Expanding the horizon of continuous glucose monitoring into the future of pediatric medicine.

Glucose monitoring has rapidly evolved with the development of minimally invasive continuous glucose monitoring (CGM) using interstitial fluid. It is recommended as standard of care in the ambulatory setting, nearly replacing capillary glucose testing in those with access to CGM. The newest CGM devices continue to be smaller and more accurate, and integration with automated insulin delivery systems has further revolutionized the management of diabetes, leading to successful improvements in care and quality of life.

Psychosocial outcomes with the Omnipod® 5 Automated Insulin Delivery System in caregivers of very young children with type 1 diabetes.

Aim: Automated insulin delivery (AID) systems have demonstrated improved glycaemic outcomes in people with type 1 diabetes (T1D), yet limited data exist on these systems in very young children and their impact on caregivers. We evaluated psychosocial outcomes following use of the tubeless Omnipod® 5 AID System in caregivers of very young children.

Materials And Methods: This 3-month single-arm, multicentre, pivotal clinical trial enrolled 80 children aged 2.

Glycemic Outcomes Persist for up to 2 Years in Very Young Children with the Omnipod 5 Automated Insulin Delivery System.

To evaluate the long-term safety and effectiveness of the Omnipod 5 Automated Insulin Delivery (AID) System in very young children with type 1 diabetes with up to 2 years of use. Following a 13-week single-arm, multicenter, pivotal trial that took place after 14 days of standard therapy data collection, participating children (2-5.9 years of age at study enrollment) were provided the option to continue use of the AID system in an extension phase.

Two Years with a Tubeless Automated Insulin Delivery System: A Single-Arm Multicenter Trial in Children, Adolescents, and Adults with Type 1 Diabetes.

The Omnipod 5 Automated Insulin Delivery (AID) System was shown to be safe and effective following 3 months of use in people with type 1 diabetes (T1D); however, data on the durability of these results are limited. This study evaluated the long-term safety and effectiveness of Omnipod 5 use in people with T1D during up to 2 years of use. After a 3-month single-arm, multicenter, pivotal trial in children (6-13.

How introduction of automated insulin delivery systems may influence psychosocial outcomes in adults with type 1 diabetes: Findings from the first investigation with the Omnipod® 5 System.

Aims: To evaluate psychosocial outcomes for adults with type 1 diabetes (T1D) using the tubeless Omnipod® 5 Automated Insulin Delivery (AID) System.

Methods: A single-arm, multicenter (across the United States), prospective safety and efficacy study of the tubeless AID system included 115 adults with T1D. Participants aged 18-70 years completed questionnaires assessing psychosocial outcomes - diabetes distress (T1-DDS), hypoglycemic confidence (HCS), well-being (WHO-5), sleep quality (PSQI), insulin delivery satisfaction (IDSS), diabetes treatment satisfaction (DTSQ), and system usability (SUS) - before and after 3 months of AID use.

Safety and Glycemic Outcomes With a Tubeless Automated Insulin Delivery System in Very Young Children With Type 1 Diabetes: A Single-Arm Multicenter Clinical Trial.

Objective: Very young children with type 1 diabetes often struggle to achieve glycemic targets, putting them at risk for long-term complications and creating an immense management burden for caregivers. We conducted the first evaluation of the Omnipod 5 Automated Insulin Delivery System in this population.

Research Design And Methods: A total of 80 children aged 2.

Long-term Continuous Glucose Monitor Use in Very Young Children With Type 1 Diabetes: One-Year Results From the SENCE Study.

Objectives: Achieving optimal glycemic outcomes in young children with type 1 diabetes (T1D) is challenging. This study examined the durability of continuous glucose monitoring (CGM) coupled with a family behavioral intervention (FBI) to improve glycemia.

Study Design: This one-year study included an initial 26-week randomized controlled trial of CGM with FBI () and CGM alone () compared with blood glucose monitoring (BGM), followed by a 26-week extension phase wherein the BGM Group received the CGM+FBI () and both original CGM groups continued this technology.

Multicenter Trial of a Tubeless, On-Body Automated Insulin Delivery System With Customizable Glycemic Targets in Pediatric and Adult Participants With Type 1 Diabetes.

Objective: Advances in diabetes technology have transformed the treatment paradigm for type 1 diabetes, yet the burden of disease is significant. We report on a pivotal safety study of the first tubeless, on-body automated insulin delivery system with customizable glycemic targets.

Research Design And Methods: This single-arm, multicenter, prospective study enrolled 112 children (age 6-13.

Predictors of response to insulin therapy in youth with poorly-controlled type 2 diabetes in the TODAY trial.

Objective: To understand the factors associated with glycemic control after starting insulin in youth with type 2 diabetes following glycemic failure (persistent HbA1c ≥8%) with metformin alone, metformin + rosiglitazone or metformin + lifestyle in the TODAY study.

Methods: Change in HbA1c after add-on insulin therapy and the factors predictive of glycemic response were evaluated. At 1-year postinsulin initiation, 253 youth had a mean of 3.