المؤلفون: ROBERT A. VIGERSKY, BRUCE W. BODE, RONALD L. BRAZG, BRUCE A. BUCKINGHAM, ANDERS L. CARLSON, KEVIN B. KAISERMAN, MARK KIPNES, DAVID R. LILJENQUIST, ATHENA PHILIS-TSIMIKAS, CATHERINE PIHOKER, RODICA POP-BUSUI, JOHN REED, JENNIFER SHERR, DOROTHY I. SHULMAN, ROBERT H. SLOVER, JAMES THRASHER, XIAOXIAO CHEN, MARGARET LIU, TONI L. CORDERO, MELISSA VELLA, ANDREW S. RHINEHART, JOHN SHIN

المصدر: Diabetes. 71

مصطلحات موضوعية: Endocrinology, Diabetes and Metabolism, Internal Medicine

الوصف: Background: Safety and effectiveness outcomes of individuals using the MiniMed™ 780G system with the no-calibration Guardian™ 4 sensor during the first three months of use were analyzed. Methods: Participants (N=176, aged 7-75 years) with T1D used the Conformitè Europëenne-marked MiniMed™ 780G system. Safety and effectiveness endpoints (mean A1C, sensor glucose [SG], percentage of time spent at SG ranges and glucose variability) were collected over three months and summarized. Endpoints were also assessed when recommended settings (target of 100mg/dL and active insulin time of 2-3 hours) were used. Results: There was no DKA or severe hypoglycemia. At 3 months, A1C was 7.1% (N=164) , 7.2% (N=101) and 6.8% (N=63) for overall, pediatric and adult participants, respectively. Additional glycemic metrics are shown (Table) . With recommended settings, time spent in target range (TIR, 70-180 mg/dL) was 74.7% (N=119) , 72.7% (N=65) and 77.0% (N=54) , respectively, and time spent below range (TBR Conclusion: This analysis demonstrates that individuals safely exceeded international consensus-recommended TIR and TBR goals when using the MiniMed™ 780G system with the Guardian™ 4 sensor. These results mirror those of the pivotal trial during use of the calibration-requiring Guardian™ sensor 3. Disclosure R. A. Vigersky: Employee; Medtronic. C. Pihoker: None. R. Pop-busui: Advisory Panel; Averitas Pharma, Inc., Boehringer Ingelheim International GmbH, Nevro Corp., Novo Nordisk, Reata Pharmaceuticals, Inc., Regenacy Pharmaceuticals, Inc. J. Reed: None. J. Sherr: Advisory Panel; Bigfoot Biomedical, Inc., Cecelia Health, Insulet Corporation, Medtronic, Vertex Pharmaceuticals Incorporated, Consultant; Insulet Corporation, Lexicon Pharmaceuticals, Inc., Research Support; Dexcom, Inc., Insulet Corporation, Jaeb Center for Health Research, JDRF, Medtronic, National Institute of Diabetes and Digestive and Kidney Diseases, Speaker’s Bureau; Lilly Diabetes. D. I. Shulman: Advisory Panel; Medtronic. R. H. Slover: None. J. Thrasher: Advisory Panel; Eli Lilly and Company, Medtronic, Board Member; Medtronic, Consultant; Eli Lilly and Company, Medtronic, Research Support; Eli Lilly and Company, Medtronic, Novo Nordisk, Speaker’s Bureau; Bayer AG, Eli Lilly and Company, Medtronic, Sanofi. X. Chen: Employee; Medtronic, Medtronic. M. Liu: None. T. L. Cordero: Employee; Medtronic, Medtronic. B. W. Bode: Advisory Panel; CeQur SA, MannKind Corporation, Medtronic, Novo Nordisk, Zealand Pharma A/S, Consultant; Bigfoot Biomedical, Inc., Research Support; Abbott, Beta Bionics, Inc., Dexcom, Inc., Diasome, Dompé, Eli Lilly and Company, Insulet Corporation, IQVIA Inc., Jaeb Center for Health Research, Medtronic, Novo Nordisk, Provention Bio, Inc., REMD Biotherapeutics, Sanvita Medical, Senseonics, ViaCyte, Inc., Speaker’s Bureau; Abbott, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Insulet Corporation, MannKind Corporation, Novo Nordisk, Sanofi, Xeris Pharmaceuticals, Inc., Stock/Shareholder; AgaMatrix, Glytec, LLC. M. Vella: Employee; Medtronic. A. S. Rhinehart: Employee; Medtronic, Stock/Shareholder; Medtronic. J. Shin: Employee; Medtronic. R. L. Brazg: Research Support; Abbott Diabetes, Lilly Diabetes, Medtronic, Novo Nordisk, Roche Diagnostics, Senseonics. B. A. Buckingham: Advisory Panel; Arecor, Lilly Diabetes, Medtronic, Other Relationship; Insulet Corporation, Research Support; Insulet Corporation, Lilly Diabetes, Medtronic. A. L. Carlson: Advisory Panel; MannKind Corporation, Employee; Bright Health Group, Other Relationship; Medtronic, Research Support; Abbott Diabetes, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Novo Nordisk, Sanofi, UnitedHealth Group. K. B. Kaiserman: Advisory Panel; Medtronic, Consultant; Medtronic, Employee; MannKind Corporation, Research Support; Medtronic, Speaker’s Bureau; Medtronic, Stock/Shareholder; MannKind Corporation. M. Kipnes: None. D. R. Liljenquist: None. A. Philis-tsimikas: Advisory Panel; Bayer AG, Novo Nordisk, Research Support; Lilly Diabetes, National Institute of Diabetes and Digestive and Kidney Diseases, Novo Nordisk, Viking Therapeutics.

