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妊娠による高血糖(糖尿病)

著者: 安田重光 埼玉医科大学 内分泌内科・糖尿病内科

監修: 野田光彦 国際医療福祉大学市川病院 糖尿病・代謝・内分泌内科

著者校正/監修レビュー済:2022/01/26
参考ガイドライン:
  1. 日本産科婦人科学会/日本産婦人科医会:産婦人科診療ガイドライン産科編2020
  1. 日本糖尿病学会:糖尿病診療ガイドライン2019
患者向け説明資料

概要・推奨   

  1. 妊娠前BMIと妊娠糖尿病発症は連続性をもって増加することから、初診時に妊娠前BMIを問診することは推奨される(推奨度2)
  1. 妊娠初期に妊娠糖尿病のスクリーニング検査を行うことは推奨される(推奨度2)
  1. 随時血糖値で妊娠糖尿病のスクリーニング検査を行うことは推奨される(推奨度2)
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薬剤監修について:
オーダー内の薬剤用量は日本医科大学付属病院 薬剤部 部長 伊勢雄也 以下、林太祐、渡邉裕次、井ノ口岳洋、梅田将光による疑義照会のプロセスを実施、疑義照会の対象については著者の方による再確認を実施しております。
※薬剤中分類、用法、同効薬、診療報酬は、エルゼビアが独自に作成した薬剤情報であり、 著者により作成された情報ではありません。
尚、用法は添付文書より、同効薬は、薬剤師監修のもとで作成しております。
※同効薬・小児・妊娠および授乳中の注意事項等は、海外の情報も掲載しており、日本の医療事情に適応しない場合があります。
※薬剤情報の(適外/適内/⽤量内/⽤量外/㊜)等の表記は、エルゼビアジャパン編集部によって記載日時にレセプトチェックソフトなどで確認し作成しております。ただし、これらの記載は、実際の保険適応の査定において保険適応及び保険適応外と判断されることを保証するものではありません。また、検査薬、輸液、血液製剤、全身麻酔薬、抗癌剤等の薬剤は保険適応の記載の一部を割愛させていただいています。
(詳細はこちらを参照)
著者のCOI(Conflicts of Interest)開示:
安田重光 : 特に申告事項無し[2022年]
監修:野田光彦 : 特に申告事項無し[2022年]

改訂のポイント:
  1. 日本糖尿病学会の糖尿病診療ガイドライン2019に基づき、主に妊娠中の血糖コントロール目標について改訂を行った。

病態・疫学・診察

疾患情報(疫学・病態)  
  1. 妊婦の糖代謝異常は「妊娠糖尿病」、「妊娠中の明らかな糖尿病」、「糖尿病合併妊娠」に分類される。この中で、「妊娠糖尿病」及び「妊娠中の明らかな糖尿病」の2つをまとめて「妊娠による高血糖(糖尿病)」と称し、本稿で述べる。
  1. 妊娠糖尿病とは、妊娠中にはじめて発見または発症した糖尿病に至っていない糖代謝異常である。妊娠中に診断された明らかな糖尿病は含まれない。
  1. 2008年に発表されたHAPO研究の結果により、血糖値と周産期合併症増加に強い連続的な関連があることが確認された。
  1. 妊娠糖尿病のスクリーニングについて:糖尿病診療ガイドラインでは、初診時に随時血糖測定(≧100mg/dLを陽性とする)を行い、陽性の場合には75gOGTT(oral glucose tolerance test)を施行する。スクリーニングで陰性であった妊婦もしくは75gOGTTで診断に至らなかった妊婦は再度、妊娠24~28週に随時血糖測定(≧95または100mg/dLを陽性とする)あるいは50gグルコースチャレンジテスト(GCT)(負荷後の血糖値≧140mg/dLを陽性とする)を行い、陽性の場合には75gOGTTを行う。
  1. 産婦人科診療ガイドラインによると、妊娠初期に随時血糖測定(カットオフ値は各施設で独自に設定する)を行い、スクリーニングで陰性であった妊婦もしくは75gOGTTで診断に至らなかった妊婦は、妊娠24~28週に50gGCT(≧140mg/dLを陽性とする)あるいは随時血糖測定 (≧100mg/dLを陽性とする)を行う。
  1. 妊娠糖尿病は、75gOGTTで次の基準の1点以上を満たした場合に診断する。
  1. 空腹時血糖値 ≧92mg/dL
  1. 1時間値   ≧180mg/dL
  1. 2時間値   ≧153mg/dL
  1. 妊娠糖尿病の妊婦は分娩後に耐糖能が正常化しても糖尿病を発症するリスクが高いことから、分娩後早期からの糖代謝の再評価が必要であり、まずは分娩後6~12週に75gOGTT施行を行い、その後も定期的にフォローする必要がある。併せて食事療法や運動療法などの継続指導も行う。
  1. 妊娠中に発⾒された場合において、下記の基準を満たせば妊娠中の明らかな糖尿病とする。
妊娠中の明らかな糖尿病(妊娠中の糖代謝異常と診断基準より):以下のいずれかを満たした場合には“妊娠中の明らかな糖尿病、overt diabetes in pregnancy”と診断する。
  1. 空腹時血糖値≧126mg/dL
  1. HbA1c≧6.5%
※随時血糖値≧200mg/dLあるいは75gOGTTで2時間値≧200mg/dLの場合は、妊娠中の明らかな糖尿病の存在を念頭に置き、①または②の基準を満たすかどうか確認する。
  1. 妊娠中の明らかな糖尿病は、妊娠前から糖尿病があった可能性が高いが、妊娠中に糖代謝異常が発見された場合には、分類上ではこの「妊娠中の明らかな糖尿病」とされる。ただし、妊娠中に発見された場合でも確実な糖尿病網膜症があるものは糖尿病合併妊娠とする(この場合は糖尿病合併妊娠の項を参照)。
 
