Regular physical activity and exercise (PA) are cornerstones of diabetes care for individuals with type 1 diabetes. In recent years, the availability of automated insulin delivery (AID) systems has improved the ability of people with type 1 diabetes to achieve the recommended glucose target ranges. PA provides additional health benefits but can cause glucose fluctuations, which challenges current AID systems.
View Article and Find Full Text PDFRegular physical activity and exercise (PA) are cornerstones of diabetes care for individuals with type 1 diabetes. In recent years, the availability of automated insulin delivery (AID) systems has improved the ability of people with type 1 diabetes to achieve the recommended glucose target ranges. PA provide additional health benefits but can cause glucose fluctuations, which challenges current AID systems.
View Article and Find Full Text PDFThe introduction of automated insulin delivery (AID) systems represents a significant advancement in diabetes care, offering substantial benefits in outpatient settings. Although clinical studies suggest that these systems can also help improve glycemic control in acutely ill patients, several barriers remain for the actual implementation and use of these technologies in clinical practice. Three main contexts for inpatient use are addressed, including: (a) continuation of personal AID systems, (b) initiation of AID during hospitalization, and (c) initiation of AID systems at discharge.
View Article and Find Full Text PDFAim: 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.
Objective: We aimed to assess the feasibility, clinical accuracy, and acceptance of a hospital-wide continuous glucose monitoring (CGM) policy with electronic health record (EHR)-integrated validation for insulin dosing.
Research Design And Methods: A hospital policy was developed and implemented at Stanford Health Care for using personal CGMs in lieu of fingerstick blood glucose (FSBG) monitoring. It included requirements specific to each CGM, accuracy monitoring protocols, and EHR integration.
Objectives: To report the safety and side effects associated with taking verapamil for beta-cell preservation in children with newly-diagnosed T1D.
Research Design And Methods: Eighty-eight participants aged 8.5 to 17.
Diabetes Technol Ther
December 2024
Background/objective: The main objective of this study is to evaluate the incremental cost-effectiveness (ICER) of the Cambridge hybrid closed-loop automated insulin delivery (AID) algorithm versus usual care for children and adolescents with type 1 diabetes (T1D).
Methods: This multicenter, binational, parallel-controlled trial randomized 133 insulin pump using participants aged 6 to 18 years to either AID (n = 65) or usual care (n = 68) for 6 months. Both within-trial and lifetime cost-effectiveness were analyzed.
The use of automated insulin delivery (AID) has led to a decrease in the burden of diabetes, allowing for better sleep, decreased anxiety about hypoglycemia, and automatic corrections doses, and meal recognition algorithms have provided "forgiveness" for imprecise carbohydrate (CHO) entries and missed or late meal boluses. We provide a case report and review of the current literature assessing the effect of AID on the burden of meal bolus. The case also demonstrates how sensor and pump data provide insight into insulin bolus behavior, and access to integrated cloud-based data has allowed for virtual patient visits.
View Article and Find Full Text PDFObjective: Examine patient-reported outcomes (PROs) after the use of t:slim X2 insulin pump with Control-IQ technology (CIQ) in young children with type 1 diabetes.
Methods: Children with type 1 diabetes, ages 2 to < 6 years (n = 102), were randomly assigned 2:1 to either CIQ or standard care (SC) with pump or multiple daily injections (MDI) plus continuous glucose monitoring (CGM) for 13 weeks. Both groups were offered to use CIQ for an additional 13 weeks after the randomized control trial's (RCT) completion.
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.
View Article and Find Full Text PDFDiabetic ketoacidosis (DKA) at diagnosis is associated with short- and long-term complications. We assessed the relationship between DKA status and hemoglobin A1c (A1c) levels in the first year following type 1 diabetes (T1D) diagnosis. The Pilot Teamwork, Targets, Technology, and Tight Control (4T) study offered continuous glucose monitoring to youth with T1D within 1 month of diagnosis.
View Article and Find Full Text PDFThe 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.
View Article and Find Full Text PDFObjective: Modeling the effect of meal composition on glucose excursion would help in designing decision support systems (DSS) for type 1 diabetes (T1D) management. In fact, macronutrients differently affect post-prandial gastric retention (GR), rate of appearance (R[Formula: see text]), and insulin sensitivity (S[Formula: see text]). Such variables can be estimated, in inpatient settings, from plasma glucose (G) and insulin (I) data using the Oral glucose Minimal Model (OMM) coupled with a physiological model of glucose transit through the gastrointestinal tract (reference OMM, R-OMM).
View Article and Find Full Text PDFDuring 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.
View Article and Find Full Text PDFMultiple daily injection insulin therapy frequently fails to meet hospital glycemic goals and is prone to hypoglycemia. Automated insulin delivery (AID) with remote glucose monitoring offers a solution to these shortcomings. In a single-arm multicenter pilot trial, we tested the feasibility, safety, and effectiveness of the Omnipod 5 AID System with real-time continuous glucose monitoring (CGM) for up to 10 days in hospitalized patients with insulin-requiring diabetes on nonintensive care unit medical-surgical units.
View Article and Find Full Text PDFSafety 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.
View Article and Find Full Text PDFRegular exercise is essential to overall cardiovascular health and well-being in people with type 1 diabetes, but exercise can also lead to increased glycemic disturbances. Automated insulin delivery (AID) technology has been shown to modestly improve glycemic time in range (TIR) in adults with type 1 diabetes and significantly improve TIR in youth with type 1 diabetes. Available AID systems still require some user-initiated changes to the settings and, in some cases, significant pre-planning for exercise.
View Article and Find Full Text PDFTo 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.
View Article and Find Full Text PDFBackground: 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.
Importance: In preclinical studies, thioredoxin-interacting protein overexpression induces pancreatic beta cell apoptosis and is involved in glucotoxicity-induced beta cell death. Calcium channel blockers reduce these effects and may be beneficial to beta cell preservation in type 1 diabetes.
Objective: To determine the effect of verapamil on pancreatic beta cell function in children and adolescents with newly diagnosed type 1 diabetes.