Journal of Diabetes Science and Technology最新文献

{"title":"Automated Insulin Delivery in Pregnancies Complicated by Type 1 Diabetes.","authors":"Katrien Benhalima, Sarit Polsky","doi":"10.1177/19322968251323614","DOIUrl":"10.1177/19322968251323614","url":null,"abstract":"<p><p>Automated insulin delivery (AID) systems adapt insulin delivery via a predictive algorithm integrated with continuous glucose monitoring and an insulin pump. Automated insulin delivery has become standard of care for glycemic management of people with type 1 diabetes (T1D) outside pregnancy, leading to improvements in time in range, with lower risk for hypoglycemia and improved treatment satisfaction. The use of AID facilitates optimal preconception care, thus more women of reproductive age are becoming pregnant while using AID. The effectiveness and safety in pregnant populations of using AID systems with algorithms for non-pregnant populations may be impacted by requirements for lower glucose targets and existence of increased insulin resistance during gestation. The CamAPS FX is the only AID system approved for use in pregnancy. A large randomized controlled trial (RCT) with this AID system demonstrated a 10.5% increase in time in pregnancy range (an additional 2.5 hours/day) compared with standard insulin therapy in pregnant women with T1D with a baseline glycated hemoglobin A1c (HbA_1c) ≥48 mmol/mol (6.5%). A RCT of AID not approved for use in pregnancy (MiniMed 780G) has also demonstrated some benefits of AID compared with standard insulin therapy with improved time in pregnancy range overnight (24 minutes), less hypoglycemia, and improved treatment satisfaction. There is also increasing evidence that AID can be safely continued during delivery and postpartum, while maintaining glycemic goals with lower risk for hypoglycemia. More AID systems are needed with flexible glucose targets in the pregnancy range and possibly with algorithms that better adapt to changing insulin requirements. 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 postpartum.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"19322968251323614"},"PeriodicalIF":4.1,"publicationDate":"2025-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11904923/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143604885","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":"Classifying Continuous Glucose Monitoring Documents From Electronic Health Records.","authors":"Yaguang Zheng, Eduardo Iturrate, Lehan Li, Bei Wu, William R Small, Susan Zweig, Jason Fletcher, Zhihao Chen, Stephen B Johnson","doi":"10.1177/19322968251324535","DOIUrl":"10.1177/19322968251324535","url":null,"abstract":"<p><strong>Background: </strong>Clinical use of continuous glucose monitoring (CGM) is increasing storage of CGM-related documents in electronic health records (EHR); however, the standardization of CGM storage is lacking. We aimed to evaluate the sensitivity and specificity of CGM Ambulatory Glucose Profile (AGP) classification criteria.</p><p><strong>Methods: </strong>We randomly chose 2244 (18.1%) documents from NYU Langone Health. Our document classification algorithm: (1) separated multiple-page documents into a single-page image; (2) rotated all pages into an upright orientation; (3) determined types of devices using optical character recognition; and (4) tested for the presence of particular keywords in the text. Two experts in using CGM for research and clinical practice conducted an independent manual review of 62 (2.8%) reports. We calculated sensitivity (correct classification of CGM AGP report) and specificity (correct classification of non-CGM report) by comparing the classification algorithm against manual review.</p><p><strong>Results: </strong>Among 2244 documents, 1040 (46.5%) were classified as CGM AGP reports (43.3% FreeStyle Libre and 56.7% Dexcom), 1170 (52.1%) non-CGM reports (eg, progress notes, CGM request forms, or physician letters), and 34 (1.5%) uncertain documents. The agreement for the evaluation of the documents between the two experts was 100% for sensitivity and 98.4% for specificity. When comparing the classification result between the algorithm and manual review, the sensitivity and specificity were 95.0% and 91.7%.</p><p><strong>Conclusion: </strong>Nearly half of CGM-related documents were AGP reports, which are useful for clinical practice and diabetes research; however, the remaining half are other clinical documents. Future work needs to standardize the storage of CGM-related documents in the EHR.