Noninvasive Type 2 Diabetes Screening

Abstract

OBJECTIVE -This study compared the performance of a novel noninvasive technology to fasting plasma glucose (FPG) and A1C tests for detecting undiagnosed diabetes and impaired glucose tolerance.RESEARCH DESIGN AND METHODS -The design was a head-to-head evaluation in a naïve population. Consented subjects received FPG and A1C tests and an oral glucose tolerance test (OGTT). Subjects were also measured by a noninvasive device that detects the fluorescence of skin advanced glycation end products. A total of 351 subjects participated.RESULTS -Subjects with 2-h OGTT values Ն140 mg/dl defined the positive screening class. A total of 84 subjects (23.9% prevalence) screened positive. The performances of the noninvasive device, FPG, and A1C were evaluated for sensitivity and specificity against this classification. At the impaired fasting glucose threshold (FPG ϭ100 mg/dl), the FPG testing sensitivity was 58% and the specificity was 77.4%. At that same specificity, the sensitivity for A1C testing was 63.8%, while the noninvasive testing sensitivity was 74.7%. The sensitivity advantage of the noninvasive device over both blood tests for detecting diabetes and precursors was statistically significant (P Ͻ 0.05).CONCLUSIONS -The noninvasive technology showed clinical performance advantages over both FPG and A1C testing. The sensitivity differential indicated that the noninvasive device is capable of identifying 28.8% more individuals in the OGTT-defined positive screening class than FPG testing and 17.1% more than A1C testing. The combination of higher sensitivity and greater convenience-rapid results with no fasting or blood draws-makes the device well suited for opportunistic screening. Diabetes Care 30:1120 -1124, 2007T he U.S. is facing a dangerous epidemic in type 2 diabetes. Of the estimated 20.6 million individuals with diabetes, ϳ30% are undiagnosed (1). Another 54 million people have some form of pre-diabetes, and many will progress to frank diabetes within 3 years (1-3). Numerous studies have shown that with early detection and effective intervention, diabetes can be prevented or delayed (2-7). In patients with diagnosed diabetes, other studies have shown that glucose control can lower the incidence of complications (8,9).Diagnosis is typically initiated during a physical exam with a primary care physician. However, current screening methods for type 2 diabetes and pre-diabetes are inadequate due to their inconvenience and inaccuracy. Specifically, the most widely applied screening test in the U.S., fasting plasma glucose (FPG) testing, has convenience barriers in the form of an overnight fast and a blood draw. FPG also suffers from poor sensitivity (40 -60%) contributing to late diagnoses (10). In fact, about one-half of diabetic patients present with one or more irreversible complications at the time of diagnosis (11,12). A more accurate and convenient screening method could dramatically improve early detection of type 2 diabetes and its precursors, facilitating interventions that can prevent or at least delay th...

New screening technologies for type 2 diabetes mellitus appropriate for use in tuberculosis patients [Review article]

“…Table 3 provides a summary of novel DM screening technologies identifi ed, and indicates whether they meet the proposed TPP requirements described earlier. 35,[47][48][49] A summary of each category of test is also provided below.…”

“…51 For this reason, non-invasive tools using skin autofl uoresence quantifi cation that correlate with levels of tissue AGEs have been developed that take advantage of the characteristic fl uorescence of AGEs in the skin. 49 Due to the fact that the glycated products (the major contribution in fl uorescence comes from fl uorescent AGEs linked mostly to collagen, but also to other proteins and lipids) remain present in the dermal layer for a long period of time, measurements from AGE readers represent averages of hyperglycemia over a long period of time (average 12 months); 51 they therefore present an opportunity for use in TB patients, given the need to distinguish medium-and long-term glycemic control from short-term, infection-induced hyperglycemia. Two non-invasive AGE devices are currently at an advanced stage of development, by the companies DiagnOptics Technologies BV (AGE Reader™; Groningen, The Netherlands) and Veralight (SCOUT DS ® ; Miraculins Inc., Winnipeg, MB, Canada).…”

“…12 Although more studies are required, one study demonstrated the SCOUT DS ® to have 74.7% sensitivity, and the same study calculated the sensitivity differential to mean that the device would detect 28.8% more individuals in the OGTT-defi ned positive screening class than FPG testing and 17.1% more than A1c testing. 49 Despite these promising results, more information is needed regarding the performance of AGE readers in the 22 high TB burden countries, given potential variations in performance due to genetic and socio-cultural variations, skin color, skin dryness, or the use of topical creams and substances. Overall, in addition to their non-invasiveness and operational advantages, AGE readers offer the potential for very low-cost screening.…”

Screening for type 2 diabetes: a short report for the National Screening Committee

“…Maynard et al (2007) 154 reported an entirely different method of screening -spectroscopic measurement of advanced glycation end-products (AGEs) in the skin using a fluorescent technique. The authors report that within a minute, skin AGEs (SAGEs) can be measured.…”

Расчет Передаточных Функций Многослойных Биотканей В Задачах Коррекции Их Спектров Флуоресценции

“…Имеется ряд доклинических и клинических данных, убедительно показывающих высокую эффективность использования природных флуорофоров биоткани (коллагена, эластина, NADH, флавинов, порфиринов и др.) для контроля мета-болической активности клеток, оценки степени ишемии ткани и ранней диагностики сахарного диабета [3][4][5]. Однако для разработки и использования в клиниче-ской практике объективных диагностических критериев, основанных на связи спектра флуоресценции биотка-ни с происходящими в ней деструктивными и иными процессами, необходимо иметь возможность извлечения из измеряемого спектра информации о концентрациях флуоресцирующих биомаркеров, чувствительных к этим процессам.…”