human
***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: Background Hyperglycemia in pregnancy is associated with poor perinatal outcome . Even if pregnant women with diabetes are monitored according to current guidelines , they do much worse than their normoglycaemic counterparts , marked by increased risks of pre-eclampsia , macrosomia , and caesarean section amongst others . Continuous Glucose Monitoring ( CGM ) is a new method providing detailed information on daily fluctuations , used to optimize glucose control . Whether this tool improves pregnancy outcome remains unclear . In the present protocol , we aim to assess the effect of CGM use in diabetic pregnancies on pregnancy outcome . Methods / design The GlucoMOMS trial is a multicenter open label r and omized clinical trial with a decision and cost-effectiveness study alongside . Pregnant women aged 18 and over with either diabetes mellitus type 1 or 2 on insulin therapy or with gestational diabetes requiring insulin therapy before 30 weeks of gestation will be asked to participate . Consenting women will be r and omly allocated to either usual care or complementary CGM . All women will determine their glycaemic control by self-monitoring of blood glucose levels and HbA1c . In addition , women allocated to CGM will use it for 5–7 days every six weeks . Based on their CGM profiles they receive dietary advice and insulin therapy adjustments if necessary . The primary outcome measure is rate of macrosomia , defined as a birth weight above the 90th centile . Secondary outcome measures will be birth weight , composite neonatal morbidity , maternal outcome and costs . The analyses will be according to the intention to treat principle . Discussion With this trial we aim at clarifying whether the CGM improves pregnancy outcome when used during diabetic pregnancies . Trial registration Nederl and s Trial Register : Objective To evaluate the effectiveness of continuous glucose monitoring during pregnancy on maternal glycaemic control , infant birth weight , and risk of macrosomia  in women with type 1 and type 2 diabetes . Design Prospect i ve , open label r and omised controlled trial . Setting Two secondary care multidisciplinary obstetric clinics for diabetes in the United Kingdom . Participants 71 women with type 1 diabetes ( n=46 ) or type 2 diabetes ( n=25 ) allocated to antenatal care plus continuous glucose monitoring  ( n=38 ) or to st and ard antenatal care  ( n=33 ) . Intervention Continuous glucose monitoring was used as an educational tool to inform shared decision making and future therapeutic changes at intervals of 4 - 6 weeks during pregnancy . All other aspects of antenatal care were equal between the groups . Main outcome measures The primary outcome was maternal glycaemic control during the second and third trimesters from measurements of HbA1c levels every four weeks . Secondary outcomes were birth weight and risk of macrosomia using birthweight st and ard deviation scores and customised birthweight centiles . Statistical analyses were done on an intention to treat basis . Results Women r and omised to continuous glucose monitoring had lower mean HbA1c levels from 32 to 36 weeks ’ gestation compared with women r and omised to st and ard antenatal care : 5.8 % ( SD 0.6 ) v 6.4 % ( SD 0.7 ) . Compared with infants of mothers in the control arm those of mothers in the intervention arm had decreased mean birthweight st and ard deviation scores ( 0.9 v 1.6 ; effect size 0.7 SD , 95 % confidence interval 0.0 to 1.3 ) , decreased median customised birthweight centiles ( 69 % v 93 % ) , and a reduced risk of macrosomia ( odds ratio 0.36 , 95 % confidence interval 0.13 to 0.98 ) . Conclusion Continuous glucose monitoring during pregnancy is associated with improved glycaemic control in the third trimester , lower birth weight , and reduced risk of macrosomia . Trial registration Current Controlled Trials IS RCT N84461581 The calibration of a continuous glucose monitoring system , i.e. the transformation of the signal I(t ) generated by the glucose sensor at time ( t ) into an estimation of glucose concentration G(t ) , represents a key issue . The two-point