Continuous Subcutaneous Glucose Monitoring in Diabetic Patients

Abstract

RESEARCH DESIGN -A multicenter study was performed in 70 diabetic patients. A microdialysis fiber was inserted subcutaneously into the periumbelical region and perfused with a buffer solution. Glucose concentrations in the dialysate were then measured every 3 min by the glucose sensor over a 24-h period, during which nine venous blood samples were also collected throughout the day.RESULTS -Both the insertion of the fiber and the wearing of the device were well tolerated by the patients. Subcutaneous glucose levels were well correlated with venous glucose measurements (r ϭ 0.9, P Ͻ 0.001) over a wide range (40 -400 mg/dl) for up to 24 h, with a single-point calibration. An analysis of 381 data pairs showed a linear relationship between the GlucoDay and serial venous blood glucose levels, and 97% of the data fell in the A and B regions of the error grid analysis. Percentage bias between the GlucoDay and the blood venous levels was Ϫ2.0% in the hypoglycemic range (Ͻ70 mg/dl), 6.9% in the euglycemic range (70 -180 mg/dl), and 11.2% in the hyperglycemic range (Ͼ180 mg/dl).CONCLUSIONS -The GlucoDay system demonstrated high reliability and reported values that closely agreed with venous blood glucose measurements. The system was well tolerated and thus constitutes a relatively easy method to monitor glucose excursions in diabetic patients. Diabetes Care 25:347-352, 2002T he benefits of strict metabolic control on microvascular complications of both type 1 and type 2 diabetes have been well established (1,2). In the last decade, self-monitoring of blood glucose levels has been the only available measure for diabetic patients to achieve a good metabolic control; however, glucose fluctuations during the day are often missed with this technique (3), and only continuous glucose measurements over prolonged periods can ensure optimal blood glucose management. Recently, minimally invasive techniques have been proposed for continuous monitoring of subcutaneous glucose in both normal and diabetic patients. Microdialysis of subcutaneous adipose tissue has been shown to identify glucose variations in vivo that closely mimic blood glucose patterns observed in patients on intensified insulin therapy. A monitoring system that provides automatic and frequent determinations would therefore identify the glycemic excursions and typical glucose trends in diabetic patients in a manner that is not possible even with frequent blood glucose meter readings. The ability to detect such fluctuations during the day, and particularly during the night, would enable appropriate changes in diabetes management in order to achieve the goal of optimal metabolic control in diabetic patients.We documented the efficacy of a new glucose sensor and its accuracy in monitoring glucose levels in type 1 and type 2 diabetic patients recruited in a multicenter study. The GlucoDay is composed of a subcutaneous microdialysis probe connected to a portable unit. The system takes a glucose measurement every second and stores an average value every 3 min, for a total of ...

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“…With the use of a validated continuous glucose-monitoring system (Maran et al, 2002;Poscia et al, 2003;Varalli et al, 2003;Maran et al, 2004;Wentholt et al, 2005), we assessed 24 h blood glucose concentrations in long-standing type 2 diabetes patients under strict dietary standardization but otherwise free-living conditions. Despite a healthy, balanced diet and the continued use of oral blood glucoselowering medication (ADA 2006), these type 2 diabetes patients showed substantial hyperglycemia throughout the greater part of the day.…”

“…The GlucoDay S system is an ambulant continuous glucose monitoring system based on the microdialysis technique and allows continuous glucose monitoring for a period of 48 h (Maran et al, 2002). A detailed description of the device is provided elsewhere (Poscia et al, 2003;Varalli et al, 2003).…”

“…Values reported by the CGMS were converted into glucose values using the SMBG values. The efficacy and the accuracy of the GlucoDay S has been validated for both diabetes patients (Maran et al, 2002;Wentholt et al, 2005) and healthy subjects (Maran et al, 2004). CGMS data of the second day (from 0700 to 0700 h) were used for data analyses and are expressed as means7s.e.m.…”

Continuous Glucose Monitoring System in children with type 1 diabetes mellitus: a systematic review and meta-analysis

“…There are several devices for CGM [5][6][7][8][9][10]. Generally, two types of CGM are distinguished.…”

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“…2). In comparison, currently available semi-invasive glucose sensors show a mean correlation between sensor values and reference values of ±90%, a mean MAD of ±11% and no values in the D and E zones [12][13][14].…”