TY - JOUR
T1 - Conversations and Reactions Around Severe Hypoglycemia (CRASH)
T2 - Japan Results From a Global Survey of People with T1DM or Insulin-Treated T2DM and Caregivers
AU - Iwahori, Toshiyuki
AU - Snoek, Frank
AU - Nagai, Yukiko
AU - Spaepen, Erik
AU - Mitchell, Beth D.
AU - Peyrot, Mark
N1 - Funding Information: This study was sponsored by Eli Lilly and Company. The journal’s Rapid Service Fee was funded by Eli Lilly Japan K.K. Funding Information: Medical writing and editorial assistance were provided by Lisa Cossens and Dana Schamberger of Syneos Health and funded by Eli Lilly Japan K.K. We thank those who participated in this study and Shingo Kojima for his dedication to participant recruitment. Funding Information: This study was sponsored by Eli Lilly and Company. The journal?s Rapid Service Fee was funded by Eli Lilly Japan K.K. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole and have given their approval for this manuscript to be published. Beth Mitchell and Frank Snoek created the study concept and design; Erik Spaepen and Mark Peyrot analyzed data; and data interpretation was performed by Toshiyuki Iwahori, Yukiko Nagai, Mark Peyrot, and Beth Mitchell. Medical writing and editorial assistance were provided by Lisa Cossens and Dana Schamberger of Syneos Health and funded by Eli Lilly Japan K.K. We thank those who participated in this study and Shingo Kojima for his dedication to participant recruitment. Frank Snoek reports advisory roles with Abbott, Eli Lilly and Company, Novo Nordisk, and Roche Diabetes; consultant roles with Eli Lilly and Company and Novo Nordisk; research support from Sanofi and Novo Nordisk; and speaker honoraria from Eli Lilly and Company, Novo Nordisk, and Servier. Toshiyuki Iwahori and Yukiko Nagai are employees of Eli Lilly Japan K.K. Beth Mitchell is an employee of Eli Lilly and Company. Yukiko Nagai and Beth Mitchell are shareholders of Eli Lilly and Company. Erik Spaepen is a paid consultant working for Eli Lilly and Company. Mark Peyrot reports advisory roles with Calibra, Eli Lilly and Company, and Novo Nordisk; and speaker honoraria from Eli Lilly and Company. The study protocol was approved by Eli Lilly and Company. Informed consent was obtained from all individual participants included in the study. This study was performed in accordance with the Helsinki Declaration of 1964 and its later amendments. Eli Lilly and Company provides access to all individual participant data collected during the trial, after anonymization, with the exception of pharmacokinetic or genetic data. Data are available to request 6?months after the indication studied has been approved in the USA and EU and after primary publication acceptance, whichever is later. No expiration date of data requests is currently set once data are made available. Access is provided after a proposal has been approved by an independent review committee identified for this purpose and after receipt of a signed data sharing agreement. Data and documents, including the study protocol, statistical analysis plan, clinical study report, and blank or annotated case report forms, will be provided in a secure data sharing environment. For details on submitting a request, see the instructions provided at www.vivli.org. Publisher Copyright: © 2022, The Author(s).
PY - 2022/3
Y1 - 2022/3
N2 - Aims: The CRASH study examined severe hypoglycemia (SH) experiences among people with diabetes (PWD) and caregivers across eight countries. Here we report findings from the Japan cohort, with references to data from the United Kingdom (UK) cohort. Materials and Methods: Adults with type 1 (T1DM) or insulin-treated type 2 diabetes mellitus (T2DM) and caregivers (not necessarily related) were recruited from online patient panels. Participants who had experienced at least one SH event in the past 3 years were eligible for study inclusion. Participants completed an online survey regarding their experience with SH, its treatment, and actions during and after an event. Results: Of the 9367 PWD and caregivers from the online patient panels, 8475 participants were ineligible and a total of 53 Japanese participants (35 T1DM, 9 T2DM, 9 caregivers) completed the survey. Most SH incidents occurred at home and were unattended by a healthcare provider. For T1DM, 29% of Japan PWD and 13% of the UK PWD called an ambulance during an SH event; of these, 90% (Japan) and 50% (UK) were transported to hospital. Glucagon use was low (3% Japan and 10% UK for T1DM). Japanese respondents reported emotional impacts of SH, including feeling scared (86% T1DM, 56% T2DM), unprepared (63% T1DM, 78% T2DM), and helpless (60% T1DM, 33% T2DM). Despite the emotional burden, most PWD did not immediately discuss their SH event with a healthcare provider, with the majority (75% T1DM, 71% T2DM) waiting until their next doctor’s appointment. Conclusion: Conversations around SH between healthcare providers and PWD appear to be insufficient in Japan. An emotional burden of SH was reported by PWD and caregivers. Education regarding the prevention of SH and available treatment options may reduce SH events and improve treatment preparation, while alleviating PWD concerns.
AB - Aims: The CRASH study examined severe hypoglycemia (SH) experiences among people with diabetes (PWD) and caregivers across eight countries. Here we report findings from the Japan cohort, with references to data from the United Kingdom (UK) cohort. Materials and Methods: Adults with type 1 (T1DM) or insulin-treated type 2 diabetes mellitus (T2DM) and caregivers (not necessarily related) were recruited from online patient panels. Participants who had experienced at least one SH event in the past 3 years were eligible for study inclusion. Participants completed an online survey regarding their experience with SH, its treatment, and actions during and after an event. Results: Of the 9367 PWD and caregivers from the online patient panels, 8475 participants were ineligible and a total of 53 Japanese participants (35 T1DM, 9 T2DM, 9 caregivers) completed the survey. Most SH incidents occurred at home and were unattended by a healthcare provider. For T1DM, 29% of Japan PWD and 13% of the UK PWD called an ambulance during an SH event; of these, 90% (Japan) and 50% (UK) were transported to hospital. Glucagon use was low (3% Japan and 10% UK for T1DM). Japanese respondents reported emotional impacts of SH, including feeling scared (86% T1DM, 56% T2DM), unprepared (63% T1DM, 78% T2DM), and helpless (60% T1DM, 33% T2DM). Despite the emotional burden, most PWD did not immediately discuss their SH event with a healthcare provider, with the majority (75% T1DM, 71% T2DM) waiting until their next doctor’s appointment. Conclusion: Conversations around SH between healthcare providers and PWD appear to be insufficient in Japan. An emotional burden of SH was reported by PWD and caregivers. Education regarding the prevention of SH and available treatment options may reduce SH events and improve treatment preparation, while alleviating PWD concerns.
KW - Caregivers
KW - Diabetes
KW - Emotional burden
KW - Glucagon
KW - Japan
KW - Severe hypoglycemia
UR - http://www.scopus.com/inward/record.url?scp=85125088822&partnerID=8YFLogxK
U2 - https://doi.org/10.1007/s13300-022-01211-5
DO - https://doi.org/10.1007/s13300-022-01211-5
M3 - Article
C2 - 35199292
SN - 1869-6953
VL - 13
SP - 517
EP - 533
JO - Diabetes Therapy
JF - Diabetes Therapy
IS - 3
ER -