Total for the last 12 months
number of access : ?
number of downloads : ?
ID 118709
Title Alternative
Protocol for a Randomized, Crossover Trial : ISCHIA study
Author
Suzuki, Shota Nara Medical University|Kyoto University
Tone, Atsuhito Okayama Saiseikai General Hospital
Murata, Takashi National Hospital Organization Kyoto Medical Center
Nishimura, Kunihiro National Cerebral and Cardiovascular Center
Miyamoto, Yoshihiro National Cerebral and Cardiovascular Center
Sakane, Naoki National Hospital Organization Kyoto Medical Center
Satoh-Asahara, Noriko National Hospital Organization Kyoto Medical Center
Toyoda, Masao Tokai University
Hirota, Yushi Kobe University
Kato, Ken National Hospital Organization Osaka National Hospital
Kouyama, Ryuji Tsuchiura Kyodo General Hospital
Miura, Junnosuke Tokyo Women’s Medical University
Suganuma, Akiko National Hospital Organization Kyoto Medical Center
Tomita, Tsutomu National Cerebral and Cardiovascular Center
Noguchi, Michio National Cerebral and Cardiovascular Center
Son, Cheol National Cerebral and Cardiovascular Center
Kasahara, Masato Nara Medical University
Ito, Yukie Nara Medical University
Kasama, Shu Nara Medical University
Hosoda, Kiminori National Cerebral and Cardiovascular Center
Keywords
continuous glucose monitoring
hypoglycemia
type 1 diabetes
educational program
trend arrow
Content Type
Journal Article
Description
Objective: Intermittent-scanning continuous glucose monitoring (isCGM) is widely used in type 1 diabetes (T1D) patients; however, the education required to prevent hypoglycemia by using isCGM is not established. This study examines the combined effect of isCGM device usage and the education to reduce the time in hypoglycemia in comparison to conventional self-monitoring of blood glucose (SMBG).
Methods: The Effect of Intermittent-Scanning Continuous Glucose Monitoring to Glycemic Control Including Hypoglycemia and Quality of Life of Patients with Type 1 Diabetes Mellitus Study (ISCHIA Study), a randomized, crossover trial, enrolls 104 T1D patients (age, 20-74 years) with T1D. Participants are randomized to use isCGM combined with structured education (Intervention period) or SMBG (Control period) for 84 days, followed by the other for a further 84 days. During the Intervention period, participants have access to the sensor glucose levels and trend arrow of the device. During the Control period, participants conduct SMBG at least three times a day, and retrospective CGM is used to record the blinded sensor glucose levels. The primary endpoint is the decrease of time in hypoglycemia ( < 70 mg/dL) per day (hour/day) during the Intervention period compared with the Control period. The secondary endpoints include other indices of glycemic control, glycoalbumin, accuracy of isCGM, diabetes-related quality of life (QOL), adherence, and cost-effectiveness. The study protocol has received Certified Review Board (CRB) approval from National Hospital Organization Osaka National Hospital (N2018002, February 14, 2019). This study is carried out in accordance with the Declaration of Helsinki and the Clinical Trials Act. The findings will be published in peer-reviewed journals.
Conclusion: The ISCHIA study will contribute to the standardization of patient education regarding the prevention of hypoglycemia by using isCGM.
Journal Title
The Tokai Journal of Experimental and Clinical Medicine
ISSN
21852243
Publisher
The Tokai Medical Association
Volume
46
Issue
2
Start Page
59
End Page
68
Published Date
2021-07
EDB ID
FullText File
language
eng
TextVersion
Publisher
departments
Institute of Advanced Medical Sciences