Sato Junko, Kanazawa Akio, Ikeda Fuki, Shigihara Nayumi, Kawaguchi Minako, Komiya Koji, Uchida Toyoyoshi, Ogihara Takeshi, Mita Tomoya, Shimizu Tomoaki, Fujitani Yoshio, Watada Hirotaka
Department of Metabolism and Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Department of Metabolism and Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan Centre for Therapeutic Innovations in Diabetes, Juntendo University Graduate School of Medicine, Tokyo, Japan
J Int Med Res. 2016 Feb;44(1):109-21. doi: 10.1177/0300060515600190. Epub 2015 Dec 7.
To assess the effect of treatment guidance based on data from a continuous glucose monitoring (CGM) device on glycaemic control, and patient satisfaction, in patients with type 2 diabetes mellitus (T2DM).
Patients with poorly-controlled T2DM treated with insulin were randomly assigned to the intervention or nonintervention group. Continuous blood-glucose levels were recorded for 4-5 days using a CGM device on three separate occasions during the 8-month study period. The intervention group received treatment guidance based on the CGM data; the nonintervention group received advice based on blood glucose and glycosylated haemoglobin (HbA1c) levels.
A total of 34 patients were enrolled in the study. The mean ± SD baseline HbA1c was 8.2 ± 1.2% in the intervention group and 8.2 ± 0.9% in the nonintervention group. At the study end, there was no significant difference in the change from baseline of HbA1c between the two groups. There was also no significant difference in the change from baseline in the Diabetes Treatment Satisfaction Questionnaire score between the two groups.
The present study did not demonstrate that treatment guidance using retrospective CGM data was effective for improving glycaemic control and therapeutic satisfaction in Japanese patients with T2DM.
评估基于持续葡萄糖监测(CGM)设备数据的治疗指导对2型糖尿病(T2DM)患者血糖控制及患者满意度的影响。
将胰岛素治疗的血糖控制不佳的T2DM患者随机分为干预组或非干预组。在为期8个月的研究期间,使用CGM设备在三个不同时间点连续记录4 - 5天的血糖水平。干预组基于CGM数据接受治疗指导;非干预组基于血糖和糖化血红蛋白(HbA1c)水平接受建议。
共有34例患者纳入研究。干预组的平均±标准差基线HbA1c为8.2±1.2%,非干预组为8.2±0.9%。研究结束时,两组间HbA1c较基线的变化无显著差异。两组间糖尿病治疗满意度问卷评分较基线的变化也无显著差异。
本研究未证明使用回顾性CGM数据的治疗指导对改善日本T2DM患者的血糖控制和治疗满意度有效。