Use of a decision support tool and quick start onboarding tool in individuals with type 1 diabetes using advanced automated insulin delivery: a single-arm multi-phase intervention study.

Background: Multiple clinician adjustable parameters impact upon glycemia in people with type 1 diabetes (T1D) using Medtronic Mini Med 780G (MM780G) AHCL. These include glucose targets, carbohydrate ratios (CR), and active insulin time (AIT). Algorithm-based decision support advising upon potential settings adjustments may enhance clinical decision-making.

Simplified Meal Management in Adults Using an Advanced Hybrid Closed-Loop System.

The advanced hybrid closed-loop (AHCL) algorithm combines automated basal rates and corrections yet requires meal announcement for optimal performance, which poses a challenge for some. We aimed to compare glucose control in adults with type 1 diabetes (T1D) using the MiniMed 780G AHCL system, utilizing simplified meal announcement versus precise carbohydrate (CHO) counting. In a study involving 14 adults with T1D, we evaluated glycemic control during a 13-week "precise phase," followed by two 3- to 4-week simplified meal announcement phases: "fixed one-step" (preset of one personalized fixed CHO amount) and "multistep" (entry of multiples of one, two, or three of these presets depending on meal size estimate).

Improved Satisfaction While Maintaining Safety and High Time in Range (TIR) With a Medtronic Investigational Enhanced Advanced Hybrid Closed-Loop (e-AHCL) System.

Objective: To determine feasibility and compare acceptance of an investigational Medtronic enhanced advanced hybrid closed-loop (e-AHCL) system in adults with type 1 diabetes with earlier iterations.

Research Design And Methods: This nonrandomized three-stage (12 weeks each) exploratory study compared e-AHCL (Bluetooth-enabled MiniMed 780G insulin pump with automatic data upload [780G] incorporating an updated algorithm; calibration-free all-in-one disposable sensor; 7-day infusion set) preceded by a run-in (non-Bluetooth 780G [670G V4.0 insulin pump] requiring manual data upload; Guardian Sensor 3 [GS3] requiring calibration; 3-day infusion set), stage 1 (780G; GS3; 3-day infusion set), and stage 2 (780G; calibration-free Guardian Sensor 4; 3-day infusion set).

Unannounced Meal Challenges Using an Advanced Hybrid Closed-Loop System.

The advanced hybrid closed-loop (AHCL) algorithm combines automated basal rates and corrections yet requires meal announcement for optimal outcomes. We aimed to compare the performance of the MiniMed™ 780G AHCL algorithm with and without meal announcement. In a single-arm study involving 14 adults with type 1 diabetes, we evaluated the safety and efficacy of AHCL when meals were not announced.

Comparable Glucose Control with Fast-Acting Insulin Aspart Versus Insulin Aspart Using a Second-Generation Hybrid Closed-Loop System During Exercise.

This study compared glucose control with fast-acting insulin aspart (FiAsp) versus insulin aspart following moderate-intensity exercise (MIE) and high-intensity exercise (HIE) using a second-generation closed-loop (CL) system in people with type 1 diabetes. This randomized crossover study compared FiAsp versus insulin aspart over four sessions during MIE and HIE with CL insulin delivery by the MiniMed™ Advanced hybrid CL system. Participants were randomly assigned FiAsp and insulin aspart each for 6 weeks and within each period performed, in random order, 40 min MIE (∼50% VOmax) and HIE (6 × 2 min ∼80% VOmax; 5 min recovery).

Improved technology satisfaction and sleep quality with Medtronic MiniMed® Advanced Hybrid Closed-Loop delivery compared to predictive low glucose suspend in people with Type 1 Diabetes in a randomized crossover trial.

Background: Automated insulin delivery aims to lower treatment burden and improve quality of life as well as glycemic outcomes.

Methods: 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.

Fast-Acting Insulin Aspart Versus Insulin Aspart Using a Second-Generation Hybrid Closed-Loop System in Adults With Type 1 Diabetes: A Randomized, Open-Label, Crossover Trial.

Objective: To evaluate glucose control using fast-acting insulin aspart (faster aspart) compared with insulin aspart (IAsp) delivered by the MiniMed Advanced Hybrid Closed-Loop (AHCL) system in adults with type 1 diabetes.

Research Design And Methods: In this randomized, open-label, crossover study, participants were assigned to receive faster aspart or IAsp in random order. Stages 1 and 2 comprised of 6 weeks in closed loop, preceded by 2 weeks in open loop.