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_________::2ad1ab3c86af12c2910313a11fd45e99Test
https://doi.org/10.2337/db22-100-lbTest

المؤلفون: MADISON SMITH, GLEN HEUNGYONG IM, ANGELA GAETANO, SNEHA THANASEKARAN, JANICE MACLEOD, ROBERT A. VIGERSKY

المصدر: Diabetes. 71

مصطلحات موضوعية: Endocrinology, Diabetes and Metabolism, Internal Medicine

الوصف: Background: Previous InPen decision tree modeling (DTM) in adults indicated that missed meal dosing was a major modifiable factor associated with TIR (70-180mg/dL) . We used DTM to find characteristics/use-behaviors associated with TIR for InPen+CGM users Methods: InPen+CGM data from youth (N=883) with T1D starting InPen between 7/20 and 6/21 were used to identify characteristics (prior delivery method, diabetes duration) and use-behaviors (frequency of missed/correction doses, priming/bolus count, meal therapy mode, InPen bolus calculator use, app reminders, time settings, and report generation) associated with TIR. A variance inflation factor >10 was used to reduce multicollinearity for feature importance. Those with insufficient CGM and/or bolus data and lack of consistent insulin therapy settings were excluded. Results: DTM of users determined 1) diabetes duration, 2) frequency of missed meal doses, 3) bolus count and 4) correction frequency as the top variables associated with TIR (Figure) . Highest average TIR (68.0%) was observed in newly diagnosed (≤1 year) users. Users with >2 years diabetes duration, 35.1% missed dose frequency demonstrated lowest average TIR (35%) . Conclusions: DTM is a novel application for understanding glycemic outcomes due to modifiable and non-modifiable factors. Disclosure M. Smith: Employee; Medtronic. G. Im: Employee; Medtronic. A. Gaetano: None. S. Thanasekaran: None. J. Macleod: Employee; Medtronic. R. A. Vigersky: Employee; Medtronic.

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_________::5eb84eafbbe3c9e2ff1bde4f9b26471bTest
https://doi.org/10.2337/db22-152-lbTest

المؤلفون: ROBERT A. VIGERSKY, JAVIER CASTAÑEDA, ARCELIA ARRIETA, TONI L. CORDERO, ANDREW S. RHINEHART, JOHN SHIN

المصدر: Diabetes. 71

مصطلحات موضوعية: Endocrinology, Diabetes and Metabolism, Internal Medicine

الوصف: Objective: The MiniMed™ 780G system with the adjunctive Guardian™ sensor 3 that requires calibration has been commercially available in Europe, since October 2020. Since October 2021, the system has been available with the non-adjunctive Guardian™ 4 sensor, which does not require calibration. In this study, glycemic outcomes during real-world MiniMed™ 780G system use with both sensors were evaluated. Methods: Analyses were based on data collected on Dec 10, 2021, from consenting system users (N=674) residing in Europe with ≥days of sensor glucose (SG) data from both sensors. Glycemic outcomes including mean±SD of the glucose management indicator (GMI) and percentage of time spent in target range of 70-180mg/dL (TIR) , at 180mg/dL (TAR) were assessed. The time spent in AHCL, number of AHCL exits/week and self-monitoring of blood glucose (SMBG) measurements/day were also determined. Results: System use with the Guardian™ 4 sensor versus Guardian™ sensor 3 demonstrated 94±9% vs 93±11% of time in AHCL, 73.1±11.4% vs 74.6±9.8% TIR, 0.11±0.16% vs 0.51±0.58% TBR180. The GMI was 6.98±0.43% vs 6.84±0.38%. Closed-loop exits were 0.83±1.02 vs 1.1±1.06/week and SMBG measurements were 0.9±0.9 vs 3.3±0.9/day. Conclusion: Real-world MiniMed™ 780G system use findings indicate reduced burden related to SMBG measurements and closed-loop exits, with the Guardian™ 4 sensor, while maintaining favorable glycemic outcomes of the MiniMed™ 780G + Guardian™ sensor 3 system. Disclosure R.A. Vigersky: Employee; Medtronic. J. Castañeda: Employee; Medtronic. A. Arrieta: Employee; Medtronic. T.L. Cordero: Employee; Medtronic, Medtronic. A.S. Rhinehart: Employee; Medtronic. Stock/Shareholder; Medtronic. J. Shin: Employee; Medtronic.

