Newsgroup: it.scienza.medicina
Titolo: Nuovi rilevatori glicemia !

Salve !
Sono al mio primo post su questo NG, dopo aver lurkato un bel pò, per
aprire, se possibile, un thread sull'argomento in oggetto!
Come diabetico insulino-diprendente mi rendo conto che non c'è migliore
terapia dell'autocontrollo da parte del paziente, però.........se la cosa
provocasse meno fastidio sarebbe meglio !!
Infatti, come Terapista della Riabilitazione, vedo evolversi in modo
esponenziale le varie metodologie di diagnosi e terapia offerte a chi
abbisogna delle nostre cure, con particolare attenzione al dolore fisico
provocato dalle varie patologie: perchè non è possibile (per ora) alleviare
l'ulteriore sofferenza di chi già deve iniettarsi insulina 3-4 volte al
giorno evitando di bucarsi le dita 4-6 volte al dì :-((( ???????
Come spunto x aprire l'argomento a tutti, posso affermare che ci sono studi
che porterebbero a prossime novità in questo campo: rilevatori da applicare
al polso (tipo orologio) a raggi infrarossi rileverebbero il tasso glicemico
attraverso la cute del polso (fonti U.S.A.) ma......pare che la sudorazione
umana provochi un'alterazione della lettura :-((((
C'è qualcuno in grado di illuminarci su novità, aggiornamenti, siti, link,
collegamenti e quant'altro riguardi questo problema ??
Grazie a tutti in anticipo !!
Ad majora
T.d.R. Silver

 collegamenti e quant'altro riguardi questo problema ??
Alcune fra le più importanti pubblicazioni sull'argomento sono
queste:
JAMA 1999 Nov 17;282(19):1839-44
Noninvasive glucose monitoring: comprehensive clinical results.
Cygnus Research Team.
Tamada JA, Garg S, Jovanovic L, Pitzer KR, Fermi S, Potts RO.
Cygnus Inc, Redwood City, Calif 94063, USA.
CONTEXT: Intensive diabetes management using frequent blood
glucose measurements to guide therapy has been shown to
significantly improve short- and long-term outcomes. Development
of a device that makes possible frequent, automatic, painless,
and accurate measurements of glucose would facilitate intensive
management. OBJECTIVE: To determine the accuracy of the
GlucoWatch automatic glucose biographer (Cygnus Inc) compared
with that of serial blood glucose measurements. DESIGN:
Multicenter comparative study of the GlucoWatch biographer and
the HemoCue blood glucose analyzer (Aktiebolaget Leo) performed
between August 29 and October 17, 1998. Participants wore up to 2
biographers during the 15-hour study session and performed 2
fingersticks per hour for comparative blood glucose measurements.
The biographers were calibrated with a single HemoCue measurement
after a 3-hour warm-up period. Diet and insulin were manipulated
to produce a broad glycemic range during the study. SETTING:
Controlled clinical environment at 2 diabetes centers and 3
contract research organizations in the United States.
PARTICIPANTS: A total of 92 subjects (mean [SD] age, 42.1 [15.1]
years; 59.8% women) with type 1 or 2 diabetes requiring treatment
with insulin. MAIN OUTCOME MEASURES: Mean error, mean absolute
error, correlation, slope, and intercept using Deming regression,
and clinical significance of differences between biographer
readings and blood glucose measurements using the Clarke error
grid. RESULTS: Results showed close tracking of blood glucose
over a range of 2.2 to 22.2 mmol/L (40-400 mg/dL) for up to 12
hours using a single point calibration. The biographer readings
lagged behind serial blood glucose values by a mean of 18
minutes. An analysis of 2167 data pairs shows a linear
relationship (r = 0.88; slope = 1.03; intercept = -0.33 mmol/L
[-6 mg/dL]) between biographer readings and serial glucose
measurements. The mean absolute error between the 2 measurements
was 15.6% (mean error [SD], -0.07 [1.82] mmol/L [-1 [33] mg/dL]),
and 96.8% of the data fell in the therapeutically relevant
regions of the error grid analysis. CONCLUSION: These results
demonstrate close agreement between GlucoWatch biographer
readings and blood glucose measurements using repeated
fingerstick blood samples. The automatic, frequent, and
noninvasive measurements obtained with the biographer provides
more information about glucose levels than the current standard
of care.
Publication Types:
Multicenter Study
PMID: 10573275 [PubMed - indexed for MEDLINE]
Diabetes Care 1999 Oct;22(10):1708-14
Correlation of fingerstick blood glucose measurements with
GlucoWatch biographer glucose results in young subjects with type
1 diabetes.
Garg SK, Potts RO, Ackerman NR, Fermi SJ, Tamada JA, Chase HP.
Department of Pediatrics, Barbara Davis Center for Childhood
Diabetes, University of Colorado Health Sciences Center, Denver
80262, USA.
OBJECTIVE: The purpose of this study was to compare measurements
of glucose obtained via iontophoretic extraction with the
GlucoWatch automatic glucose biographer (Cygnus, Inc., Redwood
City, CA) with capillary blood glucose values that were
determined 1) in a controlled outpatient clinic setting and 2) in
a home setting. RESEARCH DESIGN AND METHODS: There were 76
GlucoWatch biographers used on 28 different young adults (21
women and 7 men) with type 1 diabetes (age 30.9 +/- 6.9 years and
duration of diabetes 18.4 +/- 8.1 years [mean +/- SD]) in a
controlled outpatient clinic setting. Some subjects participated
on multiple days. Subjects wore two GlucoWatch biographers, each
on the forearm (ventral aspect). Comparisons were made to HemoCue
blood glucose analyzer (Aktiebolgat Leo, Helsingborg, Sweden)
capillary blood glucose measurements. In addition, GlucoWatch
biographers (one each day for 3 consecutive days) were used by 12
subjects (8 women, 4 men) in a home setting. Comparisons were
made to capillary blood glucose values determined using the One
Touch Profile meter (Johnson & Johnson, New Brunswick, NJ).
