Alleviating carbohydrate counting with a FiASP‐plus‐pramlintide closed‐loop delivery system (artificial pancreas): Feasibility and pilot studies

• Published in: Diabetes, obesity & metabolism obesity & metabolism, 2021-09, Vol.23 (9), p.2090-2098
• Main Authors: Tsoukas, Michael A., Cohen, Elisa, Legault, Laurent, Oettingen, Julia E., Yale, Jean‐François, Vallis, Michael, Odabassian, Madison, El Fathi, Anas, Rutkowski, Joanna, Jafar, Adnan, Ghanbari, Milad, Gouchie‐Provencher, Nikita, René, Jennifer, Palisaitis, Emilie, Haidar, Ahmad
• Format: Article
• Language: English
• Subjects: artificial pancreas; carbohydrate counting; Carbohydrates; Diabetes; Diabetes mellitus; Dietary restrictions; Feasibility studies; Meals; Pancreas; Placebos; pramlintide; simple meal announcement; type 1 diabetes
• ISSN: 1462-8902; 1463-1326
• DOI: 10.1111/dom.14447

Aim To assess whether a FiASP‐and‐pramlintide closed‐loop system has the potential to replace carbohydrate counting with a simple meal announcement (SMA) strategy (meal priming bolus without carbohydrate counting) without degrading glycaemic control compared with a FiASP closed‐loop system. Materials and Methods We conducted a 24‐hour feasibility study comparing a FiASP system with full carbohydrate counting (FCC) with a FiASP‐and‐pramlintide system with SMA. We conducted a subsequent 12‐day outpatient pilot study comparing a FiASP‐and‐placebo system with FCC, a FiASP‐and‐pramlintide system with SMA, and a FiASP‐and‐placebo system with SMA. Basal‐bolus FiASP‐and‐pramlintide were delivered at a fixed ratio (1 U:10 μg). Glycaemic outcomes were measured, surveys evaluated gastrointestinal symptoms and diabetes distress, and participant interviews helped establish a preliminary coding framework to assess user experience. Results Seven participants were included in the feasibility analysis. Time spent in 3.9‐10 mmol/L was similar between both interventions (81%‐84%). Four participants were included in the pilot analysis. Time spent in 3.9‐10 mmol/L was similar between the FiASP‐and‐placebo with FCC and FiASP‐and‐pramlintide with SMA interventions (70%), but was lower in the FiASP‐and‐placebo with SMA intervention (60%). Time less than 3.9 mmol/L and gastrointestinal symptoms were similar across all interventions. Emotional distress was moderate at baseline, after the FiASP‐and‐placebo with FCC and SMA interventions, and fell after the FiASP‐and‐pramlintide with SMA intervention. SMA reportedly afforded participants flexibility and reduced mealtime concerns. Conclusions The FiASP‐and‐pramlintide system has the potential to substitute carbohydrate counting with SMA without degrading glucose control.