Peter Adolfsson, Ragnar Hanas, Dessi P Zaharieva, Klemen Dovc, Johan Jendle
{"title":"Automated Insulin Delivery Systems in Pediatric Type 1 Diabetes: A Narrative Review.","authors":"Peter Adolfsson, Ragnar Hanas, Dessi P Zaharieva, Klemen Dovc, Johan Jendle","doi":"10.1177/19322968241248404","DOIUrl":"10.1177/19322968241248404","url":null,"abstract":"<p><p>This narrative review assesses the use of automated insulin delivery (AID) systems in managing persons with type 1 diabetes (PWD) in the pediatric population. It outlines current research, the differences between various AID systems currently on the market and the challenges faced, and discusses potential opportunities for further advancements within this field. Furthermore, the narrative review includes various expert opinions on how different AID systems can be used in the event of challenges with rapidly changing insulin requirements. These include examples, such as during illness with increased or decreased insulin requirements and during physical activity of different intensities or durations. Case descriptions give examples of scenarios with added user-initiated actions depending on the type of AID system used. The authors also discuss how another AID system could have been used in these situations.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"1324-1333"},"PeriodicalIF":4.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11535396/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141087624","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}
Laura Beate von Kobyletzki, Josefin Ulriksdotter, Elisa von Kobyletzki, Martin Mowitz, Johan Jendle, Cecilia Svedman
{"title":"Insulin Pump Therapy and Adverse Skin Reactions With Focus on Allergic Contact Dermatitis in Individuals Living With Diabetes Mellitus: A Systematic Review and Clinical-Based Update.","authors":"Laura Beate von Kobyletzki, Josefin Ulriksdotter, Elisa von Kobyletzki, Martin Mowitz, Johan Jendle, Cecilia Svedman","doi":"10.1177/19322968241252613","DOIUrl":"10.1177/19322968241252613","url":null,"abstract":"<p><strong>Background: </strong>The use of insulin pumps (continuous subcutaneous insulin infusion [CSII]) in individuals living with type 1 diabetes (T1D) improves disease control. However, adverse skin reactions may hamper compliance. We aimed to assess the relationship of insulin pumps, particularly that of infusion set therapy, used in children and adults with T1D and dermatitis including allergic contact dermatitis (ACD).</p><p><strong>Methods: </strong>A systematic search of PubMed, and EMBASE, of full-text studies reporting dermatitis in persons with diabetes using a CSII was conducted from 2020 to 2023. The Newcastle-Ottawa Scale was used to assess study quality. The inventory performed at the Department of Occupational and Environmental Dermatology, Malmö, Sweden (YMDA) was also performed highlighting the diagnostic process.</p><p><strong>Results: </strong>Among the 391 screened abstracts, 21 studies fulfilled the inclusion criteria. Seven studies included data on children only, four studies were on adults, and nine studies reported data on both children and adults. Participants were exposed to a broad range of pumps. Dermatitis was rarely specified. Up to 60% of those referred to a university hospital due to skin reactions possibly related to insulin pumps had an ACD.</p><p><strong>Conclusions: </strong>The review and our findings indicate that there is not sufficient focus on contact allergy in the primary toxicological evaluations of substances used also for insulin pump therapy products and that possible adverse skin reactions are not correctly followed up in the clinical setting.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"1300-1312"},"PeriodicalIF":4.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11535278/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141296148","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}
Frank Dong, Paul Johnson, Grant Fong, Alex Nguyen, Felipe Lauand, Todd Vienneau
