يعرض 11 - 20 نتائج من 222 نتيجة بحث عن '"Francine R. Kaufman"', وقت الاستعلام: 1.75s تنقيح النتائج
  1. 11

    المصدر: Diabetes. 70

    الوصف: Background: The prospective, multi-center PROMISE study evaluated the safety and accuracy of the next generation Eversense CGM System for up to 180 days in 181 adults with diabetes at 8 US clinical sites. Methods: Accuracy was evaluated by comparing CGM and reference values from Yellow Springs Instruments (YSI) during 10 clinic visits from day 1-180, which included hyperglycemia and hypoglycemia challenges. Eighty-five and 96 subjects had 1 and 2 sensors inserted in the arm, respectively, with 2 replaced sensors for 279 sensors (558 insertions/removals). The CGM prompts 2 calibrations/day to day 21, after which it primarily prompts 1 calibration/day. Results: The Table shows accuracy analyses based on 49,613 matched pairs over 180 days. Percent CGM readings within 15/15% and 20/20% of YSI values was 85.6% and 92.9%, respectively, and the MARD was 9.1%. MARDs across different glucose ranges from 40-400 mg/dL were ≤9.4% (Table). The confirmed hypoglycemia detection rates at 70mg/dL and 60 mg/dL were 93% and 87%, respectively. Hyperglycemia at 180mg/dL was detected in 99%. There were no device or insertion/removal procedure-related serious adverse events. Two mild skin infections occurred for a rate of 0.36% per procedure. Conclusion: These results indicate the next generation Eversense long-term implantable CGM System has sustained accuracy and safety up to 180 days with primarily one calibration/day. Disclosure S. K. Garg: Advisory Panel; Self; Eli Lilly and Company, Medtronic, Novo Nordisk Inc., Zealand Pharma A/S, Research Support; Self; Dexcom, Inc., Eli Lilly and Company, Medtronic. A. D. Dehennis: Employee; Self; Senseonics. K. Tweden: Employee; Self; Senseonics. F. R. Kaufman: Advisory Panel; Self; Virta Health Corp., Employee; Self; Senseonics, Stock/Shareholder; Self; Medtronic. D. R. Liljenquist: Research Support; Self; Abbott Diabetes, AbbVie Inc., Ascensia Diabetes Care, Dexcom, Inc., Drawbridge Health, Inc., Eyenuk, Inc., Jaeb Center for Health Research, Medtronic, Provention Bio, Inc., Senseonics. B. W. Bode: Advisory Panel; Self; Eli Lilly and Company, Consultant; Self; Bigfoot Biomedical, Inc., Companion Medical, Lexicon Pharmaceuticals, Inc., Medtronic, Novo Nordisk Inc., Zealand Pharma A/S, Research Support; Self; Abvance Therapeutics, Dexcom, Inc., Diasome Pharmaceuticals, Inc., Dompe, Eli Lilly and Company, Eyenuk, Inc., Insulet Corporation, Jaeb Center for Health Research, Medtronic, Nova Biomedical, Novo Nordisk, Provention Bio, Inc., REMD Biotherapeutics, Sanofi, Senseonics, Viacyte, Inc., vTv Therapeutics, Xeris Pharmaceuticals, Inc., Speaker’s Bureau; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, MannKind Corporation, Medtronic, Novo Nordisk, Sanofi, Stock/Shareholder; Self; AgaMatrix, Aseko, Inc., Glytec, LLC. M. P. Christiansen: Research Support; Self; Abbott Diabetes, Biolinq, Dexcom, Inc., Eli Lilly and Company, Medtronic, Merck & Co., Inc., Novo Nordisk A/S, Pfizer Inc., Viacyte, Inc. T. S. Bailey: Consultant; Self; Abbott Diabetes, LifeScan, Novo Nordisk, Sanofi, Research Support; Self; Abbott, Abbott Diabetes, Biolinq, Capillary Biomedical, Inc., Dexcom, Inc., Eli Lilly and Company, Kowa Research Institute, Inc., Lexicon Pharmaceuticals, Inc., Livongo, Medtronic, Medtrum Technologies, Novo Nordisk, REMD Biotherapeutics, Sanofi, Sanvita, Viacyte, Inc., vTv Therapeutics, Zealand Pharma A/S, Speaker’s Bureau; Self; BD, Medtronic, Sanofi. R. L. Brazg: Research Support; Self; Abbott Diabetes, Ascensia Diabetes Care, Lexicon Pharmaceuticals, Inc., Lilly Diabetes, Medtronic, Pfizer Inc., Roche Diagnostic USA, Senseonics. D. S. Denham: None. A. Chang: None. H. K. Akturk: Consultant; Self; American Diabetes Association, Research Support; Self; Dexcom, Inc., Eli Lilly and Company, IM Therapeutics, MannKind Corporation, REMD Biotherapeutics, Senseonics, Speaker’s Bureau; Self; American Diabetes Association. Funding Senseonics, Inc.

