Effect of treatment guidance using a retrospective continuous glucose monitoring system on glycaemic control in outpatients with type 2 diabetes mellitus: A randomized controlled trial

Junko Sato, Akio Kanazawa, Fuki Ikeda, Nayumi Shigihara, Minako Kawaguchi, Koji Komiya, Toyoyoshi Uchida, Takeshi Ogihara, Tomoya Mita, Tomoaki Shimizu, Yoshio Fujitani, Hirotaka Watada, Junko Sato, Akio Kanazawa, Fuki Ikeda, Nayumi Shigihara, Minako Kawaguchi, Koji Komiya, Toyoyoshi Uchida, Takeshi Ogihara, Tomoya Mita, Tomoaki Shimizu, Yoshio Fujitani, Hirotaka Watada

Abstract

Objectives: 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).

Methods: 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.

Results: 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.

Conclusions: 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.

Keywords: Continuous glucose monitoring; insulin therapy; type 2 diabetes.

© The Author(s) 2015.

Figures

Figure 1.
Figure 1.
The design of an open-label, two-arm, randomized controlled study that aimed to determine whether a wireless retrospective continuous glucose monitoring (CGM) device is useful for glycaemic control and therapeutic satisfaction in obese Japanese patients with type 2 diabetes mellitus treated with insulin. Patients were randomly assigned to the intervention group or the nonintervention group. Patients visited the hospital every 2 months for blood tests; CGM recording was performed three times prior to these visits throughout the 8-month study period. The patients were also instructed to complete the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at the beginning and end of the study.
Figure 2.
Figure 2.
CONSORT flow diagram of Japanese patients with type 2 diabetes mellitus (n = 34) included in an open-label, two-arm, randomized controlled study.

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