{"title":"Analysis of Fasting Skin Spectra to Characterize Background Spectral Variance for Non-Invasive Glucose Sensing in People.","authors":"Ariel B Kauffman, Gary W Small, Mark A Arnold","doi":"10.1177/19322968261474469","DOIUrl":"10.1177/19322968261474469","url":null,"abstract":"<p><strong>Background: </strong>Background spectral variance (BSV) is a critical parameter that strongly impacts calibration models for noninvasive glucose measurements. To date, the ability to characterize such variances is limited. A protocol is described for collecting skin spectra under fasting conditions and using these spectra to characterize how the BSV impacts measurement accuracy.</p><p><strong>Methods: </strong>Transmission noninvasive skin spectra were collected over the combination region of the near infrared spectrum. These spectra were collected continuously over a period of 270 minutes while maintaining fasting conditions. A glucose transient was created by linearly adding a set of concentration-scaled pure component glucose spectra to each fasting spectrum.</p><p><strong>Results: </strong>Quality of the noninvasive fasting spectra was evaluated by root mean square noise analysis of 100% lines, resulting in a noise level of 26 micro absorbance units (µAU). Evaluation of the BSV was done by (1) creating a set of net analyte signal calibration models for glucose with different subsets of the fasting spectra and (2) using each calibration model to predict the concentration of glucose from a set of synthesized skin spectra that represent the transient glucose concentration profile. Results reveal that the glucose transient can be predicted when the BSV is captured within the calibration dataset. Specific time points were identifiable, however, when the calibration dataset no longer fully represented the BSV in the prediction dataset.</p><p><strong>Conclusions: </strong>This preliminary report proposes a fasting protocol suitable for characterizing the BSV for noninvasive near infrared spectra. Net analyte signal calibration models are used to illustrate how unaccounted for BSV negatively impacts analytical accuracy. This protocol is general and can be applied to other approaches for noninvasive glucose sensing.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"1525-1532"},"PeriodicalIF":4.9,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13473209/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148720588","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Josefin Ulriksdotter, Thanisorn Sukakul, Magnus Bruze, Nils Hamnerius, Martin Mowitz, Cecilia Svedman
{"title":"A Cross-Sectional Study Demonstrating a High Prevalence of Skin Rash to Diabetes Medical Devices: An Underestimated Problem.","authors":"Josefin Ulriksdotter, Thanisorn Sukakul, Magnus Bruze, Nils Hamnerius, Martin Mowitz, Cecilia Svedman","doi":"10.1177/19322968251336261","DOIUrl":"10.1177/19322968251336261","url":null,"abstract":"<p><strong>Background: </strong>Adverse skin reactions to continuous glucose monitors (CGMs) and devices for continuous subcutaneous insulin infusions (CSIIs) (\"diabetes medical devices\" (MDs)) are well known. However, epidemiological studies on prevalence and skin rash details are lacking. The objective of this study was to describe the prevalence and details of skin rash to diabetes MDs in adults with type 1 diabetes.</p><p><strong>Method: </strong>All adult individuals (≥18 years) with type 1 diabetes attending outpatient diabetes clinics at two hospitals in southern Sweden were invited to participate (n = 1943) in a questionnaire study.</p><p><strong>Results: </strong>The questionnaire was completed by 667. Of the respondents 95.1% had used CGM and 36.7% had used CSII. Skin rash to the devices was reported by 42.1% of CGM users and 44.9% of CSII users. Skin rash was reported with use of all types of diabetes MDs. For diabetes MDs with ≥50 users, 18.0% to 56.5% of the participants with skin rash had to change the device more often than recommended and 4.0% to 18.0% had to stop using the device due to skin rash. In multivariable analyses, the odds for skin rash to diabetes MDs were higher among younger individuals and individuals with childhood atopic dermatitis. Odds increased with use of higher numbers of devices. Of the participants with skin rash, 13 of the 289 (4.5%) had been investigated for contact allergy.</p><p><strong>Conclusions: </strong>Skin rash to diabetes MDs is common. The problem is underdiagnosed in clinical practice. With use of diabetes MDs expected to increase, an increasing prevalence of skin rash is to be expected.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"1576-1584"},"PeriodicalIF":4.9,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12058707/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143998506","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Bader Nasser Alamri, Nellie Kamkar, Anthony S L Tang
