Use of Personal Continuous Glucose Monitoring Device Is Associated With Reduced Risk of Hypoglycemia in a 16-Week Clinical Trial of People With Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion.

Abstract

Continuous glucose monitoring (CGM) has the potential to promote diabetes self-management at home with a better glycemic control as outcome. Investigation of the effect of CGM has typically been carried out based on randomized controlled trials with prespecified CGM devices on CGM-naïve participants. The aim of this study was to investigate the effect on glycemic control in people using their personal CGM before and during the trial. Data from the Onset 5 trial of 472 people with type 1 diabetes using either their personal CGM (n = 117) or no CGM (n = 355) and continuous subcutaneous insulin infusion in a 16-week treatment period were extracted. Change from baseline in glycated hemoglobin A1c (HbA1c), number of hypoglycemic episodes, and CGM metrics at the end of treatment were analyzed with analysis of variance repeated-measures models. Use of personal CGM compared with no CGM was associated with a reduction in risk of documented symptomatic hypoglycemia (event rate ratio: 0.82; 95% CI: 0.69-0.97) and asymptomatic hypoglycemia (event rate ratio: 0.72; 95% CI: 0.53-0.97), reduced time spent in hypoglycemia (P = .0070), and less glycemic variability (P = .0043) without a statistically significant increase in HbA1c (P = .2028). Results indicate that use of personal CGM compared with no CGM in a population of type 1 diabetes is associated with a safer glycemic control without a statistically significantly deteriorated effect on HbA1c, which adds to the evidence about the real-world use of CGM, where device type is not prespecified, and users are not CGM naïve.