Medtronic CGMS - Medaval

Description:

The Medtronic CGMS is an automatic blood glucose meter. Although its blood glucose measurement technology has been evaluated, it is not possible to base a determination on its accuracy from this research. Blood glucose measurements are taken from the abdomen. It is intended for self-measurement and home use. This device is now obsolete.

Assessment:

The technology used in the Medtronic CGMS, to measure blood glucose, has been assessed, in a specific population, according to a non-standard protocol.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BG	Medaval	None	When an evaluation is carried out using a non-standard protocol, no inference can be made on accuracy based on a standard protocol.

Validation Publications:

Diabetes Research in Children Network (DIRECNET) Study Group. The accuracy of the CGMS in children with type 1 diabetes: results of the Diabetes Research in Children Network (DirecNet) accuracy study. Diabetes Technol Ther. 2003;5(5):781-9. doi: 10.1089/152091503322526987. PMID: 14633343. Available from: PMC2249698.

Ad Hoc protocol Children and adolescents with T1DM, aged 3.5 to 17.7 years (n=78) (Note: The "original" sensor was used.)

Ad Hoc protocol Children and adolescents with T1DM, aged 3.5 to 17.7 years (n=14) (Note: The "modified" sensor was used.)

Unplanned changes in sensors occurred during the study, thereby changing the original aim of the study. The authors concluded that the modified sensor functioned substantially better than the original sensor. Measurements were also compared to those from the J&J LifeScan OneTouch Ultra.