The MiniMed™ 780G system (780G) received Conformité Européenne mark in June 2020 and was, recently, approved by the U.S. Food and Drug Administration (April 2023).
View Article and Find Full Text PDFThe MiniMed™ 780G system (MM780G) with Guardian™ 4 sensor includes a 100 mg/dL glucose target (GT) and automated insulin corrections up to every 5 min and was recently approved for use in the United States. In the present study, early real-world MM780G performance and the use of recommended system settings (100 mg/dL GT with an active insulin time of 2 h), by individuals with type 1 diabetes, were evaluated. CareLink™ personal data uploaded between the launch of the MM780G to August 22, 2023 were aggregated and underwent retrospective analysis (based on user consent) and if users had ≥10 days of continuous glucose monitoring (CGM) data.
View Article and Find Full Text PDFDuring MiniMed™ advanced hybrid closed-loop (AHCL) use by adolescents and adults in the pivotal trial, glycated hemoglobin (A1C) was significantly reduced, time spent in range (TIR) was significantly increased, and there were no episodes of severe hypoglycemia or diabetic ketoacidosis (DKA). The present study investigated the same primary safety and effectiveness endpoints during AHCL use by a younger cohort with type 1 diabetes (T1D). An intention-to-treat population ( = 160, aged 7-17 years) with T1D was enrolled in a single-arm study at 13 investigational centers.
View Article and Find Full Text PDFWhile evidence supports glycemic control benefits for individuals with type 1 diabetes mellitus (T1DM) using hybrid closed-loop (HCL) systems, HCL automated insulin delivery therapy in China has not been assessed. This study evaluated safety events and effectiveness during HCL system use by Chinese adolescents and adults with T1DM. Sixty-two participants ( = 12 adolescents with a mean ± standard deviation [SD] of 15.
View Article and Find Full Text PDFSafety and significant improvement in overall glycated hemoglobin (A1C) and percentage of time spent in (TIR), below (TBR), and above (TAR) glucose range were demonstrated in the pivotal trial of adolescents and adults using the MiniMed™ advanced hybrid closed-loop (AHCL) system with the adjunctive, calibration-required Guardian™ Sensor 3. The present study evaluated early outcomes of continued access study (CAS) participants who transitioned from the pivotal trial investigational system to the approved MiniMed™ 780G system with the non-adjunctive, calibration-free Guardian™ 4 Sensor (MM780G+G4S). Study data were presented alongside those of real-world MM780G+G4S users from Europe, the Middle East, and Africa.
View Article and Find Full Text PDFTo evaluate safety and effectiveness of MiniMed™ 670G hybrid closed loop (HCL) in comparison with continuous subcutaneous insulin infusion (CSII) therapy for 6 months in persons with type 1 diabetes (T1D). Adults (aged 18-80 years), adolescents, and children (aged 2-17 years) with T1D who were using CSII therapy were enrolled and randomized (1:1) to 6 months of HCL intervention (n = 151, mean age of 39.9 ± 19.
View Article and Find Full Text PDFIn silico simulation studies using 5807 virtual patients with insulin dependent diabetes have been conducted to estimate the risk and efficacy with the closed-loop 780G pump when switching between Medtronic Guardian Sensor 3 (GS3) and Medtronic Guardian 4 Sensor (G4S), next generation calibration free glucose sensor. To demonstrate by utilizing a case study that captures the merits of in silico studies with single hormone insulin dependent virtual patients that include variability in pharmacokinetics/pharmacodynamics, age, gender, insulin sensitivity and BMIs. Also, to show that in silico studies can uniquely isolate the effect of a single variable on clinical outcomes.
View Article and Find Full Text PDFStandard insulin infusion sets (IISs) are to be replaced every 2 to 3 days to avoid complications and diabetic ketosis due to set failure. This pivotal trial evaluated the safety and performance of a new extended-wear infusion set (EIS) when used for 7 days by adults with type 1 diabetes (T1D). This single-arm, nonrandomized trial enrolled adults (18-80 years of age) with T1D, who used their own MiniMed™ 670G system with insulin lispro or insulin aspart and the EIS for up to 7 days, across 12 consecutive wears.
View Article and Find Full Text PDFThis trial assessed safety and effectiveness of an advanced hybrid closed-loop (AHCL) system with automated basal (Auto Basal) and automated bolus correction (Auto Correction) in adolescents and adults with type 1 diabetes (T1D). This multicenter single-arm study involved an intent-to-treat population of 157 individuals (39 adolescents aged 14-21 years and 118 adults aged ≥22-75 years) with T1D. Study participants used the MiniMed™ AHCL system during a baseline run-in period in which sensor-augmented pump +/- predictive low glucose management or Auto Basal was enabled for ∼14 days.
