insulin--isophane and Diabetes--Gestational

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

Gestational diabetes mellitus (GDM) is one of the prevalent adverse conditions among pregnant women which needs delicate monitoring and control. GDM is a state in which the pregnant women's blood glucose level exceeds the normal range. Our goal was to determine the best therapeutic method to control the blood glucose level among GDM patients by comparing of the efficacy between two Insulin consisting, Novo-rapid + Levemir Insulin and Regular + NPH Insulin.. In this double-blind, randomized clinical trial study, we enrolled 100 women with GDM as an inpatient. In group A, patients underwent treating with Regular + NPH Insulin, and in group B, patients underwent treating with Novo-rapid + Levemir Insulin. Patient's demographic and clinical information gathered by specified several times during the study and analysis performed by SPSS21.. Despite significant changes in the two groups patient's blood glucose levels; we could not find any remarkable differences between the two groups. In the case of patient and health care system satisfaction and the length of the hospitalization group, B was better than group A.. Altogether, The Novo-rapid and Levemir Insulin in comparing with the Regular and NPH Insulin were practically advantageous due to the simple using method and short hospitalization period of the patient. Thus, we prefer and suggest this beneficial method (using Novo-rapid and Levemir Insulin) to reach therapeutic goals.

Topics: Adult; Blood Glucose; Diabetes, Gestational; Double-Blind Method; Female; Humans; Hypoglycemic Agents; Insulin Detemir; Insulin, Isophane; Insulin, Long-Acting; Insulin, Regular, Human; Pregnancy; Young Adult

We sought to determine if insulin detemir (IDet) is noninferior to insulin neutral protamine Hagedorn (NPH) for the treatment of gestational diabetes mellitus (GDM) and type 2 diabetes mellitus (T2DM) in pregnancy.. We conducted a randomized, controlled noninferiority trial of women with GDM and T2DM who entered our Diabetes in Pregnancy Program from March 2013 through October 2014. Exclusion criteria were type 1 diabetes, age <18 years, and insulin allergy. Women who failed to achieve good glycemic control (GC) (mean blood glucose [BG] <100 mg/dL) on diet and/or hypoglycemic agents were randomized to receive either IDet or NPH, with short-acting insulin aspart added as needed. Patients were instructed to test BG 4 times a day (fasting and 2-hour postprandial). Targets of GC were fasting BG <90 mg/dL and postprandial BG <120 mg/dL, and insulin was adjusted as needed to achieve the targets. The primary outcome was overall mean BG during insulin treatment; secondary outcomes included overall mean postprandial and fasting BG, median number of weeks to achieve GC, percent of patients with overall GC, maternal weight gain, perinatal/neonatal outcomes, and number of hypoglycemic events. Power analysis (90% power) determined that 88 patients would need to be randomized, assuming a maximal acceptable difference in overall mean BG of 7 mg/dL (SD ± 10 mg/dL). A per protocol analysis was performed.. In all, 105 women were randomized. Eighteen women were excluded leaving 87 participants for analysis (45 NPH, 42 IDet). Maternal characteristics were similar in both groups. The difference in the mean BG of the groups was 2.1 mg/dL with a 1-sided upper 95% confidence limit of 5.5 mg/dL (less than the maximal acceptable difference of 7 mg/dL; P = .2937). There was no significant difference in the primary outcome when an intent-to-treat analysis was performed or when the T2DM patients were excluded. The time to achieve GC was similar in both groups. There were no differences in perinatal outcomes and maternal weight gain among the groups. There were more hypoglycemic events per patient in the NPH group.. IDet is noninferior to insulin NPH for the treatment of GDM and T2DM in pregnancy.

