Please find the PPT summary of the April AP CPI Journal Club April 27, 2021
April_JC_Slides.pptx
Journal Article: Reducing the need for carbohydrate counting in type1 diabetes using closed-loop automated insulin delivery (artificial pancreas) and empagliflozin: A randomized, controlled, non-inferiority, crossover pilot trial
Authors: Ahmad Haidar PhD | Jean-Francois Yale MD| Leif Erik Lovblom MSc |
Nancy Cardinez NP | Andrej Orszag MD| C. Marcelo Falappa MD |
Nikita Gouchie-Provencher RN | Michael A. Tsoukas MD | Anas El Fathi PhD |
Jennifer Rene RN | Devrim Eldelekli BM | Sebastien O. Lanctôt |
Daniel Scarr BSc | Bruce A. Perkins MD
Abstract
Aim: To assess whether adding empagliflozin to closed-loop automated insulin delivery
could reduce the need for carbohydrate counting in type 1 diabetes (T1D) without
worsening glucose control.
Materials and Methods: In an open-label, crossover, non-inferiority trial, 30 adult
participants with T1D underwent outpatient automated insulin delivery interventions
with three random sequences of prandial insulin strategy days: carbohydrate counting,
simple meal announcement (no carbohydrate counting) and no meal announcement.
During each sequence of prandial insulin strategies, participants were randomly
assigned empagliflozin (25 mg/day) or not, and crossed over to the comparator. Mean
glucose for carbohydrate counting without empagliflozin (control) was compared with
no meal announcement with empagliflozin (in the primary non-inferiority comparison)
and simple meal announcement with empagliflozin (in the conditional primary noninferiority
comparison).
Results: Participants were aged 40 ± 15 years, had 27 ± 15 years diabetes duration
and HbA1c of 7.6% ± 0.7% (59 ± 8 mmol/mol). The system with no meal announcement
and empagliflozin was not non-inferior (and thus reasonably considered inferior)
to the control arm (mean glucose 10.0 ± 1.6 vs. 8.5 ± 1.5 mmol/L; non-inferiority
p = .94), while simple meal announcement and empagliflozin was non-inferior
(8.5 ± 1.4 mmol/L; non-inferiority p = .003). Use of empagliflozin on the background
of automated insulin delivery with carbohydrate counting was associated with lower
mean glucose, corresponding to a 14% greater time in the target range. While no
ketoacidosis was observed, mean fasting ketones levels were higher on empagliflozin
(0.22 ± 0.18 vs. 0.13 ± 0.11 mmol/L; p < .001).
Conclusions: Empagliflozin added to automated insulin delivery has the potential to
eliminate the need for carbohydrate counting and improves glycaemic control in conjunction
with carbohydrate counting, but does not allow for the elimination of meal
announcement.