Journal of Diabetes Science and Technology最新文献

{"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}

{"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_1c (HbA_1c) 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_1c 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}

{"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}

{"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}

{"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}

{"title":"The Diabetes Technology Society Error Grid and Trend Accuracy Matrix for Glucose Monitors.","authors":"David C Klonoff, Guido Freckmann, Stefan Pleus, Boris P Kovatchev, David Kerr, Chui Cindy Tse, Chengdong Li, Michael S D Agus, Kathleen Dungan, Barbora Voglová Hagerf, Jan S Krouwer, Wei-An Andy Lee, Shivani Misra, Sang Youl Rhee, Ashutosh Sabharwal, Jane Jeffrie Seley, Viral N Shah, Nam K Tran, Kayo Waki, Chris Worth, Tiffany Tian, Rachel E Aaron, Keetan Rutledge, Cindy N Ho, Alessandra T Ayers, Amanda Adler, David T Ahn, Halis Kaan Aktürk, Mohammed E Al-Sofiani, Timothy S Bailey, Matt Baker, Lia Bally, Raveendhara R Bannuru, Elizabeth M Bauer, Yong Mong Bee, Julia E Blanchette, Eda Cengiz, James Geoffrey Chase, Kong Y Chen, Daniel Cherñavvsky, Mark Clements, Gerard L Cote, Ketan K Dhatariya, Andjela Drincic, Niels Ejskjaer, Juan Espinoza, Chiara Fabris, G Alexander Fleming, Monica A L Gabbay, Rodolfo J Galindo, Ana María Gómez-Medina, Lutz Heinemann, Norbert Hermanns, Thanh Hoang, Sufyan Hussain, Peter G Jacobs, Johan Jendle, Shashank R Joshi, Suneil K Koliwad, Rayhan A Lal, Lawrence A Leiter, Marcus Lind, Julia K Mader, Alberto Maran, Umesh Masharani, Nestoras Mathioudakis, Michael McShane, Chhavi Mehta, Sun-Joon Moon, James H Nichols, David N O'Neal, Francisco J Pasquel, Anne L Peters, Andreas Pfützner, Rodica Pop-Busui, Pratistha Ranjitkar, Connie M Rhee, David B Sacks, Signe Schmidt, Simon M Schwaighofer, Bin Sheng, Gregg D Simonson, Koji Sode, Elias K Spanakis, Nicole L Spartano, Guillermo E Umpierrez, Maryam Vareth, Hubert W Vesper, Jing Wang, Eugene Wright, Alan H B Wu, Sewagegn Yeshiwas, Mihail Zilbermint, Michael A Kohn","doi":"10.1177/19322968241275701","DOIUrl":"10.1177/19322968241275701","url":null,"abstract":"<p><strong>Introduction: </strong>An error grid compares measured versus reference glucose concentrations to assign clinical risk values to observed errors. Widely used error grids for blood glucose monitors (BGMs) have limited value because they do not also reflect clinical accuracy of continuous glucose monitors (CGMs).</p><p><strong>Methods: </strong>Diabetes Technology Society (DTS) convened 89 international experts in glucose monitoring to (1) smooth the borders of the Surveillance Error Grid (SEG) zones and create a user-friendly tool-the DTS Error Grid; (2) define five risk zones of clinical point accuracy (A-E) to be identical for BGMs and CGMs; (3) determine a relationship between DTS Error Grid percent in Zone A and mean absolute relative difference (MARD) from analyzing 22 BGM and nine CGM accuracy studies; and (4) create trend risk categories (1-5) for CGM trend accuracy.</p><p><strong>Results: </strong>The DTS Error Grid for point accuracy contains five risk zones (A-E) with straight-line borders that can be applied to both BGM and CGM accuracy data. In a data set combining point accuracy data from 18 BGMs, 2.6% of total data pairs equally moved from Zones A to B and vice versa (SEG compared with DTS Error Grid). For every 1% increase in percent data in Zone A, the MARD decreased by approximately 0.33%. We also created a DTS Trend Accuracy Matrix with five trend risk categories (1-5) for CGM-reported trend indicators compared with reference trends calculated from reference glucose.</p><p><strong>Conclusion: </strong>The DTS Error Grid combines contemporary clinician input regarding clinical point accuracy for BGMs and CGMs. The DTS Trend Accuracy Matrix assesses accuracy of CGM trend indicators.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"1346-1361"},"PeriodicalIF":4.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11531029/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142377877","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":"A Retrospective Cohort Study of Racial/Ethnic and Socioeconomic Disparities in Initiation and Meaningful Use of Continuous Glucose Monitoring Among Youth With Type 1 Diabetes.","authors":"Elise Schlissel Tremblay, Allison Bernique, Katherine Garvey, Christina M Astley","doi":"10.1177/19322968231183985","DOIUrl":"10.1177/19322968231183985","url":null,"abstract":"<p><strong>Background: </strong>Continuous glucose monitor (CGM) use improves type 1 diabetes (T1D) outcomes, yet children from diverse backgrounds and on public insurance have worse outcomes and lower CGM utilization. Using novel CGM data acquisition and analysis of two T1D cohorts, we test the hypothesis that T1D youth from different backgrounds experience disparities in meaningful CGM use following both T1D diagnosis and CGM uptake.