WO2002032303A2 - Glucose measurement utilizing non-invasive assessment methods - Google Patents
Glucose measurement utilizing non-invasive assessment methods Download PDFInfo
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- WO2002032303A2 WO2002032303A2 PCT/US2001/042570 US0142570W WO0232303A2 WO 2002032303 A2 WO2002032303 A2 WO 2002032303A2 US 0142570 W US0142570 W US 0142570W WO 0232303 A2 WO0232303 A2 WO 0232303A2
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- Prior art keywords
- glucose
- measuring
- extraction
- skin
- spectroscopy
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/14507—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue specially adapted for measuring characteristics of body fluids other than blood
- A61B5/1451—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue specially adapted for measuring characteristics of body fluids other than blood for interstitial fluid
- A61B5/14514—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue specially adapted for measuring characteristics of body fluids other than blood for interstitial fluid using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/14507—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue specially adapted for measuring characteristics of body fluids other than blood
- A61B5/14517—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue specially adapted for measuring characteristics of body fluids other than blood for sweat
- A61B5/14521—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue specially adapted for measuring characteristics of body fluids other than blood for sweat using means for promoting sweat production, e.g. heating the skin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
Definitions
- This invention involves non-invasive glucose measurement and a process for determining blood glucose levels in the human body.
- the process is used on a fingertip or other part of the body, typically a skin surface of the body.
- Diabetes is a chronic disease having no cure.
- the complications of the disease include blindness, kidney disease, nerve disease, and heart disease, perhaps with stroke. Diabetes is said to be the leading cause of new cases of blindness in individuals in the range of ages between 20 and 74; from 12,000-24,000 people per year lose their sight because of diabetes. Diabetes is the leading cause of end- stage renal disease, accounting for nearly 40% of new cases. Nearly 60-70% of people with diabetes have mild to severe forms of diabetic nerve damage which, in severe forms, can lead to lower limb amputations. People with diabetes are 2-4 times more likely to have heart disease and to suffer strokes.
- Type I diabetes is a disease in which the body does not produce or properly use insulin, a hormone needed to convert sugar, starches, and the like into energy. Although the cause of diabetes is not completely understood, genetics, environmental factors, and viral causes have been partially identified. There are two major types of diabetes: Type I and Type II. Type I diabetes
- Type II diabetes is a metabolic disorder resulting from the body's inability to make enough, or properly to use, insulin. Type II diabetes accounts for 90-95% of diabetes. In the United States, Type II diabetes is nearing epidemic proportions, principally due to an increased number of older Americans and a greater prevalence of obesity and a sedentary lifestyle.
- Insulin in simple terms, is the hormone that unlocks the cells of the body, allowing glucose to enter those cells and feed them. Since, in diabetics, glucose cannot enter the cells, the glucose builds up in the blood and the body's cells literally starve to death.
- Diabetics having Type I diabetes typically are required to self-administer insulin using, e.g., a syringe or a pin with needle and cartridge. Continuous subcutaneous insulin infusion via implanted pumps is also available. Insulin itself is typically obtained from pork pancreas or is made chemically identical to human insulin by recombinant DNA technology or by chemical modification of pork insulin. Although there are a variety of different insulins for rapid-, short-, intermediate-, and long-acting forms that may be used variously, separately or mixed in the same syringe, use of insulin for treatment of diabetes is not to be ignored.
- SMBG blood glucose
- individuals may make insulin dosage adjustments before injection. Adjustments are necessary since blood glucose levels vary day to day for a variety of reasons, e.g., exercise, stress, rates of food absorption, types of food, hormonal changes (pregnancy, puberty, etc.) and the like.
- SMBG blood glucose
- several studies have found that the proportion of individuals who self-monitor at least once a day significantly declines with age. This decrease is likely due simply to the fact that the typical, most widely used, method of SMBG involves obtaining blood from a finger stick. Many patients consider obtaining blood to be significantly more painful than the self-administration of insulin.
- Glucose may be measured by non-invasive or minimally-invasive techniques, such as those making the skin or mucous membranes permeable to glucose or those placing a reporter molecule in the subcutaneous tissue. Needle-type sensors have been improved in accuracy, size, and stability and may be placed in the subcutaneous tissue or peripheral veins to monitor blood glucose with small instruments. See, "An Overview of Minimally Invasive Technologies ", Clin. Chem. 1992 Sep.; 38(9): 1596-1600.
- This invention involves non-invasive glucose measurement and a process for determining blood glucose levels in the human body upon achieving a static level of glucose at a skin surface over a period of time.
- Processes which are able to assess glucose concentrations predictably from a skin surface may include a step of extracting a sample from the skin and then measuring that sample from the skin.