{"title":"Impact of X-Ray Exposure From Computed Tomography on Wearable Insulin Delivery Devices.","authors":"Frank Dong, Paul Johnson, Grant Fong, Alex Nguyen, Felipe Lauand, Todd Vienneau","doi":"10.1177/19322968231169722","DOIUrl":"10.1177/19322968231169722","url":null,"abstract":"<p><strong>Background: </strong>To investigate the impact of radiation exposure from a computed tomography (CT) scanner on the functional integrity of a wearable insulin delivery system.</p><p><strong>Methods: </strong>A total of 160 Omnipods and four personal diabetes managers (PDMs) were evenly divided into four groups: (1) control group (no radiation exposure), (2) typical radiation exposure group, (3) 4× typical radiation exposure group, and (4) scatter radiation group. Pods were attached to an anthropomorphic torso phantom on the abdomen (direct irradiation) or shoulder (scatter radiation) region. A third-generation dual-source CT scanner was used to scan the pods using either a typical exposure (used for routine CT abdominal study of a median size patient) or 4× typical exposure. A manufacturer-recommended 20-step functionality test was performed for all 160 Omnipods.</p><p><strong>Results: </strong>The radiation dose (measured in volume CT Dose index) was 16 mGy for a typical exposure, and 64 mGy for 4× typical exposure. The scatter radiation is less than 0.1 mGy. All Pods passed the functionality test except one pod in the scatter radiation group, which sounded an alarm due to occlusion. The blockage to the fluid was due to a kink in the soft cannula, a mechanical issue not caused by the radiation exposure.</p><p><strong>Conclusions: </strong>This study suggests X-ray exposure levels used in radiological imaging procedures do not negatively impact the functional integrity of Omnipods. This finding may support the potential for the manufacturer to remove the warning that patients should remove the Pod for X-ray imaging procedures, which will have a huge impact on patient care.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"1387-1391"},"PeriodicalIF":4.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11528719/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9703964","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}
Jean C Lu, Petrova Lee, Francesco Ierino, Richard J MacIsaac, Elif Ekinci, David O'Neal
{"title":"Challenges of Glycemic Control in People With Diabetes and Advanced Kidney Disease and the Potential of Automated Insulin Delivery.","authors":"Jean C Lu, Petrova Lee, Francesco Ierino, Richard J MacIsaac, Elif Ekinci, David O'Neal","doi":"10.1177/19322968231174040","DOIUrl":"10.1177/19322968231174040","url":null,"abstract":"<p><p>Diabetes is the leading cause of chronic kidney disease (CKD) and end-stage kidney disease in the world. It is known that maintaining optimal glycemic control can slow the progression of CKD. However, the failing kidney impacts glucose and insulin metabolism and contributes to increased glucose variability. Conventional methods of insulin delivery are not well equipped to adapt to this increased glycemic lability. Automated insulin delivery (AID) has been established as an effective treatment in patients with type 1 diabetes mellitus, and there is emerging evidence for their use in type 2 diabetes mellitus. However, few studies have examined their role in diabetes with concurrent advanced CKD. We discuss the potential benefits and challenges of AID use in patients with diabetes and advanced CKD, including those on dialysis.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"1500-1508"},"PeriodicalIF":4.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11531035/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9438896","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 Importance of Fructosamine for Monitoring the Compensation and Effectiveness of Diabetes Treatment.","authors":"Natalya Akhetova, Zhangentkhan Abylaiuly, Svetlana Bolshakova","doi":"10.1177/19322968231174921","DOIUrl":"10.1177/19322968231174921","url":null,"abstract":"<p><strong>Background: </strong>The use of fructosamine to assess the glycemic control represents a new step in diagnostics, and it has been accompanied by the active scientific discussion in recent years. That is why the purpose of this work is to study the average level of fructosamine in apparently healthy individuals and individuals with diabetes mellitus (DM), as well as the possibility to use it when evaluating the effectiveness of inpatient treatment of patients with hyperglycemia on the seven to ten days of hospitalization.