</p><p><strong>Methods: </strong>Cohorts drawn from a pediatric T1D program were followed for one year beginning at diagnosis (<i>n</i> = 815, 2016-2020) or CGM uptake (<i>n</i> = 1392, 2015-2020). Using chart and CGM data, CGM start and meaningful use outcomes between racial/ethnic and insurance groups were compared using median days, one-year proportions, and survival analysis.</p><p><strong>Results: </strong>Publicly compared with privately insured were slower to start CGM (233, 151 days, <i>P</i> < .01), had fewer use-days in the year following uptake (232, 324, <i>P</i> < .001), and had faster first discontinuation rates (hazard ratio [HR] = 1.61, <i>P</i> < .001). Disparities were more pronounced among Hispanic and black compared with white subjects for CGM start time (312, 289, 149, <i>P</i> = .0013) and discontinuation rates (Hispanic HR = 2.17, <i>P</i> < .001; black HR = 1.45, <i>P</i> = .038), and remained even among privately insured (Hispanic/black HR = 1.44, <i>P</i> = .0286).</p><p><strong>Conclusions: </strong>Given the impact of insurance and race/ethnicity on CGM initiation and use, it is imperative that we target interventions to support universal access and sustained CGM use to mitigate the potential impact of provider biases and systemic disadvantage and racism. By enabling more equitable and meaningful T1D technology use, such interventions will begin to alleviate outcome disparities between youth with T1D from different backgrounds.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"1433-1444"},"PeriodicalIF":4.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11531052/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9795160","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":"Combining an Electrochemical Continuous Glucose Sensor With an Insulin Delivery Cannula: A Feasibility Study.","authors":"Cheng Yi Yuan, Bella Halim, Yee W Kong, Jean Lu, Ralph Dutt-Ballerstadt, Peter Eckenberg, Ken Hillen, Anh Koski, Vlad Milenkowic, Emma Netzer, Varuni Obeyesekere, Solomon Reid, Catriona Sims, Sara Vogrin, Huan-Ping Wu, Thomas Seidl, David N O'Neal","doi":"10.1177/19322968241236771","DOIUrl":"10.1177/19322968241236771","url":null,"abstract":"<p><strong>Background: </strong>Combining a continuous glucose monitor with an insulin delivery cannula (CGM-IS) could benefit clinical outcomes. We evaluated the feasibility of a single-needle insertion electrochemical investigational CGM-IS (Pacific Diabetes Technologies, Portland, Oregon) in type 1 diabetes adults.</p><p><strong>Methods: </strong>Following 48 hours run-in using a Medtronic 780G in manual mode with a commercial insulin set, 12 participants commenced insulin delivery using the CGM-IS. A standardized test meal was eaten on the mornings of days 1 and 4. Venous samples were collected every 10 minutes one hour prior to and 15 minutes post-meal for four hours. CGM-IS glucose measurements were post-processed with a single capillary blood calibration during warm-up and benchmarked against YSI. A Dexcom G6 sensor was worn post-consent to study end.</p><p><strong>Results: </strong>Mean absolute relative difference (MARD) for the CGM-IS glucose measurements was 9.2% (484 paired data points). Consensus error grid revealed 88.6% within zone A and 100% in A + B. Mean (SD) % bias was -3.5 (11.7) %. There were 35 paired YSI readings <100 mg/dL cutoff and 449 ≥100 mg/dL with 81.4% within ±15 mg/dL or ±15%, and 89.9% within ±20 mg/dL or ±20%. Two cannula occlusions required discontinuation of insulin delivery: one at 70 hours post insertion and another during the day 4 meal test. Mean (SD) Dexcom glucose measurements during run-in and between meal tests was respectively 161.3 ± 27.3 mg/dL versus 158.0 ± 25.6 mg/dL; <i>P</i> = .39 and corresponding mean total daily insulin delivered by the pump was 58.0 ± 25.4 Units versus 57.1 ± 28.8 Units; <i>P</i> = .47.</p><p><strong>Conclusions: </strong>Insulin delivery and glucose sensing with the investigational CGM-IS was feasible. Longer duration studies are needed.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"1273-1280"},"PeriodicalIF":4.