  1. 妊娠初期に妊娠糖尿病のスクリーニング検査を行うことは推奨される(推奨度2)
  1. 研究背景妊娠初期の空腹時血糖値と周産期合併症発症との関係を示した研究がある。
  1. 研究事例の説明2009年のRiskin-Mashiahらの発表では、retrospectiveに6,129人の妊娠初期妊婦(平均妊娠9.5週)について、空腹時血糖値と周産期合併症発症の後ろ向き解析をしている。空腹時血糖値が<75mg/dLと100~105mg/dLでは、それぞれ妊娠糖尿病発症頻度は1.0%と11.7%(OR 11.92、95%CI 5.39~26.37)、LGA児・巨大児の頻度は7.9%と19.4%(OR 2.82、95%CI 1.67~4.76)、帝王切開率は12.7%と20.0%(OR 1.94、95%CI 1.11~3.41)であった。よって、妊娠初期の軽度の空腹時血糖値上昇と周産期合併症発症リスクには関係があることが認められた[1]
  1. 結論妊娠初期に空腹時血糖値で妊娠糖尿病のスクリーニング検査を行うことは、周産期合併症発症リスクを低減することから、おそらく推奨される。
  1. 追記日本の糖尿病診療ガイドラインおよび産婦人科診療ガイドラインにおいても、妊娠初期に妊娠糖尿病スクリーニング検査を行うことは奨められている[2][3]
 
  1. 随時血糖値で妊娠糖尿病のスクリーニング検査を行うことは推奨される(推奨度2)
  1. 研究背景妊娠糖尿病のスクリーニング法が検討された研究がある。
  1. 研究事例の説明2006年に杉山隆らにより日本で行われた、妊娠糖尿病のスクリーニング法を検討する多施設共同prospective study(前向き研究)がある。これによると、妊娠糖尿病のスクリーニング検査を随時血糖値と50gGCTで比較し、妊娠初期では随時血糖値のカットオフ値を95mg/dLとすると感度61.5%・特異度85.1%、50gGCTのカットオフ値を140mg/dLとすると感度66.7%・特異度90.2%だった。コストパフォーマンスの検討では、随時血糖測定が最も安価であった。妊娠中期では50gGCTのカットオフ値を140mg/dLとすると感度・特異度が高く、コストパフォーマンスにおいても50gGCTが最も安価であった[4]
  1. 結論検査の精度とコストパフォーマンスの点で、妊娠糖尿病スクリーニング法は妊娠初期には随時血糖測定のカットオフ値を95mg/dL、妊娠中期には50gGCTのカットオフ値を140mg/dLとすることが、おそらく推奨される。
  1. 追記これらの結果を踏まえ、糖尿病診療ガイドラインでは、妊娠初期に随時血糖測定(≧95または100mg/dLを陽性)を行い、陰性であった場合には妊娠24~28週にスクリーニング検査として随時血糖測定(≧100mg/dLを陽性)あるいは50gグルコースチャレンジテスト(GCT)(負荷後の血糖値≧140mg/dLを陽性とする)の施行を推奨している[2]。産婦人科診療ガイドラインでも、妊娠初期に随時血糖測定(カットオフ値は各施設で設定可能)、妊娠24~28週に50gGCT (≧140mg/dLを陽性) の実施を推奨し、50gGCTが施行困難な場合は随時血糖測定 (≧100mg/dLを陽性) での判定でもよいとしている[3]
 
