ID | 118709 |
Title Alternative | Protocol for a Randomized, Crossover Trial : ISCHIA study
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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
Matsuhisa, Munehide
Tokushima University
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Kuroda, Akio
Tokushima University
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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
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Keywords | continuous glucose monitoring
hypoglycemia
type 1 diabetes
educational program
trend arrow
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Content Type |
Journal Article
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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
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ISSN | 21852243
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Publisher | The Tokai Medical Association
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Volume | 46
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Issue | 2
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Start Page | 59
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End Page | 68
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Published Date | 2021-07
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EDB ID | |
FullText File | |
language |
eng
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TextVersion |
Publisher
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departments |
Institute of Advanced Medical Sciences
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