Fast-acting insulin aspart (Fiasp®) improves glycemic outcomes when used with MiniMed 670G hybrid closed-loop system in simulated trials compared to NovoLog®.

Introduction: Medtronic has developed a virtual patient simulator for modeling and predicting insulin therapy outcomes for people with type 1 diabetes (T1D). An enhanced simulator was created to estimate outcomes when using the MiniMed 670G system with standard NovoLog® (EU: NovoRapid, US: NovoLog) versus Fiasp ® by using clinical data.

Methods: Sixty-seven participants' PK profiles were generated per type of insulin (Total of 134 PK profiles).

Improved Glycemic Outcomes With Medtronic MiniMed Advanced Hybrid Closed-Loop Delivery: Results From a Randomized Crossover Trial Comparing Automated Insulin Delivery With Predictive Low Glucose Suspend in People With Type 1 Diabetes.

Objective: To study the MiniMed Advanced Hybrid Closed-Loop (AHCL) system, which includes an algorithm with individualized basal target set points, automated correction bolus function, and improved Auto Mode stability.

Research Design And Methods: This dual-center, randomized, open-label, two-sequence crossover study in automated-insulin-delivery-naive participants with type 1 diabetes (aged 7-80 years) compared AHCL to sensor-augmented pump therapy with predictive low glucose management (SAP + PLGM). Each study phase was 4 weeks, preceded by a 2- to 4-week run-in and separated by a 2-week washout.

Closed-Loop Insulin Delivery for Adults with Type 1 Diabetes Undertaking High-Intensity Interval Exercise Versus Moderate-Intensity Exercise: A Randomized, Crossover Study.

Background: We aimed to compare closed-loop glucose control for people with type 1 diabetes undertaking high-intensity interval exercise (HIIE) versus moderate-intensity exercise (MIE).

Methods: Adults with type 1 diabetes established on insulin pumps undertook HIIE and MIE stages in random order during automated insulin delivery via a closed-loop system (Medtronic). Frequent venous sampling for glucose, lactate, ketones, insulin, catecholamines, cortisol, growth hormone, and glucagon levels was performed.

Glycemia, Treatment Satisfaction, Cognition, and Sleep Quality in Adults and Adolescents with Type 1 Diabetes When Using a Closed-Loop System Overnight Versus Sensor-Augmented Pump with Low-Glucose Suspend Function: A Randomized Crossover Study.

Background: We compared glycemia, treatment satisfaction, sleep quality, and cognition using a nighttime Android-based hybrid closed-loop system (Android-HCLS) with sensor-augmented pump with low-glucose suspend function (SAP-LGS) in people with type 1 diabetes.

Materials And Methods: An open-label, prospective, randomized crossover study of 16 adults (mean [SD] age 42.1 [9.

Exploration of the Performance of a Hybrid Closed Loop Insulin Delivery Algorithm That Includes Insulin Delivery Limits Designed to Protect Against Hypoglycemia.

Background: Hypoglycemia remains a risk for closed loop insulin delivery particularly following exercise or if the glucose sensor is inaccurate. The aim of this study was to test whether an algorithm that includes a limit to insulin delivery is effective at protecting against hypoglycemia under those circumstances.

Methods: An observational study on 8 participants with type 1 diabetes was conducted, where a hybrid closed loop system (HCL) (Medtronic™ 670G) was challenged with hypoglycemic stimuli: exercise and an overreading glucose sensor.

Effectiveness of a Predictive Algorithm in the Prevention of Exercise-Induced Hypoglycemia in Type 1 Diabetes.

Background: Sensor-augmented pump therapy (SAPT) with a predictive algorithm to suspend insulin delivery has the potential to reduce hypoglycemia, a known obstacle in improving physical activity in patients with type 1 diabetes. The predictive low glucose management (PLGM) system employs a predictive algorithm that suspends basal insulin when hypoglycemia is predicted. The aim of this study was to determine the efficacy of this algorithm in the prevention of exercise-induced hypoglycemia under in-clinic conditions.

Automated hybrid closed-loop control with a proportional-integral-derivative based system in adolescents and adults with type 1 diabetes: individualizing settings for optimal performance.