</p><p><strong>Methods: </strong>This research work was carried out in Alma-Ata, Republic of Kazakhstan, based on the endocrinology department in the period from 2020 to 2022. The work consists of a retrospective analysis of previously examined patients and a prospective stage. The statistical evaluation was carried out with the calculation of reliability coefficient, confidence interval, and criteria for testing for normality. The level of fructosamine in healthy individuals in the corresponding region was analyzed in this article for the first time, and the correlation between this indicator and the level of glycated hemoglobin was found.</p><p><strong>Results: </strong>The effectiveness of treatment of the Type 2 DM (according to the treatment protocol) has also been studied in stationary conditions for the seven to ten days, which makes it possible to judge the effectiveness of the prescribed therapy.</p><p><strong>Conclusions: </strong>These results will allow identifying the irrationality of the prescribed therapy at an early stage, which is especially important for the correct management of patients with this pathology, and minimizing the possible complications.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"1377-1386"},"PeriodicalIF":4.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11531054/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9571177","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}
Susan Kohl Malone, Austin M Matus, Anneliese J Flatt, Amy J Peleckis, Laura Grunin, Gary Yu, Sooyong Jang, James Weimer, Insup Lee, Michael R Rickels, Namni Goel
{"title":"Prolonged Use of an Automated Insulin Delivery System Improves Sleep in Long-Standing Type 1 Diabetes Complicated by Impaired Awareness of Hypoglycemia.","authors":"Susan Kohl Malone, Austin M Matus, Anneliese J Flatt, Amy J Peleckis, Laura Grunin, Gary Yu, Sooyong Jang, James Weimer, Insup Lee, Michael R Rickels, Namni Goel","doi":"10.1177/19322968231182406","DOIUrl":"10.1177/19322968231182406","url":null,"abstract":"<p><strong>Background: </strong>This study assessed changes in actigraphy-estimated sleep and glycemic outcomes after initiating automated insulin delivery (AID).</p><p><strong>Methods: </strong>Ten adults with long-standing type 1 diabetes and impaired awareness of hypoglycemia (IAH) participated in an 18-month clinical trial assessing an AID intervention on hypoglycemia and counter-regulatory mechanisms. Data from eight participants (median age = 58 years) with concurrent wrist actigraph and continuous glucose monitoring (CGM) data were used in the present analyses. Actigraphs and CGM measured sleep and glycemic control at baseline (one week) and months 3, 6, 9, 12, 15, and 18 (three weeks) following AID initiation. HypoCount software integrated actigraphy with CGM data to separate wake and sleep-associated glycemic measures. Paired sample <i>t</i>-tests and Cohen's <i>d</i> effect sizes modeled changes and their magnitude in sleep, glycemic control, IAH (Clarke score), hypoglycemia severity (HYPO score), hypoglycemia exposure (CGM), and glycemic variability (lability index [LI]; CGM coefficient-of-variation [CV]) from baseline to 18 months.</p><p><strong>Results: </strong>Sleep improved from baseline to 18 months (shorter sleep latency [<i>P</i> < .05, <i>d</i> = 1.74], later sleep offset [<i>P</i> < .05, <i>d</i> = 0.90], less wake after sleep onset [<i>P</i> < .01, <i>d</i> = 1.43]). Later sleep onset (<i>d</i> = 0.74) and sleep midpoint (<i>d</i> = 0.77) showed medium effect sizes. Sleep improvements were evident from 12 to 15 months after AID initiation and were preceded by improved hypoglycemia awareness (Clarke score [<i>d</i> = 1.18]), reduced hypoglycemia severity (HYPO score [<i>d</i> = 2.13]), reduced sleep-associated hypoglycemia (percent time glucose was < 54 mg/dL, < 60 mg/dL,< 70 mg/dL; <i>d</i> = 0.66-0.81), and reduced glucose variability (LI, <i>d</i> = 0.86; CV, <i>d</i> = 0.62).</p><p><strong>Conclusion: </strong>AID improved sleep initiation and maintenance. Improved awareness of hypoglycemia, reduced hypoglycemia severity, hypoglycemia exposure, and glucose variability preceded sleep improvements.This trial is registered with ClinicalTrials.gov NCT03215914 https://clinicaltrials.gov/ct2/show/NCT03215914.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"1416-1423"},"PeriodicalIF":4.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11528733/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10065590","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}
