We evaluated the function of the insulin-only iLet bionic pancreas delivering Fiasp vs. iLet delivering insulin lispro or aspart vs. usual care in a home-use study in adults on pump and MDI therapy with type 1 diabetes.
We performed a 3-way, random-order cross-over, home use study comparing the iLet delivering Fiasp (iLet-F) vs. the iLet delivering insulin lispro or aspart according to the usual-care insulin (iLet-LA) vs. usual care (UC) for 7 days each. Bionic pancreas sessions were initiated by entering only the body weight; the iLet autonomously and continuously adapts to individual insulin needs. The PK setting in the iLet algorithm was not adjusted for Fiasp.
The mean CGMG in the iLet-F arm (155±11, p=0.042), but not in the iLet-LA (155±13, p=0.097), was significantly lower than in the UC arm (162±26). There was no difference in mean CGMG between the iLet-F and iLet-LA arms (p=0.64). There were no differences in median % time <54 mg/dl between the arms (0.49 [0.0,1.0] vs. 0.53 [0.2,1.0] vs. 0.35 [0.1,1.2], p>0.64). The % time in range was greater in the iLet-F (70.6±8.1%, p=0.001) and iLet-LA (70.1±9.2%, p=0.006) arms vs. the UC arm (61.5%). There was no difference between the iLet-F and iLet-LA arms (p=0.54). There were no differences in mean insulin TDD between arms (p>0.45).
The iLet can provide effective glucose control when delivering Fiasp, insulin aspart, or insulin lispro. Adjustment to the PK settings of the iLet may be necessary to further improve glycemic outcomes with Fiasp.