FDA OK’s first artificial pancreas for managing type 1 diabetes during pregnancy
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Key takeaways:
- The CamAPS FX links compatible CGMs and insulin pumps into an artificial pancreas system.
- This is the first algorithm to be approved in the U.S. for use during pregnancy by women with type 1 diabetes.
The FDA authorized a closed-loop algorithm for an artificial pancreas system for use by people with type 1 diabetes aged 2 years and older, including during pregnancy, according to press release from Cambridge University.
The CamAPS FX (CamDiab), previously CE-marked for use in the U.K. and EU, is an Android app that can link a compatible continuous glucose monitor and insulin pump into a hybrid closed-loop system. Currently, the app is compatible with the Dexcom G6 and the Abbott FreeStyle Libre 3 CGM systems.
This is the first hybrid closed-loop algorithm cleared for use in the U.S. during pregnancy.
In the AiDAPT trial, published in The New England Journal of Medicine in 2023, pregnant women with type 1 diabetes were randomly assigned to use the CamAPS FX hybrid closed-loop insulin delivery system or standard care from 16 weeks gestation until delivery. The hybrid closed-loop group had a time in range 10.5 percentage points higher than the standard care group, with no differences observed in most neonatal and fetal outcomes.
“We set out to help people with type 1 diabetes and their families live better lives, and we’re delighted that the FDA has reviewed the safety and effectiveness of CamAPS FX and has given the technology its approval,” Roman Hovorka, PhD, professor of metabolic technology at the Institute of Metabolic Science and department of pediatrics at the University of Cambridge, said in the release. “It has been extensively tested, and we’re proud that it is considered by many to be the best algorithm out there.”
Reference:
Lee TTM, et al. N Engl J Med. 2023;doi:10.1056/NEJMoa2303911.
Perspective
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More and more young people are using hybrid closed-loop systems outside of pregnancy, but its safety and efficacy during pregnancy remained unproven. Randomized trial evidence were thus sorely needed to determine if such systems — for the most part not designed for pregnancy — could improve pregnancy time in range and pregnancy outcomes.
This approval of the Cam APS FX in pregnancy is based on the recent AiDAPT randomized controlled trial where pregnant women with type 1 diabetes were randomized to receive the Cam APS FX hybrid closed-loop system or continuous glucose monitoring alone. Investigators found a 10.5% improvement in time spent in the pregnancy range (63 mg/dL to 140 mg/dL) with the closed-loop system, with more time spent in range overnight, improved mean glucose and less time spent in the hyperglycemia range. While this system was not specifically developed for pregnancy, it is the only commercially available system that is programmable for a target glucose as low as 80 mg/dL, allowing for glucose levels appropriate for pregnancy. The study was not powered for maternal or neonatal outcomes.
We look forward to real-world data to inform the effect of this hybrid closed-loop system on pregnancy outcomes. Given the increasing use of such systems, in general, and the benefit and safety shown in the recent randomized trial, this approval for use in pregnancy will be greeted with much enthusiasm.
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