Introduction: The advanced hybrid closed loop (a-HCL) system Medtronic
Minimed 780G is licensed for use in children ≥7 years and with
a minimum insulin daily dose ≥ of 8 units.
Objectives: To study the safety and the effectiveness of the a-HCL
system Medtronic Minimed 780G in children younger than 7 years.
Methods: Retrospective study in children with type 1 diabetes mellitus
(T1DM) who started using a-HCL before the age limit of 7 years
when the clinician considered this treatment to be beneficial, and the
family agreed on off-label use of the system. The “G2 clinico” platform
was employed to access patients' clinical data. We extracted the
latest data on glycemic control from reports generated with Care-
LinkTM Personal Software with observation time frames of 2 weeks.
Data are presented as median and interquartile ranges (IQRs). Wilcoxon
signed-rank test was performed to check whether the differences
between paired data were statistically significant.
Results: This retrospective study included 10 individuals (5 females)
with T1DM (median age at diagnosis 3.8 years [IQR 2.5;4.9]). The
median duration of T1DM was 37 days (IQR 5; 418) at the beginning
of insulin pump in manual mode and 164 days (IQR 32–451; min
14 days) when starting treatment with a-HCL in auto mode, at a
median age of 4.7 years (IQR 2.9; 5.5, min 2.1 years) and with a
median insulin daily requirement of 9.4 U (IQR 8.1;11.6, min 5.6). The
median age at the last data download was 5.1 years (IQR 3.3–6.6),
with a median duration of a-HCL treatment of 179 days (IQR 72;385).
No ketoacidosis or severe hypoglycemia events were reported. Time
above range (TAR) and mean glucose sensor significantly decreased
since the beginning of a-HCL use and until the last download
(p < 0.01), while time in range (TIR) significantly reduced (p < 0.01).
Conclusions: The use of a-HCL system Minimed 780G is safe and
effective also in children below the age of 7 years and with a total
daily insulin dose below 8 U.
