GlucoMOMS

GlucoMOMS: Effectiveness of continuous glucose monitoring during diabetic pregnancy

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GlucoMOMS: Effectiveness of continuous glucose monitoring during diabetic pregnancy.

Objective
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 normoglycemic counterparts. The Continuous Glucose Monitoring System (CGMS) is an efficacious new method to optimize glucose control in pregnant women with diabetes. In the present proposal, we aim to assess the effectiveness, costs and cost-effectiveness of the use of the CGMS to optimize glycemic control during diabetic pregnancies and reduce macrosomia, relative to standard control methods.

Study design
Multicenter open label randomized clinical trial (RCT) with a decision and cost-effectiveness study alongside it.

Study population
Pregnant women with type 1 and 2 diabetes or with gestational diabetes.

Inclusion Criteria
- Pregnant women with pre-existing diabetes (type 1 or type 2) on onsulin treatment regimen or use of insulinpump,  before 16 weeks of pregnancy.
- Pregnant women with gestational diabetes on insulin treatment, before 30 weeks of pregnancy.

Exclusion Criteria
Severe medical or psychological comorbidity
Multiple pregnancies

Intervention
Consenting women will be randomly allocated to either additional use of CGMS or usual care. All women will determine their glycemic control by self-monitoring of blood glucose levels and HbA1c. In addition, women allocated to CGMS will use CGMS every month and adjust their insulin regimen based on their CGMS profile.

Outcome measures of the RCT
Primary outcome of the RCT will be macrosomia rate, defined as a birth weight above the 90th centile. Secondary outcomes will be birth weight, composite neonatal morbidity, maternal outcome and costs. The analyses will be according to the intention to treat principle.

Sample size calculation
We anticipate that a reduction of macrosomia from 45% to 30% will outweigh the costs of the additional use of the CGMS. Under these assumptions, we need to randomize 300 women (two groups of 150).

Economic evaluation
As we expect a reduction of macrosomia but an increased use of resources in the intervention group, the economic analysis will be a cost-effectiveness analysis, with the costs per prevented case of macrosomia as the primary outcome measure, and a cost-benefit-analysis based on modeling, where also the economic consequences of (reduction of) complications and care-use due to macrosomia will be evaluated on the long term.

Time schedule
Total study time 24 months.

Projectleaders
Dr I M Evers, gynaecologist, Meander MC
Dr H W de Valk, diabetologist, UMCU

Dr J H de Vries, internist-endocrinoloog, AMC
Prof Dr BW Mol, gynaecologist, AMC
Prof Dr A Franx, gynaecologist, UMCU
Drs D. van Munster, arts-onderzoeker UMCU

Subsidy
ZonMW (www.zonmw.nl)
Dossier number 80-82310-97-11157

Contact
Drs D. van Munster,
arts-onderzoeker UMC Utrecht
tel: 0031-618356448
GlucoMOMS@studies-obsgyn.nl