Techniques of monitoring blood glucose during pregnancy for women with pre-existing diabetes.

Publisher: Wiley Country of Publication: England NLM ID: 100909747 Publication Model: Electronic Cited Medium: Internet ISSN: 1469-493X (Electronic) Linking ISSN: 13616137 NLM ISO Abbreviation: Cochrane Database Syst Rev Subsets: MEDLINE

Publication: 2004- : Chichester, West Sussex, England : Wiley
Original Publication: Oxford, U.K. ; Vista, CA : Update Software,

Blood Glucose/*metabolism ; Blood Glucose Self-Monitoring/*methods ; Diabetes Mellitus, Type 1/*blood ; Diabetes Mellitus, Type 2/*blood; Adult ; Canada ; Europe ; Female ; Humans ; Hypertension/prevention & control ; Hypoglycemia/chemically induced ; Infant, Newborn ; Perinatal Mortality ; Pre-Eclampsia/prevention & control ; Pregnancy ; United States

Background: There are a number of ways of monitoring blood glucose in women with diabetes during pregnancy, with self-monitoring of blood glucose (SMBG) recommended as a key component of the management plan. No existing systematic reviews consider the benefits/effectiveness of different techniques of blood glucose monitoring on maternal and infant outcomes among pregnant women with pre-existing diabetes. The effectiveness of the various monitoring techniques is unclear. This review is an update of a review that was first published in 2014 and subsequently updated in 2017.
Objectives: To compare techniques of blood glucose monitoring and their impact on maternal and infant outcomes among pregnant women with pre-existing diabetes.
Search Methods: For this update, we searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (1 November 2018), and reference lists of retrieved studies.
Selection Criteria: Randomised controlled trials (RCTs) and quasi-RCTs comparing techniques of blood glucose monitoring including SMBG, continuous glucose monitoring (CGM), automated telemedicine monitoring or clinic monitoring among pregnant women with pre-existing diabetes mellitus (type 1 or type 2). Trials investigating timing and frequency of monitoring were also eligible for inclusion. RCTs using a cluster-randomised design were eligible for inclusion but none were identified.
Data Collection and Analysis: Two review authors independently assessed study eligibility, extracted data and assessed the risk of bias of included studies. Data were checked for accuracy. The quality of the evidence was assessed using the GRADE approach.
Main Results: This review update includes a total of 12 trials (863) women (792 women with type 1 diabetes and 152 women with type 2 diabetes). The trials took place in Europe, the USA and Canada. Three of the 12 included studies are at low risk of bias, eight studies are at moderate risk of bias, and one study is at high risk of bias. Four trials reported that they were provided with the continuous glucose monitors free of charge or at a reduced cost by the manufacturer.Continuous glucose monitoring (CGM) versus intermittent glucose monitoring, (four studies, 609 women)CGM may reduce hypertensive disorders of pregnancy (pre-eclampsia and pregnancy-induced hypertension) (risk ratio (RR) 0.58, 95% confidence interval (CI) 0.39 to 0.85; 2 studies, 384 women; low-quality evidence), although it should be noted that only two of the four relevant studies reported data for this composite outcome. Conversely, this did not translate into a clear reduction for pre-eclampsia (RR 0.65, 95% CI 0.39 to 1.08; 4 studies, 609 women, moderate-quality evidence). There was also no clear reduction in caesarean section (average RR 0.94, 95% CI 0.75 to 1.18; 3 studies, 427 women; I ² = 41%; moderate-quality evidence) or large-for-gestational age (average RR 0.84, 95% CI 0.57 to 1.26; 3 studies, 421 women; I ² = 70%; low-quality evidence) with CGM. There was not enough evidence to assess perinatal mortality (RR 0.82, 95% CI 0.05 to 12.61, 71 infants, 1 study; low-quality evidence), or mortality or morbidity composite (RR 0.80, 95% CI 0.61 to 1.06; 1 study, 200 women) as the evidence was based on single studies of low quality. CGM appears to reduce neonatal hypoglycaemia (RR 0.66, 95% CI 0.48 to 0.93; 3 studies, 428 infants). Neurosensory disability was not reported.Other methods of glucose monitoringFor the following five comparisons, self-monitoring versus a different type of self-monitoring (two studies, 43 women); self-monitoring at home versus hospitalisation (one study, 100 women), pre-prandial versus post-prandial glucose monitoring (one study, 61 women), automated telemedicine monitoring versus conventional system (three studies, 84 women), and constant CGM versus intermittent CGM (one study, 25 women), it is uncertain whether any of the interventions has any impact on any of our GRADE outcomes (hypertensive disorders of pregnancy, caesarean section, large-for-gestational age) because the quality of the evidence was found to be very low. This was due to evidence largely being derived from single trials, with design limitations and limitations with imprecision (wide CIs, small sample sizes, and few events). There was not enough evidence to assess perinatal mortality and neonatal mortality and morbidity composite. Other important outcomes, such as neurosensory disability, were not reported in any of these comparisons.
Authors' Conclusions: Two new studies (406 women) have been incorporated to one of the comparisons for this update. Although the evidence suggests that CGM in comparison to intermittent glucose monitoring may reduce hypertensive disorders of pregnancy, this did not translate into a clear reduction for pre-eclampsia, and so this result should be viewed with caution. No differences were observed for other primary outcomes for this comparison. The evidence base for the effectiveness of other monitoring techniques analysed in the other five comparisons is weak and based on mainly single studies with very low-quality evidence. Additional evidence from large well-designed randomised trials is required to inform choices of other glucose monitoring techniques and to confirm the effectiveness of CGM.

