Real-world effectiveness and safety of sensor-augmented insulin pump therapy in adults with type 1 diabetes: Long-term follow-up

Nicolás Coronel-Restrepo; Víctor Manuel Blanco; Andres Palacio; Alex Ramírez-Rincón; Sebastián Arbeláez; Valentina Duque; Juan José Pino; Javier Carvajal; Jorge Bedoya; Diana Paola Cuesta; José Fernando Botero

doi:10.1016/j.endinu.2020.07.012

Real-world effectiveness and safety of sensor-augmented insulin pump therapy in adults with type 1 diabetes: Long-term follow-up

Endocrinol Diabetes Nutr (Engl Ed). 2020 Dec 23:S2530-0164(20)30243-3. doi: 10.1016/j.endinu.2020.07.012. Online ahead of print.

[Article in English, Spanish]

Affiliations

¹ Clínica Integral de Diabetes (CLID), Medellín, Colombia; Universidad Pontificia Bolivariana, Medellín, Colombia. Electronic address: ncoronel.restrepo@gmail.com.
² Universidad Pontificia Bolivariana, Medellín, Colombia.
³ Clínica Integral de Diabetes (CLID), Medellín, Colombia; Universidad Pontificia Bolivariana, Medellín, Colombia.
⁴ Clínica Integral de Diabetes (CLID), Medellín, Colombia.

PMID: 33358488
DOI: 10.1016/j.endinu.2020.07.012

Abstract

Objective: To evaluate the effectiveness and safety of sensor-augmented insulin pump therapy (SAP) in addition to a comprehensive diabetes program on glycated hemoglobin (HbA1c), severe hypoglycemia, ketoacidosis, and the hospital admission rate in patients with type 1 diabetes under real-world settings during a 2-year follow-up.

Methods: This was a retrospective real-life study comparing diabetes control before and after SAP therapy initiation. Patients ≥18 years old with type 1 diabetes were included. They were followed for 2 years with clinical assessments at months 3, 6, 12, 18, and 24. Effectiveness was estimated by difference in medians of HbA1c from baseline and at each follow-up visit. Safety was assessed by comparing the annual rates of severe hypoglycemia, hyperglycemic crisis, and hospital admission related to diabetes.

Results: 162 patients were included, median age 32 years, women 73%). The main indication for SAP was poor metabolic control (51.2%). At 2 years HbA1c decreased from 8.4% to 7.5% (-0.9%, 95% CI: 0.5-1.2; p<0.0001), HbA1c ≤7% improved from 14.2% to 25.3% (11.1%, 95% CI: 19.7-2.5; p=0.006), and severe hypoglycemia decreased from 22.2% to 14.1% (-8.1%, 95% CI: -16.5 to 0.3; p=0.03).

Conclusions: SAP therapy improved glycemic control after the third month of use and for up to 2 years of follow-up, with lower rates of hospital admission and severe hypoglycemia. More studies are needed to assess the add-on impact of education programs and technologies for diabetes care.

Keywords: Continuous glucose monitoring; Continuous insulin infusion systems; Diabetes mellitus tipo 1; Diabetes mellitus tipo 2; Glycated hemoglobin A1c; Hemoglobina glicada A1c; Monitoreo continuo de glucosa; Sensor-augmented insulin pump therapy; Sistemas de infusión continua de insulina; Terapia con bomba de insulina aumentada por sensor; Type 1 diabetes mellitus; Type 2 diabetes mellitus.