Use of a real time continuous glucose monitoring system as a motivational device for poorly controlled type 2 diabetes

https://doi.org/10.1016/j.diabres.2008.06.015Get rights and content

Abstract

Objective

The use of a real time continuous glucose monitoring system (RT-CGM) was studied as a behavior modification tool and the effectiveness of a RT-CGM in glucose control for patients with type 2 diabetes was determined.

Methods

We conducted a prospective, open-label, randomized, controlled clinical trial in 65 patients with poorly controlled type 2 diabetes (8.0  HbA1c  10%) over a 3-month period. The intervention group was monitored monthly with a RT-CGM (three days at a time for 3 months) and the control group continued self-monitoring blood glucose (SMBG) at least four times a week for 3 months.

Results

The HbA1c of the RT-CGM group was significantly reduced after 12 weeks compared with the SMBG group (9.1 ± 1.0% to 8.0 ± 1.2% vs. 8.7 ± 0.7% to 8.3 ± 1.1%, respectively; P = 0.004). In the RT-CGM group, there was a significant reduction in total daily calorie intake, weight, body mass index (BMI), and postprandial glucose level, and a significant increase in total exercise time per week after 3 months.

Conclusions

We demonstrated that the RT-CGM was useful in modifying a patient's diet and exercise habits and could induce better glycemic control than SMBG for patients with type 2 diabetes.

Introduction

Compliance, disease awareness, and empowerment of the patient play important roles in the management of diabetes. Self-management education for diabetes has been an integral part of high quality primary care [1]. Immediate feedback on the effects of diet and exercise that self-monitoring blood glucose (SMBG) provides can enhance empowerment of the patient [2]. SMBG might improve adherence to pharmacologic treatment and motivate patients to make appropriate changes of lifestyle [3]. Guerci et al. [4] demonstrated that SMBG for 6 months was statistically associated with a better quality of metabolic control in patients with type 2 diabetes who were not receiving insulin therapy than usual traditional recommendations alone. However, a recent study of longer duration suggested that SMBG monitoring in patients with non-insulin treated type 2 diabetes did not improve glycemic control [5]. Because of many factors, such as pain and inconvenience, many diabetic patients do not accept frequent finger-sticks for SMBG [6]. In addition, SMBG gives a single instant reading without any information on glucose trends and thus may miss significant glucose fluctuations [7]. Therefore, a new glucose monitoring method that can continuously reflect glucose trends and effectively modulate glycemic control is needed.

The Guardian continuous glucose monitoring system (Guardian RT; Medtronic MiniMed, Northridge, CA, USA) is a real time continuous glucose-sensing and display device that alerts patients to predetermine thresholds of impending hypo- and hyper-glycemia, allowing immediate corrective action that may preempt severe consequences [8]. Since 2004, there have been several studies about real time continuous glucose monitoring systems (RT-CGM). First, Bode et al. [8] reported the accuracy and the effectiveness of the Guardian RT for type 1 diabetes and Deiss et al. [9] demonstrated a clinically meaningful reduction of HbA1c in type 1 diabetic patients in a randomized, controlled trial using a RT-CGM. However, there have been no studies regarding the effectiveness of a RT-CGM as a behavior modification tool for type 2 diabetes and measurement of the changes in diet pattern and physical activity following the application of a RT-CGM.

The purpose of this study was to determine whether a RT-CGM in the home setting is useful for poorly controlled type 2 diabetes with a view to modify a patient's diet and exercise habits and improve disease self-control efforts, thereby inducing better glycemic control compared with SMBG.

Section snippets

Patients

Sixty-five patients from four general hospitals in Seoul, Incheon, and Sungnam, Korea were enrolled between January and June 2007. The eligibility criteria included the following: (1) 20–80 years of age, (2) type 2 diabetes with use of oral hypoglycemic agents (OHA) or insulin for at least 1 year, (3) HbA1c between 8.0% and 10%, (4) a stable insulin or OHA regimen for the prior 2 months, and (5) a stable dose of anti-hypertensive or lipid-lowering drugs for at least 4 weeks. Major exclusion

Results

Among the 65 enrolled patients, 57 patients completed the trial. The flow chart of this randomized controlled trial is shown in Fig. 1. Baseline characteristics of the participants who finished the clinical trial are summarized for the Guardian RT and SMBG groups separately in Table 1. There were no significant differences of baseline characteristics between the two groups.

Discussion

In the present study, the intermittent usage of the Guardian RT for poorly controlled type 2 diabetes was superior to SMBG in that it effectively reduced total calorie intake per day and increased total exercise time per week, thereby significantly reducing body weight, BMI, postprandial glucose level, and HbA1c after 3 months.

The management of diabetes requires disease awareness by the patients and self-control of their disease. Visits to a clinic a few times a year alone cannot successfully

Conflict of interest

There are no conflicts of interest.

Acknowledgements

This study was supported by a grant from the Korean Health 21 R&D Project, Ministry of Health & Welfare, Republic of Korea (A050463). We would like to thank Medtronic Korea Co., Ltd for the assistance with this study.

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