insulin-glargine and Diabetes--Gestational

Diabetes during pregnancy has been linked to unfavorable maternal-fetal outcomes. Human insulins are the first drug of choice because of the proven safety in their use. However, there are still questions about the use of insulin analogs during pregnancy. The objective of the present study was to determine the effectiveness of insulin analogs compared with human insulin in the treatment of pregnant women with diabetes through a systematic review with meta-analysis. The search comprised the period since the inception of each database until July 2017, and the following databases were used: MEDLINE, CINAHL, EMBASE, ISI Web of Science, LILACS, Scopus, SIGLE and Google Scholar. We have selected 29 original articles: 11 were randomized clinical trials and 18 were observational studies. We have explored data from 6,382 participants. All of the articles were classified as having an intermediate to high risk of bias. The variable that showed favorable results for the use of insulin analogs was gestational age, with a mean difference of - 0.26 (95 % confidence interval [CI]: 0.03-0.49;. Diabetes durante a gestação tem sido relacionado a desfechos materno-fetais desfavoráveis. As insulinas humanas são a primeira escolha medicamentosa, devido à comprovada segurança no seu uso. Entretanto, ainda há questionamentos sobre o uso dos análogos da insulina na gestação. O objetivo do presente estudo foi determinar a efetividade dos análogos da insulina comparados às insulinas humanas no tratamento de gestantes com diabetes por meio de uma revisão sistemática com metanálise. A busca compreendeu desde o início de cada base de dados até julho de 2017, e foi realizada nos seguintes bancos de dados: MEDLINE, CINAHL, EMBASE, ISI Web of Science, LILACS, Scopus, SIGLE e Google Scholar. Selecionamos 29 artigos originais, sendo 11 ensaios clínicos randomizados e 18 estudos observacionais. Exploramos dados de 6.382 participantes. Todos os artigos foram classificados como sendo de intermediário a alto risco de viés. A variável que demonstrou resultado favorável ao uso dos análogos da insulina foi idade gestacional, com uma diferença média de - 0.26 (95% índice de confiança [IC]: 0.03–0.49;

Topics: Abortion, Spontaneous; Birth Weight; Diabetes Mellitus, Type 2; Diabetes, Gestational; Female; Fetal Macrosomia; Gestational Age; Humans; Hypoglycemia; Hypoglycemic Agents; Insulin; Insulin Aspart; Insulin Glargine; Insulin Lispro; Observational Studies as Topic; Pregnancy; Prenatal Care; Randomized Controlled Trials as Topic; Treatment Outcome

The objective of this study was to assess the safety of four insulin analogs (aspart, lispro, glargine, and detemir) for the treatment of diabetes in pregnancy.. We searched Embase, Pubmed, and the Cochrane Central Register for Controlled Trials database through May 31, 2014. All articles were reviewed by two independent researchers, and if a discrepancy was noted, a third researcher was consulted. Results data were summarized by RevMan 5.2 software.. Our search resulted in the retrieval and screening of 3519 studies. Of those, 24 studies met the eligibility criteria; the studies reported on a total of 3734 women with pre-gestational or gestational diabetes during pregnancy. The use of lispro was associated with lower rates of neonatal jaundice (RR = 0.63) and severe maternal hypoglycemia (RR = 0.33) than regular insulin. Lispro use was also associated with higher birth weight (WMD = 116.44) and an increased incidence of large for gestational age (LGA) births (RR = 1.42) compared with regular insulin. Rates of cesarean section and macrosomia were similar in pregnant women treated with aspart and regular insulin. Birth weights and rates of severe maternal hypoglycemia, respiratory dysfunction syndrome, and neonatal intensive care unit admission were similar after pregnant women were treated with glargine and NPH insulin. Rates of LGA, macrosomia, and neonatal hypoglycemia were similar after pregnant women were treated with detemir and NPH insulin.. Aspart, glargine, and detemir are safe treatment options for diabetes during pregnancy; these insulin analogs did not increase complications for the mothers or fetuses in our study. However, lispro was related to higher birth weight and increased rate of LGA in neonates. More high-quality randomized controlled trials are needed to clarify the best treatment options for diabetes during pregnancy.

