{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,27]],"date-time":"2026-02-27T02:39:45Z","timestamp":1772159985854,"version":"3.50.1"},"reference-count":67,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2017,12,14]],"date-time":"2017-12-14T00:00:00Z","timestamp":1513209600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["obgyn.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Acta Obstet Gynecol Scand"],"published-print":{"date-parts":[[2018,3]]},"abstract":"Abstract<\/jats:title>\n \n Introduction<\/jats:title>\n \n There is inconclusive evidence from randomized controlled trials (\n RCT<\/jats:styled-content>\n s) to support any specific criteria for pharmacologic therapy dose adjustment in diabetes in pregnancy. Our objective was to analyze the criteria for dose adjustment of pharmacologic treatment for diabetes mellitus (\n DM<\/jats:styled-content>\n ) in pregnancy.\n <\/jats:p>\n <\/jats:sec>\n \n Material and methods<\/jats:title>\n \n Data sources:\n MEDLINE<\/jats:styled-content>\n ,\n OVID<\/jats:styled-content>\n and Cochrane Library were searched from their inception to September 2017. Selection criteria included all trials of\n DM<\/jats:styled-content>\n in pregnancy managed by oral hypoglycemic agents or insulin reporting criteria for pharmacologic therapy dose adjustment.\n RCT<\/jats:styled-content>\n s in women with pregestational\n DM<\/jats:styled-content>\n and gestational\n DM<\/jats:styled-content>\n (\n GDM<\/jats:styled-content>\n ) were included. For each trial, data regarding glucose values used for pharmacologic therapy dose adjustment were extracted and carefully reviewed.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Of 51\n RCT<\/jats:styled-content>\n s on therapy for\n GDM<\/jats:styled-content>\n or pregestational\n DM<\/jats:styled-content>\n , 17 (4230 women) were included as they reported criteria for pharmacologic therapy dose adjustment. Most of them (88%, 15\/17) included women with\n GDM<\/jats:styled-content>\n only. For\n RCT<\/jats:styled-content>\n s including women with\n GDM<\/jats:styled-content>\n , 12\/16 (75%) used the two\u2010step approach, three (19%) the one\u2010step approach and one (6%) either the one\u2010 or two\u2010step approach. Regarding the type of initial therapy, 13 (77%)\n RCT<\/jats:styled-content>\n s used different types and doses of insulin; nine (53%) used metformin; five (30%) used glyburide; and one (6%) used placebo. In most\n RCT<\/jats:styled-content>\n s, glucose monitoring was assessed four times daily, i.e. fasting (all\n RCT<\/jats:styled-content>\n s) and two hours (15\n RCT<\/jats:styled-content>\n s, 88%) after each of the three main meals \u2013 breakfast, lunch, and dinner. For fasting glucose target, all used a value <105\u00a0mg\/\n dL<\/jats:styled-content>\n ; nine (53%) used 95\u00a0mg\/\n dL<\/jats:styled-content>\n as target. Of the 15\n RCT<\/jats:styled-content>\n s using a two\u2010hour postprandial value as target, 11 (73%) had 120\u00a0mg\/\n dL<\/jats:styled-content>\n as cutoff. Regarding the criteria for pharmacologic therapy dose adjustment, we found six different criteria. The majority of\n RCT<\/jats:styled-content>\n s (9\/17, 53%) used either one or two values per week higher than the target values, of which two\u2010thirds used only one value (35% of total), and one\u2010third (18% of total) two values. Five\n RCT<\/jats:styled-content>\n s (29%) used >50%, one (6%) >30%, and one (6%) >20% of the values higher than the target value; one (6%) used the appearance of glycosuria.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n \n When evaluating\n RCT<\/jats:styled-content>\n s which included criteria for pharmacologic\n GDM<\/jats:styled-content>\n therapy dose adjustment, the most common criterion for diagnosis was the two\u2010step test, and the most common used therapies were insulin and metformin. Regarding glucose monitoring, the most common frequency was four times per day, fasting and two hours after each main meal, using as target glucose values 95 and 120\u00a0mg\/\n dL<\/jats:styled-content>\n , respectively. Importantly, we found six different criteria for pharmacologic\n GDM<\/jats:styled-content>\n therapy dose adjustment, with the majority using very tight criteria of either one or two values per week higher than the target values, of which two\u2010thirds used only one value, and one\u2010third used two values.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/aogs.13257","type":"journal-article","created":{"date-parts":[[2017,11,10]],"date-time":"2017-11-10T10:18:41Z","timestamp":1510309121000},"page":"235-247","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["Very tight vs. tight control: what should be the criteria for pharmacologic therapy dose adjustment in diabetes in pregnancy? Evidence from randomized controlled trials"],"prefix":"10.1111","volume":"97","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6535-4497","authenticated-orcid":false,"given":"Claudia","family":"Caissutti","sequence":"first","affiliation":[{"name":"Department of Experimental Clinical and Medical Science (DISM) Clinic of Obstetrics and Gynecology University of Udine Udine Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0078-2113","authenticated-orcid":false,"given":"Gabriele","family":"Saccone","sequence":"additional","affiliation":[{"name":"Department of Neuroscience, Reproductive Sciences and Dentistry School of Medicine University of Naples Federico II Naples Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrea","family":"Ciardulli","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynecology Catholic University of Sacred Heart Rome Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7420-1807","authenticated-orcid":false,"given":"Vincenzo","family":"Berghella","sequence":"additional","affiliation":[{"name":"Division of Maternal\u2010Fetal Medicine Department of Obstetrics and Gynecology Sidney Kimmel Medical College of Thomas Jefferson University Philadelphia PA 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