Objective: The aim of this pilot study was to assess if a FiASP-and-pramlintide artificial pancreas (AP) could alleviate the need for CHO counting by using a simple meal announcement system (pressing a button, no CHO counting) without degrading glycemic control.
Methods: We conducted a 24-hour inpatient, randomized, crossover, non-inferiority, pilot study to compare (i) FiASP AP with full CHO counting (FCC) and CHO-matched boluses with (ii) FiASP-and-pramlintide AP with simple meal announcement (SMA). Pramlintide and FiASP were delivered in a basal-bolus manner using a fixed ratio (1U: 10µg).
Results: Seven participants (age 26.2±16, HbA1c 8.4±0.8%) were included in the analysis. The time in range (3.9-10 mmol/L) was 85.7% (IQR: [72-93]) in the FCC arm and 87.3% [75-95] in the SMA arm (p=0.21). Time spent >10mmol/L did not differ between interventions (FCC: 11.4% [0.9-22], SMA: 10.1% [3.1-25], p=0.38). Time <3.9mmol/L was lower in the SMA arm (2.1% vs. 4.1%, p=0.02). One participant experienced persistent GI symptoms in the SMA arm.
Conclusions: The FiASP-and-pramlintide SMA system has the potential of reducing the burden of CHO counting without degrading glucose control. Outpatient studies are warranted.
M. Tsoukas: Advisory Panel; Self; Eli Lilly and Company, Novo Nordisk Inc. Speaker’s Bureau; Self; Boehringer Ingelheim (Canada) Ltd., Janssen Scientific Affairs, LLC. E. Palisaitis: None. J. Rutkowski: None. J.E. von Oettingen: None. L. Legault: Advisory Panel; Self; Dexcom, Inc., Lilly Diabetes. Research Support; Self; AstraZeneca K.K., Merck & Co., Inc., Sanofi-Aventis. Other Relationship; Self; Lilly Diabetes. J. Yale: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim (Canada) Ltd., Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk A/S, Sanofi. Board Member; Self; Diagnos. Research Support; Self; Bayer Inc., Novo Nordisk A/S, Sanofi. Speaker’s Bureau; Self; Abbott, AstraZeneca, Boehringer Ingelheim (Canada) Ltd., Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Medtronic, Novo Nordisk A/S, Sanofi. A. Haidar: Consultant; Self; Eli Lilly and Company. Research Support; Self; Dexcom, Inc., Eli Lilly and Company.