Topics: Adult; Birth Weight; Diabetes, Gestational; Female; Glycated Hemoglobin; Humans; Hypoglycemic Agents; Infant, Newborn; Infant, Newborn, Diseases; Insulin; Insulin Aspart; Insulin Detemir; Insulin Glargine; Insulin Lispro; Pregnancy; Pregnancy in Diabetics; Pregnancy Outcome

Excellent glycaemic control is essential in pregnancy to optimise maternal and foetal outcomes. The aim of this review is to assess the efficacy and safety of insulin analogues in pregnancy. Insulin lispro and insulin aspart are safe in pregnancy and may improve post-prandial glycaemic control in women with type 1 diabetes. However, a lack of data indicating improved foetal outcomes would suggest that there is no imperative to switch to a short-acting analogue where the woman's diabetes is well controlled with human insulin. There are no reports of the use of insulin glulisine in pregnancy and so its use cannot be recommended. Most studies of insulin glargine in pregnancy are small, retrospective and include women with pre-existing diabetes and gestational diabetes. There appear to be no major safety concerns and so it seems reasonable to continue insulin glargine if required to achieve excellent glycaemic control. A head-to-head comparison between insulin detemir and NPH insulin in women with type 1 diabetes showed that while foetal outcomes did not differ, fasting plasma glucose improved with insulin detemir without an increased incidence of hypoglycaemia. The greater evidence base supports the use of insulin detemir as the first line long-acting analogue in pregnancy but the lack of definitive foetal benefits means that there is no strong need to switch a woman who is well controlled on NPH insulin. There seems little justification in using long acting insulin analogues in women with gestational diabetes or type 2 diabetes where the risk of hypoglycaemia is low.

Topics: Blood Glucose; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetes, Gestational; Dose-Response Relationship, Drug; Female; Glycated Hemoglobin; Humans; Hypoglycemia; Hypoglycemic Agents; Insulin; Insulin Detemir; Insulin Glargine; Insulin, Isophane; Insulin, Long-Acting; Pregnancy; Pregnancy in Diabetics; Randomized Controlled Trials as Topic; Treatment Outcome

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.. To determine the fetal safety of insulin glargine use in the treatment of diabetes in pregnancy compared with NPH insulin therapy.. 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.. 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.. 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.

Topics: Diabetes, Gestational; Female; Humans; Hypoglycemic Agents; Infant, Newborn; Infant, Newborn, Diseases; Insulin; Insulin Glargine; Insulin, Isophane; Insulin, Long-Acting; Male; Pregnancy; Pregnancy in Diabetics; Pregnancy Outcome; Risk Factors

It is well known that good metabolic control maintained throughout pregnancy reduces maternal and fetal complications in diabetes. Before conception and throughout pregnancy, insulin therapy needs to be optimized and, in this context, the insulin analogs currently available in the market may help to achieve good metabolic control. We therefore review here what is known about the potential benefits and risks related to the use of these new insulins in pregnancy. Clinical and experimental data on insulin aspart and lispro strongly suggest that they have no adverse maternal or fetal effects during pregnancy in women with pregestational and gestational diabetes, and that their use results in improved glycemic control, fewer hypoglycemic episodes, and improved patient satisfaction. At present there are no published data on the use of glulisine in pregnancy. Insulin glargine during pregnancy is not recommended but, in the last years, larger surveys (retrospective and case-control studies) have been published on this field and, to date, results of about 335 pregnancies with type 1 diabetes are available showing an incidence of congenital malformation similar to that obtained with human insulin. There are no published data concerning the use of detemir in pregnancy but the results of a prospective study are expected in 2010.

Topics: Diabetes, Gestational; Female; Humans; Hypoglycemic Agents; Insulin; Insulin Aspart; Insulin Detemir; Insulin Glargine; Insulin Lispro; Insulin, Long-Acting; Pregnancy

This review reports the literature on the safety and efficacy of insulin analogues in pregnancy and thereby enables the clinician to choose the optimal insulin treatment protocol to achieve and maintain normoglycemia throughout pregnancies complicated by diabetes. This article also reviews the literature on the insulin analog during pregnancy and presents the authors' opinion as to the safety and efficacy of insulin analog treatment for the pregnant diabetic woman.

