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Cited by 366Gestational Diabetes Research and ManagementPregnancy and Medication ImpactDiabetes Management and Research

Treatment of Gestational Diabetes Mellitus Diagnosed Early in Pregnancy

Simmons, David, Immanuel, Jincy, Hague, William M., Teede, Helena, Nolan, Christopher J., Peek, Michael J., Flack, Jeff R., McLean, Mark +10 more·2023·New England Journal of Medicine
DOI 10.1056/nejmoa2214956
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Abstract

BACKGROUND: Whether treatment of gestational diabetes before 20 weeks' gestation improves maternal and infant health is unclear. METHODS: We randomly assigned, in a 1:1 ratio, women between 4 weeks' and 19 weeks 6 days' gestation who had a risk factor for hyperglycemia and a diagnosis of gestational diabetes (World Health Organization 2013 criteria) to receive immediate treatment for gestational diabetes or deferred or no treatment, depending on the results of a repeat oral glucose-tolerance test [OGTT] at 24 to 28 weeks' gestation (control). The trial included three primary outcomes: a composite of adverse neonatal outcomes (birth at <37 weeks' gestation, birth trauma, birth weight of ≥4500 g, respiratory distress, phototherapy, stillbirth or neonatal death, or shoulder dystocia), pregnancy-related hypertension (preeclampsia, eclampsia, or gestational hypertension), and neonatal lean body mass. RESULTS: A total of 802 women underwent randomization; 406 were assigned to the immediate-treatment group and 396 to the control group; follow-up data were available for 793 women (98.9%). An initial OGTT was performed at a mean (±SD) gestation of 15.6±2.5 weeks. An adverse neonatal outcome event occurred in 94 of 378 women (24.9%) in the immediate-treatment group and in 113 of 370 women (30.5%) in the control group (adjusted risk difference, -5.6 percentage points; 95% confidence interval [CI], -10.1 to -1.2). Pregnancy-related hypertension occurred in 40 of 378 women (10.6%) in the immediate-treatment group and in 37 of 372 women (9.9%) in the control group (adjusted risk difference, 0.7 percentage points; 95% CI, -1.6 to 2.9). The mean neonatal lean body mass was 2.86 kg in the immediate-treatment group and 2.91 kg in the control group (adjusted mean difference, -0.04 kg; 95% CI, -0.09 to 0.02). No between-group differences were observed with respect to serious adverse events associated with screening and treatment. CONCLUSIONS: Immediate treatment of gestational diabetes before 20 weeks' gestation led to a modestly lower incidence of a composite of adverse neonatal outcomes than no immediate treatment; no material differences were observed for pregnancy-related hypertension or neonatal lean body mass. (Funded by the National Health and Medical Research Council and others; TOBOGM Australian New Zealand Clinical Trials Registry number, ACTRN12616000924459.).

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  • There was a suggestion of more benefit (per prespecified subgroup analyses) among individuals who had the OGTT at less than 14 weeks and among those with OGTT glycemic values in higher ranges.

    “There was also a suggestion of more benefit (per prespecified subgroup analyses) among individuals who had the OGTT at <14 weeks and among those with OGTT glycemic values in higher ranges (180).”

    From 2. Diagnosis and classification of diabetes: standards of care in diabetes-2025 (2025) · cites this paper as [180]

  • In the TOBOGM study, no statistically significant differences were observed between the intervention and control groups for hypertensive disorders of pregnancy and neonatal lean body mass.

    “Furthermore, no statistically significant differences were observed between hypertensive disorders of pregnancy and neonatal lean body mass.”

    From Clinical challenges in early pregnancy in Japan: An update on gestational diabetes (2024) · cites this paper as [15]

  • The diagnostic criteria for GDM in the first half of pregnancy used in the TOBOGM study were the same as those used in Japan.

    “As aforementioned, the diagnostic criteria for GDM in the first half of pregnancy used in the TOBOGM study were the same as those used in Japan; as such, these findings could be considered useful.”

    From Clinical challenges in early pregnancy in Japan: An update on gestational diabetes (2024) · cites this paper as [15]

  • Many of the women studied in the TOBOGM study met the Japanese definition of obesity.

