TY - JOUR
T1 - Different methods and settings for glucose monitoring for gestational diabetes during pregnancy
AU - Raman, Puvaneswary
AU - Shepherd, Emily
AU - Dowswell, Therese
AU - Middleton, Philippa
AU - Crowther, Caroline A.
N1 - Funding Information:
Seven trials received funding support from non-commercial organisations: • Given 2015: the Department for Employment and Learning for Northern Ireland and the Derry City Council, Ireland; • Homko 2002: the General Clinical Research Center Branch of the National Center for Research Resources, USA; • Homko 2007: the National Institute of Nursing Research, National Institutes of Health, USA; • Homko 2012: the National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health USA; • Kestila 2007 the Turku University Central Hospital Research Fund and the Foundation of Gynaecologists and Obstetricians, Finland; • Perez-Ferre 2010: ’Fundacion para Estudios Metabolicos’; and • Wei 2016: the Social Development Project of JiangSu Province, China.
Funding Information:
Three trials received some support from commercial partners: Homko 2002 was provided with glucose meters by LifeScan Inc; Kruger 2003 was provided with a grant, and glucose meters from Roche Diagnostics; and Rey 1997 was supported by Lilly Canada. Two trials did not report any funding sources (Dalfra 2009; De Veciana 1995). Given 2015 reported that one author had received research funding from Nova Biomedical (a manufacturer of glucose meters); and Homko 2012 reported that one author had stock ownership in, and another was a consultant for, Insight Telehealth Systems. Perez-Ferre 2010 and Wei 2016 reported that the authors had no conflicts of interest. The other seven trials did not report on declarations of interest (Dalfra 2009; De Veciana 1995; Homko 2002; Homko 2007; Kestila 2007; Kruger 2003; Perez-Ferre 2010). For further details, see Characteristics of included studies.
Funding Information:
We acknowledge the support from the Cochrane Pregnancy and Childbirth editorial team in Liverpool, and the Australia and New Zealand Satellite of Cochrane Pregnancy and Childbirth (funded by the Australian National Health and Medical Research Council (NHMRC)).
Funding Information:
We thank Lambert Felix and Anna Cuthbert from Cochrane Pregnancy and Childbirth who provided support for this update, including assisting with producing the ’Summary of findings’ tables. Their contribution to this project was supported by the National Institute for Health Research (NIHR), via Cochrane programme grant funding to Cochrane Pregnancy and Childbirth. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Systematic Reviews Programme, NIHR, National Health Service or the Department of Health.
Funding Information:
This project was supported by the National Institute for Health Research, via Cochrane Infrastructure funding and Cochrane Programme Grant funding to Cochrane Pregnancy and Childbirth. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Systematic Reviews Programme, NIHR, NHS, or the Department of Health.