{"title":"Guideline-Algorithmized Digital Screening Uncovers Undiagnosed Dysglycemia in Cardiovascular Patients and Yields Early HbA1c Improvement.","authors":"Bader Nasser Alamri, Nellie Kamkar, Anthony S L Tang","doi":"10.1177/19322968261460488","DOIUrl":"10.1177/19322968261460488","url":null,"abstract":"","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"1739-1740"},"PeriodicalIF":4.9,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13372791/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148447005","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Paul Dupenloup, Grace Guan, Grazia Aleppo, Richard M Bergenstal, Korey Hood, Davida Kruger, Teresa McArthur, Beth Olson, Sean Oser, Tamara Oser, Ruth S Weinstock, Robin L Gal, Craig Kollman, David Scheinker
{"title":"Assessing the Financial Sustainability of a Virtual Clinic Providing Comprehensive Diabetes Care.","authors":"Paul Dupenloup, Grace Guan, Grazia Aleppo, Richard M Bergenstal, Korey Hood, Davida Kruger, Teresa McArthur, Beth Olson, Sean Oser, Tamara Oser, Ruth S Weinstock, Robin L Gal, Craig Kollman, David Scheinker","doi":"10.1177/19322968251340664","DOIUrl":"10.1177/19322968251340664","url":null,"abstract":"<p><strong>Introduction: </strong>The Virtual Diabetes Specialty Clinic (VDiSC) study demonstrated the feasibility of providing comprehensive diabetes care entirely virtually by combining virtual visits with continuous glucose monitoring support and remote patient monitoring (RPM). However, the financial sustainability of this model remains uncertain.</p><p><strong>Methods: </strong>We developed a financial model to estimate the variable costs and revenues of virtual diabetes care, using visit data from the 234 VDiSC participants with type 1 or type 2 diabetes. Data included virtual visits with certified diabetes care and education specialists (CDCES), endocrinologists, and behavioral health services (BHS). The model estimated care utilization, variable costs, reimbursement revenue, gross profit, and gross profit margin per member, per month (PMPM) for privately insured, publicly insured, and overall clinic populations (75% privately insured). We performed two-way sensitivity analyses on key parameters.</p><p><strong>Results: </strong>Gross profit and gross profit margin PMPM (95% confidence interval) were estimated at $-4 ($-14.00 to $5.68) and -4% (-3% to -6%) for publicly insured patients; $267.26 ($256.59-$277.93) and 73% (58%-88%) for privately insured patients; and $199.41 ($58.43-$340.39) and 67% (32%-102%) for the overall clinic. Profits were primarily driven by CDCES visits and RPM. Results were sensitive to insurance mix, cost-to-charge ratio, and commercial-to-Medicare price ratio.</p><p><strong>Conclusions: </strong>Virtual diabetes care can be financially viable, although profitability relies on privately insured patients. The analysis excluded fixed costs of clinic infrastructure, and securing reimbursement may be challenging in practice. The financial model is adaptable to various care settings and can serve as a planning tool for virtual diabetes clinics.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"1619-1629"},"PeriodicalIF":4.9,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12075182/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143998917","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Lukas van Baal, Lutz Heinemann, Johanna Reinold, Jill von Conta, Fin Hendrik Bahnsen, Jens Kleesiek, Dagmar Fuehrer, Susanne Tan
{"title":"Accuracy and Reliability of Intermittent Scanning and Real-Time Continuous Glucose Monitoring Systems in Diabetes Emergencies.","authors":"Lukas van Baal, Lutz Heinemann, Johanna Reinold, Jill von Conta, Fin Hendrik Bahnsen, Jens Kleesiek, Dagmar Fuehrer, Susanne Tan","doi":"10.1177/19322968251334633","DOIUrl":"10.1177/19322968251334633","url":null,"abstract":"<p><strong>Background: </strong>Diabetes care is a major challenge of patients treated in hospitals. A continuous glucose monitoring system (CGM) provides a more comprehensive assessment of glucose control than capillary blood glucose measurements. Especially in emergencies, data on CGM use in inpatients are limited. To evaluate real-world usability, accuracy of an intermittent scanning and a real-time CGM in patients admitted due to diabetes emergencies was assessed.