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Treatment of Gestational Diabetes Mellitus Diagnosed Early in Pregnancy
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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In the citing paper
“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 citing paper
“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]
In the citing paper
“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]
In the citing paper
“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 citing paper
“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]
In the citing paper
“When the outcome was birthweight, no significant association was found between the high‐threshold group's intervention and the risk of large for gestational age or small for gestational age in infants.”
From Clinical challenges in early pregnancy in Japan: An update on gestational diabetes (2024) · cites this paper as [15]
In the citing paper
“In individuals with GDM in the first half of pregnancy, the intervention group had a significantly reduced risk of adverse neonatal events compared with the control group.”
From Clinical challenges in early pregnancy in Japan: An update on gestational diabetes (2024) · cites this paper as [15]
In the citing paper
“Immediate treatment of gestational diabetes mellitus (75 g two‐hour oral glucose tolerance test [OGTT] WHO 2013 criteria) diagnosed before 20 weeks’ gestation modestly reduced the risk of the perinatal composite outcome.”
From Australasian Diabetes in Pregnancy Society ( ADIPS ) 2025 consensus recommendations for the screening, diagnosis and classification of gestational diabetes (2025) · cites this paper as [25]
In the citing paper
“The remaining 33% of the women had discordant OGTTs, that is a negative OGTT at 24–28 weeks’ gestation despite their positive OGTT in early pregnancy (22% in the higher band and 49% in the lower band).”
From Australasian Diabetes in Pregnancy Society ( ADIPS ) 2025 consensus recommendations for the screening, diagnosis and classification of gestational diabetes (2025) · cites this paper as [25]
In the citing paper
“At 24–28 weeks’ gestation in the delayed treatment group, gestational diabetes mellitus was diagnosed and treated in 78% of women in the higher glycaemic band compared with 51% in the lower band.”
From Australasian Diabetes in Pregnancy Society ( ADIPS ) 2025 consensus recommendations for the screening, diagnosis and classification of gestational diabetes (2025) · cites this paper as [25]
In the citing paper
“No differences were observed in the other primary outcomes of pregnancy‐related hypertension or neonatal lean body mass.”
From Australasian Diabetes in Pregnancy Society ( ADIPS ) 2025 consensus recommendations for the screening, diagnosis and classification of gestational diabetes (2025) · cites this paper as [25]
In the citing paper
“benefit was observed in women who had the OGTT and were treated before 14 weeks’ gestation (adjusted odds ratio [aOR], 0.75; 95% confidence interval [CI], 0.57–0.98)”
From Australasian Diabetes in Pregnancy Society ( ADIPS ) 2025 consensus recommendations for the screening, diagnosis and classification of gestational diabetes (2025) · cites this paper as [25]
In the citing paper
“Pre‐specified subgroup analyses suggested an effect from immediate treatment among women with high glycaemic band (HAPO OR 2.0) OGTT diagnostic thresholds, but not in women diagnosed with the currently recommended low glycaemic band thresholds (HAPO OR 1.75).”
From Australasian Diabetes in Pregnancy Society ( ADIPS ) 2025 consensus recommendations for the screening, diagnosis and classification of gestational diabetes (2025) · cites this paper as [25]
In the citing paper
“The TOBOGM subgroup analysis supports higher glycaemic thresholds for gestational diabetes mellitus diagnosis in early pregnancy, 25”
From Australasian Diabetes in Pregnancy Society ( ADIPS ) 2025 consensus recommendations for the screening, diagnosis and classification of gestational diabetes (2025) · cites this paper as [25]
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Metadata
- 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
- 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
- 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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