Topics: Adolescent; Adult; Diabetes Mellitus, Type 2; Diabetes, Gestational; Drug Administration Schedule; Female; Humans; Hypoglycemic Agents; Insulin Detemir; Insulin, Isophane; Insulin, Long-Acting; Intention to Treat Analysis; Pregnancy; Pregnancy in Diabetics; Treatment Outcome; Young Adult

A randomized, open-label, parallel study was conducted to assess the efficacy and safety of premixed insulin aspart 30 (biphasic insulin aspart [BIAsp] 30) in managing gestational diabetes mellitus (GDM). A total of 323 women with GDM registered at a single center in India were randomly assigned to receive 6 U of either BIAsp 30 (Group A) or premixed human insulin (biphasic human insulin [BHI] 30; Group B) in a 1:1 ratio. Subjects performed home glucose monitoring and visited their care provider twice a month. The primary outcome was the degree of neonatal macrosomia (neonatal birth weight >90th percentile). Groups A and B were demographically comparable at study entry. Before labor onset, Groups A and B achieved similar degrees of fasting plasma glucose and postprandial plasma glucose control (92.97 ± 14.44 vs. 95.43 ± 18.96 and 127.59 ± 28.99 vs. 126.98 ± 29.89, respectively; both p = NS). Neonatal macrosomia frequency was 6.3% in Group A and 6.9% in Group B; however, this difference was not statistically significant. By last visit, the required insulin dose was significantly lower for Group A than Group B (19.83 ± 15.75 IU vs. 26.34 ± 23.15 IU, respectively; p = 0.006). BIAsp 30 was noninferior to BHI 30, producing comparable fetal outcomes when administered during pregnancy. Based on final doses, BIAsp 30 may offer greater treat-to-target potential for pregnant women.

Topics: Biphasic Insulins; Birth Weight; Blood Glucose; Cohort Studies; Diabetes, Gestational; Drug Combinations; Female; Fetal Macrosomia; Humans; Hyperglycemia; Hypoglycemia; Hypoglycemic Agents; Incidence; India; Infant, Newborn; Insulin Aspart; Insulin, Isophane; Intention to Treat Analysis; Male; Pregnancy

Evaluation of adjuvant insulin therapy effects on glycemic control, perinatal outcome and postpuerperal glucose tolerance in impaired glucose tolerance (IGT) pregnant women who failed to achieve desired glycemic control by dietary regime.. A total of 280 participants were classified in two groups: Group A patients continued with dietary regime and Group B patients were treated with adjuvant insulin therapy. Glycemic control was assessed by laboratory and ultrasonograph means. Pregnancy outcomes were evaluated by prevalence of pregnancy induced hypertension (PIH), high birth weight, neonatal hypoglycemia and caesarean section rates. Postpuerperal glucose tolerance was assessed by oral glucose tolerance test (oGTT).. All laboratory and ultrasound indicators of glycemic control had significantly lower values in Group B. Group A women were more likely to develop the EPH (Edema, Proteinuria, Hypertension) syndrome, 20% versus 7.86% (p = 0.003). High birth weight occurred more frequently in Group A, but the difference was not significant (p = 0.197). Higher rate of caesarean delivery was in Group A than in Group B, 16.43% versus 26.43% (p = 0.041). The difference in neonatal hypoglycemia was not significant (p = 0.478). Pathological oGTT results were observed in 73 Group A patients and in 15 Group B patients.. Lower caesarean section rates and the EPH syndrome incidence are the benefits of adjuvant insulin therapy in IGT patients.

Topics: Adolescent; Adult; Biomarkers; Blood Glucose; Chemotherapy, Adjuvant; Diabetes, Gestational; Diet Therapy; Drug Administration Schedule; Drug Therapy, Combination; Exercise Therapy; Female; Glucose Metabolism Disorders; Glucose Tolerance Test; Humans; Hypoglycemic Agents; Insulin; Insulin, Isophane; Insulin, Regular, Human; Insulin, Regular, Pork; Isophane Insulin, Human; Pregnancy; Pregnancy Complications; Pregnancy Outcome; Treatment Outcome; Young Adult