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"19322968251324535"},"PeriodicalIF":4.1,"publicationDate":"2025-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11904921/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143604893","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":"Performance of an Automated Insulin Delivery System in People Living With Type 2 Diabetes and Insulin Resistance: First Real-World Evidence in 26 427 Users.","authors":"Isabeau Thijs, Arcelia Arrieta, Javier Castañeda, Michael Joubert, Francesco Giorgino, Benedikt Voelker, Tim Van den Heuvel, Jeremy Basset-Sagarminaga, Goran Petrovski, John Shin, Robert Vigersky, Ohad Cohen","doi":"10.1177/19322968251318373","DOIUrl":"10.1177/19322968251318373","url":null,"abstract":"<p><strong>Background: </strong>Type 2 diabetes (T2D) is a phenotypically heterogeneous disease. The use of insulin is required in a significant portion of people with T2D, despite recent developments in antidiabetic medications. This study analyzes glycemic outcomes in automated insulin delivery (AID) users with T2D with different insulin requirements.</p><p><strong>Methods: </strong>This is a retrospective, real-world analysis including MiniMed 780G (MM780G) data uploaded to CareLink Personal (January 2020 to April 2024). Four cohorts were identified based on phenotypes of T2D: (A) users with total daily dose of insulin (TDD) ≥ 100 IU, (B) users with self-reported T2D, (C) users with self-reported T2D and TDD ≥ 100 IU, and (D) users with self-reported T2D and TDD <100 IU. Glycemic outcomes and insulin use were assessed post-AID, pre-AID versus post-AID, and six-month longitudinal post-AID.</p><p><strong>Results: </strong>A total of 26 427 users were included in this study, of which 18 466 in cohort A, 10 795 in cohort B, 2 834 in cohort C, and 7 961 in cohort D. Mean time in range (TIR) was 71.1% ± 12.2 for cohort A, 75.1% ±14.1 for cohort B, 72.2% ± 15.0 for cohort C, and 76.1% ± 13.6 for cohort D. Mean time below range (TBR) <70 mg/dL was ≤1% in all cohorts. The users in cohort C using the recommended optimal settings (glucose target [GT] of 100 mg/dL and active insulin time [AIT] of two hours) had a greater TIR with 78.7% ± 10.8. All cohorts increased ≥10% post-AID compared with pre-AID.</p><p><strong>Conclusions: </strong>The use of this AID is associated with effective therapy outcomes, as indicated by over 70% TIR, and appears to be safe, as demonstrated by a low TBR in a large cohort of real-life users with self-reported T2D and high or low TDD.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"19322968251318373"},"PeriodicalIF":4.1,"publicationDate":"2025-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11954135/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143604895","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":"Predicting Postprandial Glycemic Responses With Limited Data in Type 1 and Type 2 Diabetes.","authors":"Yiheng Shen, Euiji Choi, Samantha Kleinberg","doi":"10.1177/19322968251321508","DOIUrl":"10.1177/19322968251321508","url":null,"abstract":"<p><strong>Background: </strong>A core challenge in managing diabetes is predicting glycemic responses to meals. Prior work identified significant interindividual variation in responses and developed personalized forecasts. However, intraindividual variation is still not well understood, and the most accurate approaches require invasive microbiome data. We aimed to investigate (1) whether postprandial glycemic responses (PPGRs) can be predicted with limited data and (2) sources of intraindividual variation.</p><p><strong>Methods: </strong>We used data collected from 397 people with Type 1 Diabetes (T1DEXI) and 100 people with Type 2 Diabetes (ShanghaiT2DM) who wore continuous glucose monitors (CGMs) and logged meals. Using dietary, demographic, and temporal features, we predicted 2 hours PPGR, and peak 2 hours postprandial glucose rise (Glu_max). We evaluated the contribution of food features (eg, macronutrients, food category) and use of personal training data and investigated intraindividual variability in responses.</p><p><strong>Results: </strong>We achieved comparable accuracy to prior work for PPGR (T1DEXI R = 0.61, ShanghaiT2DM R = 0.72) and Glu_max (T1DEXI R = 0.64, ShanghaiT2DM R = 0.73), without using invasive data like microbiome. Including food category features led to higher accuracy than macronutrients alone. Analysis of glycemic responses to duplicate meals identified time of day (PPGR: T1DEXI <i>P</i> < .05 for lunch, ShanghaiT2DM <i>P</i> < .001 for lunch and dinner) and menstrual cycle (Glu_max: <i>P</i> < .05 for perimenstrual) as sources of variability.</p><p><strong>Conclusions: </strong>We demonstrate that in individuals with T1D and T2D, glycemic responses to meals can be predicted without personalized training data or invasive physiological data.