Diabetes Technologies, Inc.,
(DTI) is considered a leader in finger stick A1c (glycohemoglobin)
sample collection and analysis
technology.
DTI is the developer and manufacturer of the
AccuBase A1c , cleared by the FDA for over-the-counter
(OTC) use.
The AccuBase A1cTest
Kit uses the 'gold standard" HPLC-IE
and/or BA methodology to collect and
analyze A1c samples in alternate site locations such as the home, physicians
office and/or clinic.
DTI conducted the first
clinical trials using the HPLC-IE technology during 1995-6 in a one-year patient study at
the Tulane Endocrine Clinic. In 1998, DTI received FDA clearance to market the
kit "by prescription use only" in the U.S.
In January 2002, DTI received approval from the FDA to
market the new version of the AccuBase A1c with
out the need for a prescription (OTC). Our coefficient of variation
(CV's) are under 1.44%. CV's represent the level of repeated accuracy and precision as
measured against a know A1c laboratory value.
The lower the CV, the more accurate the
test. In the case of A1c a low CV is very important in order to monitor
small changes (.1%) in the rate and direction of change for individual glycohemoglobin
levels.
DTI has also lead the industry in development of
comprehensive professional and patient education materials in the area of glycated
proteins including the "A1c Reference Guide". DTI is currently
developing and/or distributing several new products including: microalbumin, AccuBase SC a finger stick sickle cell anemia test kit
(S/C-Trait), AccuBase
eAG, estimated Average Glucosetest, diabetes management
software programs (Easy Log) and a medical reminder wrist watch (Cadex Watch). The
President and Chief Scientific Officer of DTI, Arthur Williams, is recognized for his
innovative work in the area of glycohemoglobin analysis, insulin algorithms and
information management technology software.
Available Products
Diabetes Technologies, Inc., manufactures and distributes the
AccuBase A1c. The kit is available in a one test kit
configuration. DTI also produces aan A1c Multi-Test
Kit test kit designed for high volume diabetes
screening (ideal for health/wellness screening companies)..
DTI also manufactures private
labeled kits for a number of companies in the diabetes outcomes management
field. DTI also furnishes custom labeled standard and
multi-test kits for clinical trials and/or studies (prices available on request).
The A1c Multi-Test kits can be purchased at market prices, which include custom
clinical protocol (usually 50 tests per kit). Other DTI products include a Mean Blood
Glucose Monitoring Journal, which includes graphic representation of 12 weeks of average
glucose values at five baseline intervals during a 24 hour period. Educational products
include, the "A1c Reference Guide", and a power point presentation
entitled the "Clinical significance of A1c in the diagnosis, management
and control of diabetes mellitus", the "AIIM Program" developed to provide
for tele-medicine support to individuals with all forms of DM, "Diabetes 2009"
presentation, outlining recommended QC/QA aspects of diabetes care in the U.S..
DTI Guarantee...
Diabetes Technologies, guaranties complete satisfaction of our
products. The AccuBase A1cTest Kit has a shelf-life of
5 years from DOM
and the samples are stable for 30 days un-refrigerated after collection.
Technical support on products and educational
presentations: The DTI technical staff is available to discuss any aspect of diabetes
management and care with qualified individuals seeking responsible dialogue on any area of
diabetes, glycohemoglobin and diabetes outcomes management markers.
Technical assistance is available to our clients 24 hours a day via
our toll-free number 888.872.2443. DTI is delighted to provide clinical
advice to physicians and health care professionals on any area of our expertise.