Summary:
Modern strategies in the treatment of Diabetes mellitus require frequent blood glucose tests. Near-infrared spectroscopy [NIR] is considered to be a method for non-invasive blood glucose testing. The present study evaluated the long-term accuracy and stability of the method. Spectra of 10 patients were recorded. An individual calibration models were calculated for each patient from spectra which were recorded at the beginning of the investigation. These models were then applied to calculate blood glucose values from spectra which were recorded 84 to 169 days later. The long-term accuracy and stability of the calibration models expressed as root mean squared error of prediction [RMSP] varied from 3.1 to 35.9 mmol/l and the error grid analysis [EGA] from 13 to 92% clinically acceptable values in zones A and B. The results of the investigation indicate that long-term monitoring of blood glocose by means of NIR-spectroscopy and individual calibration models over a period of 3 to 4 months is basically possible once long-term stability of the method will be improved. Further technological progress and a better understanding of the underlying physiological processes is necessary to achieve a level of accuracy, reliability and stability of the method as required for clinical application.
Abbreviations: RMSP root mean squared error of prediction; EGA error grid analysis; LOO-CV leaving-one-out cross-validation
Key words:
Glucose self monitoring - diabetes mellitus - NIR-spectroscopy - non-invasive blood glucose determination - multivariate calibration
References
1 Alcock S J. Technology for continous invasive monitoring of glucose. Proceed IEEE Eng Med & Biol Amsterdam, Paper 838: 31. 10.-3. 11. 1996
2
Brunelle R L, Llewely J, Anderson J H, Gale E AM, Koivisto V A.
Meta-analysis of the effect of insulin lispro on severe Hypoglycemia in patients with type 1 diabetes.
Diabetes Care.
21
1726-1731
1998;
3
Clarke W L, Cox D, Gonder-Frederick L A, Carter W, Pohl S L.
Evaluating clinical accuracy of systems for self-monitoring of blood glucose.
Diabetes Care.
10
622-628
1987;
4 Cote G L, Fox M D, Northrop R B. Noninvasive optical polarimetric glucose sensing using a true phase measurement technique. IEEE Transactions on Biomedical Engeneering 39, No. 7 1992
5
de Boer J, Baarsma R, Okken A, Plijter-Groendijk H, Korf J.
Application of transcutaneous microdialysis and continuous flow analysis for on-line glucose monitoring in newborn infants.
J Lab Clin Med.
124
210-217
1994;
6 Demuth H, Beale M. MATLAB 4.3 for Windows. The Mathworks Inc., South Natick, MA24, Neural network toolbox 2 for use with matlab, user's guide. Natick, MA: The MathWorks, Inc. 1994
7
European Diabetes Policy Group 1998 .
A desktop guide to type-1 (insulin-dependent) diabetes mellitus.
Diabetic Medicine.
16
253-266
1999;
8
Hashiguchi Y, Uemura T, Sakakida M, Kajiwara K, Nishida K.
Development of a miniaturized glucose monitoring systems by combining a needle-type glucose sensor with microdialysis sampling method.
Diabetes Care.
17
(No. 59)
1994;
9 Heise H M. Technology for non-invasive monitoring of glucose. Proc IEEE Eng Med & Biol 18th Ann. Int. Conf., Amsterdam, Paper 1151: 31. 10.-3. 11. 1996
10
Jaffari S A, Turner P F.
Recent advances in amperometric glucose biosensors for in vivo monitoring.
Physiol Meas.
16
1-15
1995;
11
Jagemann K U, Fischbacher Ch, Danzer K, Müller U A, Mertes B.
Application of near-infrared spectroscopy for non-invasive determination of blood/tissue glucose using neural networks.
Zeit Phys Chem.
191
179-190
1995;
12
Kajiwara K, Uemura T, Kishikawa H, Nishida K, Hashigushi Y, Uehara M, Sakakida M, Ichibose M, Shichiri M.
Noninvasive measurement of blood glucose concentrations by analysing Fourier transform infra-red absorbance spectra through oral mucosa.
Med Biol Eng Comp.
31
17
1993;
13
Kayashima S, Arai T, Noritake M, Nagata N, Kikuchi M, Ito N, Matsumoto Y, Kaneyoshi A, Kimura J, Kuriyama T.
New transcutaneous sampling of glucose for patients with type II diabetes using an ion-sensitive field-effect transistor.
Clinica Chimica Acta.
240
1910-1911
1995;
14
Koschinsky T, Dannehl K, Gries F A.
New approach to technical and clinical evaluation of devices for self-monitoring of blood glucose.
Diab Care.