To evaluate the effect of metformin and insulin in glycemic control and compare pregnancy outcome in women with gestational diabetes mellitus (GDM).. This randomized controlled trial was conducted in GDM women with singleton pregnancy and gestational age between 20 and 34 weeks who did not achieve glycemic control on diet were assigned randomly to receive either metformin (n=80) or insulin (n=80). The primary outcomes were maternal glycemic control and birth weight. The secondary outcomes were neonatal and obstetric complications.. Two groups were comparable regarding the maternal characteristics. Two groups were similar in mean FBS (P=0.68) and postprandial measurements (P=0.87) throughout GDM treatment. The neonates of metformin group had less rate of birth weight centile >90 than insulin group (RR: 0.5, 95% CI: 0.3-0.9, P=0.012). Maternal weight gain was reduced in the metformin group (P<0.001). Two groups were comparable according to neonatal and obstetric complications (P>0.05). In metformin group 14% of women needed to supplemental insulin to achieve euglycemia.. Metformin is an effective and safe alternative treatment to insulin for women with GDM. This study does not show significant risk of maternal or neonatal adverse outcome with the use of metformin.

Topics: Adult; Birth Weight; Blood Glucose; Diabetes, Gestational; Drug Therapy, Combination; Female; Fetal Macrosomia; Humans; Hyperglycemia; Hypoglycemia; Hypoglycemic Agents; Insulin, Isophane; Lost to Follow-Up; Metformin; Pregnancy; Pregnancy Outcome; Pregnancy Trimester, Second; Pregnancy Trimester, Third; Single-Blind Method; Weight Gain

The objective of the study was to compare premixed insulin aspart 30 (BIAsp 30) vs premixed human insulin 30 (BHI 30) on efficacy, safety, fetal and perinatal outcomes in pregnancies associated with gestational diabetes mellitus [GDM]. This was the first randomized study to use pre mixed insulin analogue [BIAsp] in GDM.. The study population consisted of 76 GDM women assigned to BIAsp 30 (group A) and an equal number to BHI 30 (group B).. There was no statistically significant difference between the age, BMI, gestational weeks and glycemic level at entry between the group A and group B women (p > 0.05). There was no statistical difference between the two groups in glycemic control or insulin dose (p > 0.05) before confinement. The frequency of birth weight of new born above 90 percentile was 6.8% in Group 1 and 9.2% in Group 2. The proportion of macrosomia was higher in Group 2 when compared to Group 1, however the difference was not statistically significant (P = 0.819).. BIAsp was safe during pregnancy and pregnant women found it convenient due to meal time dosing. Fetal outcome using BIAsp was also comparable with BHI 30.

Topics: Adult; Biphasic Insulins; Birth Weight; Blood Glucose; Body Mass Index; Chromatography, High Pressure Liquid; Diabetes, Gestational; Female; Glycated Hemoglobin; Humans; Hypoglycemic Agents; Infant, Newborn; Injections, Subcutaneous; Insulin; Insulin Aspart; Insulin, Isophane; Pilot Projects; Pregnancy; Pregnancy Outcome; Treatment Outcome; Young Adult

Topics: Blood Glucose; Cohort Studies; Diabetes, Gestational; Female; Glycated Hemoglobin; Humans; Hypoglycemic Agents; Infant, Newborn; Insulin; Insulin Aspart; Insulin Lispro; Insulin, Isophane; Perinatal Care; Pregnancy; Weight Gain

Topics: Adult; Blood Glucose; Diabetes, Gestational; Female; Fetal Macrosomia; Glycated Hemoglobin; Humans; Hypoglycemic Agents; Infant, Newborn; Insulin; Insulin, Isophane; Insulin, Long-Acting; Insulin, Regular, Human; Insulin, Regular, Pork; Isophane Insulin, Human; Patient Compliance; Pregnancy; Pregnancy in Diabetics; Pregnancy Outcome; Pregnancy Trimester, Third; Prospective Studies