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_________::33fb89637ef5b897d23ed6770e73a3b3Test
https://doi.org/10.2337/db22-763-pTest

المؤلفون: MALLIKA KOMMAREDDI, KAEL WHERRY, ROBERT A. VIGERSKY

المصدر: Diabetes. 71

مصطلحات موضوعية: Endocrinology, Diabetes and Metabolism, Internal Medicine

الوصف: Objective: Recent research highlighted racial and ethnic inequities in the use of diabetes technology among Medicare Fee-For-Service beneficiaries with type 1 diabetes. This study considers inequities among Medicare Advantage beneficiaries. Methods: We assessed use of continuous glucose monitoring (CGM) and insulin pump technologies among beneficiaries with type 1 diabetes using a national database of health care claims between 2018 and 2020. The prevalence of CGM, pump, and combined technology was assessed annually (N = 17231 in 2018; N = 16298 in 2019; N = 15877 in 2020) by race and ethnicity. Within each year and type of technology, chi-square tests assessed differences in use between racial and ethnic groups. Results: Prevalence of diabetes technology increased within each racial and ethnic group over the study period. There were significant differences in technology use between groups by year (p < 0.001) . In 2020, 37.1% of White beneficiaries used CGM devices, compared to 27.8% of Asian, 25.8% of Black, and 21.0% of Hispanic beneficiaries. The absolute difference in CGM use between White beneficiaries and those in other groups was stable or increased from 2018 to 2020. Similar trends were observed in pump use alone or with CGM. Conclusion: While prevalence of diabetes technology increased across all racial and ethnic groups from 2018 to 2020, racial and ethnic inequities have persisted. Disclosure M.Kommareddi: Employee; Medtronic. K.Wherry: Employee; Medtronic. R.A.Vigersky: Employee; Medtronic.

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_________::8209ec08c1e7ddac4e48a1299d933709Test
https://doi.org/10.2337/db22-1264-pTest

المؤلفون: Kevin T. Nguyen, Nicole Y. Xu, Bruce A. Buckingham, Sarnath Chattaraj, Ohad Cohen, Lutz Heinemann, John Pickup, Jannet Svensson, Robert A. Vigersky, Jenise C. Wong, Ralph Ziegler

المصدر: Journal of diabetes science and technology, vol 16, iss 3
J Diabetes Sci Technol

مصطلحات موضوعية: insulin, Nutrition and Dietetics, diabetes, Endocrinology, Diabetes and Metabolism, Biomedical Engineering, Proceedings of Meetings/Conferences, Bioengineering, Autoimmune Disease, infusion set, longer wear, Patient Outcome Assessment, Diabetes Mellitus, Type 1, Insulin Infusion Systems, Clinical Research, insulin pump, Internal Medicine, Diabetes Mellitus, Insulin, Humans, Hypoglycemic Agents, waste, Metabolic and endocrine, Type 1, Biotechnology

الوصف: Continuous subcutaneous insulin infusion (CSII) therapy is becoming increasingly popular. CSII provides convenient insulin delivery, precise dosing, easy adjustments for physical activity, stress, or illness, and integration with continuous glucose monitors in hybrid or other closed-loop systems. However, even as insulin pump hardware and software have advanced, technology for insulin infusion sets (IISs) has stayed relatively stagnant over time and is often referred to as the “Achilles heel” of CSII. To discuss barriers to insulin pump therapy and present information about advancements in, and results from clinical trials of extended wear IISs, Diabetes Technology Society virtually hosted the “Improving the Patient Experience with Longer Wear Infusion Sets Symposium” on December 1, 2021. The symposium featured experts in the field of IISs, including representatives from Steno Diabetes Center Copenhagen, University of California San Francisco, Stanford University, Medtronic Diabetes, and Science Consulting in Diabetes. The webinar’s seven speakers covered (1) advancements in insulin pump therapy, (2) efficacy of longer wear infusion sets, and (3) innovations to reduce plastics and insulin waste.