  1. 全妊婦に妊娠糖尿病スクリーニング検査を行うことは推奨される(推奨度2)
  1. 研究背景妊娠糖尿病スクリーニング検査を全妊婦に行うか、危険因子を持つ妊婦のみに行うかを検討した研究がある。
  1. 研究事例の説明2000年のGriffinらのRCTによると、妊娠糖尿病の診断率は、全妊婦にスクリーニング検査を行った群では2.7%、危険因子を持つ妊婦のみにスクリーニング検査を行った群では1.45%(P<0.03)だった。また妊娠糖尿病と診断された時期は、全妊婦にスクリーニング検査を行った群では30±2.6週、危険因子を持つ妊婦のみにスクリーニング検査を行った群では33±3.7週 (P<0.05)だった。さらに、全妊婦にスクリーニング検査を行い早期に妊娠糖尿病と診断された群で、巨大児出産、帝王切開、前子癇けいれん、NICU入院率はより低く、一方、経腟分娩率は高かった[5]
  1. 結論全妊婦に対する妊娠糖尿病スクリーニング検査は、危険因子を持つ妊婦にのみスクリーニング検査を行うよりも、多くの患者を早期に診断する助けになり、周産期合併症発症率の改善にも関係することから、おそらく推奨される。
  1. 追記日本の糖尿病診療ガイドラインと産婦人科診療ガイドラインでも、全妊婦に対して妊娠糖尿病スクリーニング検査を行うことが推奨されている[2][3]
病歴・診察のポイント  
  1. 妊娠前BMI、糖尿病歴、妊娠糖尿病歴、過度の体重増加、尿糖陽性、糖尿病家族歴、巨大児出産歴、年齢を確認する。

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文献 

Shlomit Riskin-Mashiah, Grace Younes, Amit Damti, Ron Auslender
First-trimester fasting hyperglycemia and adverse pregnancy outcomes.
Diabetes Care. 2009 Sep;32(9):1639-43. doi: 10.2337/dc09-0688. Epub 2009 Jun 23.
Abstract/Text OBJECTIVE: The Hyperglycemia and Adverse Pregnancy Outcome (HAPO) study found strong associations between higher levels of maternal glucose at 24-32 weeks, within what is currently considered normoglycemia and adverse pregnancy outcomes. Our aim was to evaluate the associations between first-trimester fasting plasma glucose level and adverse pregnancy outcomes.
RESEARCH DESIGN AND METHODS: Charts of all patients who delivered at our hospital between June 2001 and June 2006 were reviewed. Only subjects with singleton pregnancy and a recorded first-trimester fasting glucose level were included. Women with pregestational diabetes, fasting glucose level >105 mg/dl, or delivery <24 weeks were excluded. Fasting glucose levels were analyzed in seven categories, similar to the HAPO study. The main outcomes were development of gestational diabetes mellitus (GDM), large-for-gestational-age (LGA) neonates and/or macrosomia, and primary cesarean section. Multivariate logistic regression analysis was used; significance was <0.05.
RESULTS: A total of 6,129 women had a fasting glucose test at median of 9.5 weeks. There were strong, graded associations between fasting glucose level and primary outcomes. The frequency of GDM development increased from 1.0% in the lowest glucose category to 11.7% in the highest (adjusted odds ratio 11.92 [95% CI 5.39-26.37]). The frequency of LGA neonates and/or macrosomia increased from 7.9 to 19.4% (2.82 [1.67-4.76]). Primary cesarean section rate increased from 12.7 to 20.0% (1.94 [1.11-3.41]).
CONCLUSIONS: Higher first-trimester fasting glucose levels, within what is currently considered a nondiabetic range, increase the risk of adverse pregnancy outcomes. Early detection and treatment of women at high risk for these complications might improve pregnancy outcome.

