The public health impact of the MiniMed Continuous Glucose Monitoring System (CGMS)-an assessment of the literature.
The Medtronic MiniMed (Northridge, CA) Continuous Glucose Monitoring System (CGMS) was approved by the U. S. Food and Drug Administration in 1999, for the continuous tracking of glucose concentration. The rationale for the use of this device is that frequent glucose measurements allow a more precise understanding of daily glucose fluctuations, without the inconvenience of frequent needle sticks. A review of the medical literature was undertaken to assess the public health impact of this device. Glucose readings from the MiniMed CGMS were found to correlate well with blood glucose (r = 0.73-0.92) and with hemoglobin A(1c) (HBA(1c)) (r = 0.53-0.59). Most important from a public health standpoint is the ability of the MiniMed device to detect episodes of asymptomatic hypoglycemia, and to lower HBA(1c) (absolute decline of 0.3%), as compared with controls. If these findings hold, the use of the MiniMed CGMS could result in a substantial reduction of morbidity and mortality associated with diabetes. The limitations of this analysis, most importantly the paucity of controlled studies that assess the ability of this device to result in improved control of diabetes over long periods of time, are discussed.
Epidemiology Branch, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, Maryland 20850, USA. drt@cdrh.fda.gov
Dale R
DR
Tavris
Azadeh
A
Shoaibi
D001786:Blood Glucose / Q000032:analysis*; D015190:Blood Glucose Self-Monitoring / Q000379:methods* / Q000592:standards; D003920:Diabetes Mellitus / Q000097:blood*; D006801:Humans; D018670:Monitoring, Ambulatory / Q000379:methods* / Q000592:standards; D011634:Public Health; D012016:Reference Values; D015203:Reproducibility of Results
D001786:Blood Glucose