Health Canada has approved Dexcom G7 for use with myLoop, powered by CamAPS FX, making it the only automated insulin delivery system in Canada approved for use during pregnancy in women living with type 1 diabetes
MONTREAL, Nov. 9, 2026 /CNW/ -- Health Canada has approved the use of the Dexcom G7 Continuous Glucose Monitoring System with myLoop, powered by CamAPS FX, making it the only automated insulin delivery (AID) system in Canada approved specifically for use during pregnancy.*
myLoop pairs the YpsoPump insulin pump with the CamAPS FX app and algorithm, developed by CamDiab Ltd., alongside a compatible continuous glucose monitor, like Dexcom G7.
Managing type 1 diabetes during pregnancy
Managing type 1 diabetes requires constant attention and daily decision-making. Pregnancy adds another layer of complexity, as hormonal changes and the baby's development can cause insulin needs to vary significantly throughout pregnancy.
"Pregnancy can be particularly demanding for women living with type 1 diabetes, as insulin requirements can shift considerably while glucose targets remain tight. Technologies that automatically adapt insulin delivery may help women and their healthcare teams respond to these changing needs while easing some of the day-to-day burden of glucose management," said Dr. Ilana Halperin, Endocrinologist and Chief Medical Informatics Officer at Sunnybrook Hospital, and Associate Professor of Medicine at University of Toronto.
Evidence from the AiDAPT trial
The pregnancy indication is supported by AiDAPT, a randomized controlled trial of 124 pregnant women with type 1 diabetes conducted across nine clinics and published in The New England Journal of Medicine.¹ Women using CamAPS FX spent 10.5 percentage points more time in the pregnancy-specific glucose target range than those on standard monitoring and insulin delivery, with lower mean glucose and HbA1c levels and no added risk of hypoglycemia. The trial found these improvements took hold as early as the first trimester.
"Pregnancy places exceptional demands on glucose management, and this approval gives women in Canada access to adaptive technology at a time when tight control matters most. CamAPS FX was developed to adjust insulin delivery continuously as needs change, and the AiDAPT evidence shows the difference this approach can make. Extending our collaboration with mylife Diabetes Care and Dexcom to include Dexcom G7 in myLoop gives women and their healthcare teams choice during pregnancy," said Professor Roman Hovorka, Managing Director of CamDiab.
"This Canadian first represents an important milestone for diabetes care in the country. Women living with type 1 diabetes deserve access to technology that reflects the realities and specific demands of pregnancy," said Karina Schneider, General Manager of mylife Diabetes Care Canada Inc. "With this new indication, myLoop can support women and their healthcare teams through a period when glucose management can be particularly complex, while continuing to advance our commitment to making diabetes management simpler and more personalized at every stage of life."
More choice throughout the myLoop experience
myLoop powered by CamAPS FX debuted in Canada in March 2025 as the country's first smartphone-based AID system. Since then, its ecosystem has widened to include iOS and additional sensor options. The addition of Dexcom G7 now gives users another sensor option, including women living with type 1 diabetes during pregnancy.
The addition was made possible through close technical collaboration between CamDiab and Dexcom, working in partnership with mylife Diabetes Care and informed by the experiences of people living with diabetes and the clinicians who support them.
Availability is subject to launch timing and local market conditions.
About mylife Diabetes Care
mylife Diabetes Care is a global diabetes care company based in Switzerland, dedicated to improving the lives of people living with diabetes by empowering them to gain more freedom through better control. The company is fully focused on modern automated insulin delivery (AID) solutions designed for people living with diabetes, enabled through close collaboration with healthcare professionals and payers worldwide. For more information, visit www.mylife-diabetescare.ca.
About CamDiab
CamDiab Ltd is a digital health and personalized medicine company focused on the design, development and commercialization of its world-leading, interoperable CamAPS FX hybrid closed-loop app. CamAPS FX uses an adaptive, self-learning control algorithm, linked to a compatible continuous glucose monitor and insulin pump, to autonomously compute and direct insulin delivery to maintain tight glycaemic control. Since its founding in 2019, CamDiab's mission has been to help people with type 1 diabetes and their families live better lives. Find out more at www.camdiab.com.
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Important safety information and disclaimers |
1 Lee TTM, Collett C, Bergford S, et al. Automated Insulin Delivery in Women with Pregnancy Complicated by Type 1 Diabetes. N Engl J Med. 2023;389(17):1566–1578. doi:10.1056/NEJMoa2303911. |
* CamAPS FX is a mobile app intended for managing glucose levels in people with type 1 diabetes, including type 1 diabetes pregnancy, aged two years and over, using a hybrid closed-loop approach (automated basal insulin delivery with manual bolusing for meals). CamAPS FX requires a smartphone, an insulin pump and a continuous glucose monitor (CGM) to fulfil its intended use. CamAPS FX should only be used during pregnancy if the linked CGM's Canadian labelling explicitly permits use in pregnant women. Refer to the compatible CGM's labelling to confirm. Use of myLoop requires appropriate training and should be initiated and managed under the guidance of a healthcare professional. |
mylife, myLoop and YpsoPump are registered trademarks of mylife Diabetes Care AG or its affiliates. CamAPS is a registered trademark of CamDiab Ltd. Dexcom and Dexcom G7 are registered trademarks of Dexcom, Inc. in the United States and/or other countries. |
Individual results may vary. The AiDAPT trial reflects results from a controlled clinical study and does not replace individual clinical judgment. |
SOURCE YPSOMED CANADA INC.
mylife Diabetes Care: Media contact: Catherine Perreault, [email protected]; CamDiab: Media contact: [email protected]
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