RESULTS: GlucoWatch biographer glucose values correlated well
with capillary blood glucose values determined using the HemoCue
analyzer in the clinic setting (r = 0.90, 1,554 paired data
points) and using the One Touch Profile meter in the home setting
(r = 0.85, 204 paired data points). When 36 subjects wore two
biographers simultaneously, the correlation between the two
biographers was r = 0.94. The error grid analysis demonstrated
that > 96% of biographer glucose values determined in the clinic
or home setting were in the clinically acceptable A and B
regions. CONCLUSIONS: This study confirms the accuracy and
precision of glucose values as determined using the GlucoWatch
biographer in clinic and home settings.
Publication Types:
Clinical Trial
Controlled Clinical Trial
PMID: 10526740 [PubMed - indexed for MEDLINE]
L'articolo intero è qui:
http://care.diabetesjournals.org/cgi/reprint/22/10/1708.pdf
Diabetes Technol Ther 2000 Summer;2(2):199-207
Effect of acetaminophen on the accuracy of glucose measurements
obtained with the GlucoWatch biographer.
Tierney MJ, Garg S, Ackerman NR, Fermi SJ, Kennedy J, Lopatin M,
Potts RO, Tamada JA.
Cygnus, Inc, Redwood City, California 94063, USA.
BACKGROUND: Improved glycemic control significantly reduces
long-term microvascular complications of diabetes mellitus
associated with chronic hyperglycemia. The GlucoWatch biographer
is designed to facilitate intensive diabetes management by
providing automatic, frequent, and noninvasive glucose readings
up to three times per hour for as long as 12 hours. METHODS: The
device extracts glucose through intact skin using reverse
iontophoresis and measures the extracted glucose with an
electrochemical biosensor. A clinical trial was performed to
assess the effect of acetaminophen, a potential interference for
traditional blood glucose meters, on the accuracy of the
GlucoWatch biographer in adult subjects with diabetes (n = 18).
One thousand milligram doses of acetaminophen were administered
to subjects in two groups: one to achieve Cmax (peak
acetominophen concentration) at the time of biographer
calibration and the other to achieve Cmax during the measurement
period. The biographer readings were compared to serial
fingerstick blood glucose measurements. RESULTS: Time profiles
over 9 hours show close tracking of the biographer glucose
results with fingerstick blood glucose measurements for all
groups. The mean difference between the two measurements is
between 8 and 12 mg/dL for all groups. The mean absolute value of
the relative difference is less than 20%, and more than 93% of
the points were in the clinically acceptable (A+B) region of the
Clarke Error Grid. No statistically significant differences were
found for any accuracy measurement across all groups.
CONCLUSIONS: The GlucoWatch Biographer provides frequent
measurements of glucose over a 12-hour period with high accuracy.
No effect of therapeutic dosage of acetaminophen on the accuracy
of the glucose readings was found.
PMID: 11469259 [PubMed - indexed for MEDLINE]
Diabetes Care 2001 May;24(5):881-5
Comment in:
Diabetes Care. 2001 May;24(5):803-4
Detection of hypoglycemia with the GlucoWatch biographer.
Pitzer KR, Desai S, Dunn T, Edelman S, Jayalakshmi Y, Kennedy J,
Tamada JA, Potts RO.
Cygnus Incorporated, Redwood City, California 94063, USA.
OBJECTIVE: Hypoglycemia is a common acute complication of
diabetes therapy. The GlucoWatch biographer provides frequent and
automatic glucose measurements with an adjustable low-glucose
alarm. We have analyzed the performance of the biographer
low-glucose alarm relative to hypoglycemia as defined by blood
glucose < or = 3.9 mmol/l. RESEARCH DESIGN AND METHODS: The
analysis was based on 1,091 biographer uses from four clinical
trials. which generated 14,487 paired (biographer and blood
glucose) readings. RESULTS: The results show that as the
low-glucose alert level of the biographer is increased, the
number of true positive alerts (alarm sounds and blood glucose <
or = 3.9 mmol/l) and false positive alerts (alarm sounds but
blood glucose >3.9 mmol/l) increased. When analyzed as a function
of varying low-glucose alert levels, the results show receiver
operator characteristic curves consistent with a highly useful
diagnostic tool. Setting the alert level from 1.1 to 1.7 mmol/l
above the level of concern is likely to optimize the trade-off
between true positives and false positives for each user. When
the same blood glucose data are analyzed for typical monitoring
practices (two or four measurements per day), the results show
that fewer hypoglycemic events are detected than those detected
with the biographer.
Publication Types:
Clinical Trial
PMID: 11347748 [PubMed - indexed for MEDLINE]
L'articolo intero è qua:
http://www.diabetesliving.com/manage/glwatch.htm
Le informazioni dell'FDA su questo device sono qui:
http://www.fda.gov/cdrh/mda/docs/p990026.html
http://www.fda.gov/cdrh/pdf/p990026a.pdf
http://www.fda.gov/cdrh/pdf/p990026b.pdf
http://www.fda.gov/cdrh/pdf/p990026c.pdf
http://www.fda.gov/cdrh/pdf/p990026d.pdf
http://www.fda.gov/bbs/topics/NEWS/2001/NEW00758.html
mentre quelle del NIH sono qua:
http://www.niddk.nih.gov/health/diabetes/dateline/fall00/3.htm
Dovrebbe essere commercializzato negli USA a partire dal 2002, al
costo di circa 500 USD.
    KS