PMID 19549728
M E Griffin, M Coffey, H Johnson, P Scanlon, M Foley, J Stronge, N M O'Meara, R G Firth
Universal vs. risk factor-based screening for gestational diabetes mellitus: detection rates, gestation at diagnosis and outcome.
Diabet Med. 2000 Jan;17(1):26-32.
Abstract/Text AIMS: Gestational diabetes mellitus (GDM) is associated with adverse maternal and fetal outcome. Screening for GDM is therefore recommended but the best screening method remains controversial. This prospective, randomized study compared a risk factor-based screening programme with a universally based one.
METHODS: Subjects were randomized at booking to one of two groups: the risk factor group had a 3-h 100-g oral glucose tolerance test (OGTT) at 32 weeks if any risk factor for GDM was present; the universal group had a 50-g glucose challenge test performed and if their plasma glucose at 1 h was > or = 7.8 mmol/l, a formal 3-h 100-g OGTT was then performed.
RESULTS: Universal screening detected a prevalence of GDM of 2.7%, significantly more than the 1.45% detected in the risk factor screened group (P<0.03). Universal screening facilitated earlier diagnosis than risk factor screening - mean gestation 30 +/- 2.6 weeks vs. 33 +/- 3.7 weeks (P<0.05). A higher rate of spontaneous vaginal delivery at term, and lower rates of macrosomia, Caesarean section, prematurity, pre-eclampsia and admission to neonatal intensive care unit were observed in the universally screened, early diagnosis group.
CONCLUSIONS: Universal screening for GDM is superior to risk factor based screening-detecting more cases, facilitating early diagnosis and is associated with improved pregnancy outcome.

PMID 10691156
M R Torloni, A P Betrán, B L Horta, M U Nakamura, A N Atallah, A F Moron, O Valente
Prepregnancy BMI and the risk of gestational diabetes: a systematic review of the literature with meta-analysis.
Obes Rev. 2009 Mar;10(2):194-203. doi: 10.1111/j.1467-789X.2008.00541.x. Epub 2008 Nov 24.
Abstract/Text The objective of this study is to assess and quantify the risk for gestational diabetes mellitus (GDM) according to prepregnancy maternal body mass index (BMI). The design is a systematic review of observational studies published in the last 30 years. Four electronic databases were searched for publications (1977-2007). BMI was elected as the only measure of obesity, and all diagnostic criteria for GDM were accepted. Studies with selective screening for GDM were excluded. There were no language restrictions. The methodological quality of primary studies was assessed. Some 1745 citations were screened, and 70 studies (two unpublished) involving 671 945 women were included (59 cohorts and 11 case-controls). Most studies were of high or medium quality. Compared with women with a normal BMI, the unadjusted pooled odds ratio (OR) of an underweight woman developing GDM was 0.75 (95% confidence interval [CI] 0.69 to 0.82). The OR for overweight, moderately obese and morbidly obese women were 1.97 (95% CI 1.77 to 2.19), 3.01 (95% CI 2.34 to 3.87) and 5.55 (95% CI 4.27 to 7.21) respectively. For every 1 kg m(-2) increase in BMI, the prevalence of GDM increased by 0.92% (95% CI 0.73 to 1.10). The risk of GDM is positively associated with prepregnancy BMI. This information is important when counselling women planning a pregnancy.

PMID 19055539
HAPO Study Cooperative Research Group, Boyd E Metzger, Lynn P Lowe, Alan R Dyer, Elisabeth R Trimble, Udom Chaovarindr, Donald R Coustan, David R Hadden, David R McCance, Moshe Hod, Harold David McIntyre, Jeremy J N Oats, Bengt Persson, Michael S Rogers, David A Sacks
Hyperglycemia and adverse pregnancy outcomes.
N Engl J Med. 2008 May 8;358(19):1991-2002. doi: 10.1056/NEJMoa0707943.
Abstract/Text BACKGROUND: It is controversial whether maternal hyperglycemia less severe than that in diabetes mellitus is associated with increased risks of adverse pregnancy outcomes.
METHODS: A total of 25,505 pregnant women at 15 centers in nine countries underwent 75-g oral glucose-tolerance testing at 24 to 32 weeks of gestation. Data remained blinded if the fasting plasma glucose level was 105 mg per deciliter (5.8 mmol per liter) or less and the 2-hour plasma glucose level was 200 mg per deciliter (11.1 mmol per liter) or less. Primary outcomes were birth weight above the 90th percentile for gestational age, primary cesarean delivery, clinically diagnosed neonatal hypoglycemia, and cord-blood serum C-peptide level above the 90th percentile. Secondary outcomes were delivery before 37 weeks of gestation, shoulder dystocia or birth injury, need for intensive neonatal care, hyperbilirubinemia, and preeclampsia.
RESULTS: For the 23,316 participants with blinded data, we calculated adjusted odds ratios for adverse pregnancy outcomes associated with an increase in the fasting plasma glucose level of 1 SD (6.9 mg per deciliter [0.4 mmol per liter]), an increase in the 1-hour plasma glucose level of 1 SD (30.9 mg per deciliter [1.7 mmol per liter]), and an increase in the 2-hour plasma glucose level of 1 SD (23.5 mg per deciliter [1.3 mmol per liter]). For birth weight above the 90th percentile, the odds ratios were 1.38 (95% confidence interval [CI], 1.32 to 1.44), 1.46 (1.39 to 1.53), and 1.38 (1.32 to 1.44), respectively; for cord-blood serum C-peptide level above the 90th percentile, 1.55 (95% CI, 1.47 to 1.64), 1.46 (1.38 to 1.54), and 1.37 (1.30 to 1.44); for primary cesarean delivery, 1.11 (95% CI, 1.06 to 1.15), 1.10 (1.06 to 1.15), and 1.08 (1.03 to 1.12); and for neonatal hypoglycemia, 1.08 (95% CI, 0.98 to 1.19), 1.13 (1.03 to 1.26), and 1.10 (1.00 to 1.12). There were no obvious thresholds at which risks increased. Significant associations were also observed for secondary outcomes, although these tended to be weaker.
CONCLUSIONS: Our results indicate strong, continuous associations of maternal glucose levels below those diagnostic of diabetes with increased birth weight and increased cord-blood serum C-peptide levels.

