The Virtual DCCT #3: Relationship of HbA1c and CGM Metrics with Cardiovascular Outcomes.

Using a multistep machine-learning approach, the aim is to create virtual continuous glucose monitoring (CGM) traces from glycemic data collected in the Diabetes Control and Complications Trial (DCCT) to assess the relationship between CGM metrics and DCCT cardiovascular (CV) outcomes in people with type 1 diabetes. Utilizing the virtual CGM traces created for each DCCT participant, as previously published, discrete Cox proportional hazard models were used to calculate hazard ratios (HRs) for the association between glycemic metrics (hemoglobin A1c [HbA1c] and virtual CGM) and 3 separate DCCT CV outcome definitions: (1) all DCCT-recorded events; (2) a restricted set of "hard" CV end points; and (3) a restricted set of major CV and major peripheral vascular events. Mean HbA1c and CGM metrics reflective of hyperglycemia were consistently higher, and time-in-range (70-180 mg/dL) and time-in-tight-range (70-140 mg/dL) were consistently lower, in DCCT participants who experienced a CV outcome versus those who did not.

The Association of Time-in-Range and Time-in-Tight-Range with Retinopathy Progression in the Virtual Diabetes Control and Complications Trial Continuous Glucose Monitoring Dataset.

In a prior work, a virtual continuous glucose monitoring (CGM) trace was generated for each of the 1441 participants in the landmark Diabetes Control and Complications trial (DCCT). These new data allow us to compare whether time-in-tight-range (TITR) is a better predictor of diabetic microvascular complications (specifically retinopathy development or progression) than time-in-range (TIR). Discrete Cox proportional hazard models were used to calculate the hazard ratios (HRs) for the development/progression of retinopathy.

Diabetes technology in people with diabetes and advanced chronic kidney disease.

Diabetes is the leading cause and a common comorbidity of advanced chronic kidney disease. Glycaemic management in this population is challenging and characterised by frequent excursions of hypoglycaemia and hyperglycaemia. Current glucose monitoring tools, such as HbA, fructosamine and glycated albumin, have biases in this population and provide information only on mean glucose exposure.

A Meta-Analysis of Randomized Trial Outcomes for the t:slim X2 Insulin Pump with Control-IQ Technology in Youth and Adults from Age 2 to 72.

To evaluate the effect of hybrid-closed loop Control-IQ technology (Control-IQ) in randomized controlled trials (RCTs) in subgroups based on baseline characteristics such as race/ethnicity, socioeconomic status (SES), prestudy insulin delivery modality (pump or multiple daily injections), and baseline glycemic control. Data were pooled and analyzed from 3 RCTs comparing Control-IQ to a Control group using continuous glucose monitoring in 369 participants with type 1 diabetes (T1D) from age 2 to 72 years old. Time in range 70-180 mg/dL (TIR) in the Control-IQ group ( = 256) increased from 57% ± 17% at baseline to 70% ± 11% during follow-up, and in the Control group ( = 113) was 56% ± 15% and 57% ± 14%, respectively (adjusted treatment group difference = 11.

Trial of Hybrid Closed-Loop Control in Young Children with Type 1 Diabetes.

Background: Closed-loop control systems of insulin delivery may improve glycemic outcomes in young children with type 1 diabetes. The efficacy and safety of initiating a closed-loop system virtually are unclear.

Methods: In this 13-week, multicenter trial, we randomly assigned, in a 2:1 ratio, children who were at least 2 years of age but younger than 6 years of age who had type 1 diabetes to receive treatment with a closed-loop system of insulin delivery or standard care that included either an insulin pump or multiple daily injections of insulin plus a continuous glucose monitor.

Biobehavioral Changes Following Transition to Automated Insulin Delivery: A Large Real-life Database Analysis.

Objective: To document glycemic and user-initiated bolus changes following transition from predictive low glucose suspend (PLGS) system to automated insulin delivery (AID) system during real-life use.

Research Design And Methods: We conducted analysis of 2,329,166 days (6,381 patient-years) of continuous glucose monitoring (CGM) and insulin therapy data for 19,354 individuals with type 1 Diabetes, during 1-month PLGS use (Basal-IQ technology) followed by 3-month AID use (Control-IQ technology). Baseline characteristics are as follows: 55.

Outcomes in Pump- and CGM-Baseline Use Subgroups in the International Diabetes Closed-Loop Trial.

Background: We investigated the potential benefits of automated insulin delivery (AID) among individuals with type 1 diabetes (T1D) in sub-populations of baseline device use determined by continuous glucose monitor (CGM) use status and insulin delivery via multiple daily injections (MDI) or insulin pump.

Materials And Methods: In a six-month randomized, multicenter trial, 168 individuals were assigned to closed-loop control (CLC, Control-IQ, Tandem Diabetes Care), or sensor-augmented pump (SAP) therapy. The trial included a two- to eight-week run-in phase to train participants on study devices.

Glycemic Outcomes in Baseline Hemoglobin A1C Subgroups in the International Diabetes Closed-Loop Trial.

Using a closed-loop system significantly improves time in range (TIR) 70-180 mg/dL in patients with type 1 diabetes (T1D). In a 6-month RCT, 112 subjects were randomly assigned to closed-loop control (Tandem Control-IQ) after obtaining 2 weeks of baseline Continuous glucose monitoring (CGM) data from sensor-augmented pump therapy. We compared glycemic outcomes from baseline to end of study among subgroups classified by baseline HbA1c levels.

Assessment for Predictors of Rise in Hemoglobin A1c During Extended Use of a Closed-Loop Control System.

