Journal of Diabetes Science and Technology最新文献

{"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":null,"pages":null},"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}

{"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":null,"pages":null},"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":null,"pages":null},"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":null,"pages":null},"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":"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":null,"pages":null},"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}

{"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":null,"pages":null},"PeriodicalIF":4.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140140277","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","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":null,"pages":null},"PeriodicalIF":4.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141158331","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","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":null,"pages":null},"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":"Automated Insulin Delivery for Pregnant Women With Type 1 Diabetes: Where Do We Stand?","authors":"Katrien Benhalima, Johan Jendle, Kaat Beunen, Lene Ringholm","doi":"10.1177/19322968231223934","DOIUrl":"10.1177/19322968231223934","url":null,"abstract":"<p><p>Automated insulin delivery (AID) systems mimic an artificial pancreas via a predictive algorithm integrated with continuous glucose monitoring (CGM) and an insulin pump, thereby providing AID. Outside of pregnancy, AID has led to a paradigm shift in the management of people with type 1 diabetes (T1D), leading to improvements in glycemic control with lower risk for hypoglycemia and improved quality of life. As the use of AID in clinical practice is increasing, the number of women of reproductive age becoming pregnant while using AID is also expected to increase. The requirement for lower glucose targets than outside of pregnancy and for frequent adjustments of insulin doses during pregnancy may impact the effectiveness and safety of AID when using algorithms for non-pregnant populations with T1D. Currently, the CamAPS^® FX is the only AID approved for use in pregnancy. A recent randomized controlled trial (RCT) with CamAPS^® FX demonstrated a 10% increase in time in range in a pregnant population with T1D and a baseline glycated hemoglobin (HbA1c) ≥ 48 mmol/mol (6.5%). Off-label use of AID not approved for pregnancy are currently also being evaluated in ongoing RCTs. More evidence is needed on the impact of AID on maternal and neonatal outcomes. We review the current evidence on the use of AID in pregnancy and provide an overview of the completed and ongoing RCTs evaluating AID in pregnancy. In addition, we discuss the advantages and challenges of the use of current AID in pregnancy and future directions for research.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":null,"pages":null},"PeriodicalIF":4.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139403113","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety and Feasibility Evaluation of Automated User Profile Settings Initialization and Adaptation With Control-IQ Technology.","authors":"Viral N Shah, Halis K Akturk, Alex Trahan, Nicole Piquette, Alex Wheatcroft, Elain Schertz, Karen Carmello, Lars Mueller, Kirstin White, Larry Fu, Ravid Sassan-Katchalski, Laurel H Messer, Steph Habif, Alex Constantin, Jordan E Pinsker","doi":"10.1177/19322968241229074","DOIUrl":"10.1177/19322968241229074","url":null,"abstract":"<p><strong>Background: </strong>Optimization of automated insulin delivery (AID) settings is required to achieve desirable glycemic outcomes. We evaluated safety and efficacy of a computerized system to initialize and adjust insulin delivery settings for the t:slim X2 insulin pump with Control-IQ technology in adults with type 1 diabetes (T1D).</p><p><strong>Methods: </strong>After a 2-week continuous glucose monitoring (CGM) run-in period, adults with T1D using multiple daily injections (MDI) (N = 33, mean age 36.1 years, 57.6% female, diabetes duration 19.7 years) were transitioned to 13 weeks of Control-IQ technology usage. A computerized algorithm generated recommendations for initial pump settings (basal rate, insulin-to-carbohydrate ratio, and correction factor) and weekly follow-up settings to optimize glycemic outcomes. Physicians could override the automated settings changes for safety concerns.</p><p><strong>Results: </strong>Time in range 70 to 180 mg/dL improved from 45.7% during run-in to 69.1% during the last 30 days of Control-IQ use, a median improvement of 18.8% (95% confidence interval [CI]: 13.6-23.9, <i>P</i> < .001). This improvement was evident early in the study and was sustained over 13 weeks. Time <70 mg/dL showed a gradual decreasing trend over time. Percentage of participants achieving HbA1c <7% went from zero at baseline to 55% at study end (<i>P</i> < .001). Only six of the 318 automated settings adaptations (1.9%) were overridden by study investigators.</p><p><strong>Conclusions: </strong>Computerized initiation and adaptation of Control-IQ technology settings from baseline MDI therapy was safe in adults with T1D. The use of this simplified system for onboarding and optimizing Control-IQ technology may be useful to increase uptake of AID and reduce staff and patient burden in clinical care.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":null,"pages":null},"PeriodicalIF":4.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139697626","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}