Funding Information:
Review outcomes reported: hypertensive disorders of pregnancy (pre-eclampsia, pregnancy-induced hypertension), caesarean section; induction of labour; use of additional pharmacotherapy (diabetes therapy at time of delivery); glycaemic control (HbA1c at 36 weeks; mean self-monitored blood glucose); maternal hypoglycaemia; gestational weight gain (weight at 36 weeks); adherence (appointments attended; average daily self-monitored blood glucose frequency (meter memory, diary)); average review length; stillbirth (intrauterine death); preterm birth; macrosomia; shoulder dystocia; respiratory distress syndrome (or transient tachypnoea of the newborn); hypoglycaemia (treated with dextrose); jaundice (no treatment needed; requiring phototherapy); malformations (diabetes-related); neonatal intensive care unit admission; gestational age at birth; birthweight; head circumference; length Funding: “This work constituted part of a PhD for J.E.G., which was funded by the Department for Employment and Learning for Northern Ireland. A small start-up grant was provided for the study by Derry City Council. The telemedicine service was provided free of charge at one of the trial sites;” “There was no involvement of the funders of this research or the telemedicine service provider in study design, data collection, data analysis, and manuscript preparation or publication decisions.” Declarations of interest: “M.J.O’K. has received research funding from Nova Biomedical (a manufacturer of glucose meters). J.E.G., B.P.B., F.D., and V.E.C. declare no competing financial interests exist.” Dates: January 2012 and May 2013
Funding Information:
Review outcomes reported: pre-eclampsia; caesarean section; perinatal mortality; large-for-gestational age; placental abruption; postpartum haemorrhage; gestational weight gain; adherence to the intervention (Dietary Compliance Questionnaire); sense of well-being and quality of life (Diabetes Empowerment Scale; Appraisal of Diabetes Scale); use of additional pharmacotherapy; glycaemic control (preprandial and post-prandial glucose); stillbirth; neonatal mortality; gestational age at birth; birthweight; hypoglycaemia; hyperbilirubinaemia; number of antenatal visits or admissions (visits with diabetes team) ; neonatal intensive care unit admission; ’birth trauma’; ’respiratory complications’ Funding: “This work was supported by a grant from the General Clinical Research Center branch of the National Center for Research Resources, Grant No. 2M01-RR-349” and “We would also like to thank LifeScan Inc, who generously donated the glucose meters for this study.” Declarations of interest: not reported Dates: March 1998 to November 1999
Funding Information:
Funding: “This study was supported by grant RO3 NR008776-01 from the National Institute of Nursing Research, National Institutes of Health” Declarations of interest: not reported Dates: September 2004 to May 2006
Funding Information:
Funding: “This study was supported by grant R21-DK-071694 from the National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health” Declarations of interest: “C.J.H., L.D., K.R., W.M., D.M., and J.G. have nothing to disclose. W.P.S. has stock ownership in Insight Telehealth Systems. A.A.B. is a consultant for Insight Telehealth Systems” Dates: September 2007 to November 2009
Funding Information:
Funding: “Turku University Central Hospital Research Fund, and The Foundation of Gynaecologists and Obstetricians in Finland supported this study” Declarations of interest: not reported Dates: not specified
Funding Information:
Funding: “This study was supported by a grant from Lilly Canada” Declarations of interest: not reported Dates: June 1993 to May 1994
Funding Information:
Review outcomes reported: caesarean section; use of additional pharmacotherapy (insulin use; dose); glycaemic control (HbA1c); hypoglycaemia; gestational weight gain (and excessive; inadequate; appropriate gain); views of intervention; large-for-gestational age; perineal mortality; stillbirth; neonatal death; preterm birth; macrosomia; small-for-gestational age; hypoglycaemia; gestational age at birth; birthweight Funding: “This work was partially supported by the following foundation: the Social Development Project of JiangSu Province (No. SBE201170735, Wang SH)” Declarations of interest: “The authors declare no competing financial interests”.