- sample extraction processes may include suction blister extraction, wick extraction, microdialysis extraction, iontophoretic extraction, promptophoretic extraction, and chemically enhanced extraction.
- non-invasive measurement processes may include electrochemical sensors (e.g., glucose electrodes), optoche ical sensors (e.g., colorimetric strips), near-infrared spectroscopy (NLR), mid-infrared spectroscopy (MIR), infrared spectroscopy (IK), Raman spectroscopy, photoacoustic spectroscopy. measurement of refractive index or scatter changes, fluorescent spectroscopy. and polarization spectroscopy.
- electrochemical sensors e.g., glucose electrodes
- optoche ical sensors e.g., colorimetric strips
- NLR near-infrared spectroscopy
- MIR mid-infrared spectroscopy
- IK infrared spectroscopy
- Raman spectroscopy Raman spectroscopy
- photoacoustic spectroscopy photoacoustic spectroscopy.
- refractive index or scatter changes e.g., fluorescent spectroscopy. and polarization spectros
- Figure 1 shows a graph representing a glucose level rising sharply and reaching a static value.
- Figure 2 shows a graph correlating glucose levels measured using a specific variation of the device with glucose levels in the blood determined using a commercial device.
- Figure 3 shows a pair of glucose IR curves (taken before and after eating) for an individual having diabetes made using the inventive glucose measuring device.
- Figure 4 shows a graph comparing glucose levels in a non-diabetic individual (taken before and after eating) made using the inventive glucose measuring device and direct blood measurement. This graph shows that the inventive procedure tracks blood glucose levels with minimum time lag.
- the device in co-pending Application Serial No. 09/547,433 described the use of IR attenuated total reflectance ("ATR") spectroscopy to detect and ultimately to determine the level of a selected analyte, preferably blood glucose, in the human body.
- ATR IR attenuated total reflectance
- the inventive device used an ATR procedure in which the size and configuration of the crystal permits a number of internal reflections before the beam is allowed to exit the crystal with its measured information.
- the skin is made up of a number of layers: the outermost ⁇ the stratum corneiim — is a layer substantially free of interference from cholesterol, water, gamma globulin, albumin, and blood. It is a shallow outer region covering the stratum graniilosiim, the stratum spinosum, and the basal layer. The area between the basal layer to the outside is not vascularized. It is unlikely that any layer other than the stratum corneum is traversed by the mid-IR light involved in this inventive device.
- the stratum corneum is the outer layer of skin and is substantially unvascularized.
- the stratum corneum is the final outer product of epidermal differentiation or keratinization. It is made up of a number of closely packed layers of flattened polyhedral comeocytes (also known as squames). These cells overlap and interlock with neighboring cells by ridges and grooves. In the thin skin of the human body, this layer may be only a few cells deep, but in thicker skin, such as may be found on the toes and feet, it may be more than 50 cells deep.
- the plasma membrane of the comeocyte appears thickened compared with that of keratinocytes in the lower layers of the skin, but this apparent deposition of a dense marginal band formed by stabilization of a soluble precursor, involucrin. just below the stratum corneum. It is sometimes necessary to clean the skin exterior prior before sampling to remove extraneous glucose from the skin surface. At least when using IR spectra to measure glucose, it is important to select cleaning materials having IR spectra that do not interfere with the IR spectra of glucose. We consider a kit of the following to be suitable for preparation of the sample skin for the testing.
- the components are: a.) a glucose solvent, e.g., water or other highly polar solvent; b.) a solvent for removing the water, e.g., isopropanol, and c.) a skin softener or pliability enhancer not having significant IR peaks in the noted IR regions, e.g., mineral oils such as those sold as "Nujol".
- a glucose solvent e.g., water or other highly polar solvent
- a solvent for removing the water e.g., isopropanol
- a skin softener or pliability enhancer not having significant IR peaks in the noted IR regions e.g., mineral oils such as those sold as "Nujol”.
- the b.) and c.) components are admixed, although they need not be. Certain mixtures of the first two components may be acceptable, but only if the sampling situation is such that the solvents evaporate without IR spectrographically significant residue. We have also
- the inventive kit preferably is made up of sealed packets of the components, most preferably each packet containing an absorbent pad.
- the curve representing the glucose level rises sharply and eventually plateaus over a time period.
- T This glucose level may be measured by any of the devices and processes as discussed in Application Serial No. 09/547,433 or herein at predetermined time periods. ⁇ T. until the glucose level reaches a substantially static value. thus representing the glucose level in the blood.
