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

Elizabeth R. Seaquist; Hélène Dulude; Xiaotian M. Zhang; Remi Rabasa-Lhoret; George M. Tsoukas; James R. Conway; Stanley J. Weisnagel; Gregg Gerety; Vincent C. Woo; Shuyu Zhang; Dolorès Carballo; Sheetal Pradhan; Claude A. Piché; Cristina B. Guzman

doi:10.1111/dom.13278

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

Elizabeth R. Seaquist, Hélène Dulude, Xiaotian M. Zhang, Remi Rabasa-Lhoret, George M. Tsoukas, James R. Conway, Stanley J. Weisnagel, Gregg Gerety, Vincent C. Woo, Shuyu Zhang, Dolorès Carballo, Sheetal Pradhan, Claude A. Piché, Cristina B. Guzman

Medicine - Endocrine and Diabetes Division

Research output: Contribution to journal › Article › peer-review

37 Scopus citations

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.

Original language	English (US)
Pages (from-to)	1316-1320
Number of pages	5
Journal	Diabetes, Obesity and Metabolism
Volume	20
Issue number	5
DOIs	https://doi.org/10.1111/dom.13278
State	Published - May 2018

Bibliographical note

Funding Information:
E.R.S. is the Principal Investigator at University of Minnesota, Minneapolis. She also consults for Eli Lilly, Locemia, Zucara, Sanofi and Novo Nordisk and receives grants from Locemia and Eli Lilly. R.R-L. is the Principal Investigator at Montreal Clinical Research Institute, Montreal, QC, Canada, and receives research grants from AMG, Astra-Zeneca, Eli Lilly, Lexicon, Merck, NIH, Novo-Nordisk and Sanofi-Aventis. He is on the consulting/advisory panel of Abbott, Amgen, Astra-Zeneca, Boehringer, Carlina Technologies, Eli Lilly, Janssen, Medtronic, Merck, Novo-Nordisk, Roche, Sanofi-Aventis and Takeda. G.M.T. is the Principal Investigator at McGill University Health Center, QC, Canada. J.R.C. is the Principal Investigator at Canadian Centre for Research on Diabetes, Smith Falls, ON, Canada. S.J.W. is the Principal Investigator at CHU de Québec-Université Laval, Quebec City, QC, Canada. He receives research grants from Astra-Zeneca, Eli Lilly, Novo-Nordisk, Sanofi-Aventis, Bayer, Novartis, Boehringer, Medtronic, Locemia and Diabetes Canada. G.F.G. is the Principal Investigator at Division of Community Endocrinology, Albany Medical College, Albany, New York. He receives research grants from Boehringer, Eli Lilly, Lexicon and Novo Nordisk and speaker honoraria from Boehringer, Dexcom, Janssen, Lilly, Merck & Novo Nordisk. V.C.W. is the Principal Investigator at University of Manitoba, Winnipeg, MB, Canada. He has been involved in clinical trials for Eli Lilly, Locemia, BMS, Astra Zeneca, Janssen, Merck, Novo Nordisk, Sanofi and he is on the advisory boards for Eli Lilly, Merck, Astra Zeneca, Novo Nordisk, Janssen and Sanofi. H.D., C.A.P. and D.C. are employees and stockholders of Locemia Solutions, which funded the study. X.M.Z. is an employee of and stockholder in Eli Lilly, Canada. S.P. is an employee of Eli Lilly, Bangalore, India. S.Z. is an employee of and stockholder in Eli Lilly and Company. C.B.G. is a former employee of and stockholder in Eli Lilly and Company. The authors report no other conflicts of interest.

Publisher Copyright:
© 2018 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

Keywords

adults
hypoglycaemia
nasal glucagon
type 1 diabetes

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Publisher link

10.1111/dom.13278

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5947579

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Seaquist, E. R., Dulude, H., Zhang, X. M., Rabasa-Lhoret, R., Tsoukas, G. M., Conway, J. R., Weisnagel, S. J., Gerety, G., Woo, V. C., Zhang, S., Carballo, D., Pradhan, S., Piché, C. A., & Guzman, C. B. (2018). 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. Diabetes, Obesity and Metabolism, 20(5), 1316-1320. https://doi.org/10.1111/dom.13278

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. / Seaquist, Elizabeth R.; Dulude, Hélène; Zhang, Xiaotian M. et al.

