Add-on therapy with dapagliflozin under full closed loop control improves time in range in adolescents and young adults with type 1 diabetes: The DAPADream study.

Aim: To investigate the effect of the sodium-glucose co-transporter-2 inhibitor dapagliflozin on glucose levels overnight and during the following day after two unannounced meals under full closed loop (FCL) conditions.

Materials And Methods: For this single-centre, double-blind, randomized, placebo-controlled, cross-over trial, non-obese persons with type 1 diabetes (T1D) were studied twice (10 mg dapagliflozin bid vs. placebo) for 24 hours with two unannounced mixed meal tests 6 hours apart under FCL conditions.

Feasibility Study of a Hybrid Closed-Loop System with Automated Insulin Correction Boluses.

The Medtronic MiniMed™ 670G system adjusts basal insulin delivery in response to continuous glucose monitoring levels and is already in use in clinical practice. We tested the home-based feasibility of the new MiniMed advanced hybrid closed-loop (AHCL) system, which includes several algorithm enhancements and an optional autocorrection bolus mode. Twelve adolescents and young adults (eight females) with type 1 diabetes [median (interquartile range)] aged 16.

Adjustment of Insulin Pump Settings in Type 1 Diabetes Management: Advisor Pro Device Compared to Physicians' Recommendations.

Aims: To compare insulin dose adjustments made by physicians to those made by an artificial intelligence-based decision support system, the Advisor Pro, in people with type 1 diabetes (T1D) using an insulin pump and self-monitoring blood glucose (SMBG).

Methods: This was a multinational, non-interventional study surveying 17 physicians from 11 countries. Each physician was asked to provide insulin dose adjustments for the settings of the pump including basal rate, carbohydrate-to-insulin ratios (CRs), and correction factors (CFs) for 15 data sets of pumps and SMBG of people with T1D (mean age 18.

Faster Compared With Standard Insulin Aspart During Day-and-Night Fully Closed-Loop Insulin Therapy in Type 1 Diabetes: A Double-Blind Randomized Crossover Trial.

Objective: We evaluated the safety and efficacy of day-and-night fully closed-loop insulin therapy using faster (Faster-CL) compared with standard insulin aspart (Standard-CL) in young adults with type 1 diabetes.

Research Design And Methods: In a double-blind, randomized, crossover trial, 20 participants with type 1 diabetes on insulin pump therapy (11 females, aged 21.3 ± 2.

DREAM5: An open-label, randomized, cross-over study to evaluate the safety and efficacy of day and night closed-loop control by comparing the MD-Logic automated insulin delivery system to sensor augmented pump therapy in patients with type 1 diabetes at home.

Aims: Previous DREAM studies demonstrated the safety and efficacy of the CE marked MD-Logic closed-loop system (DreaMed GlucoSitter) in different settings for overnight glycaemic control. The present study aimed to evaluate the system for day and night use for 60 hours during the weekend at home compared to sensor-augmented pump (SAP) therapy in participants with type 1 diabetes.

Methods: This was a prospective, multicentre, crossover, controlled study (clinicaltrials.

Adjusting insulin doses in patients with type 1 diabetes who use insulin pump and continuous glucose monitoring: Variations among countries and physicians.

Aims: To evaluate physicians' adjustments of insulin pump settings based on continuous glucose monitoring (CGM) for patients with type 1 diabetes and to compare these to automated insulin dose adjustments.

Methods: A total of 26 physicians from 16 centres in Europe, Israel and South America participated in the study. All were asked to adjust insulin dosing based on insulin pump, CGM and glucometer downloads of 15 patients (mean age 16.

Closed-loop glucose control in young people with type 1 diabetes during and after unannounced physical activity: a randomised controlled crossover trial.

Aims/hypothesis: Hypoglycaemia during and after exercise remains a challenge. The present study evaluated the safety and efficacy of closed-loop insulin delivery during unannounced (to the closed-loop algorithm) afternoon physical activity and during the following night in young people with type 1 diabetes.

Methods: A randomised, two-arm, open-label, in-hospital, crossover clinical trial was performed at a single site in Slovenia.

MD-Logic overnight type 1 diabetes control in home settings: A multicentre, multinational, single blind randomized trial.

Aims: To evaluate the safety, efficacy and need for remote monitoring of the MD-Logic closed-loop system during short-term overnight use at home.

Methods: Seventy-five patients (38 male; aged 10-54 years; average A1c, 7.8% ± 0.

A remote monitoring system for artificial pancreas support is safe, reliable, and user friendly.

Introduction: We developed a unique remote monitoring and control diabetes management system (MDRS) supporting the use of an artificial pancreas (AP) at home. In this study, we aimed at assessing the efficacy and safety of the MDRS and its ability to prevent or shorten nocturnal hypoglycemia episodes without the use of an AP, as well as evaluating parental attitudes toward the use of such a system in the future.

Materials And Methods: This was a prospective, case control, randomized study.

MD-Logic overnight control for 6 weeks of home use in patients with type 1 diabetes: randomized crossover trial.

