Diabetes technology & therapeutics最新文献

{"title":"Online Classification of Unstructured Free-Living Exercise Sessions in People with Type 1 Diabetes.","authors":"Emilia Fushimi, Eleonora M Aiello, Sunghyun Cho, Michael C Riddell, Robin L Gal, Corby K Martin, Susana R Patton, Michael R Rickels, Francis J Doyle","doi":"10.1089/dia.2023.0528","DOIUrl":"10.1089/dia.2023.0528","url":null,"abstract":"<p><p><b><i>Background:</i></b> Managing exercise in type 1 diabetes is challenging, in part, because different types of exercises can have diverging effects on glycemia. The aim of this work was to develop a classification model that can classify an exercise event (structured or unstructured) as aerobic, interval, or resistance for the purpose of incorporation into an automated insulin delivery (AID) system. <b><i>Methods:</i></b> A long short-term memory network model was developed with real-world data from 30-min structured sessions of at-home exercise (aerobic, resistance, or mixed) using triaxial accelerometer, heart rate, and activity duration information. The detection algorithm was used to classify 15 common free-living and unstructured activities and relate each to exercise-associated change in glucose. <b><i>Results:</i></b> A total of 1610 structured exercise sessions were used to train, validate, and test the model. The accuracy for the structured exercise sessions in the testing set was 72% for <i>aerobic</i>, 65% for <i>interval</i>, and 77% for <i>resistance</i>. In addition, we tested the classifier on 3328 unstructured sessions. We validated the session-associated change in glucose against the expected change during exercise for each type. Mean and standard deviation of the change in glucose of -20.8 (40.3) mg/dL were achieved for sessions classified as <i>aerobic</i>, -16.2 (39.0) mg/dL for sessions classified as <i>interval</i>, and -11.6 (38.8) mg/dL for sessions classified as <i>resistance</i>. <b><i>Conclusions:</i></b> The proposed algorithm reliably identified physical activity associated with expected change in glucose, which could be integrated into an AID system to manage the exercise disturbance in glycemia according to the predicted class.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":null,"pages":null},"PeriodicalIF":5.4,"publicationDate":"2024-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139989517","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Predicting Hypoglycemia and Hyperglycemia Risk During and After Activity for Adolescents with Type 1 Diabetes.","authors":"Simon Bergford, Michael C Riddell, Robin L Gal, Susana R Patton, Mark A Clements, Jennifer L Sherr, Peter Calhoun","doi":"10.1089/dia.2024.0061","DOIUrl":"10.1089/dia.2024.0061","url":null,"abstract":"<p><p><b><i>Objective:</i></b> To predict hypoglycemia and hyperglycemia risk during and after activity for adolescents with type 1 diabetes (T1D) using real-world data from the Type 1 Diabetes Exercise Initiative Pediatric (T1DEXIP) study. <b><i>Methods:</i></b> Adolescents with T1D (<i>n</i> = 225; [mean ± SD] age = 14 ± 2 years; HbA1c = 7.1 ± 1.3%; T1D duration = 5 ± 4 years; 56% using hybrid closed loop), wearing continuous glucose monitors (CGMs), logged 3738 total activities over 10 days. Repeated Measures Random Forest (RMRF) and Repeated Measures Logistic Regression (RMLR) models were used to predict a composite risk of hypoglycemia (<70 mg/dL) and hyperglycemia (>250 mg/dL) within 2 h after starting exercise. <b><i>Results:</i></b> RMRF achieved high precision predicting composite risk and was more accurate than RMLR Area under the receiver operating characteristic curve (AUROC 0.737 vs. 0.661; <i>P</i> < 0.001). Activities with minimal composite risk had a starting glucose between 132 and 160 mg/dL and a glucose rate of change at activity start between -0.4 and -1.9 mg/dL/min. Time <70 mg/dL and time >250 mg/dL during the prior 24 h, HbA1c level, and insulin on board at activity start were also predictive. Separate models explored factors at the end of activity; activities with glucose between 128 and 133 mg/dL and glucose rate of change between 0.4 and -0.6 mg/dL/min had minimal composite risk. <b><i>Conclusions:</i></b> Physically active adolescents with T1D should aim to start exercise with an interstitial glucose between 130 and 160 mg/dL with a flat or slightly decreasing CGM trend to minimize risk for developing dysglycemia. Incorporating factors such as historical glucose and insulin can improve prediction modeling for the acute glucose responses to exercise.