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PubMed2006

In vivo performance evaluation of a transdermal near- infrared fluorescence resonance energy transfer affinity sensor for continuous glucose monitoring.

The in vivo performance of a transdermal near-infrared fluorescence resonance energy transfer (FRET) affinity sensor was investigated in hairless rats, in order to validate its feasibility for glucose monitoring in humans. The sensor itself consists of a small hollow fiber implanted in dermal skin tissue, containing glucose-sensitive assay chemistry composed of agarose-immobilized Concanavalin A (ConA) and free dextran. The glucose-dependent fluorescence change is based on FRET between near-infrared-compatible donor and quencher dyes that are chemically linked to dextran and ConA, respectively. We conducted an acute in vivo evaluation of transdermal sensors with an optical fiber-coupled setup over 4 h, and a chronic in vivo evaluation of fully implanted sensors for up to 16 days. The fiber-coupled sensors followed trends of blood glucose concentrations very well with a delay of less than 5 min. The acute performance of the implanted sensors at the day of implantation was similar to that of the fiber-coupled sensors. After 2 weeks the implanted sensors remained functional, evidenced by an adequate correlation between sensor signal and changes in blood glucose excursions, but exhibited delays of approximately 10-15 min. Preliminary characterization of host response showed signs of mild inflammations around the implanted sensor, which were characterized by formation of a 10-20-microm-thick collagen band, typical for capsule formation. An acute study of systemic ConA biotoxicity was also conducted. A histological analysis of various organs and of clinical chemistry data showed no significant differences between rats receiving intradermal injections of ConA at 10 times the concentration in the sensor and rats in a control group (injection of saline solution). The absence of a toxicological or systemic response to ConA at a 10-fold larger amount than in the sensor should dispel concerns over the in vivo safety of ConA-based sensors. This study clearly demonstrates the feasibility of the proposed transdermal FRET-based sensor interrogation concept for glucose monitoring.

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PubMed2002

Prevention of hypoglycemia using risk assessment with a continuous glucose monitoring system.

Due to the lag between sugar intake and the beginning of recovery from hypoglycemia, it is necessary to intervene in an anticipatory way if one wants to prevent, not only detect, hypoglycemia. This article presents the principle of a hypoglycemia prevention system based on risk assessment. The risk situation can be defined as the moment when the system estimates that the glucose concentration is expected to reach a hypoglycemia threshold in less than a given time (e.g., 20 min). Since there are well-known discrepancies between blood and interstitial glucose concentrations, the aim of this experimental study performed in nondiabetic rats was first to validate this strategy, and second to determine whether it can work when the glucose concentration is estimated by a glucose sensor in subcutaneous tissue rather than in blood. We used a model of controlled decrease in blood glucose concentration. A glucose infusion, the profile of which mimicked the appearance of glucose from an intragastric load, was administered either when hypoglycemia was detected or on the basis of risk recognition. Despite the lag between the beginning of the load and that of the increase in blood glucose concentration, which was in all experiments 15-20 min, hypoglycemia was fully prevented without overshoot hyperglycemia in the groups of rats in which the glucose load was started when the hypoglycemia risk was detected, on the basis of either blood or interstitial glucose concentration. This was, of course, not the case when the same glucose load was infused at the detection of the hypoglycemia threshold.

Animals↗