In: Diabetes, Obesity and Metabolism, Vol. 20, No. 5, 05.2018, p. 1316-1320.

Research output: Contribution to journal › Article › peer-review

Seaquist, ER, Dulude, H, Zhang, XM, Rabasa-Lhoret, R, Tsoukas, GM, Conway, JR, Weisnagel, SJ, Gerety, G, Woo, VC, Zhang, S, Carballo, D, Pradhan, S, Piché, CA & Guzman, CB 2018, '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', Diabetes, Obesity and Metabolism, vol. 20, no. 5, pp. 1316-1320. https://doi.org/10.1111/dom.13278

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title = "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",

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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author = "Seaquist, {Elizabeth R.} and H{\'e}l{\`e}ne Dulude and Zhang, {Xiaotian M.} and Remi Rabasa-Lhoret and Tsoukas, {George M.} and Conway, {James R.} and Weisnagel, {Stanley J.} and Gregg Gerety and Woo, {Vincent C.} and Shuyu Zhang and Dolor{\`e}s Carballo and Sheetal Pradhan and Pich{\'e}, {Claude A.} and Guzman, {Cristina B.}",

note = "Funding Information: E.R.S. is the Principal Investigator at University of Minnesota, Minneapolis. She also consults for Eli Lilly, Locemia, Zucara, Sanofi and Novo Nordisk and receives grants from Locemia and Eli Lilly. R.R-L. is the Principal Investigator at Montreal Clinical Research Institute, Montreal, QC, Canada, and receives research grants from AMG, Astra-Zeneca, Eli Lilly, Lexicon, Merck, NIH, Novo-Nordisk and Sanofi-Aventis. He is on the consulting/advisory panel of Abbott, Amgen, Astra-Zeneca, Boehringer, Carlina Technologies, Eli Lilly, Janssen, Medtronic, Merck, Novo-Nordisk, Roche, Sanofi-Aventis and Takeda. G.M.T. is the Principal Investigator at McGill University Health Center, QC, Canada. J.R.C. is the Principal Investigator at Canadian Centre for Research on Diabetes, Smith Falls, ON, Canada. S.J.W. is the Principal Investigator at CHU de Qu{\'e}bec-Universit{\'e} Laval, Quebec City, QC, Canada. He receives research grants from Astra-Zeneca, Eli Lilly, Novo-Nordisk, Sanofi-Aventis, Bayer, Novartis, Boehringer, Medtronic, Locemia and Diabetes Canada. G.F.G. is the Principal Investigator at Division of Community Endocrinology, Albany Medical College, Albany, New York. He receives research grants from Boehringer, Eli Lilly, Lexicon and Novo Nordisk and speaker honoraria from Boehringer, Dexcom, Janssen, Lilly, Merck & Novo Nordisk. V.C.W. is the Principal Investigator at University of Manitoba, Winnipeg, MB, Canada. He has been involved in clinical trials for Eli Lilly, Locemia, BMS, Astra Zeneca, Janssen, Merck, Novo Nordisk, Sanofi and he is on the advisory boards for Eli Lilly, Merck, Astra Zeneca, Novo Nordisk, Janssen and Sanofi. H.D., C.A.P. and D.C. are employees and stockholders of Locemia Solutions, which funded the study. X.M.Z. is an employee of and stockholder in Eli Lilly, Canada. S.P. is an employee of Eli Lilly, Bangalore, India. S.Z. is an employee of and stockholder in Eli Lilly and Company. C.B.G. is a former employee of and stockholder in Eli Lilly and Company. The authors report no other conflicts of interest. Publisher Copyright: {\textcopyright} 2018 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.",

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doi = "10.1111/dom.13278",

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AU - Seaquist, Elizabeth R.

AU - Dulude, Hélène

AU - Zhang, Xiaotian M.

AU - Rabasa-Lhoret, Remi

AU - Tsoukas, George M.

AU - Conway, James R.

AU - Weisnagel, Stanley J.

AU - Gerety, Gregg

AU - Woo, Vincent C.

AU - Zhang, Shuyu

AU - Carballo, Dolorès

AU - Pradhan, Sheetal

AU - Piché, Claude A.

AU - Guzman, Cristina B.

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N2 - 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.

AB - 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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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

Abstract

Bibliographical note

Keywords

UN SDGs

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