Anders L Carlson, Timothy E Graham, Halis K Akturk, David R Liljenquist, Richard M Bergenstal, Becky Sulik, Viral N Shah, Mark Sulik, Peter Zhao, Peter Briggs, Ravid Sassan-Katchalski, Jordan E Pinsker
{"title":"Control-IQ Technology Use in Individuals With High Insulin Requirements: Results From the Multicenter Higher-IQ Trial.","authors":"Anders L Carlson, Timothy E Graham, Halis K Akturk, David R Liljenquist, Richard M Bergenstal, Becky Sulik, Viral N Shah, Mark Sulik, Peter Zhao, Peter Briggs, Ravid Sassan-Katchalski, Jordan E Pinsker","doi":"10.1177/19322968241234072","DOIUrl":"10.1177/19322968241234072","url":null,"abstract":"<p><strong>Background: </strong>Control-IQ technology version 1.5 allows for a wider range of weight and total daily insulin (TDI) entry, in addition to other changes to enhance performance for users with high basal rates. This study evaluated the safety and performance of the updated Control-IQ system for users with basal rates >3 units/h and high TDI in a multicenter, single arm, prospective study.</p><p><strong>Methods: </strong>Adults with type 1 diabetes (T1D) using continuous subcutaneous insulin infusion (CSII) and at least one basal rate over 3 units/h (N = 34, mean age = 39.9 years, 41.2% female, diabetes duration = 21.8 years) used the t:slim X2 insulin pump with Control-IQ technology version 1.5 for 13 weeks. Primary outcome was safety events (severe hypoglycemia and diabetic ketoacidosis (DKA)). Central laboratory hemoglobin A<sub>1c</sub> (HbA<sub>1c</sub>) was measured at system initiation and 13 weeks. Participants continued using glucagon-like peptide-1 (GLP-1) receptor agonists, sodium-glucose transport protein 2 (SGLT-2) inhibitors, or other medications for glycemic control and/or weight loss if on a stable dose.</p><p><strong>Results: </strong>All 34 participants completed the study. Fifteen participants used a basal rate >3 units/h for all 24 hours of the day. Nine participants used >300 units TDI on at least one day during the study. There were no severe hypoglycemia or DKA events. Time in range 70-180 mg/dL was 64.8% over the 13 weeks, with 1.0% time <70 mg/dL. Hemoglobin A<sub>1c</sub> decreased from 7.69% at baseline to 6.87% at 13 weeks (-0.82%, <i>P</i> < .001).</p><p><strong>Conclusions: </strong>Control-IQ technology version 1.5, with wider range of weight and TDI input and enhancements for users with high insulin requirements, was safe in individuals with T1D in this study.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"1288-1292"},"PeriodicalIF":4.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11535359/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140028137","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}
Mihail Zilbermint, Jordan Messler, Camille Frances Stanback, Kristen Kulasa, Andrew P Demidowich
{"title":"Bridging the Glycemic Gap: Will CMS-Mandated Reporting Improve Hospital Dysglycemia Management?","authors":"Mihail Zilbermint, Jordan Messler, Camille Frances Stanback, Kristen Kulasa, Andrew P Demidowich","doi":"10.1177/19322968241279278","DOIUrl":"10.1177/19322968241279278","url":null,"abstract":"","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"1521-1522"},"PeriodicalIF":4.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11528722/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142119972","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}
David C Klonoff, Alessandra T Ayers, Cindy N Ho, Chiara Fabris, María Fernanda Villa-Tamayo, Eleanor Allen, Eda Cengiz, Laya Ekhlaspour, Jenise C Wong, Lutz Heineman, Michael A Kohn
{"title":"Time to Moderate and Severe Hyperglycemia and Ketonemia Following an Insulin Pump Occlusion.","authors":"David C Klonoff, Alessandra T Ayers, Cindy N Ho, Chiara Fabris, María Fernanda Villa-Tamayo, Eleanor Allen, Eda Cengiz, Laya Ekhlaspour, Jenise C Wong, Lutz Heineman, Michael A Kohn","doi":"10.1177/19322968241280386","DOIUrl":"10.1177/19322968241280386","url":null,"abstract":"<p><strong>Introduction: </strong>Insulin pump therapy can be adversely affected by interruption of insulin flow, leading to a rise in blood glucose (BG) and subsequently of blood beta-hydroxybutyrate (BHB) ketone levels.