Real-World Efficacy and Safety of Continuous Subcutaneous Insulin Infusion (CSII) Therapy and Comparison of Treatment Satisfaction between CSII and Multiple Daily Injection Therapy

Abstract

Objectives: Type 1 diabetes mellitus (T1DM) is one of the most common pediatric endocrine diseases. India alone is home to around 97,700 children with T1DM. This paper evaluates the efficacy, safety, and quality of life with continuous subcutaneous insulin infusion (CSII) in patients treated for a protracted time period of 1 year in a retrospective study versus multiple-dose insulin (MDI). Methods: CSII was offered to patients with poor metabolic control (HbA1c >8.5%) on MDI, patients needing flexible timing of meals, or patients with hypoglycemia unawareness/nocturnal hypoglycemia/high blood sugar fluctuations. Continuous blood glucose monitoring (CGM) was done using the Medtronic CGM system gold/iPro 2 in all patients. Data were collected through a questionnaire completed by patients with the help of a pediatric endocrinologist. Results: A total of 45 patients completed the study evaluation period. The results demonstrated better glycemic control, reduced hypoglycemia on CGM, and no events of diabetic ketoacidosis noted on CSII. The hypoglycemic events were few and nonsevere. The patients in the CSII group reported better quality of life on the Pediatric Quality of Life Inventory 3.2 Diabetic Module diabetes score than the MDI group. Conclusions: This study is the first of this kind in India in the field of pediatric endocrinology. The clinical outcomes validate the use of CSII as the desirable intensive insulin therapy.