- the outer layer of the skin is not vascularized and the physiological source of the glucose transport to the skin surface is not all together clear. Nevertheless, it is easily assessable and quite repeatable. Our method of using mid IR to measure this glucose level is believed, on basic principals, only to penetrate the skin at best a few microns.
- Sample measurement methods may include electrochemical sensors (e.g.. glucose electrodes), optochemical sensors (e.g., colorimetric strips), near-infrared spectroscopy (N1R), infrared spectroscopy (IR), Raman spectroscopy. photoacoustic spectroscopy. measurement of refractive index or scatter changes, fluorescent spectroscopy, and polarization spectroscopy.
- Blister suction and wick extraction arc some of the most common methods for sampling subcutaneous interstitial tissue fluid, although blister extraction is less invasive than the wick extraction technique.
- Microdialysis extraction involves calculating the concentrations of compounds, including skin glucose concentrations, which are in the extracellular water space. Microdialysis has been applied to peripheral tissue types, e.g., skin, muscle, adipose, eye, lung, liver, and blood as well as having microdialysis probes implanted subcutaneously and perfused by a portable microinfusion pump. Finally, iontophoretic extraction involves noninvasive glucose measurement from subcutaneous tissue.
- Electrochemical sensors utilize electrical signal as a direct consequence of some (chemical) process occurring at a transducer/analyte interface.
- Some implantablc glucose sensors may include clcctrocalaKlic sensors, which arc based on direct electro-oxidation of glucose on noble metal electrodes, and biosensors, which combine glucose-specific enzymes with electrochemical electrodes.
- Such sensors may be fabricated by combining biologically active components (e.g., enzymes, antibodies, cells, tissues or microorganisms) with some physical transducer.
- Biosensors may be direct enzyme biosensors or affinity sensors based on enzyme labeled immunoassays. Enzymes may be used as a molecular recognition element in glucose sensing while immunoassays may provide the ability to sense extremely low amounts of an analyte.
- Electrochemical sensors may also include piezoelectric, thermoelectric, and acoustic sensors used for glucose measurement by utilizing an enzyme-catalysed reaction to create a measurable change in a physical parameter detectable by a transducer.
- Optochemical sensors are based on changes in some optical parameter due to enzyme reactions or antibody-antigen bonding at a transducer interface.
- Such sensors may include enzyme optrodes and optical immunosensors and may also include different monitoring processes such as densitometric, refractomet ic or colorimetric devices.
- Electrochemical biosensors may be constructed on the amperometric principle which is based on the oxidation or reduction of electrochemically active substances. Such sensor may also be constructed to measure the changes in local pH due to the gluconic acid produced at a potentiometric sensor, usually a coated wire pFI-selective electrode or an ion selective field effect transistor (ISFET). Also, electrical resistance changes during the overall process may be used as a basis for conduotometric biosensors. Moreover, potentiometric glucose sensors (e.g., coated wire sensors) may potentially be utilized for implantablc use. Coated wire sensors are general easy to fabricate and are suitable for miniaturization to diameters of 50-200 ⁇ m. They may also be used in combination with a standard cardiographic (EKG) reference electrode.
- EKG cardiographic
- NIR Near-Infrared Spectroscopy
- the NIR region of the spectrum extends from 700 to 2500 nm (14,000-4000 cm "1 ). In this region, absorption bands are due to overtone vibrations of anharmonic fundamental absorption bands to combinations of fundamental absorption bands primarily associated with C-H. O-I I, and N-H stretching vibrations. For overtone vibrations, only the first, second, and third overtones arc usually seen with the magnitude of the absorption peak diminishing substantially with overtone order.
- the NIR region may be attractive for quantitative spectroscopy since NIR instrumentation is readily available. In measuring aqueous glucose, the NIR region which lies between 2.0 and 2.5 ⁇ m may be utilized. This region contains a relative minimum in the water absorption spectrum and has readily identifiable glucose peak information. However, NIR spectra may generally be sensitive to a host of factors including temperature, pH, and scattering.
- the loss (Stokes shift) or gain (anti-Stokes shift) of photon energy, and hence frequency, is due to transitions of the rotational and vibrational energy states within the scattering molecule. Since the Raman spectrum is independent of excitation frequency, an excitation frequency may be chosen which is appropriate for a particular sample.
- a drawback may be that scatter and rcabsorption in biological tissues may make detection of Raman shifts due to physiological concentrations difficult.
- Photoacoustic laser spectroscopy has been utilized for measuring glucose concentrations of human whole blood samples using pulsed laser photoacoustic spectroscopy. Such a process may use. e.g., a C0 2 laser operating with ⁇ J pulse energy, to measure tiny changes of the absorption coefficient of the sample caused by the variations of blood glucose concentrations.
