Diabetes technology & therapeutics最新文献

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Real-Life Achievements of MiniMed 780G Advanced Closed-Loop System in Youth with Type 1 Diabetes: AWeSoMe Study Group Multicenter Prospective Trial. MiniMed™ 780G 高级闭环系统在 1 型糖尿病青少年患者中的实际应用效果:AWeSoMe 研究小组多中心前瞻性试验。
IF 5.7 2区 医学
Diabetes technology & therapeutics Pub Date : 2024-11-01 Epub Date: 2024-05-31 DOI: 10.1089/dia.2024.0148
Noah Gruber, Avigail Wittenberg, Avivit Brener, Shirli Abiri, Kineret Mazor-Aronovitch, Michal Yackobovitch-Gavan, Shay Averbuch, Tal Ben Ari, Noah Levek, Neriya Levran, Zohar Landau, Marianna Rachmiel, Orit Pinhas-Hamiel, Yael Lebenthal
{"title":"Real-Life Achievements of MiniMed 780G Advanced Closed-Loop System in Youth with Type 1 Diabetes: AWeSoMe Study Group Multicenter Prospective Trial.","authors":"Noah Gruber, Avigail Wittenberg, Avivit Brener, Shirli Abiri, Kineret Mazor-Aronovitch, Michal Yackobovitch-Gavan, Shay Averbuch, Tal Ben Ari, Noah Levek, Neriya Levran, Zohar Landau, Marianna Rachmiel, Orit Pinhas-Hamiel, Yael Lebenthal","doi":"10.1089/dia.2024.0148","DOIUrl":"10.1089/dia.2024.0148","url":null,"abstract":"<p><p><b><i>Background:</i></b> We assessed real-life glycemic outcomes and predictors of composite measures of optimal glycemic control in children and adolescents with type 1 diabetes (T1D) during their initial 12 months of the MiniMed™ 780G use. <b><i>Methods:</i></b> This prospective observational multicenter study collected demographic, clinical, and 2-week 780G system data at five time points. Optimal glycemic control was defined as a composite glycemic control (CGC) score requiring the attainment of four recommended continuous glucose monitoring (CGM) targets, as well as the glycemia risk index (GRI) of hypoglycemia and hyperglycemia and composite CGM index (COGI). Outcome measures included longitudinal changes in multiple glycemic parameters and CGC, GRI, and COGI scores, as well as predictors of these optimal measures. <b><i>Results:</i></b> The cohort included 93 children, 43% girls, with a median age of 15.1 years (interquartile range [IQR] 12.9,17.0). A longitudinal analysis adjusted for age and socioeconomic index yielded a significant improvement in glycemic control for the entire cohort (<i>p</i><sub>time</sub> < 0.001) after the transition to 780G. The mean hemoglobin A1c (HbA1c) (SE) was 8.65% (0.12) at baseline and dropped by >1% after 1 year to 7.54% (0.14) (<i>p</i><sub>time</sub> < 0.001). Optimal glycemic control measures improved at 12 months post 780G; CGC improved by 5.6-fold (<i>P</i> < 0.001) and was attained by 24% of the participants, the GRI score improved by 10-fold (<i>P</i> = 0.009) and was achieved by 10% of them, and the COGI improved by 7.6-fold (<i>P</i> < 0.001) and was attained by 20% of them. Lower baseline HbA1c levels and increased adherence to Advanced Hybrid Closed-Loop (AHCL) usage were predictors of achieving optimal glycemic control. <b><i>Conclusions:</i></b> The AHCL 780G system enhances glycemic control in children and adolescents with T1D, demonstrating improvements in HbA1c and CGM metrics, albeit most participants did not achieve optimal glycemic control. This highlights yet ongoing challenges in diabetes management, emphasizing the need for continued proactive efforts on the part of health care professionals, youth, and caregivers.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"869-880"},"PeriodicalIF":5.7,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140956741","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}
引用次数: 0
Assessing Patterns of Continuous Glucose Monitoring Use and Metrics of Glycemic Control in Type 1 Diabetes and Type 2 Diabetes Patients in the Veterans Health Care System: Integrating Continuous Glucose Monitoring Device Data with Electronic Health Records Data. 评估退伍军人医疗保健系统中 T1D 和 T2D 患者的 CGM 使用模式和血糖控制指标:整合 CGM 设备数据与 EHR 数据。
IF 5.7 2区 医学
Diabetes technology & therapeutics Pub Date : 2024-11-01 Epub Date: 2024-06-11 DOI: 10.1089/dia.2024.0083
