The TANGO-DM randomized controlled trial study protocol: treatment outcomes for gestational diabetes diagnosed according to WHO 2013 or WHO 1999 thresholds
Bibliographic record
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.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.009 | 0.011 |
| Meta-epidemiology (narrow) | 0.004 | 0.001 |
| Meta-epidemiology (broad) | 0.008 | 0.003 |
| Bibliometrics | 0.001 | 0.002 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.003 | 0.002 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.004 | 0.004 |
| Insufficient payload (model declined to judge) | 0.049 | 0.005 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".