It is well established that glycemic and continuous glucose monitoring (CGM) outcomes improve with increasing user engagement for both therapeutic devices (insulin pumps and pens) and diagnostic devices (CGMs, flash-glucose monitors, and blood-glucose monitors) used in the management of type 1 diabetes (T1D). Unlike any other insulin-delivery device, the iLet Bionic Pancreas (BP) determines and delivers 100% of all therapeutic insulin. Given this degree of autonomy, we hypothesized that glycemic and CGM outcomes obtained by the BP might be independent of the frequency of user engagement. To that end, data about user interactions with the BP were captured on the BP during the Bionic Pancreas Pivotal Trial (BPPT), and analyzed retrospectively. The average frequency of meal announcements initiated by each participant using the BP, and the average frequency of swipe gestures to unlock the lock screen of the BP, were analyzed and taken as proxies for user engagement with the device. Among 219 adults with T1D who used the BP for 13 weeks during the BPPT, the mean CGM glucose level was 156 ± 12 mg/dl. The average number of meal announcements and swipes to unlock the screen were 2.8/day and 9.9/day, respectively. The slope and intercept of the linear correlation between the mean CGM glucose level and the average number of daily swipes to unlock the screen were -0.08 and 157 mg/dl, respectively. The R2 correlation coefficient was 0.00. Similarly, the slope and intercept of the linear correlation between the mean CGM glucose level and the average number of daily meal announcements were -0.27 and 163 mg/dl, respectively, with an R2 of 0.06. Similar results to these are obtained when using 13-week HbA1c as an outcome. Unlike other therapeutic and diagnostic devices used in T1D management, glucose control achieved by the BP is nearly independent of the frequency of user engagement in terms of the metrics studied here.
E. Damiano: Board Member; Beta Bionics, Inc. Employee; Beta Bionics, Inc. Stock/Shareholder; Beta Bionics, Inc. R. Selagamsetty: Employee; Beta Bionics, Inc. Stock/Shareholder; Beta Bionics, Inc. R. Brandt: Employee; Beta Bionics, Inc. S.J. Russell: Employee; Beta Bionics, Inc. Stock/Shareholder; Beta Bionics, Inc. Other Relationship; Beta Bionics, Inc. Consultant; Beta Bionics, Inc. Research Support; Beta Bionics, Inc. Consultant; Novo Nordisk. Research Support; Novo Nordisk. Other Relationship; Novo Nordisk.
