Alleviating Carbohydrate Counting With a FiASP-plus-Pramlintide Closed-Loop Delivery System (Artificial Pancreas): Feasibility and Pilot Studies
| Autor: | Madison Odabassian, Julia E. Von Oettingen, Laurent Legault, Anas El Fathi, Joanna Rutkowski, Milad Ghanbari, Adnan Jafar, Elisa Cohen, Jean-François Yale, Nikita Gouchie-Provencher, Ahmad Haidar, Michael A. Tsoukas, Michael Vallis, Emilie Palisaitis, Jennifer René |
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| Rok vydání: | 2021 |
| Předmět: |
Meal
medicine.medical_specialty business.industry Endocrinology Diabetes and Metabolism Psychological intervention General Medicine SMA Pramlintide Artificial pancreas Carbohydrate counting Endocrinology Internal Medicine Physical therapy Medicine Delivery system Bolus (digestion) business medicine.drug |
| Zdroj: | Canadian Journal of Diabetes. 45:S29-S30 |
| ISSN: | 1499-2671 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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