Journal: Journal of Diabetes Science and Technology

Article Title: A Review of the First Long-term Implantable Continuous Glucose Monitoring System Available in the United States

doi: 10.1177/1932296819890865

Figure Lengend Snippet: Summary of Studies Evaluating Safety, Accuracy, and Glycemic Efficacy of Long-term Implantable Continuous Glucose Monitoring.

Article Snippet: 24 table ft1 table-wrap mode="anchored" t5 Table 2. caption a7 Study enrollment status Study title Intervention/treatment Population Key outcome(s) Enrolling Eversense and Dexcom G5 Comparison in Real Life: A Randomized Crossover Trial in Type 1 Diabetic Patients to Evaluate Differences in Accuracy, Efficacy and Quality of Life Dexcom G5 rtCGM vs Eversense LTI CGM Adults (≥18 years of age) with T1DM and HbA1c <10% and body mass index <35% Primary: Device accuracy, sensor accuracy (MARD) vs capillary blood glucose Secondary: Time spent in target glycemic range, change in HbA1c, sensor failure rate, adverse events, changes in quality of life, and changes in fear of hypoglycemia Enrolling An Investigator Initiated Pilot Study to Evaluate the Impact on Glucose Control and Safety of the Eversense Continuous Glucose Monitoring System in Children and Adolescents Eversense XL LTI CGM Children (aged 6 to <18 years) with T1DM and HbA1c <11% and pretreated with MDII or CSII for at least three months Primary: Time in glycemic range Secondary: Time of hypoglycemia Recruiting A Post- Approval Study to Evaluate the Long-term Safety and Effectiveness of the Eversense Continuous Glucose Monitoring (CGM) System Eversense LTI CGM Adults (≥18 years of age) with T1DM or T2DM Primary: Incidence of procedure-related adverse events, time in glycemic range Recruiting PROMISE Study: A Prospective, Multicenter Evaluation of Accuracy and Safety of an Implantable Continuous Glucose Sensor Lasting up to 180 days Eversense XL LTI CGM Adults (≥18 years of age) with T1DM or T2DM Primary: Effectiveness measure (MARD), safety endpoint (incidence of device-related or sensor insertion/removal procedure-related serious adverse events) Recruiting Benefits of a Long Term Implantable Continuous Glucose Monitoring System for Adults With Diabetes - France Randomized Clinical Trial Eversense XL LTI CGM Adults (≥18 years of age) with T1DM or T2DM using MDII or CSII Primary: Efficacy (percentage of HbA1c levels monitored, percentage of time spent in hypoglycemia) Secondary: Adverse events, time in glycemic range, hypoglycemia, mean sensor life, total time to wear transmitter, change in HbA1c, diabetes treatment satisfaction, quality of life, CGM satisfaction, and distress Open in a separate window Abbreviations: CGM, continuous glucose monitoring; CSII, continuous subcutaneous insulin infusion; HbA1c, hemoglobin A1c; LTI CGM, long-term implantable continuous glucose monitoring; MDII, multiple daily insulin injections; rtCGM, real-time continuous glucose monitoring; T1DM, type 1 diabetes mellitus; T2DM, type 2 diabetes mellitus.

Techniques: Infection, Functional Assay, Standard Deviation

Journal: Journal of Diabetes Science and Technology

Article Title: A Review of the First Long-term Implantable Continuous Glucose Monitoring System Available in the United States

doi: 10.1177/1932296819890865

Figure Lengend Snippet: Ongoing Clinical Trials to Evaluate Long-term Implantable Continuous Glucose Monitoring.

Article Snippet: 24 table ft1 table-wrap mode="anchored" t5 Table 2. caption a7 Study enrollment status Study title Intervention/treatment Population Key outcome(s) Enrolling Eversense and Dexcom G5 Comparison in Real Life: A Randomized Crossover Trial in Type 1 Diabetic Patients to Evaluate Differences in Accuracy, Efficacy and Quality of Life Dexcom G5 rtCGM vs Eversense LTI CGM Adults (≥18 years of age) with T1DM and HbA1c <10% and body mass index <35% Primary: Device accuracy, sensor accuracy (MARD) vs capillary blood glucose Secondary: Time spent in target glycemic range, change in HbA1c, sensor failure rate, adverse events, changes in quality of life, and changes in fear of hypoglycemia Enrolling An Investigator Initiated Pilot Study to Evaluate the Impact on Glucose Control and Safety of the Eversense Continuous Glucose Monitoring System in Children and Adolescents Eversense XL LTI CGM Children (aged 6 to <18 years) with T1DM and HbA1c <11% and pretreated with MDII or CSII for at least three months Primary: Time in glycemic range Secondary: Time of hypoglycemia Recruiting A Post- Approval Study to Evaluate the Long-term Safety and Effectiveness of the Eversense Continuous Glucose Monitoring (CGM) System Eversense LTI CGM Adults (≥18 years of age) with T1DM or T2DM Primary: Incidence of procedure-related adverse events, time in glycemic range Recruiting PROMISE Study: A Prospective, Multicenter Evaluation of Accuracy and Safety of an Implantable Continuous Glucose Sensor Lasting up to 180 days Eversense XL LTI CGM Adults (≥18 years of age) with T1DM or T2DM Primary: Effectiveness measure (MARD), safety endpoint (incidence of device-related or sensor insertion/removal procedure-related serious adverse events) Recruiting Benefits of a Long Term Implantable Continuous Glucose Monitoring System for Adults With Diabetes - France Randomized Clinical Trial Eversense XL LTI CGM Adults (≥18 years of age) with T1DM or T2DM using MDII or CSII Primary: Efficacy (percentage of HbA1c levels monitored, percentage of time spent in hypoglycemia) Secondary: Adverse events, time in glycemic range, hypoglycemia, mean sensor life, total time to wear transmitter, change in HbA1c, diabetes treatment satisfaction, quality of life, CGM satisfaction, and distress Open in a separate window Abbreviations: CGM, continuous glucose monitoring; CSII, continuous subcutaneous insulin infusion; HbA1c, hemoglobin A1c; LTI CGM, long-term implantable continuous glucose monitoring; MDII, multiple daily insulin injections; rtCGM, real-time continuous glucose monitoring; T1DM, type 1 diabetes mellitus; T2DM, type 2 diabetes mellitus.

Techniques: