtrière Hospital, Sorbonne University, AP-HP, Paris, France.ORCID http://orcid.org/0000-0002-6637-7340
Agnès HartemannDepartment of Diabetology, Pitié-Salpêtrière Hospital, Sorbonne University, AP-HP, Paris, France.ORCID http://orcid.org/0000-0002-9579-2412
Jacques LepercqDepartment of Obstetrics, Cochin-Port-Royal Hospital, Centre-Université Paris Cité, AP-HP, Paris, France.ORCID http://orcid.org/0000-0002-0574-3749
Jacky NizardDepartment of Obstetrics, Pitié-Salpêtrière Hospital, Sorbonne University, AP-HP, Paris, France.ORCID http://orcid.org/0000-0003-1537-960X
José TimsitNational Reference Center for Rare Diseases of Insulin Secretion and Insulin Sensitivity (PRISIS), Paris, France.ORCID http://orcid.org/0009-0007-8582-9123
Christine Bellanné-ChantelotNational Reference Center for Rare Diseases of Insulin Secretion and Insulin Sensitivity (PRISIS), Paris, France.ORCID http://orcid.org/0000-0001-8415-6771
Monogenic Diabetes Study Group of the Société Francophone du Diabète

Funding

Programme Hospitalier de Recherche Clinique (PHRC, France) 14-0247
6 · The paper itself

Abstract

aims/hypothesisThe management of GCK-MODY during pregnancy remains challenging. We evaluated the impact on pregnancy and neonatal outcomes of two standardised insulin strategies.

methodsIn this prospective observational study, participants chose (in agreement with their physician) to be treated with insulin either when maternal capillary blood glucose (CBG) ≥ thresholds for gestational diabetes (5.3 mmol/l before or 6.7 mmol/l 2 h after meals) (MG group) or when fetal abdominal circumference ≥75th percentile (FG group). In the FG group, insulin was also initiated if CBG ≥ safety levels (6.7 mmol/l before meals or 11.1 mmol/l 2 h after meals). Data on glycaemic management, modalities and timing of insulin therapy and maternal and neonatal outcomes were recorded.

resultsIn the MG group (n=25), insulin was initiated more frequently (100% vs 75%, p=0.01) and earlier (p=0.001), with lower CBG and more frequent hypoglycaemic episodes compared with the FG group (n=21). However, there were no differences in pregnancy and neonatal outcomes. In the total cohort, the rate of large for gestational age (LGA) neonates, preterm deliveries and Caesarean sections was 22.2%, 2.2% and 40%, respectively. The rate of LGA was 0% among the neonates with the GCK variant vs 36% in those without (p=0.005). There were no associations between LGA and pregnancy characteristics, insulin therapy strategy or glycaemic management. CONCLUSIONS/

interpretationIn our study, the rate of LGA primarily depended on the fetal GCK genotype rather than the treatment strategy or glycaemic management. Our results suggest that a standardised strategy based on ultrasound monitoring of fetal growth and glycaemic safety thresholds, leading to delayed insulin initiation, offers a good fetal prognosis and minimises the risk of maternal hypoglycaemia.

trial registrationClinTrials.gov NCT02556840.

Indexed as

Diabetes, GestationalDiabetes Mellitus, Type 2Hypoglycemic AgentsInsulinAdultBlood GlucoseFemaleHumansInfant, NewbornPregnancyPregnancy OutcomeProspective StudiesBlood GlucoseHypoglycemic AgentsInsulinFetal abdominal circumferenceGCK-MODYGlucokinaseInsulin therapyLarge for gestational ageMacrosomiaNeonatal outcomesPregnancyUltrasound

Identifiers

PMID39971752

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.