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"19322968251321508"},"PeriodicalIF":4.1,"publicationDate":"2025-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11883769/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143556984","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":"Novel Robust Needle Tip Design Enables Needle Reuse and Reduced Skin Trauma in Combination With Autoinjector Needle Shields.","authors":"Anne-Sofie Madsen Staples, Julie Schwartz, Kezia Ann Friis Præstmark, Marie Sand Traberg","doi":"10.1177/19322968231190408","DOIUrl":"10.1177/19322968231190408","url":null,"abstract":"<p><strong>Background: </strong>Pen needles and autoinjectors are necessary for millions of patients needing injectable drug treatment but pose economic and environmental burdens. A durable device with a multiuse needle could reduce cost and improve user experience. This study explores a novel robust needle tip (EXP) designed for multiple uses and durability against hooking.</p><p><strong>Method: </strong>Needle robustness was investigated through a structural analysis. Furthermore, EXP and control needles (NF30, NF28) were evaluated in an in-vivo porcine model as pen needles or embedded in autoinjectors to study the resulting increase in skin blood perfusion (SBP). The SBP was assessed by laser speckle contrast analysis (LASCA) of 192 randomized and blinded needle insertions.</p><p><strong>Results: </strong>Forming a 33 µm hook against a hard surface requires 0.92 N for the NF30 control needle and 5.38 N for EXP. The EXP did not induce more tissue trauma than the NF30. There was a positive relation between needle diameter and SBP (<i>P</i> < .05). Furthermore, the presence of an autoinjector shield and applied force of 10 N was found to significantly reduce SBP for worn EXP needles (<i>P</i> < .05) compared to insertions without autoinjector shield.</p><p><strong>Conclusions: </strong>The investigated robust needle EXP is on par with the single-use needle NF30 in terms of tissue trauma, which is further reduced by combining the needle with a needle shield. These results should encourage the innovation and development of durable, reusable injection systems with pharmacoeconomic and environmental value and a simplified and enhanced user experience for patients.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"352-360"},"PeriodicalIF":4.1,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11874290/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9957884","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 Role of Ultra-Rapid-Acting Insulin Analogs in Diabetes: An Expert Consensus.","authors":"Francesco Giorgino, Tadej Battelino, Richard M Bergenstal, Thomas Forst, Jennifer B Green, Chantal Mathieu, Helena W Rodbard, Oliver Schnell, Emma G Wilmot","doi":"10.1177/19322968231204584","DOIUrl":"10.1177/19322968231204584","url":null,"abstract":"<p><p>Ultra-rapid-acting insulin analogs (URAA) are a further development and refinement of rapid-acting insulin analogs. Because of their adapted formulation, URAA provide an even faster pharmacokinetics and thus an accelerated onset of insulin action than conventional rapid-acting insulin analogs, allowing for a more physiologic delivery of exogenously applied insulin. Clinical trials have confirmed the superiority of URAA in controlling postprandial glucose excursions, with a safety profile that is comparable to the rapid-acting insulins. Consequently, many individuals with diabetes mellitus may benefit from URAA in terms of prandial glycemic control. Unfortunately, there are only few available recommendations from authoritative sources for use of URAA in clinical practice. Therefore, this expert consensus report aims to define populations of people with diabetes mellitus for whom URAA may be beneficial and to provide health care professionals with concrete, practical recommendations on how best to use URAA in this context.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"452-469"},"PeriodicalIF":4.1,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11874134/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71482121","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":"Importance of Cybersecurity/The Relevance of Cybersecurity to Diabetes Devices: An Update from Diabetes Technology Society.","authors":"Cindy N Ho, Alessandra T Ayers, Rachel E Aaron, Tiffany Tian, Chin-Sean Sum, David C Klonoff","doi":"10.1177/19322968241296543","DOIUrl":"10.1177/19322968241296543","url":null,"abstract":"<p><p>As medical devices become more integrated with wireless technologies, the risks of cyberattacks and data breaches increase, making stringent cybersecurity measures essential. The implementation of rigorous cybersecurity standards is essential for enhancing the cybersecurity of devices. This article examines the evolving cyber threats faced by the medical technology industry, the role of IEEE 2621 in providing comprehensive security benchmarks for medical devices, and the need for continuous risk assessments and adherence to regulatory standards to mitigate future cyber risks. Adherence to cybersecurity standards establishes ensures the effective protection of sensitive data and critical infrastructure.