***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: OBJECTIVE This r and omized , controlled noninferiority trial aim ed to compare the efficacy and safety of insulin detemir ( IDet ) versus neutral protamine Hagedorn ( NPH ) ( both with pr and ial insulin aspart ) in pregnant women with type 1 diabetes . RESEARCH DESIGN AND METHODS Patients were r and omized and exposed to IDet or NPH up to 12 months before pregnancy or at 8–12 weeks gestation . The primary analysis aim ed 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 r and omized 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 result ed in lower FPG and noninferior A1C in late pregnancy compared with NPH insulin . Rates of hypoglycemia were comparable OBJECTIVE To evaluate the progression of retinopathy during pregnancy and postpartum in ( insulin-dependent ) women with type 1 diabetes treated with insulin lispro or with regular human insulin .  RESEARCH DESIGN AND METHODS A prospect i ve open study of 69 pregnant women with diabetes was performed . A total of 36 of the women were treated with insulin lispro ( lispro group ) and 33 were treated with conventional short-acting human insulin ( regular insulin group ) . The retinopathy level was estimated by color fundus photography every trimester and postpartum . Glycemic control during pregnancy , hypoglycemia ( blood glucose level <3 mmol/l ) in 24-h glucose profile , blood pressure , and proteinuria were registered . RESULTS HbA(1c ) values were similar at baseline in the first trimester but thereafter were lower in the lispro group than in the regular insulin group throughout pregnancy ( P = 0.022 , repeated- measures ANOVA ) . The number of hypoglycemic episodes did not differ between the treatment groups . In multivariable logistic regression analysis with retinopathy severity ( Diabetes Control and Complications Trial level ) in the third trimester as the dependent variable , only nulliparity qualified as a predictor in the model [ Exp(B ) = 4.0 , 95 % CI 1.1 - 13.7 , P = 0.030 ] . Factors such as duration of diabetes , type of insulin used , mean HbA(1c ) level throughout pregnancy , blood pressure ( systolic or diastolic ) , preeclampsia in the current pregnancy , smoking , or prepregnancy planning did not explain the retinopathy progression . CONCLUSIONS Insulin lispro improves glycemic control during diabetic pregnancy compared with regular insulin with no adverse impact on progression of diabetic retinopathy Background Women with hyperglycaemia detected during pregnancy are at greater risk for adverse pregnancy outcomes . Data on hyperglycaemia in pregnancy in sub-Saharan Africa is scanty and varied depending on the population s studied and the method ologies used to define hyperglycaemia in pregnancy . With the recent 2013 World Health Organisation ( WHO ) diagnostic criteria and classification , there is yet no sufficient data on the prevalence of hyperglycaemia in sub-Saharan Africa . The objective was to determine the prevalence of Hyperglycaemia first detected during pregnancy and subsequent obstetric outcomes among patients attending antenatal care ( ANC ) at St. Francis Hospital Nsambya . Methods A prospect i ve cohort study . All women with no history of diabetes mellitus attending at or after 24 weeks gestation were eligible to participate in the study . Participants underwent a st and ard 75 g oral glucose tolerance test ( OGTT ) after an informed written consent . The primary outcome was diagnosis of hyperglycaemia . Enrolled participants were followed up to delivery to assess obstetric outcomes ( secondary outcomes were birth weight , neonatal admission , maternal genital trauma , delivery mode , neonatal and maternal status at discharge ) . Results 251 women were screened between December 2013 and February 2014 . The prevalence of hyperglycaemia first detected in pregnancy was 31.9 % . We found 23.8 % of women with hyperglycaemia had no known risk factor . Macrosomia was the only obstetric outcome that was significantly associated with hyperglycaemia . Conclusion The prevalence of hyperglycaemia first detected in pregnancy was high in the studied population . Clinicians , therefore , should become more vigilant to screen for the condition . Selective screening may miss 23.8 % of pregnant women with hyperglycaemia . However the cost/benefit implication s of screening strategy and the recent 2013 WHO diagnostic criteria need to be studied in our setting 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 r and omized to IAsp or HI as meal-time insulin in an open-label , parallel-group , multicenter study . Subjects had A1C ≤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 ≤6.5 % . At the end of first and third trimesters , average postpr and ial 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 postpr and ial glucose control and preventing