</p><p><strong>Methods: </strong>In 151 patients admitted due to diabetes emergencies, this single-center prospective study investigated the mean absolute relative difference (MARD) in broad glycemic ranges. The CGM accuracy was evaluated by applying a modified version of the Food and Drug Administration (FDA) criteria for CGM use, Clark Error Grid (CEG), and Bland Altman analysis (BAA).</p><p><strong>Results: </strong>Analysis of 1,498 CGM-/POC-glucose (CGM-/POC-G) pairs revealed a MARD of 10.8% with stepwise improvement from the hypoglycemic to the hyperglycemic range. The CEG analysis showed that 99.1% of all glucose values fell within the optimal or acceptable zones. BAA indicated that 96.0% of CGM-G values fell within the limits of the POC-G values. Day-by-day analysis of overall MARD revealed the highest MARD on the first day of CGM use, followed by consistent and stable MARD levels from day 2 onward until the end of wear time. Applying a modified version of the %20/20 agreement rate of the FDA criteria, 90.7% of CGM-G laid within ±20 mg/dl/±20% agreement rule.</p><p><strong>Conclusion: </strong>This study indicates the usability of CGM for inpatient diabetes care by demonstrating a high accuracy and reliability of CGM measurement.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"1595-1603"},"PeriodicalIF":4.9,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12018364/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144027126","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Kai E Jones, Max C Petersen, Alexander M Markov, Maamoun Salam, Petra Krutilova, Alexis M McKee, Kathryn L Bohnert, Samantha E Adamson, Janet B McGill
{"title":"Breath Acetone Correlates With Capillary β-hydroxybutyrate in Type 1 Diabetes.","authors":"Kai E Jones, Max C Petersen, Alexander M Markov, Maamoun Salam, Petra Krutilova, Alexis M McKee, Kathryn L Bohnert, Samantha E Adamson, Janet B McGill","doi":"10.1177/19322968251334640","DOIUrl":"10.1177/19322968251334640","url":null,"abstract":"<p><strong>Background: </strong>Breath acetone (BrACE) is an end product of ketone metabolism that is measurable by noninvasive breath ketone analyzers. We assessed the correlation between capillary blood β-hydroxybutyrate (BOHB) and BrACE in people with type 1 diabetes during 14 days of outpatient care with and without dapagliflozin treatment and during supervised insulin withdrawal studies with and without dapagliflozin.</p><p><strong>Methods: </strong>In this randomized crossover study, participants completed two 14-day outpatient periods with or without dapagliflozin 10 mg daily. Each 14-day unsupervised outpatient period was followed by a 1-day supervised insulin withdrawal study. Paired BOHB and BrACE measurements were obtained 3 times daily during outpatient periods, then hourly during supervised insulin withdrawal. The correlation between BrACE and BOHB was assessed by Spearman's ρ.</p><p><strong>Results: </strong>Twenty people with type 1 diabetes completed the study. During outpatient periods, BrACE and BOHB were moderately correlated (n = 1425 paired readings; ρ = .41; 95% CI = 0.36 to 0.45; <i>P</i> < .0001). However, BrACE and BOHB were strongly correlated during insulin withdrawal (n = 246 paired values, ρ = .81; 95% CI = 0.77 to 0.85). In ROC analysis, BrACE > 5 ppm demonstrated optimal sensitivity (93%) and specificity (87%) for detecting capillary BOHB ≥ 1.5 mmol/L. No serious adverse events occurred.</p><p><strong>Conclusions: </strong>In adults with type 1 diabetes, measurement of breath acetone provides a noninvasive estimate of blood BOHB concentration. The correlation between BrACE and BOHB was suboptimal during unsupervised outpatient care, but was strong during supervised insulin withdrawal.</p><p><strong>Trial registration: </strong>clinicaltrials.gov (NCT05541484).</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"1636-1644"},"PeriodicalIF":4.9,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12014577/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144010247","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Xiaoru Feng, Yifei Zhang, Lili Zhang, Yue Shen, Xianbiao Zhang, Yuran Xu, Long Wang, Bei Tao, Yufei Chen, Jia Shi, Minghui Chen, Chang Chen, Lin Zhou, You Wu, Weiqing Wang
