Basal Insulin Analogs versus Neutral Protamine Hagedorn for Type 2 Diabetics

Michal Fishel Bartal; Clara Ward; Jerrie S. Refuerzo; Sunbola S. Ashimi; Cornthwaite A. Joycelyn; Han-Yang Chen; Suneet P. Chauhan; Baha M. Sibai

doi:10.1055/s-0039-1694733

American Journal of Perinatology, Inhaltsverzeichnis

Am J Perinatol 2020; 37(01): 030-036
DOI: 10.1055/s-0039-1694733

SMFM 2019

Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Basal Insulin Analogs versus Neutral Protamine Hagedorn for Type 2 Diabetics

Michal Fishel Bartal

¹Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, Texas

,

Clara Ward

¹Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, Texas

,

Jerrie S. Refuerzo

¹Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, Texas

,

Sunbola S. Ashimi

¹Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, Texas

,

Cornthwaite A. Joycelyn

¹Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, Texas

,

Han-Yang Chen

¹Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, Texas

,

Suneet P. Chauhan

¹Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, Texas

,

Baha M. Sibai

¹Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, University of Texas Health Science Center at Houston, Houston, Texas

› Institutsangaben

Abstract

Objective To determine whether basal insulin analogs reduce the rate of composite neonatal morbidity compared with neutral protamine Hagedorn (NPH) in women with type 2 diabetes mellitus (T2DM).

Study Design This was a retrospective cohort study of women with T2DM and singleton pregnancy at a single tertiary center. Primary outcome was a composite neonatal morbidity of any of the following: shoulder dystocia, large for gestational age, neonatal intensive care unit admission, neonatal hypoglycemia, or respiratory distress syndrome. Secondary outcomes were rates of maternal hypoglycemic events, hypertensive disorders, preterm birth, and primary cesarean delivery. Adjusted relative risk (aRR) and 95% confidence intervals (CI) were calculated.

Results Of 233 women with T2DM that met the inclusion criteria, 114 (49%) were treated with basal insulin analogs and 119 (51%) with NPH. The rate of composite neonatal morbidity was similar between groups (73 vs. 60%; aRR: 1.18; 95% CI: 0.92–1.51). There were no differences in the rates of maternal adverse outcomes between the groups. Basal insulin analog was associated with a lower rate of primary cesarean delivery as compared with NPH (21 vs. 36%; aRR: 0.44; 95% CI: 0.25–0.78).

Conclusion Among pregnant women with T2DM managed with either basal or NPH insulin regimen, the rates of composite neonatal morbidity and maternal complications were similar.

Keywords

diabetes - insulin - preterm birth - large for gestational age - neonatal hypoglycemia

