Effectiveness of continuous glucose monitoring during diabetic pregnancy (GlucoMOMS trial); a randomised controlled trial

BMC Pregnancy and Childbirth

Inge M Evers³  Ben WJ Mol¹  Arie Franx²  J Hans DeVries⁴  Daphne N Voormolen² 

[1] Department of Obstetrics and Gynaecology, Maxima Medical Centre Veldhoven, Veldhoven, the Netherlands;Department of Obstetrics and Gynaecology, University Medical Centre Utrecht, Utrecht, the Netherlands;Department of Obstetrics and Gynaecology, Meander Medical Centre Amersfoort, Amersfoort, the Netherlands;Department of Endocrinology, Academic Medical Centre Amsterdam, Amsterdam, the Netherlands

关键词: Effectiveness;    Macrosomia;    Continuous glucose monitor;    Pregnancy;    Diabetes;   

Others  :  1151317
DOI  :  10.1186/1471-2393-12-164

 received in 2012-10-24, accepted in 2012-11-26,  发布年份 2012

【 摘 要 】

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 randomized 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 randomly 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

Nederlands Trial Register: NTR2996

【 授权许可】

   
2012 Voormolen et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Management of diabetes from preconception to the postnatal period: summary of NICE guidance BMJ 2008, 336:714-717.
• [2]Gabbe SG: Management of diabetes mellitus in pregnancy. Am J Obstet Gynecol 1985, 153:824-828.
• [3]Hawthorne G, Robson S, Ryall EA, Sen D, Roberts SH, Ward Platt MP: Prospective population based survey of outcome of pregnancy in diabetic women: results of the northern diabetic pregnancy audit, 1994. BMJ 1997, 315:279-281.
• [4]Evers IM, de Valk HW, Visser GH: Risk of complications of pregnancy in women with type 1 diabetes: nationwide prospective study in the Netherlands. BMJ 2004, 328:915.
• [5]McLachlan K, Jenkins A, O'Neal D: The role of continuous glucose monitoring in clinical decision-making in diabetes in pregnancy. Aust N Z J Obstet Gynaecol 2007, 47:186-190.
• [6]Sachedina N, Pickup JC: Performance assessment of the medtronic-MiniMed continuous glucose monitoring system and its use for measurement of glycaemic control in type 1 diabetic subjects. Diabet Med 2003, 20:1012-1015.
• [7]Langendam MW, Luijf YM, Hooft L, Devries JH, Mudde AH, Scholten RJ: Continuous glucose monitoring systems for type 1 diabetes mellitus. Cochrane Database Syst Rev 2012, 1:CD008101.
• [8]Murphy HR, Rayman G, Lewis K, Kelly S, Johal B, Duffield K, et al.: Effectiveness of continuous glucose monitoring in pregnant women with diabetes: randomised clinical trial. BMJ 2008, 337:a1680.
• [9]Secher AL, Ringholm L, Andersen HU, Damm P, Mathiesen ER: The effect of real-time continuous glucose monitoring in diabetic pregnancy - a randomised controlled trial. Diabetologia 2012, 55(SUPPL 1):S40.
• [10]Jensen DM, Damm P, Moelsted-Pedersen L, Ovesen P, Westergaard JG, Moeller M, et al.: Outcomes in type 1 diabetic pregnancies: a nationwide, population-based study. Diabetes Care 2004, 27:2819-2823.
• [11]Clausen TD, Mathiesen E, Ekbom P, Hellmuth E, Mandrup-Poulsen T, Damm P: Poor pregnancy outcome in women with type 2 diabetes. Diabetes Care 2005, 28:323-328.
• [12]Persson M, Norman M, Hanson U: Obstetric and perinatal outcomes in type 1 diabetic pregnancies: a large, population-based study. Diabetes Care 2009, 32:2005-2009.
• [13]Ferrara A, Kahn HS, Quesenberry CP, Riley C, Hedderson MM: An increase in the incidence of gestational diabetes mellitus: Northern California, 1991–2000. Obstet Gynecol 2004, 103:526-533.
• [14]Getahun D, Nath C, Ananth CV, Chavez MR, Smulian JC: Gestational diabetes in the United States: temporal trends 1989 through 2004. Am J Obstet Gynecol 2008, 198:525.
• [15]Rijpert M, Evers IM, de Vroede MA, de Valk HW, Heijnen CJ, Visser GH: Risk factors for childhood overweight in offspring of type 1 diabetic women with adequate glycemic control during pregnancy: nationwide follow-up study in the Netherlands. Diabetes Care 2009, 32:2099-2104.
• [16]Rijpert M, Evers IM, de Valk HW, de Vroede MA, Tersteeg-Kamperman M, Heijnen CJ, et al.: Cardiovascular and metabolic outcome in 6–8 year old offspring of women with type 1 diabetes with near-optimal glycaemic control during pregnancy. Early Hum Dev 2011, 87:49-54.
• [17]Sparano S, Ahrens W, De HS, Marild S, Molnar D, Moreno LA, et al.: Being macrosomic at birth is an independent predictor of overweight in children: results from the IDEFICS study. Matern Child Health J 2012. epub Sept
• [18]Hermanides J, Vriesendorp TM, Bosman RJ, Zandstra DF, Hoekstra JB, Devries JH: Glucose variability is associated with intensive care unit mortality. Crit Care Med 2010, 38:838-842.
• [19]Oostenbrink JB, Koopmanschap MA, Rutten FF: Standardisation of costs: the dutch manual for costing in economic evaluations. PharmacoEconomics 2002, 20:443-454.
• [20]Clements KM, Barfield WD, Ayadi MF, Wilber N: Preterm birth-associated cost of early intervention services: an analysis by gestational age. Pediatrics 2007, 119:e866-e874.