DS21, a new noninvasive technology, is effective and safe for screening for prediabetes and diabetes in Chinese population

BioMedical Engineering OnLine

Jing Tang¹  Mingfeng Xia²  Hongmei Yan²  Xin Gao²  Liu Wang²  Hua Bian²  Huandong Lin²  Xiaopeng Zhu²  Xinxia Chang² 

[1] Changqiao Community Health Service Center, 200032, Shanghai, China;Department of Endocrinology, Zhongshan Hospital, Fudan University, 200032, Shanghai, China;Fudan Institute for Metabolic Disease, Fudan University, 200032, Shanghai, China;

关键词: Diabetes;    Prediabetes;    Impaired glucose regulation;    Screening;   

DOI  :  10.1186/s12938-020-00823-x

来源: Springer

【 摘 要 】

BackgroundScreening for prediabetes and asymptomatic diabetes is important for preventing development to an irreversible stage. The current diagnosis of prediabetes and diabetes is based on blood glucose or HbA1c (an invasive method). The aim of this study was to assess the efficacy and safety of DS21, a new noninvasive technology, for noninvasive screening for prediabetes and diabetes.MethodsA total of 939 subjects were divided into a normal control group (NC, n = 308), impaired glucose regulation group (IGR, n = 312), and diabetes (DM) group (n = 319). All subjects underwent the DS21 test, and mean hands–feet, hand, and feet conductance values were analyzed. The diagnostic accuracy of the conductance value was analyzed by receiver-operating characteristic (ROC) curve.ResultsThe conductance values for hands–feet, hands, and feet in the DM and IGR groups were significantly lower than those in the NC group (all P < 0.01). The area under the ROC curve  (AUCROC) for distinguishing NC/IGR was highest when using hands–feet conductance values (0.766 [95% confidence interval, CI 0.730, 0.803]). However, the AUCROCs of distinguishing NC/abnormal glucose metabolism (AGM, including IGR+DM), non-diabetes (NDM)/DM, and IGR/DM were highest when using conductance values for hands at 0.782 [95% CI 0.752, 0.812], 0.688 [95% CI 0.653, 0.723] and 0.573 [95% CI 0.528, 0.617], respectively (all P < 0.01). Hand conductance of values 75.0 (sensitivity 0.769, specificity 0.660), 77.1 (sensitivity 0.718, specificity 0.695), 68.4 (sensitivity 0.726, specificity 0.555), and 58.1 (sensitivity 0.384, specificity 0.744) were recommended as the screening thresholds for NC/AGM, NC/IGR, NDM/DM, and IGR/DM, respectively. A hand conductance value 66.0 was also recommended to distinguish NC/AGM due to its high sensitivity and high PPV. No adverse events occurred in the test.ConclusionsDS21 is fast, noninvasive, low cost, reliable and safe, which makes it a feasible device for screening for prediabetes and diabetes, especially in a large population.

【 授权许可】

CC BY