An Automated Insulin Delivery System with Automatic Meal Bolus Based on a Hand-Gesturing Algorithm.

Carbohydrate counting (CC) and meal announcements, before eating, introduce a significant burden for individuals managing type 1 diabetes (T1D). An automated insulin delivery system with automatic bolusing that eliminates the need for CC and premeal bolusing (i.e.

A Peek Under the Hood: Explaining the MiniMed™ 780G Algorithm with Meal Detection Technology.

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).

The Myth of MARD (ean bsolute elative ifference): Limitations of MARD in the Clinical Assessment of Continuous Glucose Monitoring Data.

The mean absolute relative difference (MARD) is a numerical metric that has been adopted by the diabetes technology community as the main indicator that describes the accuracy of a glucose sensor at a single point in time. The appropriateness of this adoption is questionable because there is limited evidence that MARD has meaningful clinical relevance in the current era of sensor technology. The calculation may be simple, but evaluation of MARD can be very complex because it is substantially impacted by the design of the data collection in an accuracy study.

The Health Economics of Automated Insulin Delivery Systems and the Potential Use of Time in Range in Diabetes Modeling: A Narrative Review.

Intensive therapy with exogenous insulin is the treatment of choice for individuals living with type 1 diabetes (T1D) and some with type 2 diabetes, alongside regular glucose monitoring. The development of systems allowing (semi-)automated insulin delivery (AID), by connecting glucose sensors with insulin pumps and algorithms, has revolutionized insulin therapy. Indeed, AID systems have demonstrated a proven impact on overall glucose control, as indicated by effects on glycated hemoglobin (HbA1c), risk of severe hypoglycemia, and quality of life measures.

Early Real-World Performance of the MiniMed™ 780G Advanced Hybrid Closed-Loop System and Recommended Settings Use in the United States.

The 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.

Impact of Body Composition and Anemia on Accuracy of a Real-Time Continuous Glucose Monitor in Diabetes Patients on Continuous Ambulatory Peritoneal Dialysis.

Continuous glucose monitoring (CGM) is proposed as an alternative for glycemic assessment in peritoneal dialysis, but volume overload and anemia may affect sensor accuracy. This is an exploratory analysis of a study of Guardian Connect™ with Guardian Sensor™ 3 in 30 participants with diabetes on continuous ambulatory peritoneal dialysis (CAPD) (age [mean ± standard deviation] 64.7 ± 5.

Shining the Spotlight on Multiple Daily Insulin Therapy: Real-World Evidence of the InPen Smart Insulin Pen.

Connected insulin pens are creating opportunities for the millions of individuals with diabetes using multiple daily injections (MDI) therapy across the globe. Continuous glucose monitoring (CGM) data from connected insulin pens are revealing gaps and opportunities to significantly improve care for this population. In this article, we report real-world findings of the InPen™ smart insulin pen paired with CGM (InPen system), used by persons with type 1 diabetes (T1D) and type 2 diabetes (T2D).

Safety and Glycemic Outcomes During the MiniMed Advanced Hybrid Closed-Loop System Pivotal Trial in Children and Adolescents with Type 1 Diabetes.

During 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.

Using Continuous Glucose Monitoring Values for Bolus Size Calculation in Smart Multiple Daily Injection Systems: No Negative Impact on Post-bolus Glycemic Outcomes Found in Real-World Data.

Background: Recent evidence shows that it may be safe to estimate bolus sizes based on continuous glucose monitoring (CGM) rather than blood glucose (BG) values using glycemic trend-adjusted bolus calculators. Users may already be doing this in the real world, though it is unclear whether this is safe or effective for calculators not employing trend adjustment.

Methods: We assessed real-world data from a smart multiple daily injections (MDIs) device users with a CGM system, hypothesizing that four-hour post-bolus outcomes using CGM values are not inferior to those using BG values.

Safety Event Outcomes and Glycemic Control with a Hybrid Closed-Loop System Used by Chinese Adolescents and Adults with Type 1 Diabetes Mellitus.

While 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.

Association between glycaemia risk index (GRI) and diabetic retinopathy in type 2 diabetes: A cohort study.

Aim: To investigate the association between a new composite metric, glycaemia risk index (GRI), and incident diabetic retinopathy (DR).

Methods: A total of 1204 adults with type 2 diabetes without DR at baseline were included between 2005 and 2019 from a single centre in Shanghai, China. GRI was obtained from continuous glucose monitoring data at baseline.

Glycemic Outcomes During Early Use of the MiniMed™ 780G Advanced Hybrid Closed-Loop System with Guardian™ 4 Sensor.

Safety 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.

Advanced Hybrid Closed Loop in Adult Population With Type 1 Diabetes: A Substudy From the ADAPT Randomized Controlled Trial in Users of Real-Time Continuous Glucose Monitoring.

Background: This analysis reports the findings from a predefined exploratory cohort (cohort B) from the ADAPT (ADvanced Hybrid Closed Loop Study in Adult Population with Type 1 Diabetes) study. Adults with type 1 diabetes (T1D) with suboptimal glucose control were randomly allocated to an advanced hybrid closed-loop (AHCL) system or multiple daily injections of insulin (MDI) plus real-time continuous glucose monitoring (RT-CGM).

Methods: In this prospective, multicenter, exploratory, open-label, randomized controlled trial, 13 participants using MDI + RT-CGM and with HbA1c ≥8.

Racial/Ethnic Inequities in Use of Diabetes Technologies Among Medicare Advantage Beneficiaries With Type 1 Diabetes.