Tomoki Okuno, Sharon A Macwan, Donald Miller, Gregory J Norman, Peter Reaven, Jin J Zhou
{"title":"Assessing Patterns of Continuous Glucose Monitoring Use and Metrics of Glycemic Control in Type 1 Diabetes and Type 2 Diabetes Patients in the Veterans Health Care System: Integrating Continuous Glucose Monitoring Device Data with Electronic Health Records Data.","authors":"Tomoki Okuno, Sharon A Macwan, Donald Miller, Gregory J Norman, Peter Reaven, Jin J Zhou","doi":"10.1089/dia.2024.0083","DOIUrl":"10.1089/dia.2024.0083","url":null,"abstract":"<p><p><b><i>Objective:</i></b> To integrate long-term daily continuous glucose monitoring (CGM) device data with electronic health records (EHR) for patients with type 1 and type 2 diabetes (T1D and T2D) in the national Veterans Affairs Healthcare System to assess real-world patterns of CGM use and the reliability of EHR-based CGM information. <b><i>Research Design and Methods:</i></b> This observational study used Dexcom CGM device data linked with EHR (from 2015 to 2020) for a large national cohort of patients with diabetes. We tracked the initiation and consistency of CGM use, assessed concordance of CGM use and measures of glucose control between CGM device data and EHR records, and examined results by age, ethnicity, and diabetes type. <b><i>Results:</i></b> The time from pharmacy release of CGM to patients to initiation of uploading CGM data to Dexcom servers averaged 3 weeks but demonstrated wide variation among individuals; importantly, this delay decreased markedly over the later years. The average daily wear time of CGM exceeded 22 h over nearly 3 years of follow-up. Patterns of CGM use were generally consistent across age, race/ethnicity groups, and diabetes type. There was strong concordance between EHR-based estimates of CGM use and Dexcom CGM wear time and between estimates of glucose control from both sources. <b><i>Conclusions:</i></b> The study demonstrates our ability to reliably integrate CGM devices and EHR data to provide valuable insights into CGM use patterns. The results indicate in the real-world environment that CGM is worn consistently over many years for both patients with T1D and T2D within the Veterans Affairs Healthcare System and is similar across major race/ethnic groups and age-groups.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"806-813"},"PeriodicalIF":5.7,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141070354","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}
引用次数: 0
Automated Insulin Delivery System: A Solution for Moderate to High-Risk Ramadan Fasting in People Living with Type 1 Diabetes. 胰岛素自动输送系统:1 型糖尿病患者斋月禁食的中高风险解决方案。
IF 5.7 2区 医学
Diabetes technology & therapeutics Pub Date : 2024-11-01 Epub Date: 2024-07-17 DOI: 10.1089/dia.2024.0168
Cécilia Outenah, Khadijatou Ly Sall, Alfred Penfornis, Coralie Amadou, Dured Dardari
{"title":"Automated Insulin Delivery System: A Solution for Moderate to High-Risk Ramadan Fasting in People Living with Type 1 Diabetes.","authors":"Cécilia Outenah, Khadijatou Ly Sall, Alfred Penfornis, Coralie Amadou, Dured Dardari","doi":"10.1089/dia.2024.0168","DOIUrl":"10.1089/dia.2024.0168","url":null,"abstract":"<p><p><b><i>Objectives:</i></b> Background investigated whether Ramadan, a yearly religious fasting lasting for 1 month, could challenge the metabolic control obtained under a hybrid closed-loop (HCL) therapy in patients living with type 1 diabetes (T1D). <b><i>Material and Method:</i></b> This real-life prospective study involved 20 patients with T1D and moderate to high-risk score of adverse events at baseline. We compared continuous glucose monitoring (CGM) parameters under HCL therapy 1 month before and during the Ramadan fasting month. The main outcome was the evolution of the percentage of time-in-range (TIR, 70-180 mg/dL) between the two time points, and secondary outcomes were the evolution of other CGM parameters and frequency of acute metabolic events. <b><i>Results:</i></b> We observed no statistical difference regarding TIR (mean±SD) (63 ± 11% during fasting vs. 62 ± 12% before) as well as for other parameters including time spent under 70 mg/dL (1.1 ± 1.0% vs. 1.5 ± 1.3%) and percentage of HCL use (93 ± 5% vs. 94 ± 5%). No acute metabolic event was observed during fasting under HCL. Results were homogenous across baseline risk score groups.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"e881-e884"},"PeriodicalIF":5.7,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141418273","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}
