Ypsomed announced clinical study data demonstrating the benefits of its hybrid closed-loop insulin delivery system for pregnant women in October 2023. Pregnant women with type 1 diabetes and their babies benefitted from the automated insulin delivery system based on the CamDiab CamAPS FX algorithm. The New England Journal of Medicine published these outcomes from Ypsomed’s AiDAPT clinical study.
Ypsomed says the CamAPS FX is the only automated insulin delivery (AID) algorithm approved for pregnant women with type 1 diabetes. The mylife Loop system combines that algorithm with the Ypsomed YpsoPump and the Abbott FreeStyle Libre 3 or Dexcom G6 CGM. In the case of this study, investigators evaluated the system using the Dexcom G6. Together, they form an intelligent and automated insulin delivery (AID) system for people with type 1 diabetes. Users can better control glucose levels and alleviate the burden of daily diabetes management. Ypsomed launched its first AID system in November 2022.
Mylife Loop offers an intelligent, automated process for insulin dosing, according to a news release. It does so based on real-time glucose data from the CGM. CGM data allows for the administration of the appropriate amount of insulin at the right time. “We know that for women with type 1 diabetes, unborn babies are exquisitely sensitive to small rises in blood sugars, so keeping blood sugar levels within the normal range during pregnancy is crucial to reduce risks for the mother and child,” said Dr. Helen Murphy, Leader of the Study and Professor at the University of East Anglia.
The makeup of the Ypsomed study
AiDAPT evaluated 124 pregnant women with type 1 diabetes, aged 18 to 45 years. These women treated their condition with daily insulin therapy. They took part between the 12th week and the end of their pregnancy. Ypsomed’s system adjusts insulin doses to glucose levels provided by the CGM every 10-12 minutes. It continuously reacts to persistent changes in glucose levels during pregnancy. This study compared this technology to CGM and insulin delivery systems that require pregnant women to make multiple dosing decisions each day.
The study randomly assigned half to hybrid closed-loop technology and half to traditional insulin therapy with pumps or multiple daily injections. Investigators operated the study across nine hospitals in England, Scotland and Northern Ireland. The women used the technology for more than 95% of the time over the course of the study, Ypsomed said.
From the study, 23 participants also provided interviews of their experiences with the closed-loop system. A separate study — “Listening to women: experiences of using closed-loop in type 1 diabetes pregnancy” — outlines those responses. The researchers say the study proved too small to examine the health consequences for the baby, though. Results remain specific to the CamAPS FX technology.
Outcomes from the study
Compared to traditional insulin therapy methods, women using closed-loop technology spent more time in target range for pregnancy glucose levels. AID users hit target range 68% of the time versus 56% for traditional insulin therapy. That equals an additional 2.5-3 hours every day during pregnancy with no increased risk of hypoglycemia. Murphy said previous studies showed each additional hour spent in range reduces the risk of complications for these women.
The study also found that women using the technology gained 3.5 kg less weight. They also proved less likely to have blood pressure complications during pregnancy. Women on closed-loop technology had fewer additional appointments at the maternity hospital and made fewer out-of-hours calls to maternity units. Ypsomed said this suggests that the technology could save time for both pregnant women and those maternity units.
In the separate study with interviews from the women, they reported that the technology lessened the physical, mental and emotional demand of diabetes management from women. They say it increased their confidence to reach their glucose targets, improved sleep and decreased stress and anxiety.
The women in the study said the hybrid closed-loop system had an overall positive impact on their pregnancy. It allowed them to live a “more normal life,” according to one participant, improving relationships with healthcare teams, too. “This is the news that pregnant women with type 1 diabetes have been waiting for,” Murphy said. “It is great to see advances in diabetes technology deliver such improvements for mothers and infants. We are excited to make this groundbreaking technology widely available both for pregnant women, and for those planning pregnancy.”
REFERENCE: Drug Delivery Business News: A MassDevice Resource; 12 OCT 2023; Sean Whooley