Copyright 2008 Massachusetts Medical Society.
PMID 18463375
International Association of Diabetes and Pregnancy Study Groups Consensus Panel, Boyd E Metzger, Steven G Gabbe, Bengt Persson, Thomas A Buchanan, Patrick A Catalano, Peter Damm, Alan R Dyer, Alberto de Leiva, Moshe Hod, John L Kitzmiler, Lynn P Lowe, H David McIntyre, Jeremy J N Oats, Yasue Omori, Maria Ines Schmidt
International association of diabetes and pregnancy study groups recommendations on the diagnosis and classification of hyperglycemia in pregnancy.
Diabetes Care. 2010 Mar;33(3):676-82. doi: 10.2337/dc09-1848.
Abstract/Text
PMID 20190296
Yuji Hiramatsu, Ikki Shimizu, Yasue Omori, Masao Nakabayashi, JGA (Japan Glycated Albumin) Study Group
Determination of reference intervals of glycated albumin and hemoglobin A1c in healthy pregnant Japanese women and analysis of their time courses and influencing factors during pregnancy.
Endocr J. 2012;59(2):145-51. doi: 10.1507/endocrj.k10e-410. Epub 2011 Dec 14.
Abstract/Text Glycemic control is an important issue in gestational diabetes mellitus (GDM) and in diabetic pregnant women. We determined the reference intervals of glycated albumin (GA) and hemoglobin A1c (HbA1c) as glycemic control markers in healthy Japanese pregnant women and analyzed their time courses and factors that influence these variables during pregnancy. 676 women were screened for the present study. After the exclusion of non-pregnant and puerperal women, 574 women were studied to determine the reference intervals. HbA1c, GA, casual plasma glucose, urinary glucose, urinary protein, and body mass index (BMI) (non-pregnancy) were measured. HbA1c levels significantly decreased in the second trimester of pregnancy and increased in the third trimester, while GA levels significantly decreased towards the third trimester. Casual plasma glucose levels decreased in the first trimester and subsequently remained constant. The reference intervals of GA and HbA1c in the healthy pregnant women were 11.5-15.7% and 4.5-5.7%, respectively. GA levels were lower (p<0.01) and HbA1c levels were higher (p<0.05) in pregnant women with proteinuria. In the obese group, GA levels were lower (p<0.01) than those of the control group (18.5≤ BMI <25kg/m²), and HbA1c levels were higher (p<0.01) than those of the control group. On the basis of the results of this multicenter study, the reference intervals of GA and HbA1c in healthy Japanese pregnant women were determined. Strict glycemic control is essential to reduce perinatal complications. GA appears to be a useful marker for pregnant women, since it can be measured easily and changes rapidly and markedly.