Update of: Cochrane Database Syst Rev. 2017 Jun 11;6:CD009613. (PMID: 28602020)

BMC Pregnancy Childbirth. 2016 Jul 18;16(1):167. (PMID: 27430714)
Diabetes Care. 2000 Oct;23(10):1494-8. (PMID: 11023142)
Diabetes Care. 2011 May;34(5):e53; author reply e54. (PMID: 21525493)
Cochrane Database Syst Rev. 2012 Jan 18;1:CD005060. (PMID: 22258959)
N Engl J Med. 1995 Nov 9;333(19):1237-41. (PMID: 7565999)
N Engl J Med. 1993 Sep 30;329(14):977-86. (PMID: 8366922)
Cochrane Database Syst Rev. 2019 May 23;5:CD009613. (PMID: 31120549)
Diabetes Res Clin Pract. 2013 Nov;102(2):e17-8. (PMID: 24138823)
Diabet Med. 2013 Nov;30(11):1374-81. (PMID: 23758126)
Int J Gynaecol Obstet. 2002 Jul;78(1):69-77. (PMID: 12113977)
Cochrane Database Syst Rev. 2017 Jun 11;6:CD009613. (PMID: 28602020)
Clin Diabetes. 2015 Oct;33(4):169-74. (PMID: 26487790)
Aust N Z J Obstet Gynaecol. 1999 Nov;39(4):457-60. (PMID: 10687763)
Diabetes Care. 2009 Jun;32(6):1046-8. (PMID: 19265024)
Health Qual Life Outcomes. 2018 Feb 13;16(1):34. (PMID: 29439718)
Cochrane Database Syst Rev. 2014 Apr 30;(4):CD009613. (PMID: 24782359)
Diabetes Care. 2004 Jan;27 Suppl 1:S76-8. (PMID: 14693933)
Diabetes Care. 2007 Nov;30(11):2785-91. (PMID: 17666464)
Diabetes Technol Ther. 2011 Nov;13(11):1109-13. (PMID: 21751889)
Lancet. 2017 Nov 25;390(10110):2347-2359. (PMID: 28923465)
Diabetes Obes Metab. 2018 Aug;20(8):1894-1902. (PMID: 29603547)
World Health Organ Tech Rep Ser. 1994;844:1-100. (PMID: 7941615)
Ann Ist Super Sanita. 1997;33(3):347-51. (PMID: 9542261)
Am J Med. 2005 Sep;118(Suppl 9A):27S-32S. (PMID: 16224940)
Am J Obstet Gynecol. 2000 Dec;183(6):1520-4. (PMID: 11120521)
Diabetes Technol Ther. 2009 Jan;11(1):57-62. (PMID: 19132857)
Med J Aust. 2005 Oct 3;183(7):373-7. (PMID: 16201957)
Diabet Med. 2005 Dec;22(12):1774-7. (PMID: 16401329)
Am J Obstet Gynecol. 2003 Aug;189(2):507-12. (PMID: 14520226)
PLoS One. 2015 Sep 03;10(9):e0136759. (PMID: 26336088)
Diabetologia. 2006 Jan;49(1):25-8. (PMID: 16341689)
Lancet. 1980 May 24;1(8178):1122-4. (PMID: 6103450)
BMJ. 2008 Sep 25;337:a1680. (PMID: 18818254)
J Diabetes Sci Technol. 2011 Jul 01;5(4):952-65. (PMID: 21880239)