引用次数: 0
Psychometric Properties of the Automated Insulin Delivery: Benefits and Burdens Scale for Adults with Type 1 Diabetes. 1 型糖尿病成人胰岛素自动给药--收益与负担量表 (AID-BBS) 的心理计量特性。
IF 5.7 2区 医学
Diabetes technology & therapeutics Pub Date : 2024-11-01 Epub Date: 2024-05-31 DOI: 10.1089/dia.2024.0117
Jenna B Shapiro, Anthony T Vesco, Michael S Carroll, Jill Weissberg-Benchell
{"title":"Psychometric Properties of the Automated Insulin Delivery: Benefits and Burdens Scale for Adults with Type 1 Diabetes.","authors":"Jenna B Shapiro, Anthony T Vesco, Michael S Carroll, Jill Weissberg-Benchell","doi":"10.1089/dia.2024.0117","DOIUrl":"10.1089/dia.2024.0117","url":null,"abstract":"<p><p><b><i>Objective:</i></b> To evaluate the psychometric properties of a patient-reported outcome measure, the Automated Insulin Delivery-Benefits and Burdens Scale (AID-BBS), which was designed to assess benefits and burdens of AID use in adults with type 1 diabetes (T1D). The measure was hypothesized to have validity, reliability, and clinical utility for predicting likelihood of continued use of an AID system. <b><i>Research Design and Methods:</i></b> A total of 217 adults with T1D (ages from 18 to 82 years) who were enrolled in an AID system research trial completed AID-BBS items at study midpoint (6 weeks) and at the end of the trial (13 weeks). Data were collected on pre-post glycemic outcomes. Participants completed other patient-reported psychosocial outcome measures (e.g., emotional well-being, diabetes distress, attitudes toward diabetes technology, diabetes treatment satisfaction) at Week 13. Likelihood of continued device use was assessed with three items at 13 weeks. <b><i>Results:</i></b> Exploratory factor analysis supported a one-factor structure for each subscale (15-item benefit and 9-item burden subscale) when evaluated separately. Convergent, discriminant, and predictive validity, internal consistency, and test-retest reliability were supported. Benefit and burden subscales at week 6 predicted usage intention above and beyond device impact on glycemic outcomes, also controlling for baseline glycemic outcomes. <b><i>Conclusion</i></b>: Findings support the AID-BBS as a psychometrically valid, reliable, and useful instrument for assessing burdens and benefits associated with AID system use in adults with T1D. The measure can be used to help health care providers set realistic expectations and proactively address modifiable burdens. Clinical Trial Registration Number: NCT04200313.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"842-850"},"PeriodicalIF":5.7,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140956740","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}
引用次数: 0
Partial Clinical Remission of Type 1 Diabetes in Swedish Children: A Longitudinal Study from the Swedish National Quality Register (SWEDIABKIDS) and the Better Diabetes Diagnosis (BDD) Study. 瑞典儿童 1 型糖尿病的部分临床缓解--来自瑞典国家质量登记(SWEDIABKIDS)和更好的糖尿病诊断(BDD)研究的纵向研究。
IF 5.7 2区 医学
Diabetes technology & therapeutics Pub Date : 2024-11-01 Epub Date: 2024-06-26 DOI: 10.1089/dia.2024.0112
Anna-Lena Fureman, Marie Bladh, Annelie Carlsson, Gun Forsander, Mikael Lilja, Johnny Ludvigsson, Ulf Samuelsson, Stefan Särnblad, Torbjörn Lind
