“Since their introduction into the arsenal of metabolic research tools by DeFronzo et al. in the late seventies, glucose clamps have increasingly gained importance. Based on this technical principle, including its variants, e.g., hyperglycemic, euglycemic, and hypoglycemic glucose clamps, a great variety of different scientific topics can be tackled. For example, by means of the glucose clamp technique, both whole-body and organ-specific insulin sensitivity can be measured, predefined blood glucose concentrations for various purposes can be generated, and most importantly, blood glucose properties of almost any anti diabetic drug can be characterized with respect to their time-action profile. The latter can be done with a high level of precision and accuracy so that authorities like the European Medicines Agency regard glucose clamps as the gold standard for the investigation of new blood glucose-lowering drugs.
Beyond a specific experience in how to manage a glucose clamp, which is sometimes referred to as an “”art,”” the key factor for the success of each and every glucose clamp is the frequent, fast, and reliable measurement of the subject’s actual blood glucose. This is of huge importance as the deviation of actual blood glucose from blood glucose target level provides the signal on which the computation of the amount of glucose to be infused intravenously, aiming to adjust actual blood glucose to the predefined blood glucose target, is based. Meaning, the actual data from blood glucose measurements represent the input variable for some form of algorithm, either software or investigator based (the latter is also called experience, which will then determine the amount of glucose to be administered until the next blood glucose measurement is due).
The principal objective of this approach is to maintain blood glucose during glucose clamps both stable and close to the blood glucose target, i.e., to minimize deviations of the actual blood glucose from the target value. Based on inaccurate blood glucose measurements, however, it becomes quite easy to under- or over estimate true glucose requirements of subjects, leading to potential study endpoint bias. Most obviously, flawed study results could turn into misleading conclusions about the properties of a drug or a device in development.
References: J Diabetes Sci Technol Vol 2, Issue 5, September 2008″