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Company and Product History
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. |
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| The AccuBase A1cTest
Kit™ uses the 'gold standard" HPLC-IE 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 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 (DCL Immuno-Dip), AccuBase SC a finger stick sickle cell anemia test kit (S-Trait), AccuBase MBG mean blood glucose test, 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 a Point of Care (POC) test kit designed for high volume users. DTI also manufactures private labeled kits for a number of companies in the diabetes outcomes management field. DTI also furnishes custom labeled Point of Care (POC) for clinical trials and/or studies (prices available on request). POC A1ctest kits can be purchased at market prices, which include custom clinical protocol (usually 75-100 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 2003" 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 2 years from DOM and the samples are stable for 30 days unrefrigerated 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. |
