Ypsomed reports positive outcomes from a large, randomized trial of its closed-loop insulin delivery technology during type 1 diabetes pregnancy.
The Switzerland-based company’s AiDAPT study demonstrated that hybrid closed-loop therapy significantly improves maternal glycemic control.
Pregnant women with type 1 diabetes used the automated insulin delivery system based on the CamDiab CamAPS FX algorithm in the study. These latest positive results follow strong outcomes reported about a year ago from the same 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.
Outcomes shared by Ypsomed came from 124 pregnant women across nine UK clinics. Investigators randomized them to hybrid closed-loop insulin therapy or standard insulin therapy with CGM.
Pregnant women using CamAPS FX improved their glycemic control, with 10.5% more time spent in the pregnancy-specific range of 3.5-7.8 mmol/L (63–140 mg/dL). Ypsomed reported 0.3% reduced HbA1c and no difference in time spent in hypoglycemia as well.
“These improvements were visible immediately after initiation of CamAPS FX and were sustained throughout the pregnancy,” the company said. “All women reported more enjoyable pregnancy experiences as a result of using hybrid closed-loop.”