Context: Racial/ethnic inequities have been observed in diabetes care.

Objective: To measure changes in prevalence of continuous glucose monitoring (CGM) and insulin pump therapy among Medicare Advantage beneficiaries with type 1 diabetes by race/ethnicity and to determine the impact of socioeconomic factors on racial/ethnic inequities.

Design: The prevalence of CGM and pump use was assessed by race/ethnicity for Medicare Advantage beneficiaries annually from 2017 through 2020.

Potential cost savings in the United States from a reduction in sensor-detected severe hypoglycemia among users of the InPen smart insulin pen system.

Severe hypoglycemia is a significant barrier to optimizing insulin therapy in both type 1 and type 2 diabetes and places a burden on the US health care system because of the high costs of hypoglycemia-related health care utilization. To compare the frequency of sensor-detected severe hypoglycemic events (SHEs) among a population of continuous glucose monitoring (CGM) users on insulin therapy after initiation of the InPen smart insulin pen (SIP) system and to estimate the potential hypoglycemia-related medical cost savings across a population of SIP users. SIP users of all ages with type 1 or type 2 diabetes were required to have at least 90 days of SIP use with a connected CGM device.

Advances in Insulin Infusion Set in the New Era of Automated Insulin Delivery: A Systematic Review.

Introduction: Automated insulin delivery (AID) has become a well-known research topic devoted to achieving better glycemic outcomes. AID systems consist primarily of three components: the continuous glucose monitoring system, the insulin delivery system, either tethered or patch pump, and the control system (algorithm). A key component in the tethered pump AID system is the insulin infusion set (IIS).

Improved Glycemia with Hybrid Closed-Loop Versus Continuous Subcutaneous Insulin Infusion Therapy: Results from a Randomized Controlled Trial.

To 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.

A Review of Precision Insulin Management With Smart Insulin Pens: Opening Up the Digital Door to People on Insulin Injection Therapy.

Although advances in insulin therapy and delivery have been made, global evidence indicates sub-optimal glycemic management in people on insulin therapy with either type 1 diabetes (T1D) or type 2 diabetes (T2D). In this review, we discuss connected insulin pens that include tracking insulin pens (TIPs) and smart insulin pens (SIPs) and caps, as approaches to improving mean glucose or time in range while minimizing exposure to hypoglycemia or time below range (TBR) in people with diabetes (PwD) on multiple daily injection (MDI) therapy. We discuss various factors offered by SIPs that can facilitate precision insulin management, that is, delivering the right dose at the right time.

An Assessment of Clinical Continuous Glucose Monitoring Targets for Older and High-Risk People Living with Type 1 Diabetes.

To assess relationships between continuous glucose monitoring (CGM) time in range (TIR), 70-180 mg/dL, time below range (TBR), <70 mg/dL, time above range (TAR), >180 mg/dL, and glucose coefficient of variation (CV) in relation to currently recommended clinical CGM targets for older people, which recommend reduced TIR and TBR targets relative to the general type 1 diabetes population. We conducted a post hoc analysis using the JDRF Australia Adult Hybrid Closed Loop trial database examining correlations in 120 adults with type 1 diabetes of 3 weeks masked CGM (Guardian Sensor 3; Medtronic) metrics ( = 61 on multiple daily injections, 59 on non-CGM augmented pumps) using manual insulin dosing at baseline and at 26-weeks, with 50% randomized to automated insulin dosing (AID). Correlations between baseline TIR and TAR were strong ( = -0.

In Silico Evaluation of the Medtronic 780G System While Using the GS3 and Its Calibration-Free Successor, the G4S Sensor.

In 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.

Efficacy of intermittent short-term use of a real-time continuous glucose monitoring system in non-insulin-treated patients with type 2 diabetes: A randomized controlled trial.

Aim: To evaluate the efficacy of intermittent short-term use of a real-time continuous glucose monitoring (RT-CGM) system in non-insulin-treated patients with type 2 diabetes (T2D) uncontrolled with oral antidiabetic drugs (OADs).

Materials And Methods: In this multicentre, randomized prospective study, 61 participants were randomly assigned to treatment group 1 (one session of RT-CGM), treatment group 2 (two sessions of RT-CGM with a 3-month interval between sessions) and a control group. All participants used blinded continuous glucose monitoring for up to 6 days with education before randomization, and RT-CGM was additionally applied for 1 week in the intervention groups.

Glycemic Outcomes During Real-World Hybrid Closed-Loop System Use by Individuals With Type 1 Diabetes in the United States.

Background: Glycemic outcomes during real-world hybrid closed-loop (HCL) system use by individuals with type 1 diabetes, in the United States, were retrospectively analyzed.

Methods: Hybrid closed-loop system data voluntarily uploaded to Carelink™ personal software from March 2017 to November 2020 by individuals (aged ≥7 years) using the MiniMed™ 670G system and having ≥10 days of continuous glucose monitoring data after initiating Auto Mode were assessed. Glycemic outcomes including the mean glucose management indicator (GMI), sensor glucose (SG), percentage of time spent in (TIR), below (TBR), and above (TAR) target range (70-180 mg/dL) were analyzed.

Evaluation of Extended Infusion Set Performance in Adults with Type 1 Diabetes: Infusion Set Survival Rate and Glycemic Outcomes from a Pivotal Trial.

Standard 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.

Improving the Patient Experience With Longer Wear Infusion Sets Symposium Report.

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.