Publisher Copyright:
© 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
PY - 2017/10/29
Y1 - 2017/10/29
N2 - Background: Incidence of gestational diabetes mellitus (GDM) is increasing worldwide. Blood glucose monitoring plays a crucial part in maintaining glycaemic control in women with GDM and is generally recommended by healthcare professionals. There are several different methods for monitoring blood glucose which can be carried out in different settings (e.g. at home versus in hospital). Objectives: The objective of this review is to compare the effects of different methods and settings for glucose monitoring for women with GDM on maternal and fetal, neonatal, child and adult outcomes, and use and costs of health care. Search methods: We searched the Cochrane Pregnancy and Childbirth Group Trials Register (30 September 2016) and reference lists of retrieved studies. Selection criteria: Randomised controlled trials (RCTs) or quasi-randomised controlled trials (qRCTs) comparing different methods (such as timings and frequencies) or settings, or both, for blood glucose monitoring for women with GDM. Data collection and analysis: Two authors independently assessed study eligibility, risk of bias, and extracted data. Data were checked for accuracy. We assessed the quality of the evidence for the main comparisons using GRADE, for: - primary outcomes for mothers: that is, hypertensive disorders of pregnancy; caesarean section; type 2 diabetes; and - primary outcomes for children: that is, large-for-gestational age; perinatal mortality; death or serious morbidity composite; childhood/adulthood neurosensory disability; - secondary outcomes for mothers: that is, induction of labour; perineal trauma; postnatal depression; postnatal weight retention or return to pre-pregnancy weight; and - secondary outcomes for children: that is, neonatal hypoglycaemia; childhood/adulthood adiposity; childhood/adulthood type 2 diabetes. Main results: We included 11 RCTs (10 RCTs; one qRCT) that randomised 1272 women with GDM in upper-middle or high-income countries; we considered these to be at a moderate to high risk of bias. We assessed the RCTs under five comparisons. For outcomes assessed using GRADE, we downgraded for study design limitations, imprecision and inconsistency. Three trials received some support from commercial partners who provided glucose meters or financial support, or both. Main comparisons Telemedicine versus standard care for glucose monitoring (five RCTs): we observed no clear differences between the telemedicine and standard care groups for the mother, for: - pre-eclampsia or pregnancy-induced hypertension (risk ratio (RR) 1.49, 95% confidence interval (CI) 0.69 to 3.20; 275 participants; four RCTs; very low quality evidence); - caesarean section (average RR 1.05, 95% CI 0.72 to 1.53; 478 participants; 5 RCTs; very low quality evidence); and - induction of labour (RR 1.06, 95% CI 0.63 to 1.77; 47 participants; 1 RCT; very low quality evidence); or for the child, for: - large-for-gestational age (RR 1.41, 95% CI 0.76 to 2.64; 228 participants; 3 RCTs; very low quality evidence); - death or serious morbidity composite (RR 1.06, 95% CI 0.68 to 1.66; 57 participants; 1 RCT; very low quality evidence); and - neonatal hypoglycaemia (RR 1.14, 95% CI 0.48 to 2.72; 198 participants; 3 RCTs; very low quality evidence). There were no perinatal deaths in two RCTs (131 participants; very low quality evidence). Self-monitoring versus periodic glucose monitoring (two RCTs): we observed no clear differences between the self-monitoring and periodic glucose monitoring groups for the mother, for: - pre-eclampsia (RR 0.17, 95% CI 0.01 to 3.49; 58 participants; 1 RCT; very low quality evidence); and - caesarean section (average RR 1.18, 95% CI 0.61 to 2.27; 400 participants; 2 RCTs; low quality evidence); or for the child, for: - perinatal mortality (RR 1.54, 95% CI 0.21 to 11.24; 400 participants; 2 RCTs; very low quality evidence); - large-for-gestational age (RR 0.82, 95% CI 0.50 to 1.37; 400 participants; 2 RCTs; low quality evidence); and - neonatal hypoglycaemia (RR 0.64, 95% CI 0.39 to 1.06; 391 participants; 2 RCTs; low quality evidence). Continuous glucose monitoring system (CGMS) versus self-monitoring of glucose (two RCTs): we observed no clear differences between the