View Article and Find Full Text PDFSci Diabetes Self Manag Care
February 2021
Purpose: The purpose of this study is to review the literature for Diabetes Self-Management Education and Support (DSMES) to ensure the National Standards for DSMES (Standards) align with current evidence-based practices and utilization trends.
Methods: The 10 Standards were divided among 20 interdisciplinary workgroup members. Members searched the current research for diabetes education and support, behavioral health, clinical, health care environment, technical, reimbursement, and business practice for the strongest evidence that guided the Standards revision.
Purpose: The purpose of this study is to review the literature for Diabetes Self-Management Education and Support (DSMES) to ensure the National Standards for DSMES (Standards) align with current evidence-based practices and utilization trends.
Methods: The 10 Standards were divided among 20 interdisciplinary workgroup members. Members searched the current research for diabetes education and support, behavioral health, clinical, health care environment, technical, reimbursement, and business practice for the strongest evidence that guided the Standards revision.
J Diabetes Sci Technol
July 2019
Purpose: The purpose of this study is to review the literature for Diabetes Self-Management Education and Support (DSMES) to ensure the National Standards for DSMES (Standards) align with current evidence-based practices and utilization trends.
Methods: The 10 Standards were divided among 20 interdisciplinary workgroup members. Members searched the current research for diabetes education and support, behavioral health, clinical, health care environment, technical, reimbursement, and business practice for the strongest evidence that guided the Standards revision.
Description: The American Diabetes Association (ADA) annually updates its Standards of Medical Care in Diabetes to provide clinicians, patients, researchers, payers, and other interested parties with evidence-based recommendations for the diagnosis and management of patients with diabetes.
Methods: For the 2018 standards, the ADA Professional Practice Committee searched MEDLINE through November 2017 to add, clarify, or revise recommendations on the basis of new evidence. The committee rated the recommendations as A, B, or C depending on the quality of evidence or E for expert consensus or clinical experience.
Purpose The purpose of this study is to review the literature for Diabetes Self-Management Education and Support (DSMES) to ensure the National Standards for DSMES (Standards) align with current evidence-based practices and utilization trends. Methods The 10 Standards were divided among 20 interdisciplinary workgroup members. Members searched the current research for diabetes education and support, behavioral health, clinical, health care environment, technical, reimbursement, and business practice for the strongest evidence that guided the Standards revision.
View Article and Find Full Text PDFThis article was copublished in 2017;40:1409-1419 and 2017;43:449-464 and is reprinted with permission. The previous version of this article, also copublished in and , can be found at 2012;35:2393-2401 (https://doi.org/10.
View Article and Find Full Text PDFDescription: The American Diabetes Association (ADA) annually updates Standards of Medical Care in Diabetes to provide clinicians, patients, researchers, payers, and other interested parties with evidence-based recommendations for the diagnosis and management of patients with diabetes.
Methods: For the 2017 Standards of Care, the ADA Professional Practice Committee did MEDLINE searches from 1 January 2016 to November 2016 to add, clarify, or revise recommendations on the basis of new evidence. The committee rated the recommendations as A, B, or C, depending on the quality of evidence, or E for expert consensus or clinical experience.
Purpose The purpose of this study is to review the literature for Diabetes Self-Management Education and Support (DSMES) to ensure the National Standards for DSMES (Standards) align with current evidence-based practices and utilization trends. Methods The 10 Standards were divided among 20 interdisciplinary workgroup members. Members searched the current research for diabetes education and support, behavioral health, clinical, health care environment, technical, reimbursement, and business practice for the strongest evidence that guided the Standards revision.
View Article and Find Full Text PDFDescription: The American Diabetes Association (ADA) annually updates the Standards of Medical Care in Diabetes to provide clinicians, patients, researchers, payers, and other interested parties with evidence-based recommendations for the diagnosis and management of patients with diabetes.
Methods: For the 2017 Standards, the ADA Professional Practice Committee updated previous MEDLINE searches performed from 1 January 2016 to November 2016 to add, clarify, or revise recommendations based on new evidence. The committee rates the recommendations as A, B, or C, depending on the quality of evidence, or E for expert consensus or clinical experience.
Description: The American Diabetes Association (ADA) published the 2016 Standards of Medical Care in Diabetes (Standards) to provide clinicians, patients, researchers, payers, and other interested parties with the components of diabetes care, general treatment goals, and tools to evaluate the quality of care.
Methods: The ADA Professional Practice Committee performed a systematic search on MEDLINE to revise or clarify recommendations based on new evidence. The committee assigns the recommendations a rating of A, B, or C, depending on the quality of evidence.
Recent years have seen an increased focus on merging quality care and financial results. This focus not only extends to the inpatient setting but also is of major importance in assuring effective transitions of care from hospital to home. Inducements to meld the 2 factors include tying payment to quality standards, investing in patient safety, and offering new incentives for providers who deliver high-quality and coordinated care.
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