Alexander Abitbol1,2,3, Remi Rabasa-Lhoret2,4,5,6, Virginie Messier2, Laurent Legault7, Mohamad Smaoui2, Nathan Cohen8, Ahmad Haidar3,9. 1. 1 LMC Diabetes & Endocrinology , Toronto, Canada . 2. 2 Institut de Recherches Cliniques de Montréal , Montreal, Canada . 3. 3 Division of Endocrinology and Metabolism, Department of Medicine, McGill University Health Centre , Montreal, Canada . 4. 4 Montreal Diabetes Research Center , Montreal, Canada . 5. 5 Division of Endocrinology and Metabolism, Department of Medicine, Université de Montréal , Montreal, Canada . 6. 6 Nutrition Department, Faculty of Medicine, University of Montreal , Montreal, Canada . 7. 7 Division of Pediatric Endocrinology and Metabolism, Department of Medicine, Montreal Children's Hospital, McGill University Health Centre , Montreal, Canada . 8. 8 Jaeb Center for Health Research , Tampa, Florida. 9. 9 Department of Biomedical Engineering, Faculty of Medicine, McGill University , Montreal, Canada .
Abstract
BACKGROUND: The dual-hormone (insulin and glucagon) artificial pancreas may be justifiable in some, but not all, patients. We sought to compare dual- and single-hormone artificial pancreas systems in patients with hypoglycemia unawareness and documented nocturnal hypoglycemia. METHODS: We conducted a randomized crossover trial comparing the efficacy of dual- and single-hormone artificial pancreas systems in controlling plasma glucose levels over the course of one night's sleep. We recruited 18 adult participants with hypoglycemia unawareness and 17 participants with hypoglycemia awareness, all of whom had documented nocturnal hypoglycemia during 2 weeks of screening. Outcomes were calculated using plasma glucose. RESULTS: In participants with hypoglycemia unawareness, the median (interquartile range [IQR]) percentage of time that plasma glucose was below 4.0 mmol/L was 0% (0-0) on dual-hormone artificial pancreas nights and 0% (0-10) on single-hormone artificial pancreas nights (P = 0.20). Additionally, participants with hypoglycemia unawareness experienced two hypoglycemic events (<3.0 mmol/L) on dual-hormone artificial pancreas nights and three hypoglycemic events on single-hormone artificial pancreas nights. In participants with hypoglycemia awareness, the median (IQR) percentage of time that plasma glucose was below 4.0 mmol/L was 0% (0-0) on both dual- and single-hormone artificial pancreas nights. Hypoglycemia awareness participants experiencedzero hypoglycemic events on dual-hormone artificial pancreas nights and one event on single-hormone artificial pancreas nights. DISCUSSION: In this study, dual-hormone and single-hormone systems performed equally well in preventing nocturnal hypoglycemia in participants with hypoglycemia unawareness. Longer studies over the course of multiple days and nights may be needed to explore possible specific benefits in this population. ClinicalTrials.gov No. NCT02282254.
RCT Entities:
BACKGROUND: The dual-hormone (insulin and glucagon) artificial pancreas may be justifiable in some, but not all, patients. We sought to compare dual- and single-hormone artificial pancreas systems in patients with hypoglycemia unawareness and documented nocturnal hypoglycemia. METHODS: We conducted a randomized crossover trial comparing the efficacy of dual- and single-hormone artificial pancreas systems in controlling plasma glucose levels over the course of one night's sleep. We recruited 18 adult participants with hypoglycemia unawareness and 17 participants with hypoglycemia awareness, all of whom had documented nocturnal hypoglycemia during 2 weeks of screening. Outcomes were calculated using plasma glucose. RESULTS: In participants with hypoglycemia unawareness, the median (interquartile range [IQR]) percentage of time that plasma glucose was below 4.0 mmol/L was 0% (0-0) on dual-hormone artificial pancreas nights and 0% (0-10) on single-hormone artificial pancreas nights (P = 0.20). Additionally, participants with hypoglycemia unawareness experienced two hypoglycemic events (<3.0 mmol/L) on dual-hormone artificial pancreas nights and three hypoglycemic events on single-hormone artificial pancreas nights. In participants with hypoglycemia awareness, the median (IQR) percentage of time that plasma glucose was below 4.0 mmol/L was 0% (0-0) on both dual- and single-hormone artificial pancreas nights. Hypoglycemia awarenessparticipants experienced zero hypoglycemic events on dual-hormone artificial pancreas nights and one event on single-hormone artificial pancreas nights. DISCUSSION: In this study, dual-hormone and single-hormone systems performed equally well in preventing nocturnal hypoglycemia in participants with hypoglycemia unawareness. Longer studies over the course of multiple days and nights may be needed to explore possible specific benefits in this population. ClinicalTrials.gov No. NCT02282254.
Authors: Marco Infante; David A Baidal; Michael R Rickels; Andrea Fabbri; Jay S Skyler; Rodolfo Alejandro; Camillo Ricordi Journal: Artif Organs Date: 2021-07-15 Impact factor: 2.663