CGMS and self-monitoring groups for the mother, for: - caesarean section (RR 0.91, 95% CI 0.68 to 1.20; 179 participants; 2 RCTs; very low quality evidence); or for the child, for: - large-for-gestational age (RR 0.67, 95% CI 0.43 to 1.05; 106 participants; 1 RCT; very low quality evidence) and - neonatal hypoglycaemia (RR 0.79, 95% CI 0.35 to 1.78; 179 participants; 2 RCTs; very low quality evidence). There were no perinatal deaths in the two RCTs (179 participants; very low quality evidence). Other comparisons Modem versus telephone transmission for glucose monitoring (one RCT): none of the review's primary outcomes were reported in this trial Postprandial versus preprandial glucose monitoring (one RCT): we observed no clear differences between the postprandial and preprandial glucose monitoring groups for the mother, for: - pre-eclampsia (RR 1.00, 95% CI 0.15 to 6.68; 66 participants; 1 RCT); - caesarean section (RR 0.62, 95% CI 0.29 to 1.29; 66 participants; 1 RCT); and - perineal trauma (RR 0.38, 95% CI 0.11 to 1.29; 66 participants; 1 RCT); or for the child, for: - neonatal hypoglycaemia (RR 0.14, 95% CI 0.02 to 1.10; 66 participants; 1 RCT). There were fewer large-for-gestational-age infants born to mothers in the postprandial compared with the preprandial glucose monitoring group (RR 0.29, 95% CI 0.11 to 0.78; 66 participants; 1 RCT). Authors' conclusions: Evidence from 11 RCTs assessing different methods or settings for glucose monitoring for GDM suggests no clear differences for the primary outcomes or other secondary outcomes assessed in this review. However, current evidence is limited by the small number of RCTs for the comparisons assessed, small sample sizes, and the variable methodological quality of the RCTs. More evidence is needed to assess the effects of different methods and settings for glucose monitoring for GDM on outcomes for mothers and their children, including use and costs of health care. Future RCTs may consider collecting and reporting on the standard outcomes suggested in this review.
AB - Background: Incidence of gestational diabetes mellitus (GDM) is increasing worldwide. Blood glucose monitoring plays a crucial part in maintaining glycaemic control in women with GDM and is generally recommended by healthcare professionals. There are several different methods for monitoring blood glucose which can be carried out in different settings (e.g. at home versus in hospital). Objectives: The objective of this review is to compare the effects of different methods and settings for glucose monitoring for women with GDM on maternal and fetal, neonatal, child and adult outcomes, and use and costs of health care. Search methods: We searched the Cochrane Pregnancy and Childbirth Group Trials Register (30 September 2016) and reference lists of retrieved studies. Selection criteria: Randomised controlled trials (RCTs) or quasi-randomised controlled trials (qRCTs) comparing different methods (such as timings and frequencies) or settings, or both, for blood glucose monitoring for women with GDM. Data collection and analysis: Two authors independently assessed study eligibility, risk of bias, and extracted data. Data were checked for accuracy. We assessed the quality of the evidence for the main comparisons using GRADE, for: - primary outcomes for mothers: that is, hypertensive disorders of pregnancy; caesarean section; type 2 diabetes; and - primary outcomes for children: that is, large-for-gestational age; perinatal mortality; death or serious morbidity composite; childhood/adulthood neurosensory disability; - secondary outcomes for mothers: that is, induction of labour; perineal trauma; postnatal depression; postnatal weight retention or return to pre-pregnancy weight; and - secondary outcomes for children: that is, neonatal hypoglycaemia; childhood/adulthood adiposity; childhood/adulthood type 2 diabetes. Main results: We included 11 RCTs (10 RCTs; one qRCT) that randomised 1272 women with GDM in upper-middle or high-income countries; we considered these to be at a moderate to high risk of bias. We assessed the RCTs under five comparisons. For outcomes assessed using GRADE, we downgraded for study design limitations, imprecision and inconsistency. Three trials received some support from commercial partners who provided glucose meters or financial