Coronel-Restrepo Nicolás, Blanco Víctor Manuel, Palacio Andres, Ramírez-Rincón Alex, Arbeláez Sebastián, Duque Valentina, Pino Juan José, Carvajal Javier, Bedoya Jorge, Cuesta Diana Paola, Botero José Fernando
Clínica Integral de Diabetes (CLID), Medellín, Colombia; Universidad Pontificia Bolivariana, Medellín, Colombia.
Universidad Pontificia Bolivariana, Medellín, Colombia.
Endocrinol Diabetes Nutr (Engl Ed). 2020 Dec 23. doi: 10.1016/j.endinu.2020.07.012.
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.
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.
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).
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.
在真实世界环境中,对1型糖尿病患者进行为期2年的随访,评估在综合糖尿病管理方案基础上加用传感器增强型胰岛素泵治疗(SAP)对糖化血红蛋白(HbA1c)、严重低血糖、酮症酸中毒及住院率的有效性和安全性。
这是一项回顾性真实生活研究,比较启动SAP治疗前后的糖尿病控制情况。纳入年龄≥18岁的1型糖尿病患者。在第3、6、12、18和24个月进行临床评估,随访2年。通过比较HbA1c从基线到每次随访时中位数的差异来评估有效性。通过比较严重低血糖、高血糖危象和糖尿病相关住院的年发生率来评估安全性。
纳入162例患者,中位年龄32岁,女性占73%。SAP的主要适应证是代谢控制不佳(51.2%)。2年后,HbA1c从8.4%降至7.5%(-0.9%,95%CI:0.5-1.2;p<0.0001),HbA1c≤7%的患者比例从14.2%提高到25.3%(11.1%,95%CI:19.7-2.5;p=0.006),严重低血糖发生率从22.2%降至14.1%(-8.1%,95%CI:-16.5至0.3;p=0.03)。
SAP治疗在使用3个月后及长达2年的随访期内改善了血糖控制,住院率和严重低血糖发生率降低。需要更多研究来评估糖尿病护理教育项目和技术的附加影响。