Pregnant Women Can Use CGM in Canada During COVID-19
By Karena Yan, Eliza Skoler, and Ani Gururaj
Health Canada authorizes the latest temporary approval for CGM during the pandemic: the Dexcom G6 is now available to pregnant women with diabetes
Health Canada has temporarily authorized the use of the Dexcom G6 continuous glucose monitor (CGM) in pregnant women with type 1, type 2, or gestational diabetes. Currently, CGM is approved for pregnant women in Europe but not the US or Canada; this news is the latest in temporary approvals for CGM in new settings and populations due to the pandemic.
This is the second time Health Canada has approved the G6 for special use during the pandemic: in May, Abbott’s Freestyle Libre and Dexcom’s G6 CGM devices were authorized for people with diabetes in the hospital during COVID-19. The new authorization for pregnancy will be in place in Canada through March 18, 2021. Click here to read about COVID-19 hospital-setting CGM authorization in the US.
Glucose levels need to be more actively managed during pregnancy, as insulin requirements increase and the balance of insulin at different times of day often changes. This makes CGM especially important for pregnant women with diabetes. Moreover, the International Consensus on Time in Range recommends tighter guidelines for the amount of time spent in range for pregnant women:
At least 70% of the day with blood sugars between 63 to 140 mg/dl
Less than 4% of the day with blood sugars below 63 mg/dl
Less than 25% of the day with blood sugars above 140 mg/dl
You can find time in range guidelines for other people with diabetes here.
It is hoped that increased access to CGM will help people at risk for severe COVID-19 infection by enabling them to visualize periods of hypoglycemia and hyperglycemia, limiting their direct contact with healthcare professionals, and improving data-sharing capabilities with their healthcare team through telehealth and remote monitoring. Data shows that CGM use during pregnancy reduces blood glucose variation and improves both maternal and fetal health outcomes.
While Health Canada’s authorization is a temporary response to the pandemic, both Freestyle Libre and Dexcom G6 have been approved for pregnant women in Europe since February 2020. In addition, though CGM use during pregnancy is not approved in the US, off-label use of CGM during pregnancy rose from 35% to 65% from 2010-2013 to 2016-2018. Given the overwhelmingly positive data, we are hopeful that the temporary authorization for CGM use during pregnancy will extend beyond the pandemic.