Safety Evaluation of the MiniMed 670G System in Children 7-13 Years of Age with Type 1 Diabetes.

ABSTRACT:

Objective

To evaluate the safety of in-home use of the MiniMed™ 670G system with SmartGuard™ technology in children with type 1 diabetes (T1D).

Methods

Participants (N = 105, ages 7-13 years, mean age 10.8 ± 1.8 years) were enrolled at nine centers (eight in the United States and one in Israel) and completed a 2-week baseline run-in phase in Manual Mode followed by a 3-month study phase with Auto Mode enabled. Sensor glucose (SG), glycated hemoglobin (HbA_1c), percentage of SG values across glucose ranges, and SG variability, during the run-in and study phases were compared. Participants underwent frequent sample testing with i-STAT^® venous reference measurement during a hotel period (6 days/5 nights) to evaluate the system's continuous glucose monitorin

SUBMITTER: Forlenza GP 

PROVIDER: S-EPMC6350071 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature