Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2016 Feb;44(1):109-21.
doi: 10.1177/0300060515600190. Epub 2015 Dec 7.

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  1 , Akio Kanazawa  2 , Fuki Ikeda  1 , Nayumi Shigihara  1 , Minako Kawaguchi  1 , Koji Komiya  1 , Toyoyoshi Uchida  1 , Takeshi Ogihara  1 , Tomoya Mita  1 , Tomoaki Shimizu  1 , Yoshio Fujitani  1 , Hirotaka Watada  3
Affiliations
Randomized Controlled Trial

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 et al. J Int Med Res. 2016 Feb.

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.

PubMed Disclaimer

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.
See this image and copyright information in PMC

References

    1. Whiting DR, Guariguata L, Weil C, et al. IDF diabetes atlas: global estimates of the prevalence of diabetes for 2011 and 2030. Diabetes Res Clin Pract 2011; 94: 311–321. - PubMed
    1. Klonoff DC. The need for separate performance goals for glucose sensors in the hypoglycemic, normoglycemic, and hyperglycemic ranges. Diabetes Care 2004; 27: 834–836. - PubMed
    1. Allen NA, Fain JA, Braun B, et al. Continuous glucose monitoring in non-insulin-using individuals with type 2 diabetes: acceptability, feasibility, and teaching opportunities. Diabetes Technol Ther 2009; 11: 151–158. - PMC - PubMed
    1. Sato J, Hirose T, Watada H. Continuous glucose monitoring system: is it really accurate, safe and clinically useful? J Diabetes Investig 2012; 3: 225–230. - PMC - PubMed
    1. Murphy HR, Rayman G, Lewis K, et al. Effectiveness of continuous glucose monitoring in pregnant women with diabetes: randomised clinical trial. BMJ 2008; 337: a1680–a1680. - PMC - PubMed

Publication types