Incorporación masiva de un sistema automático de administración de insulina en adultos con diabetes tipo 1 previamente tratados con un sistema integrado bomba/sensor por alto riesgo de hipoglucemia

Abstract

Introduction

Automatic insulin delivery (AID) systems improve glycemic control and quality of life in individuals with type 1 diabetes (T1D). Our aim was to assess the feasibility, effectiveness, and safety of switching from a sensor-augmented pump (SAP) to AID in T1D subjects at high risk of hypoglycemia.

Materials and methods

A manufacturer-led program consisting of three sessions was implemented. Over three days, all patients completed the first session in-person, in groups of 6-12 people, to receive device training. Subsequently, the automatic mode was activated virtually (session 2), followed by online data download (session 3). Glucometric outcomes were evaluated after one month, along with serious adverse events (SAEs), technical incidents, and perceived satisfaction.

Results

The switch was performed in 125 patients, 56.8% of whom were women, with a mean age of 44.1 ± 14.9 years. 99.2% (n = 124) initialized auto-mode. There was an increase in time in range 70-180 mg/dl (64.3 ± 11.3 vs. 74.7 ± 11.2; P<.001) and a decrease in time below 70 mg/dl (4.1 ± 3.9 vs. 2.0 ± 1.8; p < 0.001) (N = 97). Forty-one related calls were received, with 10 requiring in-person visits. Medtronic technical service handled 92 related calls (0.74 per patient), from 47 different users (37.6%). One event of severe hypoglycemia was recorded as an SAE. Perceived security and satisfaction with the switch process were high in 91% and 92% of patients, respectively.

Conclusions

Massive switch from SAP to AID in T1D patients at high risk of hypoglycemia is feasible and safe through a hybrid program conducted in collaboration with the manufacturer.