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":null,"pages":null},"PeriodicalIF":5.4,"publicationDate":"2024-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140848072","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Point-Counterpoint: The Need for Do-It-Yourself (DIY) Open Source (OS) AID Systems in Type 1 Diabetes Management.","authors":"Gregory P Forlenza, Ideen Tabatabai, Dana M Lewis","doi":"10.1089/dia.2024.0073","DOIUrl":"10.1089/dia.2024.0073","url":null,"abstract":"<p><p>In the last decade, technology developed by people with diabetes and their loved ones has added to the options for diabetes management. One such example is that of automated insulin delivery (AID) algorithms, which were created and shared as open source by people living with type 1 diabetes (T1D) years before commercial systems were first available. Now, numerous options for commercial systems exist in some countries, yet tens of thousands of people with diabetes are still choosing Open-Source AID (OS-AID), previously called \"do-it-yourself\" (DIY) systems, which are noncommercial versions of these open-source AID systems. In this article, we provide point and counterpoint perspectives regarding (1) safety and efficacy, (2) regulation and support, (3) user choice and flexibility, (4) access and affordability, and (5) patient and provider education, for open source and commercial AID systems. The perspectives reflected here include that of a person living with T1D who uses and has developed OS-AID systems, a physician-researcher based in the United States who conducts clinical trials to support development of commercial AID systems and supports people with diabetes using all types of AID, and an endocrinologist with T1D who uses both systems and treats people with diabetes using all types of AID.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":null,"pages":null},"PeriodicalIF":5.4,"publicationDate":"2024-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140862491","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Potential Impact of Continuous Glucose Monitoring Use on Diabetes-Related Attitudes and Behaviors in Adults with Type 2 Diabetes: A Qualitative Investigation of the Patient Experience.","authors":"Taylor L Clark, William H Polonsky, Emily C Soriano","doi":"10.1089/dia.2023.0612","DOIUrl":"10.1089/dia.2023.0612","url":null,"abstract":"<p><p><b><i>Background:</i></b> Despite the known glycemic benefits of continuous glucose monitoring (CGM) for adults with type 2 diabetes (T2D), the attitudinal and behavioral changes underlying these glycemic improvements remain understudied. This study aimed to qualitatively explore these changes among a sample of adults with T2D. <b><i>Methods:</i></b> In-depth, semistructured interviews were conducted with adults with T2D who had been using CGM for 3-6 months as part of a larger community project in Ohio. Thematic analysis was used to identify themes across participants' experiences. <b><i>Results:</i></b> A total of 34 participants provided insights into their experiences with CGM. Six primary themes emerged: (1) Making the Invisible Visible, highlighting the newfound awareness of T2D in daily life. (2) Effective Decision-Making, emphasizing the use of real-time glucose data for immediate and long-term choices. (3) Enhanced Self-Efficacy, describing a renewed sense of control and motivation. (4) Diabetes-Related Diet Modifications. (5) Changes in Physical Activity. (6) Changes in Medication Taking. <b><i>Conclusions:</i></b> Participants reported a far-reaching impact of CGM on their daily lives, with many stating that CGM fostered a greater understanding of diabetes and prompted positive behavior changes. The observed attitudinal and behavioral shifts likely contributed synergistically to the significant glycemic benefits observed over the study period. This study highlights the technology's potential to bring about meaningful attitudinal and behavioral changes.