Diabetes Center, National Hospital Organization Kyoto Medical Center, 1-1 Fukakusamukaihata-cho, Fushimi-ku, Kyoto, Kyoto 612-8555, Japan.
Tokai J Exp Clin Med. 2021 Jul 20;46(2):59-68.
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).
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, Feb 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.
The ISCHIA study will contribute to the standardization of patient education regarding the prevention of hypoglycemia by using isCGM.
间歇性扫描连续血糖监测（isCGM）在 1 型糖尿病（T1D）患者中广泛应用；然而，使用 isCGM 预防低血糖所需的教育尚未建立。本研究比较了 isCGM 设备使用与降低低血糖时间的教育相结合对血糖控制（包括低血糖）和 1 型糖尿病患者生活质量的影响。
间歇性扫描连续血糖监测对 1 型糖尿病患者血糖控制（包括低血糖）和生活质量影响的研究（ISCHIA 研究）是一项随机、交叉试验，共纳入 104 例年龄在 20-74 岁的 T1D 患者。参与者被随机分为使用 isCGM 联合结构化教育（干预期）或 SMBG（对照组）84 天，然后再进行 84 天的另一组治疗。在干预期，参与者可以访问设备的传感器血糖水平和趋势箭头。在对照组中，参与者每天至少进行三次 SMBG，并使用回顾性 CGM 记录盲传感器血糖水平。主要终点是与对照组相比，干预期间每天（小时/天）低血糖（<70mg/dL）时间减少。次要终点包括其他血糖控制指标、糖基化白蛋白、isCGM 的准确性、糖尿病相关生活质量（QOL）、依从性和成本效益。研究方案已获得国立医院组织大阪国立医院（N2018002，2019 年 2 月 14 日）的认证审查委员会（CRB）批准。本研究符合赫尔辛基宣言和临床试验法。研究结果将发表在同行评议的期刊上。
ISCHIA 研究将有助于规范使用 isCGM 预防低血糖的患者教育。