The objective of this retrospective study was to compare glycemic control, pregnancy outcomes, and neonatal outcomes in women with gestational diabetes mellitus (GDM) treated with (a) insulin detemir and (b) insulin neutral protamine Hagedorn (NPH).. A total of 192 women with GDM were included in the analysis. Ninety-eight women received detemir, while 94 women received NPH. Data regarding medical history, glycemic control, and time and mode of delivery, as well as neonatal outcomes, were recorded.. Baseline characteristics were comparable between the two groups. There were no differences with respect to the week of insulin initiation, total insulin dose, duration of insulin therapy, daily insulin dose/weight in early and late pregnancy, or the number of insulin injections per day. Maternal overall weight gain during pregnancy and weight gain per week did not differ either. The detemir group had slightly lower HbA1c levels at the end of gestation [median: det 5.2% (33 mmol/mol) vs NPH 5.4% (36 mmol/mol), p=0.035). There were no cases of hypoglycemia or allergic reactions in the two groups. There were also no differences regarding neonatal outcomes according to the available data, given that data in some cases were missing.. The use of insulin detemir was found to be equally effective and safe compared to NPH in women with GDM.

Topics: Diabetes Mellitus, Type 2; Diabetes, Gestational; Female; Glycemic Control; Humans; Hypoglycemic Agents; Infant, Newborn; Insulin; Insulin Detemir; Insulin, Isophane; Insulin, Long-Acting; Pregnancy; Pregnancy Outcome; Retrospective Studies; Weight Gain

The aim of this study was to study the efficacy and safety of long-acting insulin analog insulin lispro protamine suspension (ILPS) in diabetic pregnant women.. In a multicenter observational retrospective study, we evaluated pregnancy outcome in 119 women affected by type 1 diabetes and 814 with gestational diabetes (GDM) treated during pregnancy with ILPS, compared with a control group treated with neutral protamine hagedorn (NPH) insulin.. Among type 1 diabetic patients, fasting blood glucose at the end of pregnancy was significantly lower in ILPS-treated than in NPH-treated patients. HbA1c levels across pregnancy did not differ between groups. Caesarean section and preterm delivery rates were significantly lower in the ILPS-women. Fetal outcomes were similar in the ILPS and NPH groups. Among GDM women, fasting blood glucose at the end of pregnancy was significantly lower in ILPS-treated than in NPH-treated patients. Duration of gestation was significantly longer, caesarian section and preterm delivery rates were lower in the ILPS-treated group. In addition, there were significantly fewer babies with an excessive ponderal index or neonatal hypoglycemic episodes in the ILPS group than in the NPH group.. Association of ILPS with rapid-acting analogs in pregnancy is safe in terms of maternal and fetal outcomes.

Topics: Adult; Diabetes Mellitus, Type 1; Diabetes, Gestational; Female; Humans; Infant, Newborn; Insulin Lispro; Insulin, Isophane; Italy; Pregnancy; Pregnancy in Diabetics; Pregnancy Outcome; Retrospective Studies

Topics: Diabetes Mellitus, Type 2; Diabetes, Gestational; Female; Humans; Hypoglycemic Agents; Insulin, Isophane; Insulin, Long-Acting

Topics: Adult; Antipsychotic Agents; Comorbidity; Diabetes, Gestational; Dibenzothiazepines; Female; Humans; Hypoglycemic Agents; Insulin Aspart; Insulin, Isophane; Obesity; Pregnancy; Prenatal Exposure Delayed Effects; Quetiapine Fumarate; Schizophrenia