11
619-629
1988;
15
Liu D, Moberg E, Kollind M, Lins P, Adamson U, MacDonald A.
Arterial, arterialized venous, venous and capillary blood glucose measurements in normal man during hyperinsulinaemic euglycaemia and hypoglycaemia.
Diabetologia.
35
287-290
1992;
16 Marbach R. Meßverfahren zur IR-spektroskopischen Blutglucosebestimmung. Fortschr.-Ber. VDI Reihe 8 Nr. 346 1993
17
Marbach R, Koschinsky T, Gries F A, Heise H M.
Noninvasive blood glucose assay by near-infrared diffuse reflectance spectroscopy of the human inner lip.
Appl Spectrosc.
47
875
1993;
18
Müller U A, Mertes B, Fischbacher Ch, Jagemann K U, Danzer K.
Non-invasive blood glucose monitoring by means of near infrared spectroscopy: methods for improving the reliability of the calibration models.
Jour Art Org.
20
69-74
1997;
19
Ohkubo Y, Kishikawa H, Araki E, Miyata T, Isami S, Motoyoshi S, Kojima Y, Furuyoshi N, Shichiri M.
Intensive insulin therapy prevents the progression of diabetic microvascular complications in Japanese patients with non-insulin-dependent diabetes mellitus: a randomized prospective 6-year study.
Diabetes Research and Clinical Practice.
28
103-117
1995;
20
Pickup J C.
In Vivo Glucose Monitoring: Sense and Sensorbility.
Diab Care.
16
535-539
1993;
21
Poitpout V, Moatti-Sirat D, Reach G, Zang Y, Wilson G, Lemonnier F, Klein J.
A glucose monitoring system for online estimation in man of blood glucose concentrations using a miniaturized glucose sensor implanted in the subcutaneous tissue and a wearable control unit.
Diabetologia.
36
658-663
1993;
22
Quan K M, Christison G B, MacKenzie H A, Hodgson P.
Glucose determination by a pulsed photoacoustic technique: an experimental study using a gelatin-based tissue phantom.
Phys Med Biol.
38
1911-1922
1993;
23
Rao G, Glikfeld P, Guy R H.
Reverse Iontopheresis: Development of a noninvasive approach for glucose monitoring.
Pharm Res.
10
1751-1755
1993;
24
Reichard P, Pihl M, Rosenquist U, Sule J.
Complications in IDDM are caused by elevated blood glucose levels: The Stockholm Diabetes Intervention Study (SIDS) at 10-year follow up.
Diabetologia.
39
1483-1488
1996;
25
Renner R, Pfützner A, Trautmann M, Harzer O, Sauter K, Landgraf R.
on behalf of the German Humalog CSII Study Group: Use of insulin lispro in continuous subcutaneous insulin infusion treatment.
Diab Care.
22
784-788
1999;
26
Rigby G P, Crump P, Vadgama P.
Open flow microperfusion: approach to in vivo glucose monitoring.
Med & Biol Eng & Comput.
33
2310-2347
1995;
27
Robinson M R, Eaton R P, Haaland D M, Koepp G W, Thomas E V.
Noninvasive glucose monitoring in diabetic patients: a preliminary evaluation.
Clin Chem.
38
1618-1622
1992;
28
Schiel R, Müller U A, Rauchfuss J, Sprott H, Müller R.
Blood-glucose self-monitoring in insulin treated type-2 diabetes mellitus. A cross-sectional study with an intervention group.
Diab Metab (Paris).
25 (4)
334-340
1999;
29
Spanner G, Niessner R.
New concept for the non-invasive determination of physiological glucose concentrations using modulated laser diods.
Fresenius J Anal Chem.
3
354
1996;
30
Tamada J A, Bohannon N JV, Potts R O.
Measurement of glucose in diabetic subjects using noninvasive transdermal extraction.
Nature Medicine.
1 (11)
1198-1201
1995;
31
The Diabetes Control and Complication Trial Research Group .
The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus.
N Engl J Med.
329
977-986
1993;
32
UK Prospective Diabetes Study (UKPDS) Group .
Intensive blood-glucose control with sulfonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33).
Lancet.
352
837-853
1998;
33
Ward K J, Haaland D M, Robinson M R, Eaton R Ph.
Post-prandial blood glucose determination by quantitative mid-infrared spectroscopy.
Appl Spec.
46 (6)
959-964
1992;
34
Wilkins E, Atanasov P.
Integrated implantable device for long-term glucose monitoring.
Bios & Bioelec.
10
485-494
1995;
Alexander Sämann
Klinik für Innere Medizin II
Friedrich-Schiller-Universität Jena
c/o U. A. Müller, MD, MSc
D-07740 Jena
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