Obstet Gynecol. 2005 Mar;105(3):675-85. (PMID: 15738045)
Diabet Med. 2001 Dec;18(12):965-72. (PMID: 11903395)
Endocrinol Metab Clin North Am. 2006 Mar;35(1):79-97, vi. (PMID: 16310643)
Diabetes Care. 2013 Jul;36(7):1877-83. (PMID: 23349548)
Am J Obstet Gynecol. 2010 Jun;202(6):643-9. (PMID: 20430355)
QJM. 2001 Aug;94(8):435-44. (PMID: 11493721)
Diabetes Care. 1983 May-Jun;6(3):219-23. (PMID: 6347574)
Cochrane Database Syst Rev. 2016 May 04;(5):CD008540. (PMID: 27142841)
Am J Med. 1983 Oct;75(4):592-6. (PMID: 6624767)
Diabetes Technol Ther. 2001 Winter;3(4):581-9. (PMID: 11911170)
Diabetologia. 2000 Jan;43(1):79-82. (PMID: 10663219)
Curr Opin Obstet Gynecol. 2007 Dec;19(6):586-90. (PMID: 18007138)
Obstet Gynecol. 2003 Oct;102(4):857-68. (PMID: 14551019)
Am J Obstet Gynecol. 1984 Dec 1;150(7):817-21. (PMID: 6507507)
Cochrane Database Syst Rev. 2017 Oct 29;10:CD011069. (PMID: 29081069)
Acta Obstet Gynecol Scand. 2008;87(1):43-9. (PMID: 18158626)
Birth Defects Res A Clin Mol Teratol. 2010 Oct;88(10):791-803. (PMID: 20890938)
Teratology. 1989 Mar;39(3):225-31. (PMID: 2727930)
Diabetes Educ. 2004 Sep-Oct;30(5):740, 742-4, 747-53. (PMID: 15510528)
N Engl J Med. 1988 Dec 22;319(25):1617-23. (PMID: 3200277)
Diabetes Care. 2008 May;31(5):1060-79. (PMID: 18445730)
Am J Med. 2001 Jul;111(1):1-9. (PMID: 11448654)
BMC Pregnancy Childbirth. 2012 Dec 27;12:164. (PMID: 23270328)
J Clin Endocrinol Metab. 2006 Oct;91(10):3718-24. (PMID: 16849402)
Cochrane Database Syst Rev. 2012 Jan 18;1:CD008101. (PMID: 22258980)
Diabetes Care. 1996 May;19(5):514-41. (PMID: 8732721)
Obstet Gynecol. 1991 Jun;77(6):846-9. (PMID: 2030855)
BMJ Open Diabetes Res Care. 2017 Jun 8;5(1):e000329. (PMID: 28761646)
Biosens Bioelectron. 2002 Aug;17(8):641-6. (PMID: 12052349)
Diabetes Care. 2007 May;30(5):1069-74. (PMID: 17468376)
J Telemed Telecare. 2009;15(5):238-42. (PMID: 19590029)
J Telemed Telecare. 2007;13(1):44-7. (PMID: 17288659)
BMJ. 2011 Jul 07;343:d3805. (PMID: 21737469)

United Kingdom Department of Health

0 (Blood Glucose)

Date Created: 20190524 Date Completed: 20190617 Latest Revision: 20220907

20221213

PMC6532756

10.1002/14651858.CD009613.pub4

31120549