Investigators evaluate the performance of the G6 factory-calibrated continuous glucose monitoring system over 10 days.
The new Flash Glucose Monitoring System enables patients to wear the sensor for up to 14 days compared with the existing FreeStyle Libre System that was approved for 10-day wear.
Investigators conducted a randomized crossover comparison of 2 dual-hormone artificial pancreas systems — one with rapid insulin and amylin, and another with regular insulin and amylin — with a rapid insulin-alone artificial pancreas.
Researchers conducted a randomized, open-label trial to assess the effect of an automated closed-loop insulin delivery system on glycemic control in hospitalized patients.
Patients were randomly assigned to receive insulin aspart or Technosphere inhaled insulin.
The MiniMed 670G system measures glucose levels every 5 minutes and automatically adjusts insulin delivery to avoid highs and lows.
In children with type 1 diabetes, the Omnipod hybrid closed-loop personal model system was safe and performed well.
Investigators compared 2 methods of delivering bolus insulin, pen vs patch, using metrics from continuous glucose monitoring.
The ITCA 650, a small titanium osmotic mini-pump, provides a subcutaneous infusion of exenatide over 3 or 6 months.
Participants completed surveys for fear of hypoglycemia, hypoglycemia unawareness, and problem areas in diabetes questionnaire.
The safety assessment included incidence of insertion or procedure-related removal and device-related serious adverse events through 180 after insertion.
The sensor is coated with a fluorescent chemical which produces a small amount of light when exposed to blood glucose.
The Omnipod DASH system consists of a discreet, tubeless, waterproof Pod which is worn on the body, and the Personal Diabetes Manager (PDM), a handheld wireless device used to control the Pod.
Investigators recorded hypoglycemic symptoms and monitored blood sugar levels by continuous glucose monitoring for 6 days.
Investigators seek to determine he effects of continuous glucose monitoring on daytime and nocturnal hypoglycemia in patients with type 1 diabetes.
Telemedicine could provide real-time feedback loop and allow pharmacists to help patients self-manage.
For adults with type 1 diabetes with suboptimal control despite using multiple insulin injections, continuous glucose monitoring seems cost-effective, with improved glucose control.
The FDA Digital Health Software Precertification Program represents a feasible solution to regulate software classified as a medical device.
This is the first device authorized for marketing that provides a screening decision without the need for clinician interpretation.
Researchers assessed the safety and accuracy of an implantable continuous glucose measurement in adults diagnosed with type 1 and type 2 diabetes.
Users also have access to the Company's Sugar.IQ app, which uses IBM's Watson Health platform, to identify glucose patterns based on factors that may affect them (ie, food intake, insulin dosages, daily routines).
The FDA reviewed data for the device through the de novo premarket review pathway, a regulatory pathway for novel, low-to-moderate-risk devices that are not substantially equivalent to an already legally marketed device.
For pregnant women with type 1 diabetes, a closed-loop system is associated with comparable glucose control and significantly less hypoglycemia than sensor-augmented pump therapy.
Research findings indicate improved glycemic outcomes in children with T1D using the MiniMed 670G system, similar to those observed for adolescents and adults.
An increasing number of studies support the use of continuous glucose monitoring in adult patients with T2D, and the observed benefits are likely to extend to youth with T2D.
Study suggests that single-hormone artificial pancreas systems may be sufficient for overnight control even in a high-risk group of hypoglycemia-unaware participants with documented nocturnal hypoglycemia.
A novel deep learning system has high sensitivity and specificity for identifying diabetic retinopathy.
In this phase 3 study, statistically and clinically meaningful improvements in HbA1c, body weight, and the proportion of patients achieving goal HbA1c <7% (53mmol/mol) were demonstrated with 2 doses of ITCA 650 vs placebo.
A new continuous glucose monitoring system that allows patients to capture real-time glucose readings without use calibration or routine fingersticks is now available.
The system is able to calculate and recommend optimal insulin dose, track the timing of doses, monitor insulin temperature, remind users to take insulin, and create reports for the healthcare provider.
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