According to study findings published in Diabetes Technology & Therapeutics, the MiniMed 670G system is effective and safe for in-home use by children with type 1 diabetes (T1D).
To determine whether the MiniMed 670G system used at home by adolescents and adults with T1D is also safe for children, researchers recruited 105 individuals with T1D age 7 to 13 years (average age, 10.8) to test the system. Participants were asked to complete a 2-week baseline run-in phase on the MiniMed 670G’s Manual Mode, followed by a 3-month study phase utilizing the system’s SmartGuard Auto Mode.
During the baseline and study phases, the researchers assessed each participant for changes in glycated hemoglobin (HbA1c), sensor glucose, percentage of sensor glucose values across glucose ranges, and sensor glucose variability. They also conducted 6 days of i-STAT venous blood reference measurements to evaluate the system’s continuous glucose monitoring performance.
Auto Mode was utilized for a median of 81% of the study, or 19.3 hours/day. Overall, sensor glucose was reduced by 6.9 mg/dL from baseline (P <.001), HbA1c decreased from 7.9% to 7.5% (P <.001), percentage of time in target glucose range (70 to 180 mg/dL) rose from 56.2% to 65% (P <.001), and the sensor glucose coefficient of variation decreased from 39.6% to 38.5% (P =.009). In addition, 68.2% of sensor glucose values were within the target range, while 65.6% of values were within the i-STAT reference values.
With regard to safety, the researchers discovered no episodes of diabetic ketoacidosis during the study phase. There were, however, 27 episodes of severe hyperglycemia during the run-in phase and 76 during the study phase.
Study limitations included absence of a control group, as well as varying time durations for the run-in and study phases.
The researchers said their findings confirm that “in-home use of the MiniMed 670G system with the SmartGuard Auto Mode feature by children with T1D, similar to that observed for adolescents and adults with T1D, safely improves overall glycemic control by reducing glucose variability and minimizing hypo- and hyperglycemia.”
All principal investigators received compensation from Medtronic to conduct this study.
Forlenza GP, Pinhas-Hamiel O, Liljenquist DR, et al. Safety evaluation of the MiniMed 670g system in children 7–13 years of age with type 1 diabetes. Diabetes Technol Ther. 2019;21(1).