  2. 12

    المصدر: Diabetes. 69

    الوصف: Background: Data from the first ∼200 adult real-world U.S. users of the implantable 90-day fluorescence-based glucose sensor, Eversense CGM System, showed 62.3% time in range (TIR, glucose 70-180mg/dL) and 4.1% time 1600) of users with Eversense. Methods: Sensor glucose (SG) data were analyzed for users who reached a 90-day wear period. Mean SG, variability measures (SD, CV), glucose management indicator (GMI), and CGM metrics for 18-24.9, 25-44.9, 45-64.9, ≥65 years of age subgroups were computed. Transmitter wear time was calculated in users with at least 30 wear days. Results: We evaluated 1656 users (997 with T1D, 261 with T2D, 408 unreported). Percent time in range (TIR), time below ranges (180 mg/dL and >250 mg/dL) improved with age, with 52.6% and 69.0% TIR in the youngest and oldest groups, respectively (Table). Transmitter wear time was 82% overall and improved to 87% in those ≥65 years. Percent users achieving goals for targets also improved with age. Conclusion: Glycemic outcomes improved with age in a large cohort using the implantable Eversense CGM System. Younger adults had favorable outcomes compared to data from the T1D Exchange. Overall, these data suggest that the implanted Eversense CGM system is a valuable tool for management of diabetes. Disclosure K. Tweden: Employee; Self; Senseonics. S. Ghosh-Dastidar: Employee; Self; Senseonics. A.D. Dehennis: Employee; Self; Senseonics. F. Kaufman: Advisory Panel; Self; Virta Health Corp. Employee; Self; Senseonics. Stock/Shareholder; Self; Medtronic.

  3. 13
  4. 14

    المصدر: Diabetes Technology & Therapeutics

    الوصف: The Eversense® Continuous Glucose Monitoring (CGM) System, with the first long-term, implantable glucose sensor, has been commercially available in Europe and South Africa since 2016 for adults with diabetes. The performance of the sensor over multiple, sequential 90- or 180-day cycles from either real-world experience or clinical studies has not been previously published. The Eversense Data Management System (DMS) was used to evaluate the accuracy of General Data Protection Regulation (GDPR)-compliant sensor glucose (SG) values against self-monitoring of blood glucose (SMBG) from June 2016 through August 2019 among patients with at least four sensor cycles from European and South African health care practices. Mean SG and associated measures of variability, glucose management indicator (GMI), and percent and time in various hypoglycemic, euglycemic, and hyperglycemic ranges were calculated for the 24-h time period over each cycle. In addition, transmitter wear time was evaluated across each sensor wear cycle. Among the 945 users included in the analysis, the mean absolute relative difference (standard deviation [SD]) using 152,206, 174,645, 206,024, and 172,587 calibration matched pairs against SMBG was 11.9% (3.6%), 11.5% (4.0%), 11.8% (4.7%), and 11.5% (4.1%) during the first four sensor cycles, respectively. Mean values of the CGM metrics over the first sensor cycle were 156.5 mg/dL for SG, 54.7 mg/dL for SD, 0.35 for coefficient of variation, and 7.04% for GMI. Percent SG at different glycemic ranges was as follows: 180–250 mg/dL was 22.8% (328 min), and >250 mg/dL was 8.1% (117 min). The median transmitter wear time over the first cycle was 83.2%. CGM metrics and wear time were similar over the subsequent three cycles. This real-world evaluation of adult patients with diabetes using the Eversense CGM System in the home setting demonstrated that the implantable sensor provides consistent stable accuracy and CGM metrics over multiple, sequential sensor cycles with no indication of degradation of sensor performance.

  5. 15

    المصدر: Diabetes Technology & Therapeutics. 19:749-752

    الوصف: A 3-month pivotal trial using the MiniMed™ 670G hybrid closed-loop (HCL) system in adolescent and adult patients with type 1 diabetes (T1D), relative to a 2-week baseline run-in period, resulted in increased sensor glucose (SG) values in target range (71–180 mg/dL), reduced HbA1c levels, and no events of diabetic ketoacidosis or severe hypoglycemia (Clinicaltrials.gov: NCT02463097). This brief report evaluated how prior continuous glucose monitoring (CGM) experience influenced glycemic outcomes, in the same pivotal trial. HbA1c levels and the percentage of SG values in low, high, and in-target ranges were analyzed from participants (n = 124) completing the Hybrid Closed-Loop Pivotal Trial in T1D. There were 78 individuals comprising the prior CGM group and 46 comprising the no prior CGM group. Compared to baseline, HbA1c was reduced from 7.4% ± 0.9% to 6.9% ± 0.7% for the prior CGM group and from 7.5% ± 0.9% to 6.8% ± 0.5% for the no prior CGM group. For those with prior CGM experience, the mean ...