support, or both. Main comparisons Telemedicine versus standard care for glucose monitoring (five RCTs): we observed no clear differences between the telemedicine and standard care groups for the mother, for: - pre-eclampsia or pregnancy-induced hypertension (risk ratio (RR) 1.49, 95% confidence interval (CI) 0.69 to 3.20; 275 participants; four RCTs; very low quality evidence); - caesarean section (average RR 1.05, 95% CI 0.72 to 1.53; 478 participants; 5 RCTs; very low quality evidence); and - induction of labour (RR 1.06, 95% CI 0.63 to 1.77; 47 participants; 1 RCT; very low quality evidence); or for the child, for: - large-for-gestational age (RR 1.41, 95% CI 0.76 to 2.64; 228 participants; 3 RCTs; very low quality evidence); - death or serious morbidity composite (RR 1.06, 95% CI 0.68 to 1.66; 57 participants; 1 RCT; very low quality evidence); and - neonatal hypoglycaemia (RR 1.14, 95% CI 0.48 to 2.72; 198 participants; 3 RCTs; very low quality evidence). There were no perinatal deaths in two RCTs (131 participants; very low quality evidence). Self-monitoring versus periodic glucose monitoring (two RCTs): we observed no clear differences between the self-monitoring and periodic glucose monitoring groups for the mother, for: - pre-eclampsia (RR 0.17, 95% CI 0.01 to 3.49; 58 participants; 1 RCT; very low quality evidence); and - caesarean section (average RR 1.18, 95% CI 0.61 to 2.27; 400 participants; 2 RCTs; low quality evidence); or for the child, for: - perinatal mortality (RR 1.54, 95% CI 0.21 to 11.24; 400 participants; 2 RCTs; very low quality evidence); - large-for-gestational age (RR 0.82, 95% CI 0.50 to 1.37; 400 participants; 2 RCTs; low quality evidence); and - neonatal hypoglycaemia (RR 0.64, 95% CI 0.39 to 1.06; 391 participants; 2 RCTs; low quality evidence). Continuous glucose monitoring system (CGMS) versus self-monitoring of glucose (two RCTs): we observed no clear differences between the CGMS and self-monitoring groups for the mother, for: - caesarean section (RR 0.91, 95% CI 0.68 to 1.20; 179 participants; 2 RCTs; very low quality evidence); or for the child, for: - large-for-gestational age (RR 0.67, 95% CI 0.43 to 1.05; 106 participants; 1 RCT; very low quality evidence) and - neonatal hypoglycaemia (RR 0.79, 95% CI 0.35 to 1.78; 179 participants; 2 RCTs; very low quality evidence). There were no perinatal deaths in the two RCTs (179 participants; very low quality evidence). Other comparisons Modem versus telephone transmission for glucose monitoring (one RCT): none of the review's primary outcomes were reported in this trial Postprandial versus preprandial glucose monitoring (one RCT): we observed no clear differences between the postprandial and preprandial glucose monitoring groups for the mother, for: - pre-eclampsia (RR 1.00, 95% CI 0.15 to 6.68; 66 participants; 1 RCT); - caesarean section (RR 0.62, 95% CI 0.29 to 1.29; 66 participants; 1 RCT); and - perineal trauma (RR 0.38, 95% CI 0.11 to 1.29; 66 participants; 1 RCT); or for the child, for: - neonatal hypoglycaemia (RR 0.14, 95% CI 0.02 to 1.10; 66 participants; 1 RCT). There were fewer large-for-gestational-age infants born to mothers in the postprandial compared with the preprandial glucose monitoring group (RR 0.29, 95% CI 0.11 to 0.78; 66 participants; 1 RCT). Authors' conclusions: Evidence from 11 RCTs assessing different methods or settings for glucose monitoring for GDM suggests no clear differences for the primary outcomes or other secondary outcomes assessed in this review. However, current evidence is limited by the small number of RCTs for the comparisons assessed, small sample sizes, and the variable methodological quality of the RCTs. More evidence is needed to assess the effects of different methods and settings for glucose monitoring for GDM on outcomes for mothers and their children, including use and costs of health care. Future RCTs may consider collecting and reporting on the standard outcomes suggested in this review.
UR - http://www.scopus.com/inward/record.url?scp=85032355994&partnerID=8YFLogxK
U2 - 10.1002/14651858.CD011069.pub2
DO - 10.1002/14651858.CD011069.pub2
M3 - Review article
C2 - 29081069
AN - SCOPUS:85032355994
SN - 1465-1858
VL - 2017
JO - Cochrane Database of Systematic Reviews
JF - Cochrane Database of Systematic Reviews
IS - 10
M1 - CD011069
ER -