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":null,"pages":null},"PeriodicalIF":5.4,"publicationDate":"2024-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140206476","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Relationship Between Lipohypertrophy, Glycemic Control, and Insulin Dosing: A Systematic Meta-Analysis.","authors":"Julia K Mader, Ricardo Fornengo, Ahmed Hassoun, Lutz Heinemann, Bernhard Kulzer, Magdalena Monica, Trung Nguyen, Jochen Sieber, Eric Renard, Yves Reznik, Przemysław Ryś, Anita Stożek-Tutro, Emma G Wilmot","doi":"10.1089/dia.2023.0491","DOIUrl":"10.1089/dia.2023.0491","url":null,"abstract":"<p><p><b><i>Background:</i></b> Lipohypertrophy is a common complication in patients with diabetes receiving insulin therapy. There is a lack of consensus regarding how much lipohypertrophy affects diabetes management. Our study aimed to assess the potential correlation between lipohypertrophy and glycemic control, as well as insulin dosing in patients with diabetes. <b><i>Methods:</i></b> We performed a systematic review followed by a meta-analysis to collect data about glycemic control and insulin dosing in diabetic patients with and without lipohypertrophy. To identify relevant studies published in English, we searched medical databases (MEDLINE/PubMed, Embase, and CENTRAL) from 1990 to January 20, 2023. An additional hand-search of references was performed to retrieve publications not indexed in medical databases. Results of meta-analyses were presented either as prevalence odds ratios (pORs) or mean differences (MDs) with 95% confidence intervals (95% CIs). This study was registered on PROSPERO (CRD42023393103). <b><i>Results:</i></b> Of the 5540 records and 240 full-text articles screened, 37 studies fulfilled the prespecified inclusion criteria. Performed meta-analyses showed that patients with lipohypertrophy compared with those without lipohypertrophy were more likely to experience unexplained hypoglycemia (pOR [95% CI] = 6.98 [3.30-14.77]), overall hypoglycemia (pOR [95% CI] = 6.65 [1.37-32.36]), and glycemic variability (pOR [95% CI] = 5.24 [2.68-10.23]). Patients with lipohypertrophy also had higher HbA1c (MD [95% CI] = 0.55 [0.23-0.87] %), and increased daily insulin consumption (MD [95% CI] = 7.68 IU [5.31-10.06]). <b><i>Conclusions:</i></b> These results suggest that overall glycemic control is worse in patients with lipohypertrophy than in those without this condition.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":null,"pages":null},"PeriodicalIF":5.4,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11058417/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139431962","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Continuous Glucose Monitoring Alarms in Adults with Type 1 Diabetes: User Characteristics and the Impact of Hypoglycemia and Hyperglycemia Alarm Thresholds on Glycemic Control.","authors":"Tomás González-Vidal, Diego Rivas-Otero, Pablo Agüeria-Cabal, Guillermo Ramos-Ruiz, Elías Delgado, Edelmiro Menéndez-Torre","doi":"10.1089/dia.2023.0460","DOIUrl":"10.1089/dia.2023.0460","url":null,"abstract":"<p><p><b><i>Background:</i></b> Few studies have evaluated the implications of the alarm thresholds of continuous glucose monitoring (CGM) systems for individuals with diabetes. The present study aimed to investigate the influence of hypoglycemia and hyperglycemia alarm thresholds on glycemic control in adults with type 1 diabetes (T1DM) and the characteristics of patients who use these alarms more frequently. <b><i>Methods:</i></b> This observational cross-sectional study included 873 users of the <i>FreeStyle Libre 2</i> system (501 men, median age 48 years, range 18-90 years) with T1DM from a single center. We investigated the role of demographic and metabolic factors on the use of alarms and the impact of hypoglycemia and hyperglycemia alarms and their thresholds on glycemic control. <b><i>Results:</i></b> Alarm users were older than nonusers (median age 49 vs. 43 years, respectively; <i>P</i> < 0.001). The hypoglycemia alarms were set by 76.1% of women and by 69.1% of men (<i>P</i> = 0.022). The hypoglycemia alarms reduced hypoglycemia features and glucose variability, although at the expense of shorter time in range. The higher the hypoglycemia alarm threshold, the greater these effects. The hyperglycemia alarms were effective in reducing hyperglycemia and lowering the glucose management indicator, although at the expense of a greater tendency to hypoglycemia. The lower the hyperglycemia alarm threshold, the greater these effects. <b><i>Conclusions:</i></b> CGM alarms contribute to better glycemic control. However, hypoglycemia and hyperglycemia alarms have advantages and disadvantages. Adults with T1DM should explore, under medical supervision, which alarm thresholds will best help them achieve their individual glycemic goals.