  6. 16
    دورية أكاديمية
  7. 17

    المصدر: Diabetes Technology & Therapeutics. 19:288-292

    الوصف: Predictions based on continuous glucose monitoring (CGM) data are the basis for automatic suspension and resumption of insulin delivery by a predictive low-glucose management feature termed "suspend before low," which is part of the Medtronic MiniMedIn-clinic standardized increases in basal insulin delivery rates were used to induce nocturnal hypoglycemia in subjects (14-75 years) with type 1 diabetes wearing the MiniMed 640G system. The "suspend before low" feature was set at 65 mg/dL, and as a result, the predictive algorithm suspended insulin delivery when the forecasted glucose was predicted to be ≤85 mg/dL in 30 min (a 20 mg/dL safety buffer). Reference plasma glucose values (Yellow Springs Instruments [YSI], Yellow Springs, OH) were used to establish hypoglycemia and were defined as ≥2 consecutive values ≤65 mg/dL.Eighty subjects were screened. Among the 69 successful completers, 27 experienced a hypoglycemic event and 42 did not, a prevention rate of 60%. The mean (±standard deviation) YSI value at the time of pump suspension was 101 ± 18.5 mg/dL, and the mean duration of the 68 "suspend before low" events was 105 ± 27 min. At 120 min after the start of the pump suspension events, the mean YSI value was 102 ± 34.6 mg/dL.The MiniMed 640G "suspend before low" feature prevented 60% of induced predicted hypoglycemic events without significant rebound hyperglycemia.

  8. 18

    المصدر: Diabetes Technology & Therapeutics. 18:657-663

    الوصف: Background: Automated insulin management features of the MiniMed® 640G sensor-augmented pump system include suspension in response to predicted low sensor glucose (SG) values (“suspend before low”), suspension in response to existing low SG values (“suspend on low”), and automatic restarting of basal insulin delivery upon SG recovery. The effectiveness of these features was evaluated using CareLink® software data. Methods: Anonymized data from MiniMed 640G system users (n = 4818), MiniMed 530G system users (n = 39,219), and MiniMed Paradigm® Veo™ system users (n = 43,193) who voluntarily uploaded pump and sensor data were retrospectively analyzed. Comparisons were made between days in which system features were enabled at any time and those in which they were not. Comparisons were also made between pump suspension events for which insulin delivery was automatically or manually resumed and between glycemic parameters of users who switched from the MiniMed Paradigm Veo system to the MiniMed 640G sy...