{"title":"Partial Clinical Remission of Type 1 Diabetes in Swedish Children: A Longitudinal Study from the Swedish National Quality Register (SWEDIABKIDS) and the Better Diabetes Diagnosis (BDD) Study.","authors":"Anna-Lena Fureman, Marie Bladh, Annelie Carlsson, Gun Forsander, Mikael Lilja, Johnny Ludvigsson, Ulf Samuelsson, Stefan Särnblad, Torbjörn Lind","doi":"10.1089/dia.2024.0112","DOIUrl":"10.1089/dia.2024.0112","url":null,"abstract":"<p><p><b><i>Aims/Hypotheses:</i></b> To investigate the frequency and characteristics of partial remission in Swedish children with type 1 diabetes and whether the insulin delivery method, that is, continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDIs), affects incidence and duration of this period, 2007-2011. Factors that increase the proportion of subjects who enter partial remission and extend this period can improve long-term metabolic control and reduce the risk of severe hypoglycemia, improve quality of life, and, in the long run, reduce late complications. <b><i>Methods:</i></b> Longitudinal data from 2007 to 2020 were extracted from the Swedish National Quality Register (SWEDIABKIDS) with all reported newly diagnosed children. Data on C-peptide from the participants in the Better Diabetes Diagnosis study from 2007 to 2010 were used. The definition of partial remission was insulin dose-adjusted HbA1c: HbA1c (%) + [4 × total daily insulin dose (U/kg/day)] ≤9. <b><i>Results:</i></b> Of the 3887 patients, 56% were boys. More boys than girls were in partial remission throughout the follow-up period until 24 months after diabetes onset. Fewer children 0-6 years old had partial remission at 3 and 12 months but not at 24 months compared with older age-groups. A larger proportion of patients using CSII at 12 and 24 months remained in partial remission compared with those with MDI (37% vs. 33%, <i>P</i> = 0.02 and 31% vs. 27%, <i>P</i> = 0.01, respectively). The level of C-peptide was higher in the group with partial remission and mean HbA1c was lower (both <i>P</i> < 0.001). Partial remission at 12 months after diabetes onset was associated with CSII (odds ratio [OR]: 1.39, confidence interval [CI]:1.13, 1.71), shorter diabetes duration (OR: 0.80, CI: 0.76, 0.84), and male sex (OR: 1.23, CI: 1.04, 1.46). <b><i>Conclusions/Interpretation:</i></b> Insulin through MDI, longer duration of diabetes, and female sex were associated with lower frequency of partial remission. Use of CSII seems to contribute to longer partial remission among Swedish children with type 1 diabetes.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"851-861"},"PeriodicalIF":5.7,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141261066","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}
引用次数: 0
Accuracy of a Continuous Glucose Monitor in the Intensive Care Unit: A Proposed Accuracy Standard and Calibration Protocol for Inpatient Use. 重症监护室连续血糖监测仪的准确性:住院患者使用的准确性标准和校准规程建议。
IF 5.7 2区 医学
Diabetes technology & therapeutics Pub Date : 2024-11-01 Epub Date: 2024-06-24 DOI: 10.1089/dia.2024.0074
Sewon A Bann, Jess C Hercus, Paul Atkins, Areej Alkhairy, Jackson P Loyal, Mypinder Sekhon, David J Thompson
{"title":"Accuracy of a Continuous Glucose Monitor in the Intensive Care Unit: A Proposed Accuracy Standard and Calibration Protocol for Inpatient Use.","authors":"Sewon A Bann, Jess C Hercus, Paul Atkins, Areej Alkhairy, Jackson P Loyal, Mypinder Sekhon, David J Thompson","doi":"10.1089/dia.2024.0074","DOIUrl":"10.1089/dia.2024.0074","url":null,"abstract":"<p><p><b><i>Background and</i> <i>Aims:</i></b> Guidelines now recommend inpatient continuous glucose monitor (CGM) use with confirmatory blood glucose measurements. However, the Food and Drug Administration has not yet officially approved CGM for inpatient use in large part because its accuracy has not been established in this setting. We tested the accuracy of the Dexcom G6 (G6) in 28 adults on an insulin infusion in a medical-surgical intensive care unit with 1064 matched CGM and arterial point-of-care pairs. <b><i>Methods:</i></b> The participants were on average 57.29 (SD 2.39) years, of whom 13 had a prior diagnosis of diabetes and 14 were admitted for a surgical