calibration procedure consists of the determination of a sensor sensitivity S and of a background current I(o ) by plotting two values of the sensor signal versus the concomitant blood glucose concentrations . The estimation of G(t ) is subsequently given by G(t ) = ( I(t)-I(o))/S. A glucose sensor was implanted in the subcutaneous tissue of nine type 1 diabetic patients during 3 ( n = 2 ) and 7 days ( n = 7 ) . For each individual trial , S and I(o ) were determined by taking into account the values of two sets of sensor output and blood glucose concentration distant by at least 1 h , the procedure being repeated for each consecutive set of values . S and I(o ) were found to be negatively correlated , the value of I(o ) being sometimes negative . Theoretical analysis demonstrates that this phenomenon can be explained by the effect of measurement uncertainties on the determination of capillary glucose concentration and of sensor output Background Women with type 1 diabetes strive for optimal glycemic control before and during pregnancy to avoid adverse obstetric and perinatal outcomes . For most women , optimal glycemic control is challenging to achieve and maintain . The aim of this study is to determine whether the use of real-time continuous glucose monitoring ( RT-CGM ) will improve glycemic control in women with type 1 diabetes who are pregnant or planning pregnancy . Methods / design A multi-center , open label , r and omized , controlled trial of women with type 1 diabetes who are either planning pregnancy with an HbA1c of 7.0 % to ≤10.0 % ( 53 to ≤ 86 mmol/mol ) or are in early pregnancy ( < 13 weeks 6 days ) with an HbA1c of 6.5 % to ≤10.0 % ( 48 to ≤ 86 mmol/mol ) . Participants will be r and omized to either RT-CGM alongside conventional intermittent home glucose monitoring ( HGM ) , or HGM alone .  Eligible women will wear a CGM which does not display the glucose result for 6 days during the run-in phase . To be eligible for r and omization , a minimum of 4 HGM measurements per day and a minimum of 96 hours total with 24 hours overnight ( 11 pm-7 am ) of CGM glucose values are required . Those meeting these criteria are r and omized to RT- CGM or HGM . A total of 324 women will be recruited ( 110 planning pregnancy , 214 pregnant ) . This takes into account 15 and 20 % attrition rates for the planning pregnancy and pregnant cohorts and will detect a clinical ly relevant 0.5 % difference between groups at 90 % power with 5 % significance . R and omization will stratify for type of insulin treatment ( pump or multiple daily injections ) and baseline HbA1c . Analyses will be performed according to intention to treat . The primary outcome is the change in glycemic control as measured by HbA1c from baseline to 24 weeks or conception in women planning pregnancy , and from baseline to 34 weeks gestation during pregnancy . Secondary outcomes include maternal hypoglycemia , CGM time in , above and below target ( 3.5–7.8 mmol/l ) , glucose variability measures , maternal and neonatal outcomes . Discussion This will be the first international multicenter r and omized controlled trial to evaluate the impact of RT- CGM before and during pregnancy in women with type 1 diabetes . Trial registration Clinical Trials.gov Identifier : NCT01788527 Registration Date : December 19 , 2012 AIM To compare the outcomes of Type 1 and Type 2 diabetic pregnancies and identify risk factors for poor outcome of Type 2 pregnancies METHODS The data from all ( 389 Type 1 and 146 Type 2 ) pre-gestational diabetic pregnancies from 10 UK hospitals were collected prospect ively . RESULTS The Type 2 mothers were less likely to have documented  pre-pregnancy counselling  ( 28.7 vs. 40.5 % ; P<0.05 ) or be taking folic acid at conception ( 21.9 vs. 36.4 % ; P<0.001 ) than Type 1 mothers . The percentage of pregnancies having a serious adverse outcome was higher in Type 2 patients ( 16.4 vs. 6.4 % ; P=0.002 ) . Congenital abnormalities ( 12.3 % in Type 2 vs. 4.4 % in Type 1 ; P=0.002 ) accounted for most of this difference . The HbA1c of the Type 2 patients was similar to that of the Type 1 with mean first trimester HbA1c of 7.22 and 7.35 % , respectively ( P=0.5 ) . Treatment with oral hypoglycaemic agents [ odds ratio ( OR ) , 1.8 ; 95 % confidence interval ( CI ) , 1.0 - 3.3 ; P=0.04 ] , body mass index ( OR , 1.09 ; 95 % CI , 1.01 - 1.18 ; P=0.02 ) and  folic acid supplementation  ( OR , 0.3 ; 95 % CI , 0.09 - 1.0 ; P=0.04 ) were all independently associated with congenital malformation . CONCLUSION Type 2 diabetic pregnancies are characterized by poor pre-pregnancy planning , inadequate folic acid supplementation and treatment with oral hypoglycaemic agents , all of which may contribute to the serious adverse outcomes affecting one in six Type 2 diabetic pregnancies . These remediable aspects of the pre-pregnancy care of women with Type 2 diabetes provide opportunities for improving the outcome towards that of women with Type 1 diabetes BACKGROUND The fetuses of women with gestational diabetes mellitus are at risk for macrosomia and its attendant complications . The best method of achieving euglycemia in these women and reducing morbidity in their infants is not known . We compared the efficacy of postpr and ial and prepr and ial monitoring in achieving glycemic control in women with gestational diabetes . METHODS We studied 66 women with gestational diabetes mellitus who required insulin therapy at 30 weeks of gestation or earlier . The women were r and omly assigned to have their diabetes managed according to the results of prepr and ial monitoring or postpr and ial monitoring ( one hour after meals ) of blood glucose concentrations . Both groups were also monitored with  fasting blood glucose measurements . The goal of insulin therapy was a prepr and ial value of 60 to 105 mg per deciliter ( 3.3 to 5.9 mmol per liter ) or a postpr and ial value of less than 140 mg per deciliter ( 7.8 mmol per liter ) . Obstetrical data and information on neonatal outcomes were collected . RESULTS The prepregnancy weight , weight gain during pregnancy , gestational age at the diagnosis of diabetes and at delivery , degree of compliance with therapy , and degree of achievement of target blood glucose concentrations were similar in the two groups . The mean ( + /- SD ) change in the glycosylated hemoglobin value was greater in the group in which postpr and ial measurements were used ( -3.0 + /- 2.2 percent vs. 0.6 + /- 1.6 percent , P < 0.001 ) and the infants ' birth weight was lower ( 3469 + /- 668 vs. 3848 + /- 434 g , P = 0.01 ) . Similarly , the infants born to the women in the postpr and ial-monitoring group had a lower rate of neonatal hypoglycemia ( 3 percent vs. 21 percent , P = 0.05 ) , were less often large for gestational age ( 12 percent vs. 42 percent , P = 0.01 ) and were less often delivered by cesarean section because of cephalopelvic disproportion ( 12 percent vs. 36 percent , P = 0.04 ) than those in the prepr and ial-monitoring group . CONCLUSIONS Adjustment of insulin therapy in women with gestational diabetes according to the results of postpr and ial , rather than prepr and ial , blood glucose values improves glycemic control and decreases the risk of neonatal hypoglycemia , macrosomia , and cesarean delivery Existing st and ards of the management of the diabetic patients are not efficient enough , and further improvement is needed . The major objective of this paper is to present and discuss the therapeutic effectiveness of an intensive care telematic system design ed and applied for intensive treatment of pregnant type 1 diabetic women . The developed system operates automatically , every night transferring all the data recorded during the day in the patient 's glucometer memory to a central clinical unit . In order to assess the efficiency of the design ed and developed system , a 3-year r and omized prospect i ve clinical trial was conducted , using the study group and the control group , each consisting of 15 pregnant type 1 diabetic women . All patients were treated by the same diabetologist . In the presented analysis , two indices calculated weekly were used for the assessment of glycemic control : MBG represents mean blood glucose level , and the universal J-index is sensitive to the glycemic level and glycemic variations . The most important results 
    Output:
    