{"title":"Non-Invasive Glucose Monitoring Using mμSORS: A Population-Based Validation Study Across Diverse Patient Variability.","authors":"Xiaoru Feng, Yifei Zhang, Lili Zhang, Yue Shen, Xianbiao Zhang, Yuran Xu, Long Wang, Bei Tao, Yufei Chen, Jia Shi, Minghui Chen, Chang Chen, Lin Zhou, You Wu, Weiqing Wang","doi":"10.1177/19322968261464571","DOIUrl":"10.1177/19322968261464571","url":null,"abstract":"<p><strong>Background: </strong>Frequent glucose monitoring is essential for diabetes management, yet non-invasive approaches have been limited by poor generalizability across patients. This study aimed to evaluate whether a depth-resolved Raman spectroscopy approach can provide consistent glucose prediction accuracy across physiological variability.</p><p><strong>Methods: </strong>We enrolled 200 patients with type 2 diabetes and acquired depth-resolved Raman spectra using a multiple μ-spatially offset Raman spectroscopy (mμSORS) system. An overall partial least squares (PLS) model was developed using 4768 paired venous plasma glucose and concatenated spectra at 100 μm (offset 2) and 150 μm (offset 3), and validated by subject-wise tenfold cross-validation. Model robustness was assessed through stratified analyses across physical characteristics, skin parameters, and serum biomarkers, with size-matched comparisons to control for sample size effects. Prediction accuracy was evaluated using mean absolute relative difference (MARD), root mean square error (RMSE), and consensus error grid (CEG).</p><p><strong>Results: </strong>The dataset covered a wide glucose range (3.8-31.6 mmol/L; 68.4-568.8 mg/dL) and substantial physiological heterogeneity. The overall PLS model achieved a MARD of 14.5% (CEG A + B: 99.4%), with no significant differences across stratified subgroups (<i>P</i> > .05). Stratified subgroup models performed significantly worse than the overall model (<i>P</i> < .05), yet after controlling for sample size, their performance was comparable with that of the overall model.</p><p><strong>Conclusion: </strong>A single, overall model for mμSORS-based glucose monitoring achieves high accuracy across diverse patient subgroups, demonstrating its strong robustness. These findings support the clinical potential of depth-resolved Raman spectroscopy for non-invasive glucose monitoring.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT05921344; https://clinicaltrials.gov/study/NCT05921344.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"1513-1524"},"PeriodicalIF":4.9,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13486386/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148793900","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Glycated Albumin Percentage is Correlated With HbA1c: Theoretic Marker in Patients With Altered Erythrocyte Turnover.","authors":"Mats Gåfvels, Per Swärd, Ning Xu, Joel Svensson","doi":"10.1177/19322968251384304","DOIUrl":"10.1177/19322968251384304","url":null,"abstract":"<p><strong>Introduction: </strong>The gold standard for monitoring long-term glucose levels in patients with diabetes mellitus is glycated hemoglobin (HbA1c). In conditions where the erythrocyte half-life is decreased, for example, in long-term kidney diseases and hemoglobinopathies, HbA1C may underestimate the long-term glucose exposure. Therefore, in these patient groups, other methods to monitor long-term glucose have been suggested, including glycated serum protein (GSP). To further optimize the method, a correction against total serum albumin has been proposed, defined as a percentage of glycated albumin (%GA). The aim of this study was to investigate the correlation between HbA1c, GSP, and %GA-a strong correlation to HbA1c would strengthen the potential usefulness of GSP and %GA as alternative methods to monitor glucose exposure in certain patient populations.</p><p><strong>Methods: </strong>In this study, randomly collected human samples (n = 271), with different levels of HbA1c were analyzed for GSP and total serum albumin and a %GA was calculated. We also divided the samples into subgroups based on their HbA1c-result, age, and gender.</p><p><strong>Results: </strong>Both %GA and GSP were strongly correlated with HbA1c, where %GA displayed the strongest correlation (<i>R</i><sup>2</sup> 0.77 compared with <i>R</i><sup>2</sup> 0.66.). When dividing into subgroups based on HbA1c-results, statistically significant differences in %GA were observed between all the different subgroups.</p><p><strong>Conclusion: </strong>In conclusion, the findings of this study strengthen the possibility of using GSP and %GA as possible alternatives or at least a supplement to HbA1c for monitoring long-term glucose exposure. Theoretically, particularly %GA could have the potential to supplement HbA1C in patients where the erythrocyte half-life is altered.