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CONCEPTT

CONCEPTT logoWomen with type 1 diabetes continue to have adverse pregnancy outcomes, including high rates of major congenital malformations, stillbirth, neonatal death, as well as macrosomia and its associated complications. This study will consist of two parallel trials that are multi-centered, randomized, open label, and controlled with an intention-to-treat analysis.

The sample size is 214 pregnant women and 110 pre-pregnant women, to be recruited from 18 centres in total with 8 in Canada and 10 internationally.

For more information on the CONCEPTT trial, please contact: conceptt@sunnybrook.ca

The primary research questions of CONCEPTT are:

  1. Among women with diagnosed type 1 diabetes mellitus who are planning pregnancy, does the addition of RT- CGM to a standard regimen of intensive insulin therapy improve glycemic control, as measured by HbA1c from enrollment to 24 weeks (or to conception), when compared to a standard regimen of intensive insulin therapy without CGM? 
  2. Among pregnant women with diagnosed type 1 diabetes mellitus, does the addition of RT-CGM to a standard regimen of intensive insulin therapy improve glycemic control, as measured by HbA1c from enrollment in early pregnancy to 34 weeks gestation, when compared to a standard regimen of intensive insulin therapy without CGM? 

CONCEPTT blog

For recent updates on the CONCEPTT trial, visit our blog.