We determine temperature effect on the absorption and reduced scattering coefficients (mu(a) and mu(s)(')) of human forearm skin. Optical and thermal simulation data suggest that mu( a) and mu(s)(') are determined within a temperature-controlled depth of approximately 2 mm. Cutaneous mu(s)(') change linearly with temperature. Change in mu(a) was complex and irreversible above body normal temperatures. Light penetration depth (delta) in skin increased on cooling, with considerable person-to-person variations. We attribute the effect of temperature on mu(s)(') to change in refractive index mismatch, and its effect on mu(a) to perfusion changes. The reversible temperature effect on mu (s)(' ) was maintained during more than 90 min. contact between skin and the measuring probe, where temperature was modulated between 38 and 22 degrees C for multiple cycles While temperature modulated mu(s)(' ) instantaneously and reversibly, mu(a) exhibited slower response time and consistent drift. There was a statistically significant upward drift in mu(a) and a mostly downward drift in mu( s)(') over the contact period. The drift in temperature-induced fractional change in mu(s)(') was less statistically significant than the drift in mu(s)('). Deltamu( s)(') values determined under temperature modulation conditions may have less nonspecific drift than mu(s)(') which may have significance for noninvasive determination of analytes in human tissue.

Attachment of a small, medical device to the human body for an extended period of time in an ambulatory setting requires the careful consideration of the physical form of the device and the physiological constraints limiting the time a device will stay on the skin. Factors such as the size of the device, the area of the device available for attachment to the skin, and the occlusive nature of the materials in the device are likely to affect adhesion. Here, plastic acrylic disks, 25 mm in diameter, containing a crisscross pattern of air-filled channels were tested on the forearm and abdomen using a moderately aggressive, unsupported, pressure-sensitive transfer adhesive in a pilot human clinical study. After vigorous exercise, droplets of moisture were observed in the channels followed by evaporation of the droplets over time. Disks without channels remained attached to the skin for about a day and a half, while disks containing 450 microm deep channels remained on the skin about three times longer. Little difference was found when the channel-to-channel spacing was increased from 1.3 to 1.6 mm, however 230 microm deep channels were less effective than 450 microm deep channels. Overall, the moisture vapor transport channels appear capable of reducing the moisture content of the outermost stratum corneum layer of the skin, increasing the strength of the stratum corneum, and increasing the time a device remains attached to the skin. The median trial-to-trial relative standard deviation of 45% observed in the pilot study can be used to design appropriately powered studies for the comparison of different device designs.

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We used the effect of temperature on the localized reflectance of human skin to assess the role of noise sources on the correlation between temperature-induced fractional change in optical density of human skin (DeltaOD(T)) and blood glucose concentration [BG]. Two temperature-controlled optical probes at 30 degrees C contacted the skin, one was then cooled by -10 degrees C; the other was heated by +10 degrees C. DeltaOD(T) upon cooling or heating was correlated with capillary [BG] of diabetic volunteers over a period of three days. Calibration models in the first two days were used to predict [BG] in the third day. We examined the conditions where the correlation coefficient (R2) for predicting [BG] in a third day ranked higher than R2 values resulting from fitting permutations of randomized [BG] to the same DeltaOD(T) values. It was possible to establish a four-term linear regression correlation between DeltaOD(T) upon cooling and [BG] with a correlation coefficient higher than that of an established noise threshold in diabetic patients that were mostly females with less than 20 years of diabetes duration. The ability to predict [BG] values with a correlation coefficient above biological and body-interface noise varied between the cases of cooling and heating.