    “However, it should be noted that many of the women who were studied met the Japanese definition of obesity in the TOBOGM study.”

    From Clinical challenges in early pregnancy in Japan: An update on gestational diabetes (2024) · cites this paper as [15]

  • In the TOBOGM study, the low-threshold group's intervention reduced the risk in large for gestational age infants, but increased the risk in small for gestational age infants.

    “In contrast, the low‐threshold group's intervention reduced the risk in large for gestational age infants, but increased the risk in small for gestational age infants.”

    From Clinical challenges in early pregnancy in Japan: An update on gestational diabetes (2024) · cites this paper as [15]

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Authors
Simmons, D., Immanuel, J., Hague, W. M., Teede, H., Nolan, C. J., Peek, M. J., Flack, J. R., McLean, M., Wong, V., Hibbert, E., Kautzky-Willer, A., Harreiter, J., Backman, H., Gianatti, E., Sweeting, A., Mohan, V., Enticott, J., & Cheung, N. W.
Affiliations
  • Australian National University (AU)
  • From Western Sydney University, Campbelltown, NSW (D.S., J.I.), Robinson Research Institute, University of Adelaide, Adelaide, SA (W.M.H.), Monash University, Melbourne, VIC (H.T., J.E.), Canberra Hospital and Australian National University (C.J.N.) and Australian National University (M.J.P.), Canberra, ACT, Bankstown-Lidcombe Hospital (J.R.F.), Blacktown Hospital (M.M.), Liverpool Hospital and University of New South Wales (V.W.), Nepean Clinical School, University of Sydney and Nepean Hospital (E.H.), the Department of Endocrinology, Royal Prince Alfred Hospital (A.S.), and Westmead Hospital (N.W.C.), Sydney, and the Department of Endocrinology, Fiona Stanley Hospital, Murdoch, WA (E.G.) — all in Australia; the Gender Medicine Unit, Division of Endocrinology and Metabolism, Department of Medicine III, Medical University of Vienna, Vienna (A.K.-W., J.H.); the Department of Obstetrics and Gynecology, Faculty of Medicine and Health, Örebro University, Orebro, Sweden (H.B.); and Dr. Mohan’s Diabetes Speciali...
ORCID
Venue
New England Journal of Medicine
Publisher
Massachusetts Medical Society
Published
2023-06-08
Volume
388
Issue
23
Pages
2132-2144
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
DOI
10.1056/nejmoa2214956
OpenAlex
W4372284831
Cited by
366
References
28
Citations by year
2026: 92 · 2025: 138 · 2024: 110 · 2023: 25
FWCI
113.85
Type
journal article
Language
en
Open access
closed
Licence
www.nejmgroup.org/legal/terms-of-use.htm (vor)
Locations
  • New England Journal of Medicine (publishedVersion)
  • PubMed (publishedVersion)
  • Adelaide Research & Scholarship (AR&S) (University of Adelaide) (submittedVersion)
Funders
  • Western Sydney University (Ainsworth Trust grant 2019)
  • Medical Scientific Fund of the Mayor of Vienna (15205)
  • South Western Sydney Local Health District (Academic Unit grant 2016)
  • National Health and Medical Research Council (1104231, 2009326)
  • Region Örebro Research Committee, Sweden (Dnr OLL-970566, OLL-942177)
Topics
  • Health Sciences › Medicine › Obstetrics and Gynecology › Gestational Diabetes Research and Management
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Pregnancy and Medication Impact
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
Keywords
gestational diabetes mellitus, early pregnancy, immediate treatment, deferred treatment, oral glucose tolerance test, neonatal outcomes, pregnancy-related hypertension, maternal hyperglycemia, preeclampsia, eclampsia, gestational hypertension, birth weight, birth trauma, stillbirth, shoulder dystocia, respiratory distress, phototherapy, neonatal death
MeSH terms
Australia, Female, Humans, Hypertension, Infant, Newborn, Pre-Eclampsia, Pregnancy, Pregnancy Outcome, Pregnancy Trimester, First, Diabetes, Gestational, Stillbirth

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