Volltext

Referenzen

Reference
1 Fridman M, Korst LM, Chow J, Lawton E, Mitchell C, Gregory KD. Trends in maternal morbidity before and during pregnancy in California. Am J Public Health 2014; 104 (Suppl. 01) S49-S57
2 Lawrence JM, Contreras R, Chen W, Sacks DA. Trends in the prevalence of preexisting diabetes and gestational diabetes mellitus among a racially/ethnically diverse population of pregnant women, 1999-2005. Diabetes Care 2008; 31 (05) 899-904
3 Feig DS, Hwee J, Shah BR, Booth GL, Bierman AS, Lipscombe LL. Trends in incidence of diabetes in pregnancy and serious perinatal outcomes: a large, population-based study in Ontario, Canada, 1996-2010. Diabetes Care 2014; 37 (06) 1590-1596
4 Metcalfe A, Sabr Y, Hutcheon JA. , et al. Trends in obstetric intervention and pregnancy outcomes of Canadian women with diabetes in pregnancy from 2004 to 2015. J Endocr Soc 2017; 1 (12) 1540-1549
5 Hartling L, Dryden DM, Guthrie A, Muise M, Vandermeer B, Donovan L. Benefits and harms of treating gestational diabetes mellitus: a systematic review and meta-analysis for the U.S. Preventive Services Task Force and the National Institutes of Health Office of Medical Applications of Research. Ann Intern Med 2013; 159 (02) 123-129
6 Tennant PW, Glinianaia SV, Bilous RW, Rankin J, Bell R. Pre-existing diabetes, maternal glycated haemoglobin, and the risks of fetal and infant death: a population-based study. Diabetologia 2014; 57 (02) 285-294
7 American Diabetes Association. 13. Management of diabetes in pregnancy. Diabetes Care 2017; 40 (Suppl. 01) S114-S119
8 American Diabetes Association. 8. pharmacologic approaches to glycemic treatment: standards of medical care in diabetes-2018 . Diabetes Care 2018; 41 (Suppl. 01) S73-S85
9 ACOG Practice Bulletin No. ACOG Practice Bulletin No. 201: pregestational diabetes mellitus. Obstet Gynecol 2018; 132 (06) e228-e248
10 O'Neill SM, Kenny LC, Khashan AS, West HM, Smyth RM, Kearney PM. Different insulin types and regimens for pregnant women with pre-existing diabetes. Cochrane Database Syst Rev 2017; 2: CD011880
11 Alexander GR, Kogan MD, Himes JH. 1994-1996 U.S. singleton birth weight percentiles for gestational age by race, Hispanic origin, and gender. Matern Child Health J 1999; 3 (04) 225-231
12 Thornton PS, Stanley CA, De Leon DD. , et al; Pediatric Endocrine Society. Recommendations from the Pediatric Endocrine Society for evaluation and management of persistent hypoglycemia in neonates, infants, and children. J Pediatr 2015; 167 (02) 238-245
13 Bernard GR, Artigas A, Brigham KL. , et al. The American-European Consensus Conference on ARDS. Definitions, mechanisms, relevant outcomes, and clinical trial coordination. Am J Respir Crit Care Med 1994; 149 (3 Pt 1): 818-824
14 American College of Obstetricians and Gynecologists; Task Force on Hypertension in Pregnancy. Hypertension in pregnancy. Report of the American College of Obstetricians and Gynecologists' Task Force on Hypertension in Pregnancy. Obstet Gynecol 2013; 122 (05) 1122-1131
15 Jenner ZB, O'Neil Dudley AE, Mendez-Figueroa H, Ellis VS, Chen HY, Chauhan SP. Morbidity associated with fetal macrosomia among women with diabetes mellitus. Am J Perinatol 2018; 35 (05) 515-520
16 Lepore M, Pampanelli S, Fanelli C. , et al. Pharmacokinetics and pharmacodynamics of subcutaneous injection of long-acting human insulin analog glargine, NPH insulin, and ultralente human insulin and continuous subcutaneous infusion of insulin lispro. Diabetes 2000; 49 (12) 2142-2148
17 Tibaldi JM. Evolution of insulin development: focus on key parameters. Adv Ther 2012; 29 (07) 590-619
18 Frier BM, Russell-Jones D, Heise T. A comparison of insulin detemir and neutral protamine Hagedorn (isophane) insulin in the treatment of diabetes: a systematic review. Diabetes Obes Metab 2013; 15 (11) 978-986
19 Solomon MD, Vijan S, Forma FM, Conrad RM, Summers NT, Lakdawalla DN. The impact of insulin type on severe hypoglycaemia events requiring inpatient and emergency department care in patients with type 2 diabetes. Diabetes Res Clin Pract 2013; 102 (03) 175-182
20 Strandberg AY, Khanfir H, Mäkimattila S, Saukkonen T, Strandberg TE, Hoti F. Insulins NPH, glargine, and detemir, and risk of severe hypoglycemia among working-age adults. Ann Med 2017; 49 (04) 357-364
21 Rys P, Wojciechowski P, Rogoz-Sitek A. , et al. Systematic review and meta-analysis of randomized clinical trials comparing efficacy and safety outcomes of insulin glargine with NPH insulin, premixed insulin preparations or with insulin detemir in type 2 diabetes mellitus. Acta Diabetol 2015; 52 (04) 649-662
22 Bjekić-Macut J, Živković TB, Kocić R. Clinical benefit of basal insulin analogue treatment in persons with type 2 diabetes inadequately controlled on prior insulin therapy: a prospective, noninterventional, multicenter study. Diabetes Ther 2018; 9 (02) 651-662
23 Hod M, Mathiesen ER, Jovanovič L. , et al. A randomized trial comparing perinatal outcomes using insulin detemir or neutral protamine Hagedorn in type 1 diabetes. J Matern Fetal Neonatal Med 2014; 27 (01) 7-13
24 Mathiesen ER, Hod M, Ivanisevic M. , et al; 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; 35 (10) 2012-2017
25 Fang YM, MacKeen D, Egan JF, Zelop CM. Insulin glargine compared with neutral protamine Hagedorn insulin in the treatment of pregnant diabetics. J Matern Fetal Neonatal Med 2009; 22 (03) 249-253
26 Lv S, Wang J, Xu Y. Safety of insulin analogs during pregnancy: a meta-analysis. Arch Gynecol Obstet 2015; 292 (04) 749-756
27 Bimson BE, Rosenn BM, Morris SA, Sasso EB, Schwartz RA, Brustman LE. Current trends in the diagnosis and management of gestational diabetes mellitus in the United States. J Matern Fetal Neonatal Med 2017; 30 (21) 2607-2612
28 Herrera KM, Rosenn BM, Foroutan J. , et al. Randomized controlled trial of insulin detemir versus NPH for the treatment of pregnant women with diabetes. Am J Obstet Gynecol 2015; 213 (03) 426.e1-426.e7