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":null,"pages":null},"PeriodicalIF":5.7,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139073628","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Cost-Effectiveness of an Advanced Hybrid Closed-Loop System Compared to Standard Management of Type 1 Diabetes in a Singapore Setting.","authors":"Daphne Gardner, Mrinmayee Lakkad, Zhiyu Qiu, Yuta Inoue, Suresh Rama Chandran, Kael Wherry","doi":"10.1089/dia.2023.0455","DOIUrl":"10.1089/dia.2023.0455","url":null,"abstract":"<p><p><b><i>Background:</i></b> Despite advances in technology, glycemic outcomes in people with type 1 diabetes (T1D) remain suboptimal. The MiniMed 780G (MM780G) advanced hybrid closed-loop (AHCL) system is the latest technology for T1D management with established safety and efficacy. This study explores the cost-effectiveness of MM780G AHCL compared against multiple daily injections (MDI) plus intermittently scanned continuous glucose monitor (isCGM). <b><i>Methods:</i></b> A cost-utility analysis was conducted, simulating lifetime outcomes for 1000 T1D individuals, with baseline hemoglobin A1c of 8.4%, using the IQVIA Core Diabetes Model (CDM) v9.5. A Singapore health care payer perspective was taken with 2023 costs applied. Treatment effects were taken from the ADAPT study and treatment-related events from a combination of sources. T1D complication costs were derived from local literature, and health state utilities and disutilities from published literature. Scenario analyses and probabilistic sensitivity analyses (PSAs) explored uncertainty. Cost-effectiveness was assessed based on willingness-to-pay (WTP) thresholds set to Singapore Dollars (SGD) 45,000 (United States Dollars [USD] 33,087) per quality-adjusted life year (QALY) and Singapore's gross domestic product (GDP) per capita of SGD 114,165 (USD 83,941) per QALY. <b><i>Results:</i></b> A switch from MDI plus isCGM to MM780G resulted in expected gains in life-years (+0.78) and QALYs (+1.45). Cost savings through reduction in T1D complications (SGD 25,465; USD 18,723) partially offset the higher treatment costs in the AHCL arm (+SGD 74,538; +USD 54,805), resulting in an estimated incremental cost-effectiveness ratio of SGD 33,797 (USD 24,850) per QALY gained. Findings were robust, with PSA outputs indicating 81% and 99% probabilities of cost-effectiveness at the stated WTP thresholds. <b><i>Conclusion:</i></b> MM780G is a cost-effective option for people with T1D managed in a Singapore setting.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":null,"pages":null},"PeriodicalIF":5.4,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11058413/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139431880","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical Outcomes with MiniMed^TM 780G Advanced Hybrid Closed-Loop Therapy in 2- to 6-Year-Old Children with Type 1 Diabetes.","authors":"Mary B Abraham, Grant J Smith, Julie Dart, Elizabeth A Davis, Timothy W Jones","doi":"10.1089/dia.2023.0508","DOIUrl":"10.1089/dia.2023.0508","url":null,"abstract":"<p><p>Advanced hybrid closed-loop (AHCL) therapy with the Medtronic MiniMed™ 780G system improves glycemia; however, the clinical outcomes in younger children remain less established. This pilot study aimed to explore the continuous glucose monitoring (CGM) metrics in very young children on AHCL. Children between 2 and 7 years of age and on insulin pump therapy were recruited. A 2-week phase in manual mode was followed by a 6-week AHCL phase. CGM metrics were analyzed to review glycemic outcomes. Out of 11 participants enrolled [mean (standard deviation [SD]) age 5.3 (0.8) years], 10 completed the study. Time in closed loop was 96.7 (3.9)%. In AHCL, participants had a mean (SD) time in range of 72.6 (7.4)% and spent 3.0 (1.74)% and 0.63 (0.46)% in time <70 and <54 mg/dL, respectively. AHCL is a feasible option for management of young children with type 1 diabetes.