To evaluate the safety and tolerability of once or twice daily neutral protamine hagedorn (NPH) insulin in fasting pregnant diabetics during Ramadan.. This was a prospective cohort study conducted during Ramadan 2006 and 2007. Twenty four pregnant diabetic women were given NPH insulin once at 5 pm or twice daily at 5 pm and 5 am. Demographic data, blood glucose control, insulin requirement, days of fasting and hypoglycemic episodes were analyzed.. Most women were parity 1 (37.5%) in their second trimester (54.2%) and worked during the daytime (87.5%). Fourteen women (58.3%) had gestational diabetes mellitus, nine women (37.5%) had type 2 and one (4.2%) had type 1 diabetes mellitus. There were significant reductions in mean fasting blood glucose (6.16 mmol/L versus 5.34 mmol/L, P = 0.001), glycosylated hemoglobin (HbA1c) (6.70% ± 0.91 versus 6.64% ± 0.96, P = 0.001) and serum fructosamine (232.4 mmol/L ± 24.0 versus 217.0 mmol/L ± 24.3, P = 0.001) after Ramadan compared to before Ramadan. Throughout the four weeks of Ramadan, home blood glucose monitoring showed a reducing trend and was within the acceptable limits. Insulin requirement was increased from the first to the fourth week with a reduction in insulin dose noted after (38.5 U/day) compared to before the start of Ramadan (40 U/day). Most women (79.2%) were able to fast for more than 15 days without any hypoglycemia or fetal demise.. Once or twice daily NPH insulin is a safe and tolerable option for pregnant diabetics who wish to fast during Ramadan.

Topics: Adult; Blood Glucose; Blood Glucose Self-Monitoring; Cohort Studies; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetes, Gestational; Drug Administration Schedule; Fasting; Female; Humans; Insulin, Isophane; Islam; Parity; Pregnancy; Pregnancy in Diabetics; Prospective Studies; Treatment Outcome

Topics: Diabetes, Gestational; Female; Humans; Insulin; Insulin, Isophane; Pregnancy; Pregnancy in Diabetics

Diabetes in pregnancy is associated with risks to the woman and to the developing fetus. Miscarriage, pre-eclampsia, preterm labour and congenital malformations in fetus are more common in women with pre-existing diabetes. Insulin requirement increases with each trimester of pregnancy in diabetic females. Treatment of gestational diabetes consists of medical nutrition therapy but insulin treatment forms the mainstay of the therapy. Monitoring glycemic control is essential in treatment of gestational diabetes. HbA1c level is helpful to differentiate between a pre-GDM and GDM. Majority of pregnant women with diabetes fail to achieve optimum glycemic control, mostly the postprandial plasma glucose with conventional insulin. In them, the best option is to administer ultra-short-acting analogs, insulin lispro or insulin aspart. These analogs improve the postprandial glucose control during pregnancy in both type 1 and type 2 diabetes and are considered safe and effective.

Topics: Blood Glucose; Blood Glucose Self-Monitoring; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetes, Gestational; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Glycated Hemoglobin; Humans; Hypoglycemic Agents; Infant, Newborn; Insulin, Isophane; Pregnancy; Pregnancy in Diabetics; 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

Permanent neonatal diabetes mellitus is a rare disorder known to be caused by activating mutations in KCNJ11 or ABCC8, inactivating mutations in INS, or very rarely in GCK or insulin promotor factor-1 (IPF-1) genes. We report a patient with permanent neonatal diabetes mellitus and severe exocrine pancreatic insufficiency. Ultrasound examination revealed pancreatic agenesis with a suggestion of a small amount of tissue in the head of the pancreas. Genetic testing revealed that the neonate had a homozygous Pro63fsX60 IPF-1 mutation. This is the second reported case of neonatal diabetes mellitus secondary to a homozygous mutation in the IPF-1 gene and supports the previously proposed biological role of IPF-1 in the pancreatic development in human.

Topics: Birth Weight; Blood Glucose; Body Height; Body Weight; Cesarean Section; Chromosomes, Human, Pair 6; Diabetes Mellitus; Diabetes, Gestational; Female; Homeodomain Proteins; Homozygote; Humans; Hypoglycemic Agents; Infant, Newborn; Insulin, Isophane; Male; Mothers; Mutation; Pancreas; Pregnancy; Trans-Activators; Young Adult