</p><p><strong>Methods: </strong>We performed a PubMed search for English language reports (January 1982 to July 2024) estimating the rate of rise in BG and/or BHB after ≥ 60 minutes of interruption of continuous subcutaneous insulin infusion (CSII) in persons with type 1 diabetes (PwT1D). We also simulated the rise in BG in a virtual population of 100 adults with T1D following suspension of continuous subcutaneous insulin infusion.</p><p><strong>Results: </strong>We identified eight relevant studies where BG and BHB (seven of these eight studies) were measured following suspension of CSII as a model for occlusion. After 60 minutes post-suspension, the mean extracted rates of rise averaged 0.62 mg/dL/min (37 mg/dL/h) for BG and 0.0038 mmol/L/min (0.20 mmol/L/h) for BHB. Mean estimated time to moderately/severely elevated BG (300/400 mg/dL) or BHB (1.6/3.0 mmol/L) was, respectively, 5.8/8.5 and 8.0/14.2 hours. The simulation model predicted moderately/severely elevated BG (300/400 mg/dL) after 9.25/12, 6.75/8.75, and 4.75/5.75 hours in the virtual subjects post-interruption with small (5th percentile), medium (50th percentile), and large (95th percentile) hyperglycemic changes.</p><p><strong>Discussion: </strong>Clinical studies and a simulation model similarly predicted that, following CSII interruption, moderate/severe hyperglycemia can occur within 5-9/6-14 hours, and clinical studies predicted that moderate/severe ketonemia can occur within 7-12/13-21 hours. Patients and clinicians should be aware of this timing when considering the risks of developing metabolic complications after insulin pump occlusion.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"1472-1479"},"PeriodicalIF":4.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11531023/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142140183","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}
Consuelo Handy, Mohamed Sabih Chaudhry, Muhammad Rafaqat Ali Qureshi, Bradley Love, John Shillingford, Leona Plum-Mörschel, Eric Zijlstra
{"title":"Noninvasive Continuous Glucose Monitoring With a Novel Wearable Dial Resonating Sensor: A Clinical Proof-of-Concept Study.","authors":"Consuelo Handy, Mohamed Sabih Chaudhry, Muhammad Rafaqat Ali Qureshi, Bradley Love, John Shillingford, Leona Plum-Mörschel, Eric Zijlstra","doi":"10.1177/19322968231170242","DOIUrl":"10.1177/19322968231170242","url":null,"abstract":"<p><strong>Background: </strong>A noninvasive, wearable continuous glucose monitor would be a major advancement in diabetes therapy. This trial investigated a novel noninvasive glucose monitor which analyzes spectral variations in radio frequency/microwave signals reflected from the wrist.</p><p><strong>Methods: </strong>A single-arm, open-label, experimental study compared glucose values from a prototype investigational device with laboratory glucose measurements from venous blood samples (Super GL Glucose Analyzer, Dr. Müller Gerätebau GmbH) at varying levels of glycemia. The study included 29 male participants with type 1 diabetes (age range = 19-56 years). The study comprised three stages with the following aims: (1) demonstrate initial proof-of-principle, (2) test an improved device design, and (3) test performance on two consecutive days without device recalibration. The co-primary endpoints in all trial stages were median and mean absolute relative difference (ARD) calculated across all data points.</p><p><strong>Results: </strong>In stage 1, the median and mean ARDs were 30% and 46%, respectively. Stage 2 produced marked performance improvements with a median and mean ARD of 22% and 28%, respectively. Stage 3 showed that, without recalibration, the device performed as well as the initial prototype (stage 1) with a median and mean ARD of 35% and 44%, respectively.</p><p><strong>Conclusion: </strong>This proof-of-concept study shows that a novel noninvasive continuous glucose monitor was capable of detecting glucose levels. Furthermore, the ARD results are comparable to first models of commercially available minimally invasive products without the need to insert a needle. The prototype has been further developed and is being tested in subsequent studies.</p><p><strong>Trial registration number: </strong>NCT05023798.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"1408-1415"},"PeriodicalIF":4.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11529082/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9409527","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}