MiniMed 780G TM in children with type 1 diabetes under seven years of age: Prospective open-label,single-arm,double-center,follow-up study

Abstract

BACKGROUND:

Given the steadily rising incidence of type 1 diabetes (T1D), particularly among the youngest preschool children, coupled with well-documented challenges of achieving and maintaining optimal metabolic control in this age group, there is a growing need for advanced technological devices.

OBJECTIVE:

To evaluate glycaemic control in children below the age of seven with type 1 diabetes (T1D) and assess the safety of the advanced hybrid closed loop (AHCL) system in comparison to the previous treatment method, a sensor-augmented pump with predictive low-glucose suspend (SAP-PLGS).

METHOD:

Data from 10 children (aged 2.60–6.98 years) with T1D who transitioned to the AHCL system from SAP-PLGS were analysed. SAP-PLGS records from two weeks prior to the initiation of AHCL were compared with records from the initial four weeks post-switch (excluding the training period). These data were examined at two 2-week intervals and compared with records from two weeks post six-month usage of the AHCL.

RESULTS:

A significant decrease in the average nighttime glucose concentration was observed compared to pre-AHCL values ( $p=$ 0.001, concordance W $=$ 0.53). The Glucose Management Indicator (GMI) value significantly decreased from 6.88 $\pm$ 0.37% to 6.52 $\pm$ 0.32% ( $p=$ 0.018, rbc $=$ 0.93) immediately following the device switch and stabilized at 6.50 $\pm$ 0.28% ( $p=$ 0.001, W $=$ 0.53) and 6.55 $\pm$ 0.41% ( $p=$ 0.001, W $=$ 0.53) at subsequent stages of the study. An improvement was also observed in mean glucose values for time spent $<$ 54 mg/dl, while the proportion of time within this range was maintained, both during the day ( $p<$ 0.001, W $=$ 0.58) and at night ( $p=$ 0.002, W $=$ 0.83).

CONCLUSION:

The AHCL MiniMed 780G^TM system improved glycaemic control in the studied group of children under seven years of age with T1D compared to previous SAP-PLGS therapy. It proved to be safe for delivering insulin in this age group.