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"1613-1618"},"PeriodicalIF":4.9,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12540351/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145337030","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The Impact of Interfering Substances on Continuous Glucose Monitors: Part 1: Classification of Continuous Glucose Monitoring Devices and Mechanisms of Substance Interference.","authors":"Steven John Setford","doi":"10.1177/19322968251377027","DOIUrl":"10.1177/19322968251377027","url":null,"abstract":"<p><p>Presented is a series of narrative reviews that summarize published information regarding the effect or potential effect of interfering substances on the accuracy of continuous glucose monitoring (CGM) devices. While drawing together what is currently known regarding this topic, the future direction in this field and clinical implications posed by polypharmacy on CGM performance are considered. This first in a series of four review articles classifies commercially available CGMs by glucose measurement principle before reviewing what is currently known regarding substance interference mechanisms and design approaches that may serve to reduce interfering effects. Points covered include the following: minimally invasive electrochemical CGMs, which may be classified by first-, second-, or third-generational design (these models are at risk of interference from electroactive substances, or substances that can interfere with the enzymatic biorecognition process); non-invasive fluid sampling CGMs, which draw glucose across the skin barrier but are similarly reliant on the electrochemical measurement of an enzymatic reaction product; and minimally invasive implantable CGMs, which exhibit different interfering substance behaviors to other CGM classes, using a non-enzyme-based glucose-recognition agent coupled to optical detection. An understanding of substance-interfering mechanisms allows consideration of the potential impact on clinical accuracy of substances that are routinely prescribed, can be purchased over the counter, or are new to market.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"1671-1683"},"PeriodicalIF":4.9,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12614895/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145488454","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Arianna Bresci, Youngkyu Kim, Miyeon Jue, Lorenza Pia Foglia, Elyse Moores, Peter T C So, Jeon Woong Kang
{"title":"Clinical Validation on Healthy Humans of a Portable Non-Invasive Continuous Glucose Monitor Based on Transdermal Band-Pass Raman Spectroscopy.","authors":"Arianna Bresci, Youngkyu Kim, Miyeon Jue, Lorenza Pia Foglia, Elyse Moores, Peter T C So, Jeon Woong Kang","doi":"10.1177/19322968261445056","DOIUrl":"10.1177/19322968261445056","url":null,"abstract":"<p><strong>Background: </strong>Accurate and painless glucose monitoring remains a major challenge in diabetes management. To address this need, we developed a compact, portable, and non-invasive continuous glucose monitoring (CGM) device based on transdermal band-pass Raman (BPR) spectroscopy intended for benchtop point-of-care use.</p><p><strong>Methods: </strong>The BPR-CGM optically probes the molecular vibrations of glucose in the interstitial fluid targeting only three ultra-narrow Raman bands to extract glucose concentration trends while compensating for background variations through intra-spectrum referencing. By refraining from collecting redundant full-spectrum information as in standard Raman spectroscopy, our technology overcomes the need for bulky and expensive components while maintaining high sensitivity, making point-of-care non-invasive CGM a reality.</p><p><strong>Results: </strong>A six-participant clinical study compared the non-invasive BPR-CGM with a standard blood glucometer and two commercial needle-based CGMs during a standard oral glucose tolerance test, inducing dynamic postprandial glucose variations. Glucose trends inferred by the BPR-CGM closely matched reference blood glucose values without algorithmic lag compensation. Across participants, the device achieved a mean absolute relative difference of 11.34 ± 1.96%, statistically indistinguishable from needle-based CGM sensors performance (10.42 ± 2.46% and 12.93 ± 4.69%). All BPR-CGM readings fell within clinically acceptable zones A and B of the Parkes (consensus) error grid. No adverse skin reactions were observed following the trial.</p><p><strong>Conclusions: </strong>These results demonstrate that the BPR-CGM technology can achieve clinical-grade accuracy comparable to invasive systems, paving the way for wearable, needle-free, and miniaturized glucose monitoring solutions.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"1504-1512"},"PeriodicalIF":4.9,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13132996/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147815788","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}