- Measurement of refractive index or scatter changes may be feasible to measure blood glucose by measuring the scattering coefficient of human skin, e.g., by using optical sensors attached to the skin. Such techniques may be based on the fact that the refractive index of sugar solution changes with the concentration of sugar.
- Fluorescent Spectroscopy There may be two categories for fluorescent spectroscopy: glucose-oxidase based sensors and affinity-binding sensors. Sensors in the first category may use the electroenzymatic oxidation of glucose by glucose-oxidase (GOX) in order to generate an optically detectable glucose-dependent signal. The oxidation of glucose and oxygen forms gluconolactone and hydrogen peroxide.
- GOX glucose-oxidase
- a method GOX based fluorescent sensor involves the redox mediator tetrathiafulvalene (TTF) whose oxidized form TTF " reacts with the reduced form of GOX to reversibly form TTF . Since TTF ' is absorbed in the 540-580 nm range, a method for quantifying the presence of TTF " (and hence glucose driving the production of reduced GOX) is available.
- TTF redox mediator tetrathiafulvalene
- Another method involves the hydrogen peroxide (H 2 O 2 ) generated from the GOX reaction with glucose reacting with bis(2,4,6-trichlorophenyl) oxalate (TCPO) to form a peroxyoxylate.
- H 2 O 2 hydrogen peroxide
- TCPO bis(2,4,6-trichlorophenyl) oxalate
- the peroxyoxylate formed transfers chemiluminescent energy to an accepting fluorophore which in turn emits photons at a characteristic wavelength.
- the emission by the fluorophore is proportional to the glucose concentration and may be detected optically.
- Polarimetric quantification of glucose may be based on the principle of optical rotary dispersion (ORD) where a chiral molecule in an aqueous solution rotates the plane of linearly polarized light passing through the solution. This rotation is due to a difference in the indices of refraction n ⁇ , and I R for left- and right-circularly polarized light passing through a solution containing the molecule. Because the molecule has a chirality (or
- Glucose in the body is dextrorotatory, i.e., rotates light in a right-handed direction, and has a specific rotation of +52.6° dm "1 (g/L) "! .
- IR spectrometer (Nicolet 510) having a ZnSe crystal ATR plate (55mm long, 10mm wide, and 4mm thick) we tested the inventive procedure.
- the inventor used a blood stick known as "Whisper Soft” by Amira Medical Co. and "Glucometer Elite" blood glucose test strips sold by Bayer Corp. of Elkhart, Ind. On each of the various test days, the inventor took several test sticks and measured the glucose value of the resulting blood; the
- curve 3 shows the IR absorbance spectrum of the test subject's finger before eating (and after fasting overnight) and curve 2 shows IR absorbance spectrum of the same individual after having eaten.
- insulin was administered shortly after the measurement of curve 2.
- the significant difference in the two peak heights at the 9.75 micrometer wavelength and the equality of the two IR absorbance values at the 8.50 micrometer value shows the effectiveness of the procedure in measuring glucose level.
- Example 3 That the inventive glucose monitoring device non-invasively determines blood glucose level and quickly follows changes in that blood glucose level is shown in Figure 4.
- inventive procedure Using both the inventive procedure and a commercial glucose device, one of the inventors followed his glucose level for a single day. The blood sticks are considered to be accurate within 15% of the actual reading.
Abstract
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Priority Applications (4)
Application Number | Priority Date | Filing Date | Title |
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JP2002535543A JP2004511285A (en) | 2000-10-19 | 2001-10-09 | Glucose measurement using a non-invasive evaluation method |
AU3039502A AU3039502A (en) | 2000-10-19 | 2001-10-09 | Glucose measurement utilizing non-invasive assessment methods |
AU2002230395A AU2002230395B2 (en) | 2000-10-19 | 2001-10-09 | Glucose measurement utilizing non-invasive assessment methods |
CA002426249A CA2426249A1 (en) | 2000-10-19 | 2001-10-09 | Glucose measurement utilizing non-invasive assessment methods |
Applications Claiming Priority (2)
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US09/693,202 | 2000-10-19 | ||
US09/693,202 US6522903B1 (en) | 2000-10-19 | 2000-10-19 | Glucose measurement utilizing non-invasive assessment methods |
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WO2002032303A2 true WO2002032303A2 (en) | 2002-04-25 |
WO2002032303A8 WO2002032303A8 (en) | 2003-10-23 |
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US (2) | US6522903B1 (en) |
JP (1) | JP2004511285A (en) |
AU (2) | AU2002230395B2 (en) |
CA (1) | CA2426249A1 (en) |
WO (1) | WO2002032303A2 (en) |
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