Objective: We evaluated the effect of the MD-Logic system on overnight glycemic control at patients' homes.

Research Design And Methods: Twenty-four patients (aged 12-43 years; average A1c 7.5 ± 0.

Multicenter closed-loop insulin delivery study points to challenges for keeping blood glucose in a safe range by a control algorithm in adults and adolescents with type 1 diabetes from various sites.

Background: The Control to Range Study was a multinational artificial pancreas study designed to assess the time spent in the hypo- and hyperglycemic ranges in adults and adolescents with type 1 diabetes while under closed-loop control. The controller attempted to keep the glucose ranges between 70 and 180 mg/dL. A set of prespecified metrics was used to measure safety.

Night glucose control with MD-Logic artificial pancreas in home setting: a single blind, randomized crossover trial-interim analysis.

Background: Artificial pancreas (AP) systems have shown an improvement in glucose control and a reduced risk of nocturnal hypoglycemia under controlled conditions but remain to be evaluated under daily-life conditions.

Objective: To assess the feasibility, safety, and efficacy of the MD-Logic AP in controlling nocturnal glucose levels in the patient's home.

Methods: Two-arm study, each covering four consecutive nights comparing the MD-Logic AP ('closed-loop' arm) with sensor-augmented pump therapy ('control' arm).

The "Glucositter" overnight automated closed loop system for type 1 diabetes: a randomized crossover trial.

Background: Tight glucose control is needed to prevent long-term diabetes complications; this is hindered by the risk of hypoglycemia, especially at night.

Objective: To assess the safety and efficacy of the closed-loop MD-Logic Artificial Pancreas (MDLAP), controlling nocturnal glucose levels in patients with type 1 diabetes mellitus (T1DM).

Research Design And Methods: This was a randomized, multicenter, multinational, crossover trial conducted in Slovenia, Germany, and Israel.

Nocturnal glucose control with an artificial pancreas at a diabetes camp.

Background: Recent studies have shown that an artificial-pancreas system can improve glucose control and reduce nocturnal hypoglycemia. However, it is not known whether such results can be replicated in settings outside the hospital.

Methods: In this multicenter, multinational, randomized, crossover trial, we assessed the short-term safety and efficacy of an artificial pancreas system for control of nocturnal glucose levels in patients (10 to 18 years of age) with type 1 diabetes at a diabetes camp.

Clinical evaluation of a personalized artificial pancreas.

Objective: An artificial pancreas (AP) that automatically regulates blood glucose would greatly improve the lives of individuals with diabetes. Such a device would prevent hypo- and hyperglycemia along with associated long- and short-term complications as well as ease some of the day-to-day burden of frequent blood glucose measurements and insulin administration.

Research Design And Methods: We conducted a pilot clinical trial evaluating an individualized, fully automated AP using commercial devices.

Feasibility study of automated overnight closed-loop glucose control under MD-logic artificial pancreas in patients with type 1 diabetes: the DREAM Project.

Background: Artificial pancreas systems may offer a potential major impact on the normalization of metabolic control and preventing hypoglycemic events. This study aims to establish near-normal overnight glucose control and reduce the risk of nocturnal hypoglycemia using the MD-Logic Artificial Pancreas (MDLAP), an algorithm that was developed by our research group. This inpatient feasibility study is the first step towards implementing an overnight closed-loop MDLAP system at the patient's home.

Automatic learning algorithm for the MD-logic artificial pancreas system.

Background: Applying real-time learning into an artificial pancreas system could effectively track the unpredictable behavior of glucose-insulin dynamics and adjust insulin treatment accordingly. We describe a novel learning algorithm and its performance when integrated into the MD-Logic Artificial Pancreas (MDLAP) system developed by the Diabetes Technology Center, Schneider Children's Medical Center of Israel, Petah Tikva, Israel.

Methods: The algorithm was designed to establish an initial patient profile using open-loop data (Initial Learning Algorithm component) and then make periodic adjustments during closed-loop operation (Runtime Learning Algorithm component).

MD-logic artificial pancreas system: a pilot study in adults with type 1 diabetes.

Objective: Current state-of-the-art artificial pancreas systems are either based on traditional linear control theory or rely on mathematical models of glucose-insulin dynamics. Blood glucose control using these methods is limited due to the complexity of the biological system. The aim of this study was to describe the principles and clinical performance of the novel MD-Logic Artificial Pancreas (MDLAP) System.

Utilization of the foot load monitor for evaluating deep plantar tissue stresses in patients with diabetes: proof-of-concept studies.

The purposes of the present study were to (1) determine the internal plantar mechanical stresses in diabetic and healthy subjects during everyday activities, and (2) identify stress parameters potentially capable of distinguishing between diabetic and healthy subjects. A self-designed, portable, real-time and subject-specific foot load monitor which employs the Hertz contact theory was utilized to determine the internal dynamic plantar tissue stresses in 10 diabetic patients and 6 healthy subjects during free walking and outdoors stair climbing. Internal stress parameters and average stress-doses were evaluated, and the results obtained from the two groups were compared.