PMID 22166921
Otilia Perichart-Perera, Margie Balas-Nakash, Adalberto Parra-Covarrubias, Ameyalli Rodriguez-Cano, Aurora Ramirez-Torres, Carlos Ortega-González, Felipe Vadillo-Ortega
A medical nutrition therapy program improves perinatal outcomes in Mexican pregnant women with gestational diabetes and type 2 diabetes mellitus.
Diabetes Educ. 2009 Nov-Dec;35(6):1004-13. doi: 10.1177/0145721709343125. Epub 2009 Aug 20.
Abstract/Text UNLABELLED: Diabetes in pregnancy is a major public health problem in Mexico. Nutrition therapy is an important component of treatment. Intensive nutrition intervention has not been implemented for Mexican pregnant women with diabetes. Its effect on different types of diabetes mellitus has not been studied.
PURPOSE: The authors assessed the effect of a medical nutrition therapy (MNT) program on perinatal complications in Mexico City.
METHODS: Quasi-experimental design with a historical control. Women were assigned to a MNT program (n = 88) and were followed up with every 2 weeks until delivery (2004-2007). The control group (n = 86) was selected from medical charts (2001-2003) and the same inclusion criteria were used. In each group, 55% of women had type 2 diabetes mellitus and 45% had gestational diabetes. The MNT program included a moderate intake of carbohydrate (40%-45% of total energy) and reduction in energy intake, capillary glucose self-monitoring, and education. The control group received usual hospital routine care. Statistical analysis included descriptive statistics, chi-square, and multivariate logistic regression (OR, 95% CI) as indicated.
RESULTS: Women in the MNT program had a lower risk of preeclampsia, fewer maternal hospitalization, and neonatal deaths in both types of diabetes. Low birth weight was less frequent only in women with gestational diabetes receiving MNT, while neonatal intensive care unit admissions were lower only in women with type 2 diabetes.
CONCLUSIONS: An intensive MNT program, including counseling, education, and capillary glucose self-monitoring, has a positive effect over preeclampsia, maternal hospitalization, and neonatal death in women with diabetes in pregnancy. MNT guidelines should be implemented in Mexican health care facilities treating diabetes in pregnancy.

PMID 19696205
Carol A Snapp, Sue K Donaldson
Gestational diabetes mellitus: physical exercise and health outcomes.
Biol Res Nurs. 2008 Oct;10(2):145-55. doi: 10.1177/1099800408323728.
Abstract/Text PURPOSE: Gestational diabetes mellitus (GDM) is a serious complication of pregnancy associated with increased risk of adverse outcomes for both mother and infant. This study assesses the association of maternal exercise during GDM pregnancy and selected maternal and infant adverse GDM-related outcomes. The analysis uses information derived from the 1988 National Maternal Infant Health Survey (NMIHS) data.
METHODS: Women in the 1988 NMIHS database were identified and grouped as to having experienced a non-GDM (n = 2,952,482) or GDM (n = 105,600) pregnancy. Non-GDM and GDM groups were compared as to demographic and personal-attribute variables. The second part of this study focused on the women with GDM pregnancy, specifically a subset (n = 75,160) who met inclusion/exclusion criteria for the study of exercise during pregnancy. Each was categorized to either the exercise group or the nonexercise group.
RESULTS: The non-GDM and GDM groups of pregnant women were not different as to the variables studied, except that older age and increased body mass index (BMI) were associated with GDM pregnancy. For the study of exercise during GDM pregnancy, the only variable that was associated with the exercise group was size of the infant. Participants in the exercise group were less likely than those in the nonexercise group to have delivered a large for gestational age (LGA) infant (F [1, 4314] = 9.82, p = .0017).
IMPLICATIONS: The results of this study suggest that moderate maternal leisure time physical exercise during GDM pregnancy may reduce the risk of delivery of an LGA infant.

PMID 18829598
Jaya Saxena Dhulkotia, Bolarinde Ola, Robert Fraser, Tom Farrell
Oral hypoglycemic agents vs insulin in management of gestational diabetes: a systematic review and metaanalysis.
Am J Obstet Gynecol. 2010 Nov;203(5):457.e1-9. doi: 10.1016/j.ajog.2010.06.044. Epub 2010 Aug 24.
Abstract/Text OBJECTIVE: The objective of this review was to provide pooled estimates of randomized controlled trials comparing the effects of oral hypoglycemic agents with insulin in achieving glycemic control and to study the maternal and perinatal outcomes in gestational diabetes mellitus.
STUDY DESIGN: A protocol for the study was developed. All metaanalyses were performed using Stats Direct statistical software (Stats Direct Ltd, Cheshire, UK).
RESULTS: Six studies comprising 1388 subjects were analyzed. No significant differences were found in maternal fasting (weighted mean difference [WMD], 1.31; 95% confidence interval [CI], 0.81-3.43) or postprandial (WMD, 0.80; 95% CI, -3.26 to 4.87) glycemic control. Use of oral hypoglycemic agents (OHAs) was not associated with risk of neonatal hypoglycemia (odds ratio [OR], 1.59; 95% CI, 0.70-3.62), increased birthweight (WMD, 56.11; 95% CI, -42.62 to 154.84), incidence of caesarean section (OR, 0.91; 95% CI, -0.68 to 1.22), or incidence of large-for-gestational-age babies (OR, 1.01; 95% CI, 0.61-1.68).
CONCLUSION: Our study demonstrates that there are no differences in glycemic control or pregnancy outcomes when OHAs were compared with insulin.

