Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2025 Feb 17;25(1):173.
doi: 10.1186/s12884-025-07230-x.

The TANGO-DM randomized controlled trial study protocol: treatment outcomes for gestational diabetes diagnosed according to WHO 2013 or WHO 1999 thresholds

Doortje Rademaker #  1   2 , Leon de Wit #  3 , Anne van der Wel  4   5 , Eline van den Akker  6 , Babette Braams-Lisman  7 , Remke Dullemond  8 , Inge Evers  9 , Sander Galjaard  10 , Brenda Hermsen  7 , Marion van Hoorn  11 , Anjoke Huisjes  12 , Joepe Kaandorp  3 , Annemiek Lub  13 , Simone Lunshof  14 , Flip van der Made  15 , Remco Nijman  16 , Judith van Laar  17 , Karlijn Vollebregt  18 , Joost Velzel  19 , Floortje Vlemmix  20 , Michelle Westerhuis  21 , Lia Wijnberger  22 , Maurice Wouters  23 , Joost Zwart  24 , Judith Bosmans  25 , Patrick Bossuyt  26 , Ruben Duijnhoven  4 , Enrico Lopriore  27 , Esteriek de Miranda  4 , Corine Verhoeven  4   17   28   29   30   31   32 , Ben Willem Mol  33   34 , Arie Franx  9 , J Hans DeVries  35 , Bas van Rijn  17 , Rebecca Painter  10   23
Affiliations

The TANGO-DM randomized controlled trial study protocol: treatment outcomes for gestational diabetes diagnosed according to WHO 2013 or WHO 1999 thresholds

Doortje Rademaker et al. BMC Pregnancy Childbirth. .

Abstract

Introduction: Gestational diabetes mellitus (GDM), or hyperglycemia first diagnosed in pregnancy, affects 7-10% of all pregnancies worldwide. Perinatal risk rises with increasing glycemia at oral glucose tolerance test (OGTT). The new (2013) WHO criteria recommend a lower fasting, and a higher post-load threshold for GDM diagnosis in comparison to the old (1999) WHO criteria. To date, however, outcomes of GDM treatment for those affected by the altered diagnostic criteria, has not been well investigated. We hypothesized that intensive GDM treatment according to the new (2013) GDM criteria would result in a reduction in infants with birth weight > 90th centile (large for gestational age, LGA), in comparison to treatment according to the old criteria (1999).

Methods: The TANGO-DM trial is an open label, multicenter randomized controlled trial. Participants are pregnant with a gestational age between 16 + 0 and 32 + 0 weeks, who underwent a 1-step venous 2- or 3-point 75-gram oral OGTT, were eligible if they had glucose concentrations discordant between the old (1999) and the new (2013) criteria. After informed consent, women are randomized to either intensive GDM treatment, consisting of dietary advice and glucose monitoring and, if euglycemia is not reached, antihyperglycemic agents, or normal obstetric care without GDM treatment. The primary outcome is large-for-gestational-age infants (birth weight > 90th percentile). Secondary outcome measures include maternal complications, obstetric complications, neonatal complications, obstetric interventions, quality of life, and healthcare and societal costs. Outcomes will be analyzed according to the intention-to-treat principle. The study is powered to detect a reduction in LGA from 16% in the untreated to 10% in the treated group, which requires 1032 participants (516 per arm; alpha-error 5% for 80% power).

Discussion: The TANGO-DM trial will provide high-level evidence to support or refute the use of the new 2013 WHO diagnostic criteria in terms of their ability to lower the number of large for gestational age infants and/or improve maternal and perinatal outcomes and/or costs in women with gestational diabetes.

Trial registration: Central Committee on Research Involving Human Subjects (CCMO) (NL63013.018.18). Registered on 22 September 2018.

Keywords: Gestational diabetes mellitus; IADPSG; Large-for-gestational-age; Randomized controlled trial; WHO 1999.

PubMed Disclaimer

Conflict of interest statement

Declarations. Ethics approval and consent to participate: The trial has been approved by the Medical Research Ethics Committee of the Amsterdam UMC, location AMC (METC 2018_173) as well as the individual ethics boards at each center. Each participant will sign a consent form prior to participating in the study. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Consort flow diagram
Fig. 2
Fig. 2
Flowchart screening and study procedures
See this image and copyright information in PMC

References

    1. Bilous RW, Jacklin PB, Maresh MJ, Sacks DA. Resolving the gestational diabetes diagnosis conundrum: the need for a randomized controlled trial of treatment. Diabetes Care. 2021;44(4):858–64. - PMC - PubMed
    1. Behboudi-Gandevani S, Amiri M, Bidhendi Yarandi R, Ramezani Tehrani F. The impact of diagnostic criteria for gestational diabetes on its prevalence: a systematic review and meta-analysis. Diabetol Metab Syndr. 2019;11:11. - PMC - PubMed
    1. Franks PW, Looker HC, Kobes S, Touger L, Tataranni PA, Hanson RL, Knowler WC. Gestational glucose tolerance and risk of type 2 diabetes in young Pima Indian offspring. Diabetes. 2006;55(2):460–5. - PubMed
    1. Landon MB, Spong CY, Thom E, Carpenter MW, Ramin SM, Casey B, et al. A multicenter, randomized trial of treatment for mild gestational diabetes. N Engl J Med. 2009;361(14):1339–48. - PMC - PubMed
    1. Crowther CA, Hiller JE, Moss JR, McPhee AJ, Jeffries WS, Robinson JS, Australian Carbohydrate Intolerance Study in Pregnant Women Trial G. Effect of treatment of gestational diabetes mellitus on pregnancy outcomes. N Engl J Med. 2005;352(24):2477–86. - PubMed

Publication types

LinkOut - more resources