agent
***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: Background Hyperglycemia in pregnancy is associated with poor perinatal outcome . Even if pregnant women with diabetes are monitored according to current guidelines , they do much worse than their normoglycaemic counterparts , marked by increased risks of pre-eclampsia , macrosomia , and caesarean section amongst others . Continuous Glucose Monitoring ( CGM ) is a new method providing detailed information on daily fluctuations , used to optimize glucose control . Whether this tool improves pregnancy outcome remains unclear . In the present protocol , we aim to assess the effect of CGM use in diabetic pregnancies on pregnancy outcome . Methods / design The GlucoMOMS trial is a multicenter open label r and omized clinical trial with a decision and cost-effectiveness study alongside . Pregnant women aged 18 and over with either diabetes mellitus type 1 or 2 on insulin therapy or with gestational diabetes requiring insulin therapy before 30 weeks of gestation will be asked to participate . Consenting women will be r and omly allocated to either usual care or complementary CGM . All women will determine their glycaemic control by self-monitoring of blood glucose levels and HbA1c . In addition , women allocated to CGM will use it for 5–7 days every six weeks . Based on their CGM profiles they receive dietary advice and insulin therapy adjustments if necessary . The primary outcome measure is rate of macrosomia , defined as a birth weight above the 90th centile . Secondary outcome measures will be birth weight , composite neonatal morbidity , maternal outcome and costs . The analyses will be according to the intention to treat principle . Discussion With this trial we aim at clarifying whether the CGM improves pregnancy outcome when used during diabetic pregnancies . Trial registration Nederl and s Trial Register : Objective To evaluate the effectiveness of continuous glucose monitoring during pregnancy on maternal glycaemic control , infant birth weight , and risk of macrosomia  in women with type 1 and type 2 diabetes . Design Prospect i ve , open label r and omised controlled trial . Setting Two secondary care multidisciplinary obstetric clinics for diabetes in the United Kingdom . Participants 71 women with type 1 diabetes ( n=46 ) or type 2 diabetes ( n=25 ) allocated to antenatal care plus continuous glucose monitoring  ( n=38 ) or to st and ard antenatal care  ( n=33 ) . Intervention Continuous glucose monitoring was used as an educational tool to inform shared decision making and future therapeutic changes at intervals of 4 - 6 weeks during pregnancy . All other aspects of antenatal care were equal between the groups . Main outcome measures The primary outcome was maternal glycaemic control during the second and third trimesters from measurements of HbA1c levels every four weeks . Secondary outcomes were birth weight and risk of macrosomia using birthweight st and ard deviation scores and customised birthweight centiles . Statistical analyses were done on an intention to treat basis . Results Women r and omised to continuous glucose monitoring had lower mean HbA1c levels from 32 to 36 weeks ’ gestation compared with women r and omised to st and ard antenatal care : 5.8 % ( SD 0.6 ) v 6.4 % ( SD 0.7 ) . Compared with infants of mothers in the control arm those of mothers in the intervention arm had decreased mean birthweight st and ard deviation scores ( 0.9 v 1.6 ; effect size 0.7 SD , 95 % confidence interval 0.0 to 1.3 ) , decreased median customised birthweight centiles ( 69 % v 93 % ) , and a reduced risk of macrosomia ( odds ratio 0.36 , 95 % confidence interval 0.13 to 0.98 ) . Conclusion Continuous glucose monitoring during pregnancy is associated with improved glycaemic control in the third trimester , lower birth weight , and reduced risk of macrosomia . Trial registration Current Controlled Trials IS RCT N84461581 The calibration of a continuous glucose monitoring system , i.e. the transformation of the signal I(t ) generated by the glucose sensor at time ( t ) into an estimation of glucose concentration G(t ) , represents a key issue . The two-point