Copyright © 2010 Mosby, Inc. All rights reserved.
PMID 20739011
Sumeet R Singh, Fida Ahmad, Avtar Lal, Changhua Yu, Zemin Bai, Heather Bennett
Efficacy and safety of insulin analogues for the management of diabetes mellitus: a meta-analysis.
CMAJ. 2009 Feb 17;180(4):385-97. doi: 10.1503/cmaj.081041.
Abstract/Text BACKGROUND: Although insulin analogues are commonly prescribed for the management of diabetes mellitus, there is uncertainty regarding their optimal use. We conducted meta-analyses to compare the outcomes of insulin analogues with conventional insulins in the treatment of type 1, type 2 and gestational diabetes.
METHODS: We updated 2 earlier systematic reviews of the efficacy and safety of rapid-and long-acting insulin analogues. We searched electronic databases, conference proceedings and "grey literature" up to April 2007 to identify randomized controlled trials that compared insulin analogues with conventional insulins. Study populations of interest were people with type 1 and type 2 diabetes (adult and pediatric) and women with gestational diabetes.
RESULTS: We included 68 randomized controlled trials in the analysis of rapid-acting insulin analogues and 49 in the analysis of long-acting insulin analogues. Most of the studies were of short to medium duration and of low quality. In terms of hemoglobin A1c, we found minimal differences between rapid-acting insulin analogues and regular human insulin in adults with type 1 diabetes (weighted mean difference for insulin lispro: -0.09%, 95% confidence interval [CI] -0.16% to -0.02%; for insulin aspart: -0.13%, 95% CI -0.20% to -0.07%). We observed similar outcomes among patients with type 2 diabetes (weighted mean difference for insulin lispro: -0.03%, 95% CI -0.12% to -0.06%; for insulin aspart: -0.09%, 95% CI -0.21% to 0.04%). Differences between long-acting insulin analogues and neutral protamine Hagedorn insulin in terms of hemoglobin A1c were marginal among adults with type 1 diabetes (weighted mean difference for insulin glargine: -0.11%, 95% CI -0.21% to -0.02%; for insulin detemir: -0.06%, 95% CI -0.13% to 0.02%) and among adults with type 2 diabetes (weighted mean difference for insulin glargine: -0.05%, 95% CI -0.13% to 0.04%; for insulin detemir: 0.13%, 95% CI 0.03% to 0.22%). Benefits in terms of reduced hypoglycemia were inconsistent. There were insufficient data to determine whether insulin analogues are better than conventional insulins in reducing long-term diabetes-related complications or death.
INTERPRETATION: Rapid-and long-acting insulin analogues offer little benefit relative to conventional insulins in terms of glycemic control or reduced hypoglycemia. Long-term, high-quality studies are needed to determine whether insulin analogues reduce the risk of long-term complications of diabetes.

PMID 19221352
Elisabeth R Mathiesen, Brendan Kinsley, Stephanie A Amiel, Simon Heller, David McCance, Santiago Duran, Shannon Bellaire, Anne Raben, Insulin Aspart Pregnancy Study Group
Maternal glycemic control and hypoglycemia in type 1 diabetic pregnancy: a randomized trial of insulin aspart versus human insulin in 322 pregnant women.
Diabetes Care. 2007 Apr;30(4):771-6. doi: 10.2337/dc06-1887.
Abstract/Text OBJECTIVE: To assess the safety and efficacy of insulin aspart (IAsp) versus regular human insulin (HI) in basal-bolus therapy with NPH insulin in pregnant women with type 1 diabetes.
RESEARCH DESIGN AND METHODS: Subjects (n = 322) who were pregnant or planning pregnancy were randomized to IAsp or HI as meal-time insulin in an open-label, parallel-group, multicenter study. Subjects had A1C < or =8% at confirmation of pregnancy. Insulin doses were titrated toward predefined glucose targets and A1C <6.5%. Outcomes assessed included risk of major maternal hypoglycemia, A1C, plasma glucose profiles, and maternal safety outcomes.
RESULTS: Major hypoglycemia occurred at a rate of 1.4 vs. 2.1 episodes/year exposure with IAsp and HI, respectively (relative risk 0.720 [95% CI 0.36-1.46]). Risk of major/major nocturnal hypoglycemia was 52% (RR 0.48 [0.20-1.143]; P = NS) lower with IAsp compared with HI. A1C was comparable with human insulin in second (IAsp-HI -0.04 [-0.18 to 0.11]) and third (-0.08 [-0.23 to 0.06]) trimesters. A total of 80% of subjects achieved an A1C < or =6.5%. At the end of first and third trimesters, average postprandial plasma glucose increments were significantly lower with IAsp than HI (P = 0.003 and P = 0.044, respectively), as were mean plasma glucose levels 90 min after breakfast (P = 0.044 and P = 0.001, respectively). Maternal safety profiles and pregnancy outcomes were similar between treatments.
CONCLUSIONS: IAsp is at least as safe and effective as HI when used in basal-bolus therapy with NPH insulin in pregnant women with type 1 diabetes and may potentially offer some benefits in terms of postprandial glucose control and preventing severe hypoglycemia.