وصف الملف: application/pdf

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::65fe295d6ade6f4950575b5ae8874aeaTest
https://escholarship.org/uc/item/1cx1m7xnTest

المؤلفون: Junfen Fu, jianwei zhang, Wei Wu, Ke Huang, Ruimin Chen, Mireguli Maimaiti, Jing-Si Luo, Shao-Ke Chen, Jieming Zhong, Di Wu, Min Zhu, Chun-Lin Wang, Zhe Su, Yan Liang, Hui Yao, Haiyan Wei, Rongxiu Zheng, Hong-Wei Du, Fei-Hong Luo, Pin Li, MinJia Mo, Yun-Xian Yu, Er-Gang Wang, Robert A. Vigersky

المصدر: SSRN Electronic Journal.

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_________::bf7ac614d8fd342b395114e4643b31beTest
https://doi.org/10.2139/ssrn.4062764Test

المؤلفون: Lee Ling Lim, Andreas Thomas, Suresh Chandran, Jeyakantha Ratnasingam, Alexander Tong Boon Tan, Robert A. Vigersky, Daphne Gardner

المصدر: Diabetes Technology & Therapeutics. 22:103-111

مصطلحات موضوعية: Adult, Blood Glucose, Male, medicine.medical_specialty, Time Factors, endocrine system diseases, Endocrinology, Diabetes and Metabolism, 030209 endocrinology & metabolism, Type 2 diabetes, Hypoglycemia, Single measure, 03 medical and health sciences, Hba1c level, 0302 clinical medicine, Endocrinology, Internal medicine, Diabetes mellitus, Humans, Hypoglycemic Agents, Insulin, Medicine, 030212 general & internal medicine, Diabetes types, Glycated Hemoglobin, Type 1 diabetes, business.industry, Blood Glucose Self-Monitoring, digestive, oral, and skin physiology, nutritional and metabolic diseases, Middle Aged, Prognosis, medicine.disease, Medical Laboratory Technology, Cross-Sectional Studies, Diabetes Mellitus, Type 1, Glycemic index, Diabetes Mellitus, Type 2, Glycemic Index, Hyperglycemia, Female, sense organs, business, hormones, hormone substitutes, and hormone antagonists

الوصف: Background: Complex changes of glycemia that occur in diabetes are not fully captured by any single measure. The Comprehensive Glucose Pentagon (CGP) measures multiple aspects of glycemia to genera...

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e1c49f9966611bbe6ca5b821adb67356Test
https://doi.org/10.1089/dia.2019.0277Test

المؤلفون: Yuqian Bao, Yun Shen, Wei Lu, Robert A. Vigersky, Weiping Jia, Qiang Wu, Wei Zhu, Yifei Mo, Xiaojing Ma, Lei Zhang, Jian Zhou, Ren Wang, Jingyi Lu

المصدر: Diabetes Technology & Therapeutics. 22:72-78

مصطلحات موضوعية: Blood Glucose, Male, medicine.medical_specialty, Time Factors, Endocrinology, Diabetes and Metabolism, 030209 endocrinology & metabolism, Type 2 diabetes, Carotid Intima-Media Thickness, digestive system, 03 medical and health sciences, 0302 clinical medicine, Endocrinology, Diabetes mellitus, Internal medicine, parasitic diseases, Prevalence, Humans, Medicine, 030212 general & internal medicine, Aged, Glycemic, business.industry, Continuous glucose monitoring, Blood Glucose Self-Monitoring, Middle Aged, biochemical phenomena, metabolism, and nutrition, medicine.disease, Medical Laboratory Technology, Cross-Sectional Studies, Logistic Models, Diabetes Mellitus, Type 2, Intima-media thickness, Cardiovascular Diseases, Heart Disease Risk Factors, Cardiology, Female, business, Biomarkers

الوصف: Background: Time in range (TIR) is an emerging metric of glycemic control and is reported to be associated with microvascular complications of diabetes. We sought to investigate the association of ...

