Comparison of a needle-type and a microdialysis continuous glucose monitor in type 1 diabetic patients.

OBJECTIVE We examined the reliability of two continuous glucose sensors in type 1 diabetic patients at night and during rapid glucose excursions and verified the hypothesized nocturnal hypoglycemic drift of the needle-type sensor (CGMSgold) and delay of the microdialysis sensor (GlucoDay). RESEARCH DESIGN AND METHODS Blood was sampled overnight twice per hour in 13 patients. Rapid-acting insulin was given subcutaneously 30 min after breakfast. Sampling once per minute started 45 min after breakfast and 75 min after insulin injection for 30 min, with the aim of determining peak and nadir glucose values. Mean absolute differences (MADs) between sensor and blood glucose values were calculated. Sensor curves were modeled for all patients using linear regression. Horizontal and vertical shifts of sensor curves from the blood glucose curves were assessed. A vertical shift indicates sensor drift and a horizontal shift sensor delay. RESULTS Drift was minimal in the needle-type and microdialysis sensors (-0.02 and -0.04 mmol/l). Mean +/- SD delay was 7.1 +/- 5.5 min for the microdialysis sensor (P < 0.001). MAD was 15.0% for the needle-type sensor and 13.6% for the microdialysis sensor (P = 0.013). After correction for the 7-min delay, the microdialysis MAD improved to 11.7% (P < 0.0001). CONCLUSIONS The microdialysis sensor was more accurate than the needle-type sensor, with or without correction for a 7-min delay. In contrast to the previous version, the current needle-type sensor did not exhibit nocturnal hypoglycemic drift. Continuous subcutaneous glucose sensors are valuable adjunctive tools for glucose trend analyses. However, considering the large MADs, individual sensor values should be interpreted with caution.

[1]  J. Mastrototaro,et al.  Efficacy and reliability of the continuous glucose monitoring system. , 2000, Diabetes technology & therapeutics.

[2]  L. Thienpont,et al.  Evaluating clinical accuracy of systems for self-monitoring of blood glucose by error grid analysis: comment on constructing the "upper A-line". , 2000, Diabetes care.

[3]  D. Altman,et al.  Comparing methods of measurement: why plotting difference against standard method is misleading , 1995, The Lancet.

[4]  L. V. Van Gaal,et al.  Postprandial glucose monitoring in type 1 diabetes mellitus: use of a continuous subcutaneous monitoring device , 2004, Diabetes/metabolism research and reviews.

[5]  High incidence of maternal transmission of diabetes in obese Uruguayan children. , 2001, Diabetes care.

[6]  J M Bland,et al.  Statistical methods for assessing agreement between two methods of clinical measurement , 1986 .

[7]  Sunil J Rao,et al.  Regression Modeling Strategies: With Applications to Linear Models, Logistic Regression, and Survival Analysis , 2003 .

[8]  C. Saudek,et al.  Timing of changes in interstitial and venous blood glucose measured with a continuous subcutaneous glucose sensor. , 2003, Diabetes.

[9]  Sonia Caprio,et al.  Do sensor glucose levels accurately predict plasma glucose concentrations during hypoglycemia and hyperinsulinemia? , 2002, Diabetes care.

[10]  D. Cox,et al.  Evaluating the accuracy of continuous glucose-monitoring sensors: continuous glucose-error grid analysis illustrated by TheraSense Freestyle Navigator data. , 2004, Diabetes care.

[11]  Alberto Maran,et al.  Continuous subcutaneous glucose monitoring in diabetic patients: a multicenter analysis. , 2002, Diabetes care.

[12]  J. Mastrototaro,et al.  The MiniMed continuous glucose monitoring system. , 2000, Diabetes technology & therapeutics.

[13]  Reproducibility of the continuous glucose monitoring system matches previous reports and the intended use of the product. , 2003, Diabetes care.

[14]  A. Beckett,et al.  AKUFO AND IBARAPA. , 1965, Lancet.

[15]  Workgroup on Hypoglycemia Defining and reporting hypoglycemia in diabetes: a report from the American Diabetes Association Workgroup on Hypoglycemia. , 2005, Diabetes care.

[16]  D. Cox,et al.  Evaluating Clinical Accuracy of Systems for Self-Monitoring of Blood Glucose , 1987, Diabetes Care.

[17]  A. Moran,et al.  Spurious reporting of nocturnal hypoglycemia by CGMS in patients with tightly controlled type 1 diabetes. , 2002, Diabetes care.

[18]  P. Böhme,et al.  Clinical performance of CGMS in type 1 diabetic patients treated by continuous subcutaneous insulin infusion using insulin analogs. , 2003, Diabetes care.

[19]  K. Jungheim,et al.  Risky delay of hypoglycemia detection by glucose monitoring at the arm. , 2001, Diabetes care.