diagnosis. The first 19 participants received the G6 without calibration and had a mean absolute relative difference (MARD) of 13.19% (IQR 5.11, 19.03) across 659 matched pairs, which just meets the critical care expert recommendation of MARD <14%. We then aimed to improve accuracy for the subsequent 9 participants using a calibration protocol. <b><i>Results:</i></b> The MARD for calibrated participants was 9.65% (3.03, 13.33), significantly lower than for uncalibrated participants (<i>P</i> < 0.001). Calibration also demonstrated excellent safety with 100% of values within the Clarke Error Grid zones A and B compared with 99.07% without calibration. Our protocol achieved the lowest MARD and safest CEG profile in the critical care setting and well exceeds the critical care expert recommendations. Our large sample of heterogenous critically ill patients also reached comparable accuracy to the MARD of 9% for G6 in outpatients. We believe our calibration protocol will allow G6 to be used with sufficient accuracy in inpatients.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"797-805"},"PeriodicalIF":5.7,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141442295","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}
引用次数: 0
The Feasibility of an Experimental Hypobaric Simulation to Evaluate the Safety of Closed-Loop Insulin Delivery Systems in Flight-Related Atmospheric Pressure Changes. 低气压模拟实验评估闭环胰岛素输送系统在飞行相关气压变化中的安全性的可行性。
IF 5.7 2区 医学
Diabetes technology & therapeutics Pub Date : 2024-10-24 DOI: 10.1089/dia.2024.0380
Ka Siu Fan, Fariba Shojaee-Moradie, Antonios Manoli, Petra M Baumann, Gerd Koehler, Victoria Edwards, Vivienne Lee, Chantal Mathieu, Julia K Mader, David Russell-Jones
{"title":"The Feasibility of an Experimental Hypobaric Simulation to Evaluate the Safety of Closed-Loop Insulin Delivery Systems in Flight-Related Atmospheric Pressure Changes.","authors":"Ka Siu Fan, Fariba Shojaee-Moradie, Antonios Manoli, Petra M Baumann, Gerd Koehler, Victoria Edwards, Vivienne Lee, Chantal Mathieu, Julia K Mader, David Russell-Jones","doi":"10.1089/dia.2024.0380","DOIUrl":"https://doi.org/10.1089/dia.2024.0380","url":null,"abstract":"<p><p>Hybrid closed-loop (HCL) systems remain underexplored within aviation, and as atmospheric pressure changes can independently affect insulin pumps and continuous glucose monitoring readings, this preliminary study assessed the feasibility of HCL safety evaluation, in both fasting and post-prandial states, by using hypobaric chamber to simulate flights. Participants with type 1 diabetes and on HCL were studied: Medtronic Guardian 4-Medtronic 780G-SmartGuard (<i>n</i> = 4), Dexcom G6-Omnipod DASH-Android APS (<i>n</i> = 1), and Dexcom G6-Ypsomed Pump-CamAPS (<i>n</i> = 1). Flight cabin pressures of 550 mmHg and 750 mmHg were simulated in a hypobaric chamber. Seven-hundred-50 glucose measurements were taken, with glucose levels demonstrating a stable decline to 4 mmol/L during fasting. To maintain a tight fasting and post-prandial glucose range across the different pressure settings, the HCL administered insulin as expected. While not demonstrating any apparent issues, repeating flight simulation protocol with other systems, examining longer flights, and undertaking larger, powered randomised controlled trials can confirm their safety in aviation.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":""},"PeriodicalIF":5.7,"publicationDate":"2024-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142496843","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}
引用次数: 0
Possible Glycemic Effects of Vagus Nerve Stimulation Evaluated by Continuous Glucose Monitoring in People with Diabetes and Autonomic Neuropathy: A Randomized, Sham-Controlled Trial. 通过连续血糖监测评估迷走神经刺激对糖尿病和自主神经病变患者可能产生的降糖效果:随机、假对照试验。
IF 5.7 2区 医学
Diabetes technology & therapeutics Pub Date : 2024-10-24 DOI: 10.1089/dia.2024.0175
