Mar. 11 at 8:03 PM
$PODD Insulet presents 'promising' study results for AID system
Insulet has shared new clinical evidence related to the development of its first fully closed-loop A automated insulin delivery, AID, system for type 2 diabetes. Presented at the 19th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) in Barcelona, Spain, EVOLUTION 2C is the second in a series of feasibility studies supporting the development of an Omnipod fully closed-loop system. This multicenter feasibility study was designed to drive rapid innovation, allowing investigators to evaluate multiple versions of the algorithm to support continued FCL system development. It included 24 adults in a highly diverse cohort from New Zealand, aged 16-70 years with type 2 diabetes using insulin (basal-bolus or basal-only, pumps or injections with HbA1c under 12.0%).
The participants had lived with type 2 diabetes for an average of 16 years. When using the final algorithm version of FCL with no boluses, the participants' time in range increased to an average of 68%, a 24% improvement over standard injection therapy. Time Below Range remained very low, with a median of 0.14% below 70 mg/dL-well under the American Diabetes Association's recommended threshold of less than 4%. No severe hypoglycemia or diabetic ketoacidosis events were observed. Users experienced improved glycemic outcomes without compromising on low glucose events. The benefits were observed across a diverse set of participant characteristics including sex, ethnicity, baseline HbA1c, and body mass index.