Topics: Diabetes, Gestational; Female; Humans; Hypoglycemic Agents; Insulin; Insulin Aspart; Insulin Detemir; Insulin Glargine; Insulin Lispro; Insulin, Long-Acting; Pregnancy; Pregnancy in Diabetics; Receptor, IGF Type 1

To evaluate the effectiveness of the different insulin therapies on obstetrics-fetal outcomes in women with pregestational diabetes mellitus. We enrolled 147 pregnant women with pre-existing type 1 or 2 diabetes mellitus. Clinical and biochemical parameters were analysed in relation to obstetric and fetal outcomes. 14.2% received treatment with Neutral Protamine Hagedorn insulin and short-acting insulin analogues; 19% with premixed human insulin; 40.1% with insulin glargine and lispro, 6.2% with detemir and aspart and 20% with continuous subcutaneous insulin infusion. All 5 types of treatment achieved a reduction of the mean HbA1c during pregnancy (p = 0.01). Pre-pregnancy care was carried out for 48% of patients. We found no statistically significant differences between the different insulin therapies and the obstetric-fetal outcomes. In conclusión, the different insulin therapies used in patients with pregestational diabetes mellitus does not seem to affect obstetric-fetal outcomes.

Topics: Adult; Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetes, Gestational; Drug Combinations; Female; Glycated Hemoglobin; Humans; Insulin; Insulin Detemir; Insulin Glargine; Insulin Lispro; Insulin, Long-Acting; Pregnancy; Pregnancy Outcome

The effects of glargine insulin therapy in pregnancies are not well established. We compared maternal and neonatal outcomes of women with pregestational and gestational diabetes treated with glargine or NPH insulin.. A prospective cohort study was conducted analyzing outcomes from 56 women with pregestational and 82 with gestational diabetes treated with either insulin regimen.. Comparisons were performed among 138 women: 56 with pregestational and 82 with gestational diabetes. In relation to maternal complications, worsening of retinopathy and nephropathy, preeclampsia, micro and macroalbuminuria, and all kinds of hypoglycemia were found higher in women with pregestational diabetes NPH-treated vs. glargine-treated. In women with gestational diabetes NPH-treated, it was observed increased incidence of prepregnancy and new-onset pregnancy hypertension, micro and macroalbuminuria, as well as mild and frequent hypoglycemia, compared to glargine-treated. Among the neonatal outcomes, 1-min Apgar score <7, necessity of intensive care unit and fetal death in pregestational, while jaundice and congenital malformations in gestational diabetes, respectively, were more frequently observed in infants born to NPH-treated, compared to glargine-treated.. Glargine use during pregnancy from preconception through delivery, showed to be safe since it is associated with decreased maternal and neonatal adverse outcomes compared with NPH insulin-treated patients.

Topics: Adult; Diabetes Complications; Diabetes, Gestational; Female; Follow-Up Studies; Humans; Hypoglycemic Agents; Incidence; Infant, Newborn; Infant, Newborn, Diseases; Insulin; Insulin Glargine; Insulin, Isophane; Insulin, Long-Acting; Pregnancy; Pregnancy in Diabetics; Pregnancy Outcome; Prevalence; Prospective Studies; Risk Factors; Treatment Outcome; Young Adult

We compared maternal and neonatal outcomes in diabetic pregnancies treated with either insulin glargine or neutral protamine Hagedorn (NPH) insulin. We performed a retrospective chart review of diabetic pregnant patients using the Diabetes Care Center of Wake Forest University during the years 2000 to 2005. Outcomes of interest included maternal hemoglobin A1C, average fasting and 2-hour postprandial blood sugars, mode of delivery, birth weight, 5-minute Apgar score < 7, umbilical artery pH < 7.20, incidence of neonatal hypoglycemia, and pregnancy complications. A total of 52 diabetic pregnant patients were included in this study. Twenty-seven women used insulin glargine. A total of 13 women used insulin glargine during the first trimester. Glycemic control was similar in women who used NPH insulin and insulin glargine, as determined by hemoglobin A1C levels and mean blood sugar values. There were no differences in mode of delivery, average birth weight, or neonatal outcomes. Maternal and fetal/neonatal outcomes appear similar in pregnant diabetic women who use either NPH insulin or insulin glargine in combination with a short-acting insulin analogue to achieve adequate glycemic control during pregnancy. Insulin glargine appears to be an effective insulin analogue for use in women whose pregnancies are complicated by diabetes.