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11535351/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140140277","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":"Device-Related Skin Reactions Increase Emotional Burden in Youths With Type 1 Diabetes and Their Parents.","authors":"Stefano Passanisi, Francesca Galletta, Bruno Bombaci, Valentino Cherubini, Valentina Tiberi, Nicola Minuto, Marta Bassi, Dario Iafusco, Alessia Piscopo, Enza Mozzillo, Francesca Di Candia, Ivana Rabbone, Erica Pozzi, Roberto Franceschi, Vittoria Cauvin, Claudio Maffeis, Claudia Anita Piona, Giuseppina Salzano","doi":"10.1177/19322968241253285","DOIUrl":"10.1177/19322968241253285","url":null,"abstract":"<p><strong>Background: </strong>Skin reactions due to technological devices pose a significant concern in the management of type 1 diabetes (T1D). This multicentric, comparative cross-sectional study aimed to assess the psychological impact of device-related skin issues on youths with T1D and their parents.</p><p><strong>Methods: </strong>Participants with skin reactions were matched in a 1:1 ratio with a control group. Diabetes-related emotional distress was evaluated using the Problem Areas in Diabetes-Teen version (PAID-T) for participants aged 11 to 19 years and the Problem Areas in Diabetes-Parent Revised version (PAID-PR) completed by parents. In addition, glucose control was assessed through glycated hemoglobin (HbA_1c) values and continuous glucose monitoring (CGM) metrics.</p><p><strong>Results: </strong>A total of 102 children and adolescents were consecutively recruited. Adolescents with skin issues had higher PAID-T scores compared to those without (79.6 ± 21.1 vs 62 ± 16.8; <i>P</i> = .004). Parents of youths with skin reactions also reported higher PAID-PR scores than the control group (34.0 ± 11.0 vs 26.9 ± 12.3; <i>P</i> = .015). No differences were observed in HbA_1c levels (6.9 ± 0.8% vs 6.8 ± 0.8%, <i>P</i> = .555) or CGM glucose metrics between the two groups. Remarkably, 25.5% were forced to discontinue insulin pumps and/or glucose sensors (21.5% and 5.9%, respectively).</p><p><strong>Conclusions: </strong>Our study highlighted the increased emotional burden experienced by youths with T1D and their parents due to device-related skin reactions, emphasizing the need for further research and interventions in this crucial aspect of diabetes management.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"1293-1299"},"PeriodicalIF":4.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11535255/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141158331","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":"Two-Way Crossover Phase 1 Bioequivalence and Safety Studies in Healthy Adults for a Ready-to-Use, Room-Temperature, Liquid-Stable Glucagon Administered by Autoinjector, Prefilled Syringe, or Vial and Syringe.","authors":"M Khaled Junaidi, Matthew R Krecic, Nicole C Close, Valentina Conoscenti","doi":"10.1177/19322968231179164","DOIUrl":"10.1177/19322968231179164","url":null,"abstract":"<p><strong>Objective: </strong>To demonstrate bioequivalence and safety for a ready-to-use room-temperature liquid-stable glucagon administered subcutaneously (SC) through a glucagon autoinjector (GAI) or a glucagon vial and syringe kit (GVS), versus a glucagon prefilled syringe (G-PFS).</p><p><strong>Methods: </strong>Healthy adults (N = 32) were randomly assigned to receive 1-mg glucagon as GAI or G-PFS, and then as the alternative three to seven days later. Other healthy adults (N = 40) were randomly assigned to receive 1-mg glucagon as GVS or G-PFS, and then as the alternative two days later. Samples for plasma glucagon were obtained through 240 minutes after glucagon injection. Bioequivalence was declared when the geometric mean estimate ratio of the area under-the-concentration-versus-time curve from 0 to 240 minutes (AUC_0-240) and maximum concentration (<i>C</i>_max) for plasma glucagon between treatment groups was contained within the bounds of 80% and 125%. Adverse events (AEs) were recorded.</p><p><strong>Results: </strong>The 90% confidence intervals (CIs) for AUC_0-240 and <i>C</i>_max geometric mean ratios for G-PFS to GAI and GVS to G-PFS were contained within the bounds 80% to 125% (G-PFS:GAI AUC_0-240 95.05%, 119.67% and <i>C</i>_max 88.01%, 120.24%; GVS:G-PFS AUC_0-240 87.39%, 100.66% and <i>C</i>_max 89.08%, 106.08%). At least one AE occurred in 15.6% (5/32) participants with GAI, 25% (18/72) with G-PFS, and 32.5% (13/40) with GVS. Sixty-nine of 73 (94.5%) AEs were mild, and none were serious. Nausea was the most common (33/73 [45%]).</p><p><strong>Conclusions: </strong>Bioequivalence and safety were established after 1 mg of this ready-to-use room-temperature liquid-stable glucagon, administered SC to healthy adults, by autoinjector, prefilled syringe, or vial and syringe kit.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"1399-1407"},"PeriodicalIF":4.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11529056/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9593120","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}