We aimed to assess whether adding Empa to the artificial pancreas can alleviate the burden of carbohydrate counting without degrading glucose control. We conducted a randomized, open-label, crossover, non-inferiority trial in 30 adults with T1D (age 40±15 years, A1c 7.6±0.7%). Each participant used the artificial pancreas on 5 non-consecutive days at home (9-14 hours/day) with: Empa 25mg and (i) carbohydrate counting, (ii) simple meal announcements (pressing a button, no carbohydrate counting), and (iii) no meal announcements (fully automated), and with: no Empa and (iv) carbohydrate counting (control arm) and (v) simple meal announcements. The fully automated artificial pancreas with Empa was inferior to the artificial pancreas with carbohydrate counting without Empa (mean glucose 10.0±1.6 vs. 8.5±1.5 mmol/L, p<0.001), but the artificial pancreas with simple meal announcement and Empa was non-inferior (8.5±1.4 mmol/L, non-inferiority p-value with a pre-specified margin of 0.75 mmol/L = 0.003). Time spent below 3.9 mmol/L was minimal in all interventions. No diabetic ketoacidosis was observed; mean ketones levels were 0.22±0.18 and 0.13±0.11 mmol/L, with and without Empa, respectively (p<0.001). We conclude that SGLT2 inhibition added to the artificial pancreas may alleviate the need for carbohydrate counting but does not allow a fully closed-loop system.
A. Haidar: Consultant; Self; Eli Lilly and Company. Research Support; Self; Dexcom, Inc., Eli Lilly and Company. 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. L. Lovblom: None. N. Cardinez: None. A. Orszag: None. C.M. Falappa: None. N. Gouchie-Provencher: None. A. El Fathi: None. D. Eldelekli: None. D. Scarr: None. B.A. Perkins: Consultant; Self; Abbott, Boehringer Ingelheim International GmbH, Insulet Corporation. Research Support; Self; Boehringer Ingelheim International GmbH, Novo Nordisk A/S. Other Relationship; Self; Medtronic.