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":null,"pages":null},"PeriodicalIF":5.4,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139431943","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prevalence, Safety, and Metabolic Control Among Danish Children and Adolescents with Type 1 Diabetes Using Open-Source Automated Insulin Delivery Systems.","authors":"Amanda R Fagerberg, Luise Borch, Kurt Kristensen, Jesper S Hjelle","doi":"10.1089/dia.2023.0412","DOIUrl":"10.1089/dia.2023.0412","url":null,"abstract":"<p><p><b><i>Background:</i></b> Treatment of type 1 diabetes mellitus (T1DM) has become increasingly technical with rapid developments in integration of pumps and sensors to regulate insulin dosage, and patient-initiated solutions as open-source automated insulin delivery (OS-AID) systems, have gained popularity in people with diabetes. Studies have shown increased glycemic control and mental wellbeing in users of OS-AID systems. The aim of this study was to estimate the prevalence, the effect on metabolic control, the risk, and the effect on everyday life for users and their parents of OS-AID systems in Danish children and adolescents with T1DM. <b><i>Methods:</i></b> This retrospective cohort study recruited participants through pediatric diabetes outpatient clinics and social media. Surveys were distributed and current and retrospective data on glycemic control (HbA1c, time in range [TIR] etc.) were collected. <b><i>Results:</i></b> Fifty-six users of OS-AID systems out of 2950 Danish children and adolescents with T1DM were identified from all outpatient clinics in Denmark. Thirty-one responded on contact and were included (55% of the identified), median age 12 [interquartile range: 11-14] years, 51% females, and mean duration of use of OS-AID systems 2.37 ± 0.86 years. Glycemic control increased significantly with TIR increasing from mean 62.29% ± 13.68% to 70.12% ± 10.08%, *<i>P</i> < 0.01, and HbA1c decreasing from mean 50.13 ± 5.76 mmol/mol (6.7% ± 2.7%) to 47.86 ± 6.24 mmol/mol (6.5% ± 2.7%), **<i>P</i> < 0.05. No changes were found in safety parameters. Parents reported better quality of sleep evaluated by Pittsburgh Sleep Quality Index. <b><i>Conclusion:</i></b> This study is the first to provide knowledge on pediatric users of OS-AID systems in Denmark and found a prevalence of 1.89% for OS-AID systems, improved TIR, and no increased risk associated with use of OS-AID systems.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":null,"pages":null},"PeriodicalIF":5.4,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11058411/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139930413","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Performance of the Dexcom G7 Continuous Glucose Monitoring System in Pregnant Women with Diabetes.","authors":"Sarit Polsky, Amy M Valent, Elvira Isganaitis, Kristin Castorino, Grenye O'Malley, Stayce E Beck, Peggy Gao, Lori M Laffel, Florence M Brown, Carol J Levy","doi":"10.1089/dia.2023.0516","DOIUrl":"10.1089/dia.2023.0516","url":null,"abstract":"<p><p><b><i>Background:</i></b> We evaluated accuracy and safety of a seventh-generation real-time continuous glucose monitoring (CGM) system during pregnancy. <b><i>Materials and Methods:</i></b> Evaluable data for accuracy analysis were obtained from 96 G7 sensors (Dexcom, Inc.) worn by 96 of 105 enrolled pregnant women with type 1 (<i>n</i> = 59), type 2 (<i>n</i> = 21), or gestational diabetes (<i>n</i> = 25). CGM values were compared with arterialized venous glucose values from the YSI comparator instrument during 6-h clinic sessions at different time points throughout the sensors' 10-day wear period. The primary endpoint was the proportion of CGM values in the 70-180 mg/dL range within 15% of comparator glucose values. Secondary endpoints included the proportion of CGM values within 20% or 20 mg/dL of comparator values ≥ or <100 mg/dL, respectively (the %20/20 agreement rate). <b><i>Results:</i></b> Of the 1739 pairs with CGM in the 70-180 mg/dL range, 83.2% were within 15% of comparator values. The lower bound of the 95% confidence interval was 79.8%. Of the 2102 pairs with CGM values in the 40-400 mg/dL range, the %20/20 agreement rate was 92.5%. Of the 1659 pairs with comparator values in the 63-140 mg/dL range, the %20/20 agreement rate was 92.3%. The %20/20 agreement rates on days 1, 4 and 7, and 10 were 78.6%, 96.3%, and 97.3%, respectively. Consensus error grid analysis showed 99.8% of pairs in the clinically acceptable A and B zones. There were no serious adverse events. The sensors' 10-day survival rate was 90.3%. <b><i>Conclusion:</i></b> The G7 system is accurate and safe during pregnancies complicated by diabetes and does not require confirmatory fingerstick testing. <b><i>Clinical Trial Registration:</i></b> clinicaltrials.gov NCT04905628.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":null,"pages":null},"PeriodicalIF":5.7,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11058415/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139691385","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}