severe hypoglycemia Objective . To describe perinatal outcomes of women with pregestational diabetes treated with short-acting , regular insulin and the short-acting insulin analogue , lispro . Study design . This was a prospect i ve observational study of women with pregestational diabetes maintained on short-acting insulin regimens over a 3-year period . Clinical characteristics , aspects of diabetic therapy , and perinatal/neonatal outcomes were collected . Results . Of 107 women , 49 were maintained on regular insulin and 58 utilized the insulin analogue , lispro . Frequency of type 1 diabetes , maternal age , overweight/obese pregravid body mass index ( ≥25 kg/m2 ) , preexisting hypertension , and presence of vascular disease were similar between groups . Women treated with lispro had a longer duration of diabetes ( 11.4 vs. 8.3 years , p = 0.04 ) . Glycemic control was improved in women managed with lispro compared to regular insulin ( HgbA1c 5.9 vs. 6.7 , p = 0.009 ) . Total insulin requirements were lower in the lispro group in the first ( 0.58 vs. 0.79 units/kg , p = 0.02 ) , second ( 0.75 vs. 1.10 units/kg , p = 0.002 ) , and third ( 0.98 vs. 1.25 units/kg , p = 0.03 ) trimesters of pregnancy . Mean infant birth weight was greater in the lispro group , whereas the rate of large for gestational age infants and ponderal indices were similar between groups . Malformation rate , gestational age at delivery , neonatal intensive care unit admission , neonatal length of stay , rates of respiratory distress syndrome , and hypoglycemia were similar . Conclusions . Women treated with lispro  demonstrated improved glycemic control and lower total insulin requirements during pregnancy compared to those receiving regular insulin . Perinatal outcomes were similar between women treated with both types of insulin Objective To investigate maternal , perinatal , and neonatal outcomes of pregnancies in women with type 1 diabetes in the Netherl and s. Design Nationwide prospect i ve cohort study . Setting All 118 hospitals in the Netherl and s. Participants 323 women with type 1 diabetes who became pregnant between 1 April 1999 and 1 April 2000 . Main outcome measures Maternal , perinatal , and neonatal outcomes of pregnancy . Results 84 % ( n = 271 ) of the pregnancies were planned . Glycaemic control early in pregnancy was good in most women ( HbA1c  7.0 % in 75 % ( n = 212 ) of the population ) , and folic acid supplementation was adequate in 70 % ( n = 226 ) . 314 pregnancies that went beyond 24 weeks ' gestation result ed in 324 infants .  The rates of pre-eclampsia ( 40 ; 12.7 % ) , preterm delivery ( 101 ; 32.2 % ) , caesarean section ( 139 ; 44.3 % ) , maternal mortality ( 2 ; 0.6 % ) , congenital malformations ( 29 ; 8.8 % ) , perinatal mortality ( 9 ; 2.8 % ) , and macrosomia ( 146 ; 45.1 % ) were considerably higher than in the general population . Neonatal morbidity ( one or more complications ) was extremely high ( 260 ; 80.2 % ) . The incidence of major congenital malformations was significantly lower in planned pregnancies than in unplanned pregnancies ( 4.2 % ( n = 11 ) v 12.2 % ( n = 6 ) ; relative risk 0.34 , 95 % confidence interval 0.13 to 0.88 ) . Conclusion Despite a high frequency of planned pregnancies , result ing in overall good glycaemic control ( early ) in pregnancy and a high rate of adequate use of folic acid , maternal and perinatal complications were still increased in women with type 1 diabetes . Neonatal morbidity , especially hypoglycaemia , was also extremely high . Near optimal maternal glycaemic control ( HbA1c  7.0 % ) apparently is not good enough BACKGROUND Improved blood-glucose control decreases the progression of diabetic microvascular disease , but the effect on macrovascular complications is unknown . There is concern that sulphonylureas may increase cardiovascular mortality in patients with type 2 diabetes and that high insulin concentrations may enhance atheroma formation . We compared the effects of intensive blood-glucose control with either sulphonylurea or insulin and conventional treatment on the risk of microvascular and macrovascular complications in patients with type 2 diabetes in a r and omised controlled trial . METHODS 3867 newly diagnosed patients with type 2 diabetes , median age 54 years ( IQR 48 - 60 years ) , who after 3 months ' diet treatment had a mean of two fasting plasma glucose ( FPG ) concentrations of 6.1 - 15.0 mmol/L were r and omly assigned int 
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This result , in the clinical practice , does not compromise the fetal well-being , since all babies were born at term .
To date , the evidence analyzed has a moderate-to-high risk of bias and does not allow the conclusion that insulin analogs are more effective when compared with human insulin to treat diabetic pregnant women