Topics: Adult; Apgar Score; Birth Weight; Blood Glucose; Carbon Dioxide; Delivery, Obstetric; Diabetes, Gestational; Eating; Fasting; Female; Gestational Age; Glycated Hemoglobin; Humans; Hydrogen-Ion Concentration; Hypoglycemia; Hypoglycemic Agents; Infant, Newborn; Insulin; Insulin Glargine; Insulin, Isophane; Insulin, Long-Acting; Oxygen; Pregnancy; Pregnancy Complications; Pregnancy in Diabetics; Pregnancy Outcome; Retrospective Studies; Umbilical Arteries; Young Adult

To compare maternal and neonatal outcomes of pregestational and gestational diabetics treated with insulin glargine versus Neutral Protamine Hagedorn (NPH) insulin.. A retrospective cohort study examining outcomes from pregestational and gestational diabetics treated with either insulin regimen. Comparisons were made using the t-test for continuous data and the Chi-square or Fisher's exact test for categorical data.. Fifty-two pregnant women treated with insulin glargine were compared with 60 pregnant women treated with NPH. No significant differences in rates of maternal complications were noted. No significant differences in neonatal outcomes for gestational diabetics were noted. Among pregestational diabetics treated with insulin glargine, significantly fewer macrosomic infants (relative risk [RR], 0.38; 95% confidence intervals (CI), 0.17-0.87; p = 0.04) and lower rates of neonatal hyperbilirubinemia (RR, 0.27; 95% CI, 0.07-0.98; p = 0.05) were noted when compared with those treated with NPH. There were no cases of neonatal hypoglycemia in pregestational diabetics treated with glargine; however, 25% of infants born to mothers treated with NPH experienced hypoglycemia (p = 0.01). No fetal anomalies or deaths were observed in either treatment group.. Insulin glargine use during pregnancy is not associated with increased maternal or neonatal morbidity compared with NPH insulin. Among pregestational diabetics, insulin glargine use was associated with lower rates of macrosomia, neonatal hypoglycemia and neonatal hyperbilirubinemia.

Topics: Adult; Cohort Studies; Diabetes, Gestational; Female; Humans; Hypoglycemic Agents; Infant, Newborn; Insulin; Insulin Glargine; Insulin, Isophane; Insulin, Long-Acting; Male; Pregnancy; Pregnancy in Diabetics; Pregnancy Outcome; Retrospective Studies

We compared perinatal outcomes in pregnancies in which insulin glargine was used in the management of patients with pregnancies in which standard insulin therapy was used at a single institution. A retrospective analysis of 114 pregnant patients with diabetes (pregestational or gestational) managed at a single center between January 2004 and August 2006 was undertaken. Sixty-five patients managed with insulin glargine were compared with 49 patients managed with neutral protamine Hagedorn (NPH) insulin. Both groups were also treated with short-acting insulin (either regular, lispro, or aspart insulin). Maternal age, parity, prepregnancy weight, body mass index, duration of diabetes, hemoglobin A (1C) (at entry and final recorded) and gestational age at entry were similar for each group (glargine and NPH). Thirty patients had gestational diabetes (18 glargine and 12 NPH); there were no differences in numbers of patients in higher-order White's classification between the two groups. Cesarean section for obstetric reasons included labor abnormalities, malpresentation, fetal distress, and suspected macrosomia. There were no differences in gestational age at delivery, birth weight, preeclampsia, or frequency of cesarean section (total or for obstetric reasons). The frequency of shoulder dystocia was higher in the NPH group. Regarding neonatal outcomes, gestational age at delivery, birth weight, Apgar scores, admission to the neonatal intensive care unit, respiratory distress syndrome, hypoglycemia, and congenital anomalies were similar between the two groups. From this retrospective analysis, no adverse maternal or neonatal effects were seen from maternal administration of insulin glargine. A larger multicenter study is needed to confirm these findings. This preliminary report suggests that use of insulin glargine during pregnancy can be considered if maternal metabolic control is suboptimal using the standard split-mix regimen.