We assessed predictors of rising hemoglobin A1c (HbA1c) during long-term use of closed-loop control (CLC) in children aged 6-13 years with type 1 diabetes. Participants used a CLC system during a 16-week randomization phase followed by a 12-week extension phase. We compared an "Increased-HbA1c" group ( = 17, ≥0.

Patient-Reported Outcomes in a Randomized Trial of Closed-Loop Control: The Pivotal International Diabetes Closed-Loop Trial.

Closed-loop control (CLC) has been shown to improve glucose time in range and other glucose metrics; however, randomized trials >3 months comparing CLC with sensor-augmented pump (SAP) therapy are limited. We recently reported glucose control outcomes from the 6-month international Diabetes Closed-Loop (iDCL) trial; we now report patient-reported outcomes (PROs) in this iDCL trial. Participants were randomized 2:1 to CLC ( = 112) versus SAP ( = 56) and completed questionnaires, including Hypoglycemia Fear Survey, Diabetes Distress Scale (DDS), Hypoglycemia Awareness, Hypoglycemia Confidence, Hyperglycemia Avoidance, and Positive Expectancies of CLC (INSPIRE) at baseline, 3, and 6 months.

Health-Related Quality of Life and Treatment Satisfaction in Parents and Children with Type 1 Diabetes Using Closed-Loop Control.

Hybrid closed-loop systems increase time-in-range (TIR) and reduce glycemic variability. Person-reported outcomes (PROs) are essential to assess the utility of new devices and their impact on quality of life. This article focuses on the PROs for pediatric participants (ages 6-13 years) with type 1 diabetes (T1D) and their parents during a trial using the Tandem Control-IQ system, which was shown to increase TIR and improve other glycemic metrics.

Evening and overnight closed-loop control versus 24/7 continuous closed-loop control for type 1 diabetes: a randomised crossover trial.

Background: Automated closed-loop control (CLC), known as the "artificial pancreas" is emerging as a treatment option for Type 1 Diabetes (T1D), generally superior to sensor-augmented insulin pump (SAP) treatment. It is postulated that evening-night (E-N) CLC may account for most of the benefits of 24-7 CLC; however, a direct comparison has not been done.

Methods: In this trial (NCT02679287), adults with T1D were randomised 1:1 to two groups, which followed different sequences of four 8-week sessions, resulting in two crossover designs comparing SAP vs E-N CLC and E-N CLC vs 24-7 CLC, respectively.

A Randomized Trial of Closed-Loop Control in Children with Type 1 Diabetes.

Background: A closed-loop system of insulin delivery (also called an artificial pancreas) may improve glycemic outcomes in children with type 1 diabetes.

Methods: In a 16-week, multicenter, randomized, open-label, parallel-group trial, we assigned, in a 3:1 ratio, children 6 to 13 years of age who had type 1 diabetes to receive treatment with the use of either a closed-loop system of insulin delivery (closed-loop group) or a sensor-augmented insulin pump (control group). The primary outcome was the percentage of time that the glucose level was in the target range of 70 to 180 mg per deciliter, as measured by continuous glucose monitoring.

Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes.

Background: Closed-loop systems that automate insulin delivery may improve glycemic outcomes in patients with type 1 diabetes.

Methods: In this 6-month randomized, multicenter trial, patients with type 1 diabetes were assigned in a 2:1 ratio to receive treatment with a closed-loop system (closed-loop group) or a sensor-augmented pump (control group). The primary outcome was the percentage of time that the blood glucose level was within the target range of 70 to 180 mg per deciliter (3.

Beyond HbA : using continuous glucose monitoring metrics to enhance interpretation of treatment effect and improve clinical decision-making.

Assessment of glycaemic outcomes in the management of Type 1 and Type 2 diabetes has been revolutionized in the past decade with the increasing availability of accurate, user-friendly continuous glucose monitoring (CGM). This advancement has brought a need for new techniques to appropriately analyse and understand the voluminous and complex CGM data for application in research-related goals and clinical guidance for individuals. Traditionally, HbA was established using the Diabetes Control and Complications Trial (DCCT) and other trials as the ultimate measure of glycaemic control in terms of efficacy and, by default, risk of microvascular complications of diabetes.

Feasibility of Long-Term Closed-Loop Control: A Multicenter 6-Month Trial of 24/7 Automated Insulin Delivery.

Background: In the past few years, the artificial pancreas-the commonly accepted term for closed-loop control (CLC) of blood glucose in diabetes-has become a hot topic in research and technology development. In the summer of 2014, we initiated a 6-month trial evaluating the safety of 24/7 CLC during free-living conditions.

Research Design And Methods: Following an initial 1-month Phase 1, 14 individuals (10 males/4 females) with type 1 diabetes at three clinical centers in the United States and one in Italy continued with a 5-month Phase 2, which included 24/7 CLC using the wireless portable Diabetes Assistant (DiAs) developed at the University of Virginia Center for Diabetes Technology.

Population-Specific Models of Glycemic Control in Intensive Care: Towards a Simulation-Based Methodology for Protocol Optimization.

Stress-induced hyperglycemia is common in critically ill patients, where elevated blood glucose and glycemic variability have been found to contribute to infection, slow wound healing, and short-term mortality. Early clinical studies demonstrated improvement in mortality and morbidity resulting from intensive insulin therapy targeting euglycemia. Follow-up clinical studies have shown mixed results suggesting that the risk of hypoglycemia may outweigh the benefits of aggressive glycemic control.