Prospective study evaluating the use of nasal glucagon for the treatment of moderate to severe hypoglycaemia in adults with type 1 diabetes in a real‐world setting |
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Authors: | Elizabeth R. Seaquist MD Hélène Dulude PhD Xiaotian M. Zhang MD Remi Rabasa‐Lhoret MD George M. Tsoukas MDCM James R. Conway MD Stanley J. Weisnagel MD Gregg Gerety MD Vincent C. Woo MD Shuyu Zhang MS Dolorès Carballo BA Sheetal Pradhan MD Claude A. Piché DVM Cristina B. Guzman MD |
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Affiliation: | 1. University of Minnesota, Minneapolis, Minnesota;2. Locemia Solutions, Montreal, Québec, Canada;3. Medical Development, Diabetes Business Unit, Eli Lilly Canada Inc, Toronto, Ontario, Canada;4. Montreal Clinical Research Institute, Montreal, Québec, Canada;5. McGill University Health Center, Montreal, Québec, Canada;6. Canadian Centre for Research on Diabetes, Smiths Falls, Ontario, Canada;7. CHU de Québec‐Université Laval, Quebec City, Québec, Canada;8. Division of Community Endocrinology, Albany Medical College, Albany, New York;9. University of Manitoba, Winnipeg, Manitoba, Canada;10. Statistics, Eli Lilly and Company, Indianapolis, Indiana;11. Global Scientific Communications, Diabetes Business Unit, Eli Lilly Services India Pvt. Ltd, Bangalore, India;12. Medical Development, Diabetes Business Unit, Formerly Eli Lilly and Company, Indianapolis, Indiana |
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Abstract: | In the present multicentre, open‐label, prospective, phase III study, we evaluated the real‐world effectiveness and ease of use of nasal glucagon (NG) in the treatment of moderate/severe hypoglycaemic events (HEs) in adults with type 1 diabetes (T1D). Patients and caregivers were taught how to use NG (3 mg) to treat moderate/severe HEs, record the time taken to awaken or return to normal status, and measure blood glucose (BG) levels over time. Questionnaires were used to collect information about adverse events and ease of use of NG. In the efficacy analysis population, 69 patients experienced 157 HEs. In 95.7% patients, HEs resolved within 30 minutes of NG administration. In all the 12 severe HEs, patients awakened or returned to normal status within 15 minutes of NG administration without additional external medical help. Most caregivers reported that NG was easy to use. Most adverse events were local and of low to moderate severity. In this study, a single, 3‐mg dose of NG demonstrated real‐life effectiveness in treating moderate and severe HEs in adults with T1D. NG was well tolerated and easy to use. |
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Keywords: | adults hypoglycaemia nasal glucagon type 1 diabetes |
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