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- Link™ 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.
Safety and effectiveness of advanced hybrid closed loop system in children younger than 7 years
G. Tornese;E. Barbi
2022-01-01
Abstract
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- Link™ 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.Pubblicazioni consigliate
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