  9. 19

    المصدر: Diabetes. 68

    الوصف: Background: The MiniMed™ 670G system is FDA-approved and CE-marked for patients with T1D aged ≥7 years. Glycemic outcomes of patients aged 2-75 years with T1D using the system at home for 3 months were evaluated and compared. Methods: Data from 151 children (n=46, 2-6 years and n=105, 7-13 years) enrolled at 9 sites; and 124 adolescents and adults (n=30, 14-21 years and n=94, 22-75 years) enrolled at 10 sites, during 2-week Manual Mode use (run-in phase) followed by 3-month Auto Mode use (study phase) were analyzed. Glycemic outcomes (HbA1c, time spent at sensor glucose [SG] ranges, SG, and SG variability, etc.) were compared across age groups. Results: Data from run-in and study phases are shown (Table). Across age groups there was a 0.4% to 0.5% decrease in HbA1c and a 5.5% to 8.8% increase in time in range. During the study phases of the pediatric (2-13 years) and older cohort (14-75 years) trials, there were no episodes of severe hypoglycemia or DKA, and no serious device-related adverse events. Conclusions: These findings indicate that 3-month MiniMed™ 670G Auto Mode use in patients as young as two years of age with T1D, similar to older cohorts using the system, can safely improve glycemic outcomes compared to 2-week open-loop Manual Mode. Disclosure T.S. Bailey: Advisory Panel; Self; Abbott. Consultant; Self; Capillary Biomedical, Inc., Eli Lilly and Company, Medtronic, Novo Nordisk Inc., Sanofi. Research Support; Self; Abbott, Ascensia Diabetes Care, Becton, Dickinson and Company, Boehringer Ingelheim Pharmaceuticals, Inc., Calibra Medical, Capillary Biomedical, Inc., Companion Medical, Dance Biopharm Holdings Inc., Dexcom, Inc., Diasome Pharmaceuticals, Inc., Eli Lilly and Company, GlySens Incorporated, Kowa Pharmaceutical Europe Co. Ltd., Lexicon Pharmaceuticals, Inc., Medtronic, Novo Nordisk Inc., POPS! Diabetes Care, POPS! Diabetes Care, Sanofi, Senseonics, vTv Therapeutics, Xeris Pharmaceuticals, Inc., Zealand Pharma A/S. Speaker's Bureau; Self; Abbott, MannKind Corporation, Medtronic, Novo Nordisk Inc., Sanofi US, Senseonics. B.W. Bode: Consultant; Self; ADOCIA, Lexicon Pharmaceuticals, Inc., Novo Nordisk Inc. Research Support; Self; Becton, Dickinson and Company, Dexcom, Inc., Diasome Pharmaceuticals, Inc., Eli Lilly and Company, Eyenuk Inc., Insulet Corporation, National Institutes of Health, Novo Nordisk Inc., Sanofi Research & Development, Senseonics, Xeris Pharmaceuticals, Inc. Speaker's Bureau; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Janssen Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi US, Senseonics. Stock/Shareholder; Self; AgaMatrix, Glytec, LLC. B.A. Buckingham: Advisory Panel; Self; ConvaTec Inc., Novo Nordisk Inc., Profusa, Inc. Consultant; Self; Medtronic MiniMed, Inc. Research Support; Self; Beta Bionics, ConvaTec Inc., Dexcom, Inc., Insulet Corporation, Medtronic MiniMed, Inc., Tandem Diabetes Care. Other Relationship; Self; Insulet Corporation, Tandem Diabetes Care. G.P. Forlenza: Advisory Panel; Self; Dexcom, Inc. Consultant; Self; Medtronic MiniMed, Inc., Tandem Diabetes Care. Research Support; Self; Dexcom, Inc., Insulet Corporation, Medtronic MiniMed, Inc., Tandem Diabetes Care. O. Pinhas-Hamiel: None. K.K. Kaiserman: Consultant; Self; Medtronic MiniMed, Inc. Research Support; Self; Medtronic MiniMed, Inc. Speaker's Bureau; Self; Medtronic MiniMed, Inc. D.R. Liljenquist: None. D.I. Shulman: None. M.A. Wood: None. X. Chen: None. J. Shin: Employee; Self; Medtronic. T.L. Cordero: Employee; Self; Medtronic. S.W. Lee: Employee; Self; Medtronic. F.R. Kaufman: Employee; Self; Medtronic.

  10. 20

    المصدر: Diabetes. 68

    الوصف: Background: The Guardian Connect continuous glucose monitoring (CGM) system displays current and trending sensor glucose (SG) via smartphone; records insulin, carbohydrate and exercise; and sends predictive high and low SG alerts up to one hour in advance. When used with the Sugar.IQ diabetes assistant application, personalized insights based on behavior patterns (e.g., food log or insulin dose entry) and glycemic outcomes can be tracked with the Glycemic Assist feature. Methods: System data uploaded between June-November of 2018, by 1765 individuals with diabetes were analyzed. Time in target glucose range (TIR, 70-180 mg/dL) and the Glucose Management Indicator (GMI) were compared between those who used (N=530) or did not use Sugar.IQ. Both groups had ≥5 days of SG data and similar demographic and initial glucose profiles. Results: System users had a mean GMI of 7.1%, mean±SD SG of 157.0±49.1mg/dL (8.7±2.7mmol/L), and a mean TIR of 64.5%, over the data upload period. When predictive alerts were enabled, excursions were avoided after 31% of high SG alerts and 62% of low SG alerts. Those who accessed Sugar.IQ experienced a TIR increase of 2.7% (p=0.006) and a mean SG decrease of -3.0% (p Discussion: The Guardian Connect CGM system with Sugar.IQ may advance patient understanding of glucose trends, aid in behavioral change that improves therapy adherence, and lead to better glycemic outcomes. Disclosure S. Arunachalam: Employee; Self; Medtronic. Y. Zhong: None. S. Abraham: Employee; Self; Medtronic MiniMed, Inc. P. Agrawal: Employee; Self; Medtronic MiniMed, Inc. Stock/Shareholder; Self; Medtronic. R. Vigersky: Employee; Self; Medtronic MiniMed, Inc. T.L. Cordero: Employee; Self; Medtronic. F.R. Kaufman: Employee; Self; Medtronic.