PMID 17392539
Erika Pollex, Myla E Moretti, Gideon Koren, Denice S Feig
Safety of insulin glargine use in pregnancy: a systematic review and meta-analysis.
Ann Pharmacother. 2011 Jan;45(1):9-16. doi: 10.1345/aph.1P327. Epub 2011 Jan 4.
Abstract/Text BACKGROUND: The prevalence of diabetes in women of childbearing age is increasing. As such, the number of pregnancies complicated by diabetes will inevitably increase. New insulin analogues such as the long-acting analogue insulin glargine may represent beneficial treatment options in pregnancy by ensuring that patients achieve excellent glycemic control without risk of maternal hypoglycemia.
OBJECTIVE: To determine the fetal safety of insulin glargine use in the treatment of diabetes in pregnancy compared with NPH insulin therapy.
METHODS: A systematic review and meta-analysis was performed of all original human studies that reported neonatal outcomes among women with pregestational or gestational diabetes who were managed with either insulin glargine or NPH insulin during pregnancy. A systematic literature search was conducted using MEDLINE, EMBASE, CINAHL, the Cochrane Central Register for Controlled Trials database, and Web of Science from 1980 to June 1, 2010. Outcomes included large size for gestational age, macrosomia, neonatal hypoglycemia, neonatal intensive care unit admissions, birth trauma, congenital anomalies, preterm delivery, perinatal mortality, respiratory distress, and hyperbilirubinemia. Relative risk ratios and weighted mean differences were computed with 95% confidence intervals.
RESULTS: Eight studies reporting on a total of 702 women with pregestational or gestational diabetes in pregnancy treated with either insulin glargine (n = 331) or NPH insulin (n = 371) met the inclusion criteria. There were no statistically significant differences in the occurrence of fetal outcomes studied with the use of insulin glargine compared to NPH insulin.
CONCLUSIONS: No evidence has been documented for increased adverse fetal outcomes with the use of insulin glargine in pregnancy compared to the use of NPH insulin. These results increase the choices for women requiring basal insulin therapy in pregnancy.

PMID 21205954
Elisabeth R Mathiesen, Moshe Hod, Marina Ivanisevic, Santiago Duran Garcia, Lise Brøndsted, Lois Jovanovic, Peter Damm, David R McCance, Detemir in Pregnancy Study Group
Maternal efficacy and safety outcomes in a randomized, controlled trial comparing insulin detemir with NPH insulin in 310 pregnant women with type 1 diabetes.
Diabetes Care. 2012 Oct;35(10):2012-7. doi: 10.2337/dc11-2264. Epub 2012 Jul 30.
Abstract/Text OBJECTIVE: This randomized, controlled noninferiority trial aimed to compare the efficacy and safety of insulin detemir (IDet) versus neutral protamine Hagedorn (NPH) (both with prandial insulin aspart) in pregnant women with type 1 diabetes.
RESEARCH DESIGN AND METHODS: Patients were randomized and exposed to IDet or NPH up to 12 months before pregnancy or at 8-12 weeks gestation. The primary analysis aimed to demonstrate noninferiority of IDet to NPH with respect to A1C at 36 gestational weeks (GWs) (margin of 0.4%). The data were analyzed using linear regression, taking several baseline factors and covariates into account.
RESULTS: A total of 310 type 1 diabetic women were randomized and exposed to IDet (n = 152) or NPH (n = 158) up to 12 months before pregnancy (48%) or during pregnancy at 8-12 weeks (52%). The estimated A1C at 36 GWs was 6.27% for IDet and 6.33% for NPH in the full analysis set (FAS). IDet was declared noninferior to NPH (FAS, -0.06% [95% CI -0.21 to 0.08]; per protocol, -0.15% [-0.34 to 0.04]). Fasting plasma glucose (FPG) was significantly lower with IDet versus NPH at both 24 GWs (96.8 vs. 113.8 mg/dL, P = 0.012) and 36 GWs (85.7 vs. 97.4 mg/dL, P = 0.017). Major and minor hypoglycemia rates during pregnancy were similar between groups.
CONCLUSIONS: Treatment with IDet resulted in lower FPG and noninferior A1C in late pregnancy compared with NPH insulin. Rates of hypoglycemia were comparable.

PMID 22851598

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