calibration procedure consists of the determination of a sensor sensitivity S and of a background current I(o ) by plotting two values of the sensor signal versus the concomitant blood glucose concentrations . The estimation of G(t ) is subsequently given by G(t ) = ( I(t)-I(o))/S. A glucose sensor was implanted in the subcutaneous tissue of nine type 1 diabetic patients during 3 ( n = 2 ) and 7 days ( n = 7 ) . For each individual trial , S and I(o ) were determined by taking into account the values of two sets of sensor output and blood glucose concentration distant by at least 1 h , the procedure being repeated for each consecutive set of values . S and I(o ) were found to be negatively correlated , the value of I(o ) being sometimes negative . Theoretical analysis demonstrates that this phenomenon can be explained by the effect of measurement uncertainties on the determination of capillary glucose concentration and of sensor output Background Women with type 1 diabetes strive for optimal glycemic control before and during pregnancy to avoid adverse obstetric and perinatal outcomes . For most women , optimal glycemic control is challenging to achieve and maintain . The aim of this study is to determine whether the use of real-time continuous glucose monitoring ( RT-CGM ) will improve glycemic control in women with type 1 diabetes who are pregnant or planning pregnancy . Methods / design A multi-center , open label , r and omized , controlled trial of women with type 1 diabetes who are either planning pregnancy with an HbA1c of 7.0 % to ≤10.0 % ( 53 to ≤ 86 mmol/mol ) or are in early pregnancy ( < 13 weeks 6 days ) with an HbA1c of 6.5 % to ≤10.0 % ( 48 to ≤ 86 mmol/mol ) . Participants will be r and omized to either RT-CGM alongside conventional intermittent home glucose monitoring ( HGM ) , or HGM alone .  Eligible women will wear a CGM which does not display the glucose result for 6 days during the run-in phase . To be eligible for r and omization , a minimum of 4 HGM measurements per day and a minimum of 96 hours total with 24 hours overnight ( 11 pm-7 am ) of CGM glucose values are required . Those meeting these criteria are r and omized to RT- CGM or HGM . A total of 324 women will be recruited ( 110 planning pregnancy , 214 pregnant ) . This takes into account 15 and 20 % attrition rates for the planning pregnancy and pregnant cohorts and will detect a clinical ly relevant 0.5 % difference between groups at 90 % power with 5 % significance . R and omization will stratify for type of insulin treatment ( pump or multiple daily injections ) and baseline HbA1c . Analyses will be performed according to intention to treat . The primary outcome is the change in glycemic control as measured by HbA1c from baseline to 24 weeks or conception in women planning pregnancy , and from baseline to 34 weeks gestation during pregnancy . Secondary outcomes include maternal hypoglycemia , CGM time in , above and below target ( 3.5–7.8 mmol/l ) , glucose variability measures , maternal and neonatal outcomes . Discussion This will be the first international multicenter r and omized controlled trial to evaluate the impact of RT- CGM before and during pregnancy in women with type 1 diabetes . Trial registration Clinical Trials.gov Identifier : NCT01788527 Registration Date : December 19 , 2012 AIM To compare the outcomes of Type 1 and Type 2 diabetic pregnancies and identify risk factors for poor outcome of Type 2 pregnancies METHODS The data from all ( 389 Type 1 and 146 Type 2 ) pre-gestational diabetic pregnancies from 10 UK hospitals were collected prospect ively . RESULTS The Type 2 mothers were less likely to have documented  pre-pregnancy counselling  ( 28.7 vs. 40.5 % ; P<0.05 ) or be taking folic acid at conception ( 21.9 vs. 36.4 % ; P<0.001 ) than Type 1 mothers . The percentage of pregnancies having a serious adverse outcome was higher in Type 2 patients ( 16.4 vs. 6.4 % ; P=0.002 ) . Congenital abnormalities ( 12.3 % in Type 2 vs. 4.4 % in Type 1 ; P=0.002 ) accounted for most of this difference . The HbA1c of the Type 2 patients was similar to that of the Type 1 with mean first trimester HbA1c of 7.22 and 7.35 % , respectively ( P=0.5 ) . Treatment with oral hypoglycaemic agents [ odds ratio ( OR ) , 1.8 ; 95 % confidence interval ( CI ) , 1.0 - 3.3 ; P=0.04 ] , body mass index ( OR , 1.09 ; 95 % CI , 1.01 - 1.18 ; P=0.02 ) and  folic acid supplementation  ( OR , 0.3 ; 95 % CI , 0.09 - 1.0 ; P=0.04 ) were all independently associated with congenital malformation . CONCLUSION Type 2 diabetic pregnancies are characterized by poor pre-pregnancy planning , inadequate folic acid supplementation and treatment with oral hypoglycaemic agents , all of which may contribute to the serious adverse outcomes affecting one in six Type 2 diabetic pregnancies . These remediable aspects of the pre-pregnancy care of women with Type 2 diabetes provide opportunities for improving the outcome towards that of women with Type 1 diabetes BACKGROUND The fetuses of women with gestational diabetes mellitus are at risk for macrosomia and its attendant complications . The best method of achieving euglycemia in these women and reducing morbidity in their infants is not known . We compared the efficacy of postpr and ial and prepr and ial monitoring in achieving glycemic control in women with gestational diabetes . METHODS We studied 66 women with gestational diabetes mellitus who required insulin therapy at 30 weeks of gestation or earlier . The women were r and omly assigned to have their diabetes managed according to the results of prepr and ial monitoring or postpr and ial monitoring ( one hour after meals ) of blood glucose concentrations . Both groups were also monitored with  fasting blood glucose measurements . The goal of insulin therapy was a prepr and ial value of 60 to 105 mg per deciliter ( 3.3 to 5.9 mmol per liter ) or a postpr and ial value of less than 140 mg per deciliter ( 7.8 mmol per liter ) . Obstetrical data and information on neonatal outcomes were collected . RESULTS The prepregnancy weight , weight gain during pregnancy , gestational age at the diagnosis of diabetes and at delivery , degree of compliance with therapy , and degree of achievement of target blood glucose concentrations were similar in the two groups . The mean ( + /- SD ) change in the glycosylated hemoglobin value was greater in the group in which postpr and ial measurements were used ( -3.0 + /- 2.2 percent vs. 0.6 + /- 1.6 percent , P < 0.001 ) and the infants ' birth weight was lower ( 3469 + /- 668 vs. 3848 + /- 434 g , P = 0.01 ) . Similarly , the infants born to the women in the postpr and ial-monitoring group had a lower rate of neonatal hypoglycemia ( 3 percent vs. 21 percent , P = 0.05 ) , were less often large for gestational age ( 12 percent vs. 42 percent , P = 0.01 ) and were less often delivered by cesarean section because of cephalopelvic disproportion ( 12 percent vs. 36 percent , P = 0.04 ) than those in the prepr and ial-monitoring group . CONCLUSIONS Adjustment of insulin therapy in women with gestational diabetes according to the results of postpr and ial , rather than prepr and ial , blood glucose values improves glycemic control and decreases the risk of neonatal hypoglycemia , macrosomia , and cesarean delivery Existing st and ards of the management of the diabetic patients are not efficient enough , and further improvement is needed . The major objective of this paper is to present and discuss the therapeutic effectiveness of an intensive care telematic system design ed and applied for intensive treatment of pregnant type 1 diabetic women . The developed system operates automatically , every night transferring all the data recorded during the day in the patient 's glucometer memory to a central clinical unit . In order to assess the efficiency of the design ed and developed system , a 3-year r and omized prospect i ve clinical trial was conducted , using the study group and the control group , each consisting of 15 pregnant type 1 diabetic women . All patients were treated by the same diabetologist . In the presented analysis , two indices calculated weekly were used for the assessment of glycemic control : MBG represents mean blood glucose level , and the universal J-index is sensitive to the glycemic level and glycemic variations . The most important results 
    Output:
    