Topics: Adult; Diabetes, Gestational; Female; Humans; Hypoglycemic Agents; Infant, Newborn; Insulin; Insulin Aspart; Insulin Glargine; Insulin Lispro; Insulin, Isophane; Insulin, Long-Acting; Pregnancy; Pregnancy in Diabetics; Pregnancy Outcome

To review the obstetric outcome of 240 diabetic pregnancies maintained on basal glargine insulin.. This is a retrospective review of the medical data from 240 pregnant diabetics who received glargine as a basal insulin. Perinatal outcome was abstracted from August 29, 2001, to December 31, 2007.. Mean maternal age was 33 years (SD +/- 5). Seventy-seven percent (184 of 240) of the women were diagnosed with gestational diabetes. The remaining 23% (56 of 240) had a diagnosis of type 2 diabetes. Weekly evaluation of each woman's daily 7x/d fingersticks yielded an individual mean capillary glucose value. These individual mean capillary glucose values were used to calculate a mean value for our sample population. This overall mean capillary glucose value for the 240 parturients was 112 +/- 14.8 mg/dL. The mean neonatal birth weight was 3,142 +/- 606 g. Only 4 neonates had birth weights > 4,000 g (4,365, 4,384, 4,535 and 4,624). None of the neonates were hypoglycemic.. Prenatal glargine appears to be well tolerated with acceptable perinatal outcome. For well-controlled pregestational diabetics, consideration should be given to continuing glargine during pregnancy.

Topics: Adult; Birth Weight; Blood Glucose; Capillaries; Diabetes Mellitus, Type 2; Diabetes, Gestational; Female; Humans; Hypoglycemic Agents; Insulin; Insulin Glargine; Insulin, Long-Acting; Pregnancy; Pregnancy in Diabetics; Pregnancy Outcome; Retrospective Studies

To determine whether the use of insulin glargine during pregnancy is associated with an increase in the incidence of fetal macrosomia or adverse neonatal outcome.. A matched case-control study.. Women's Centre, John Radcliffe Hospital, Oxford, UK.. Sixty-four pregnant women treated with insulin during their pregnancies, 20 with type I diabetes and 44 with gestational diabetes.. Two groups of women were compared in matched pairs. A study group of 32 pregnant women with diabetes treated with insulin glargine during their pregnancy and a control group of 32 pregnant women treated with an intermediate-acting human insulin (isophane or insulin zinc suspension) and matched for weight at booking, height, gestation at delivery, parity, fetal sex, duration of insulin use in pregnancy and glycaemic control during the third trimester of pregnancy (glycosylated haemoglobin [HbA(1c)] concentration and mean blood glucose concentration).. Birthweight, centile birthweight, the incidence of fetal macrosomia (birthweight > 90th percentile) and neonatal morbidity in the two study groups.. There was no significant difference between the birthweight or centile birthweight of babies born to the women treated with insulin glargine during pregnancy and that of the babies born to those in the control group treated with intermediate-acting human insulin. The overall incidence of fetal macrosomia was 12/32 (37.5%) in the insulin glargine group and 13/32 (40.6%) in the control group. There was no significant difference in neonatal morbidity between the groups.. The results of this pilot study indicate that insulin glargine treatment during pregnancy does not appear to be associated with increased fetal macrosomia or neonatal morbidity.

Topics: Adult; Case-Control Studies; Diabetes Mellitus, Type 1; Diabetes, Gestational; Female; Humans; Hypoglycemic Agents; Insulin; Insulin Glargine; Insulin, Long-Acting; Pilot Projects; Pregnancy; Pregnancy in Diabetics; Pregnancy Outcome

Topics: Diabetes Mellitus, Type 1; Diabetes, Gestational; Female; Humans; Hypoglycemic Agents; Insulin; Insulin Glargine; Insulin-Like Growth Factor I; Insulin, Long-Acting; Pregnancy; Pregnancy in Diabetics

Topics: Diabetes, Gestational; Female; Humans; Hypoglycemic Agents; Insulin; Insulin Glargine; Insulin, Long-Acting; Pregnancy; Pregnancy Outcome