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e19829d8538b40958c8bdcdff5e879c7Test
https://doi.org/10.1089/dia.2019.0251Test

المؤلفون: Kael Wherry, Cyrus Zhu, Robert A Vigersky

المصدر: The Journal of clinical endocrinology and metabolism. 107(5)

مصطلحات موضوعية: Blood Glucose, Technology, Endocrinology, Diabetes and Metabolism, Blood Glucose Self-Monitoring, Biochemistry (medical), Clinical Biochemistry, Medicare, Biochemistry, United States, Endocrinology, Diabetes Mellitus, Type 1, Humans, Insulin, Aged

الوصف: Context Health inequity is often associated with race-ethnicity. Objective To determine the prevalence of insulin pump therapy and continuous glucose monitoring (CGM) among Medicare beneficiaries with type 1 diabetes (T1D) by race-ethnicity, and to compare diabetes-related technology users with nonusers. Design The prevalence of technology use (pump, CGM) was determined by race-ethnicity for enrollees in coverage years (CY) 2017-2019 in the Medicare fee-for-service database. Using CY2019 data, technology users were compared with nonusers by race-ethnicity, sex, average age, Medicare eligibility criteria, and visit to an endocrinologist. Setting Community Patients or Other Participants Beneficiaries with T1D and at least 1 inpatient or 2 outpatient claims in a CY. Intervention(s) Pump or CGM therapy, visit to an endocrinologist. Main Outcome Measure(s) Diabetes-related technology use by race-ethnicity groups. Results Between 2017 and 2019, CGM and insulin pump use increased among all groups. Prevalence of insulin pump use was Conclusions Significant race-ethnicity associated differences existed in T1D management. The gap in diabetic technology adoption between Black and White beneficiaries grew between 2017 and 2019.

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::dbb8c851b25578773556eb941f24f168Test
https://pubmed.ncbi.nlm.nih.gov/34910144Test

المؤلفون: Benjamin J, Wheeler, Olivia J, Collyns, Renee A, Meier, Zara L, Betts, Chris, Frampton, Carla M, Frewen, Barbara, Galland, Niranjala M, Hewapathirana, Shirley D, Jones, Denis S H, Chan, Anirban, Roy, Benyamin, Grosman, Natalie, Kurtz, John, Shin, Robert A, Vigersky, Martin I, de Bock

المصدر: Acta diabetologica. 59(1)

مصطلحات موضوعية: Adult, Blood Glucose, Technology, Cross-Over Studies, Adolescent, Blood Glucose Self-Monitoring, Personal Satisfaction, Young Adult, Diabetes Mellitus, Type 1, Insulin Infusion Systems, Sleep Quality, Quality of Life, Humans, Hypoglycemic Agents, Insulin, Child

الوصف: Automated insulin delivery aims to lower treatment burden and improve quality of life as well as glycemic outcomes.We present sub-study data from a dual-center, randomized, open-label, two-sequence crossover study in automated insulin delivery naïve users, comparing Medtronic MiniMed® Advanced Hybrid Closed-Loop (AHCL) to Sensor Augmented Pump therapy with Predictive Low Glucose Management (SAP + PLGM). At the end of each 4-week intervention, impacts on quality of life, sleep and treatment satisfaction were compared using seven age-appropriate validated questionnaires given to patients or caregivers.59/60 people completed the study (mean age 23.3 ± 14.4yrs). Statistically significant differences favoring AHCL were demonstrated in several scales (data shown as mean ± SE). In adults (≥ 18yrs), technology satisfaction favored AHCL over PLGM as shown by a higher score in the DTSQs during AHCL (n = 28) vs SAP + PLGM (n = 29) (30.9 ± 0.7 vs 27.9 ± 0.7, p = 0.004) and DTSQc AHCL (n = 29) vs SAP + PLGM (n = 30) (11.7 ± 0.9 vs 9.2 ± 0.8, p = 0.032). Adolescents (aged 13-17yrs) also showed a higher DTSQc score during AHCL (n = 16) versus SAP + PLGM (n = 15) (14.8 ± 0.7 vs 12.1 ± 0.8, p = 0.024). The DTQ "change" score (n = 59) favored AHCL over SAP + PLGM (3.5 ± 0.0 vs 3.3 ± 0.0, p 0.001). PSQI was completed in those 16 years (n = 36) and demonstrated improved sleep quality during AHCL vs SAP + PLGM (4.8 ± 0.3 vs 5.7 ± 0.3, p = 0.048) with a total score 5 indicating poor quality sleep.These data suggest that AHCL compared to SAP + PLGM mode has the potential to increase treatment satisfaction and improve subjective sleep quality in adolescents and adults with T1D.

الوصول الحر: https://explore.openaire.eu/search/publication?articleId=pmid________::c115d228ef30a11988e839c199a6b581Test
https://pubmed.ncbi.nlm.nih.gov/34453208Test