Huda Kufaishi, Davide Bertoli, Ditte Smed Kornum, Ajenthen Gayathri Ranjan, Kirsten Nørgaard, Klaus Krogh, Birgitte Brock, Tina Okdahl, Jens Brøndum Frøkjær, Asbjørn Mohr Drewes, Christina Brock, Filip Krag Knop, Tine Willum Hansen, Christian Stevns Hansen, Peter Rossing
{"title":"Possible Glycemic Effects of Vagus Nerve Stimulation Evaluated by Continuous Glucose Monitoring in People with Diabetes and Autonomic Neuropathy: A Randomized, Sham-Controlled Trial.","authors":"Huda Kufaishi, Davide Bertoli, Ditte Smed Kornum, Ajenthen Gayathri Ranjan, Kirsten Nørgaard, Klaus Krogh, Birgitte Brock, Tina Okdahl, Jens Brøndum Frøkjær, Asbjørn Mohr Drewes, Christina Brock, Filip Krag Knop, Tine Willum Hansen, Christian Stevns Hansen, Peter Rossing","doi":"10.1089/dia.2024.0175","DOIUrl":"https://doi.org/10.1089/dia.2024.0175","url":null,"abstract":"<p><p><b><i>Objective:</i></b> Autonomic neuropathy is associated with dysglycemia that is difficult to control. We investigated if transcutaneous vagus nerve stimulation (tVNS) could improve glycemic levels. <b><i>Methods:</i></b> We randomized 145 individuals with type 1 diabetes (T1D) (<i>n</i> = 70) or type 2 diabetes (T2D) (<i>n</i> = 75) and diabetic autonomic neuropathy (DAN) to self-administered treatment with active cervical tVNS (<i>n</i> = 68) or sham (<i>n</i> = 77) for 1 week (4 daily stimulations) and 8 weeks (2 daily stimulations), separated by a wash-out period of at least 2 weeks. Continuous glucose monitoring (CGM) indices were measured for 104 participants starting 5 days prior to intervention periods, during the 1-week period, and at end of the 8-week period. Primary outcomes were between-group differences in changes in coefficient of variation (CV) and in time in range (TIR 3.9-10 mmol/L). Secondary outcomes were other metrics of CGM and HbA1c. <b><i>Results:</i></b> For the 1-week period, median [interquartile range] changes of CV from baseline to follow-up were -1.1 [-4.3;2.0] % in active and -1.5 [-4.4;2.5] % in sham, with no significance between groups (<i>P</i> = 0.54). For TIR, the corresponding changes were 2.4 [-2.1;7.4] % in active and 5.1 [-2.6;8.8] in sham group (<i>P</i> = 0.84). For the 8-week treatment period, changes in CV and TIR between groups were also nonsignificant. However, in the subgroup analysis, persons with T1D receiving active tVNS for 8 weeks had a significant reduction in CV compared with the T1D group receiving sham stimulation (estimated treatment effect: -11.6 [95% confidence interval -20.2;-2.0] %, <i>P</i> = 0.009). None of the changes in secondary outcomes between treatment groups were significantly different. <b><i>Conclusions:</i></b> Overall, no significant changes were observed in CGM metrics between treatment arms, while individuals with T1D and DAN decreased their CV after 8 weeks of tVNS treatment.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":""},"PeriodicalIF":5.7,"publicationDate":"2024-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142496842","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}
引用次数: 0
Insulin Pump Use and Diabetic Ketoacidosis Risk in Type 1 Diabetes: Secular Trends over Four Decades. 1 型糖尿病患者使用胰岛素泵与糖尿病酮症酸中毒风险:四十年来的长期趋势
IF 5.7 2区 医学
Diabetes technology & therapeutics Pub Date : 2024-10-10 DOI: 10.1089/dia.2024.0272
Dalton R Budhram, Priya Bapat, Abdulmohsen Bakhsh, Mohammad I Abuabat, Natasha J Verhoeff, Doug Mumford, Wajeeha Cheema, Andrej Orszag, Akshay Jain, David Z I Cherney, Michael Fralick, Bader N Alamri, Alanna Weisman, Leif Erik Lovblom, Bruce A Perkins