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"470-474"},"PeriodicalIF":4.1,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11571616/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142604946","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":"Mealtime Insulin BOLUS Score More Strongly Predicts HbA1c Than the Self-Care Inventory in Youth With Type 1 Diabetes.","authors":"Jordan Christie, Mark A Clements, David D Williams, Joseph Cernich, Susana R Patton","doi":"10.1177/19322968231192979","DOIUrl":"10.1177/19322968231192979","url":null,"abstract":"<p><strong>Background: </strong>To meet their glycated hemoglobin (HbA1c) goals, youth with type 1 diabetes (T1D) need to engage with their daily T1D treatment. The mealtime insulin Bolus score (BOLUS) is an objective measure of youth's T1D engagement which we have previously shown to be superior to other objective engagement measures in predicting youth's HbA1c. Here, to further assess the BOLUS score's validity, we compared the strengths of the associations between youth's HbA1c with their mean insulin BOLUS score and a valid, self-report measure of T1D engagement, the Self-Care Inventory (SCI).</p><p><strong>Methods: </strong>One-hundred and five youth with T1D self-reported their T1D engagement using the SCI. We also collected two weeks of insulin pump data and a concurrent HbA1c level. We scored youth's SCI and calculated their mean insulin BOLUS score using standardized methods. For the analyses, we performed simple correlations, partial correlations, and multiple regression models.</p><p><strong>Results: </strong>Youth had a mean age of 15.03 ± 1.97 years, mean time since diagnosis of 8.11 ± 3.26 years, and a mean HbA1c of 8.78 ± 1.49%. The sample included n = 58 boys (55%) and n = 96 families (91%) self-identified as white. Simple correlations between youth's age, HbA1c, SCI total score, and BOLUS score were all significant. Partial correlation and regression models revealed that youth's insulin BOLUS score was more strongly associated with HbA1c than the SCI.</p><p><strong>Conclusions: </strong>Youths' BOLUS score has better concurrent validity with HbA1c than the SCI. We should consider reporting the BOLUS score as an outcome metric in insulin pump data reports.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"340-344"},"PeriodicalIF":4.1,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11873986/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10332767","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":"System Accuracy and Interference Evaluation of a New Glucose Dehydrogenase-Based Blood Glucose Meter for Patient Self-Testing.","authors":"Andreas Pfützner, Daiva Kalasauske, Mina Hanna, Daniela Sachsenheimer, Gerhard Raab, Silvia Weissenbacher, Nicole Thomé","doi":"10.1177/19322968231201862","DOIUrl":"10.1177/19322968231201862","url":null,"abstract":"<p><p>New European medical device regulations require the performance of postmarketing surveillance evaluations for blood glucose meters (BGMs). We conducted an ISO15197:2015-conform system performance evaluation with the approved glucose dehydrogenase (GDH)-based Wellion NEWTON BGM. One hundred subjects were enrolled into the study (44 female, 56 male, 43 healthy subjects, 23 type 1 diabetes, 34 type 2 diabetes, age: 53.7 ± 15.8 years). In addition, manipulated heparinized whole blood was used for a laboratory interference test with ten selected substances (interference definition: substance-induced bias > 10%). The mean absolute relative difference (MARD) was 4.7%, and 100% of the values were in zones A (99.7%) and B (0.3%), respectively, of the consensus error grid. Interference was observed with xylose only, which is a known interfering substance for GDH-based BGMs.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"431-435"},"PeriodicalIF":4.1,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11874304/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41139763","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":"Glycemic and Patient-Reported Outcomes for Users of a New, Compact Automated Insulin Delivery System: A First Report.","authors":"Halis K Akturk, Kagan E Karakus, Edwin D'Souza, Kimia Z Assadi, Jordan E Pinsker, Laurel H Messer","doi":"10.1177/19322968241302349","DOIUrl":"10.1177/19322968241302349","url":null,"abstract":"","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"582-583"},"PeriodicalIF":4.1,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11590071/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142716357","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}