Background: Automated insulin delivery systems, utilizing a control algorithm to dose insulin based upon subcutaneous continuous glucose sensor values and insulin pump therapy, will soon be available for commercial use. The objective of this study was to determine the preliminary safety and efficacy of initialization parameters with the Medtronic hybrid closed-loop controller by comparing percentage of time in range, 70-180 mg/dL (3.9-10 mmol/L), mean glucose values, as well as percentage of time above and below target range between sensor-augmented pump therapy and hybrid closed-loop, in adults and adolescents with type 1 diabetes.

Automated Overnight Closed-Loop Control Using a Proportional-Integral-Derivative Algorithm with Insulin Feedback in Children and Adolescents with Type 1 Diabetes at Diabetes Camp.

Objective: This study determined the feasibility and efficacy of an automated proportional-integral-derivative with insulin feedback (PID-IFB) controller in overnight closed-loop (OCL) control of children and adolescents with type 1 diabetes over multiple days in a diabetes camp setting.

Research Design And Methods: The Medtronic (Northridge, CA) Android™ (Google, Mountain View, CA)-based PID-IFB system consists of the Medtronic Minimed Revel™ 2.0 pump and Enlite™ sensor, a control algorithm residing on an Android phone, a translator, and remote monitoring capabilities.

Hybrid Closed-Loop Insulin Delivery in Type 1 Diabetes During Supervised Outpatient Conditions.

Background: Efficacy and safety of the Medtronic Hybrid Closed-Loop (HCL) system were tested in subjects with type 1 diabetes in a supervised outpatient setting.

Methods: The HCL system is a prototype research platform that includes a sensor-augmented insulin pump in communication with a control algorithm housed on an Android-based cellular device. Nine subjects with type 1 diabetes (5 female, mean age 53.

Reduced hypoglycemia and increased time in target using closed-loop insulin delivery during nights with or without antecedent afternoon exercise in type 1 diabetes.

Objective: Afternoon exercise increases the risk of nocturnal hypoglycemia (NH) in subjects with type 1 diabetes. We hypothesized that automated feedback-controlled closed-loop (CL) insulin delivery would be superior to open-loop (OL) control in preventing NH and maintaining a higher proportion of blood glucose levels within the target blood glucose range on nights with and without antecedent afternoon exercise.

Research Design And Methods: Subjects completed two 48-h inpatient study periods in random order: usual OL control and CL control using a proportional-integrative-derivative plus insulin feedback algorithm.

Model-based sensor-augmented pump therapy.

Background: In insulin pump therapy, optimization of bolus and basal insulin dose settings is a challenge. We introduce a new algorithm that provides individualized basal rates and new carbohydrate ratio and correction factor recommendations. The algorithm utilizes a mathematical model of blood glucose (BG) as a function of carbohydrate intake and delivered insulin, which includes individualized parameters derived from sensor BG and insulin delivery data downloaded from a patient's pump.

The use of an automated, portable glucose control system for overnight glucose control in adolescents and young adults with type 1 diabetes.

Objective: A key milestone in progress towards providing an efficacious and safe closed-loop artificial pancreas system for outpatient use is the development of fully automated, portable devices with fault detection capabilities to ensure patient safety. The ability to remotely monitor the operation of the closed-loop system would facilitate future physician-supervised home studies.

Research Design And Methods: This study was designed to investigate the efficacy and safety of a fully automated, portable, closed-loop system.

The effect of insulin feedback on closed loop glucose control.

Context: Initial studies of closed-loop proportional integral derivative control in individuals with type 1 diabetes showed good overnight performance, but with breakfast meal being the hardest to control and requiring supplemental carbohydrate to prevent hypoglycemia.

Objective: The aim of this study was to assess the ability of insulin feedback to improve the breakfast-meal profile.

Design And Setting: We performed a single center study with closed-loop control over approximately 30 h at an inpatient clinical research facility.

Fully automated closed-loop insulin delivery versus semiautomated hybrid control in pediatric patients with type 1 diabetes using an artificial pancreas.

Objective: The most promising beta-cell replacement therapy for children with type 1 diabetes is a closed-loop artificial pancreas incorporating continuous glucose sensors and insulin pumps. The Medtronic MiniMed external physiological insulin delivery (ePID) system combines an external pump and sensor with a variable insulin infusion rate algorithm designed to emulate the physiological characteristics of the beta-cell. However, delays in insulin absorption associated with the subcutaneous route of delivery inevitably lead to large postprandial glucose excursions.