{"title":"Insulin Pump Use and Diabetic Ketoacidosis Risk in Type 1 Diabetes: Secular Trends over Four Decades.","authors":"Dalton R Budhram, Priya Bapat, Abdulmohsen Bakhsh, Mohammad I Abuabat, Natasha J Verhoeff, Doug Mumford, Wajeeha Cheema, Andrej Orszag, Akshay Jain, David Z I Cherney, Michael Fralick, Bader N Alamri, Alanna Weisman, Leif Erik Lovblom, Bruce A Perkins","doi":"10.1089/dia.2024.0272","DOIUrl":"https://doi.org/10.1089/dia.2024.0272","url":null,"abstract":"<p><p><b><i>Introduction:</i></b> Continuous subcutaneous insulin infusion (CSII) in type 1 diabetes has been regarded as a major diabetic ketoacidosis (DKA) risk factor. We aimed to determine secular trends in risk since CSII implementation in the 1980s. <b><i>Research Design and Methods:</i></b> We assessed the relationship between time-varying CSII use and DKA events from 1983 to 2017 and by each decade in the 1441 Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Study participants using crude and adjusted Cox proportional hazards models. <b><i>Results:</i></b> Time-varying CSII exposure was associated with significantly higher DKA risk in the 1980s (adjusted hazard ratio [HR] 5.81; 95% confidence interval [CI] 3.28-10.29; <i>P</i> < 0.001), but in the 2010s, this risk was not significantly elevated (adjusted HR 1.24; 95% CI 0.73-2.12; <i>P</i> = 0.43). <b><i>Conclusions:</i></b> DKA risk associated with CSII in type 1 diabetes has declined substantially since the 1980s such that the remaining risk in the past decade appears to be of low magnitude.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":""},"PeriodicalIF":5.7,"publicationDate":"2024-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142460184","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}
引用次数: 0
Transitioning from Self-Monitoring of Blood Glucose to Continuous Glucose Monitoring in Combination with a mHealth App Improves Glycemic Control in People with Type 1 and Type 2 Diabetes. 从 SMBG 过渡到 CGM 并结合移动医疗应用程序可改善 1 型和 2 型糖尿病患者的血糖控制。
IF 5.7 2区 医学
Diabetes technology & therapeutics Pub Date : 2024-10-08 DOI: 10.1089/dia.2024.0169
Josip Zivkovic, Michael Mitter, Delphine Theodorou, Johanna Kober, Wiebke Mueller-Hoffmann, Heather Mikulski
{"title":"Transitioning from Self-Monitoring of Blood Glucose to Continuous Glucose Monitoring in Combination with a mHealth App Improves Glycemic Control in People with Type 1 and Type 2 Diabetes.","authors":"Josip Zivkovic, Michael Mitter, Delphine Theodorou, Johanna Kober, Wiebke Mueller-Hoffmann, Heather Mikulski","doi":"10.1089/dia.2024.0169","DOIUrl":"10.1089/dia.2024.0169","url":null,"abstract":"<p><p><b><i>Introduction:</i></b> Integrating mobile health (mHealth) apps into daily diabetes management allows users to monitor and track their health data, creating a comprehensive system for managing daily diabetes activities and generating valuable real-world data. This analysis investigates the impact of transitioning from traditional self-monitoring of blood glucose (SMBG) to real-time continuous glucose monitoring (rtCGM), alongside the use of a mHealth app, on users' glycemic control. <b><i>Methods:</i></b> Data were collected from 1271 diabetes type 1 and type 2 users of the mySugr<sup>®</sup> app who made a minimum of 50 SMBG logs 1 month before transitioning to rtCGM and then used rtCGM for at least 6 months. The mean and coefficient of variation of glucose, along with the proportions of glycemic measurements in and out of range, were compared between baseline and 1, 2, 3, and 6 months of rtCGM use. A mixed-effects linear regression model was built to quantify the specific effects of transitioning to a rtCGM sensor in different subsamples. A novel validation analysis ensured that the aggregated metrics from SMBG and rtCGM were comparable. <b><i>Results:</i></b> Transitioning to a rtCGM sensor significantly improved glycemic control in the entire cohort, particularly among new users of the mySugr app. Additionally, the sustainability of the change in glucose in the entire cohort was confirmed throughout the observation period. People with type 1 and type 2 diabetes exhibited distinct variations, with type 1 experiencing a greater reduction in glycemic variance, while type 2 displayed a relatively larger decrease in monthly averages.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":""},"PeriodicalIF":5.7,"publicationDate":"2024-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142281840","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}
引用次数: 0
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