Continuous glucose monitoring in people with diabetes: the randomized controlled Glucose Level Awareness in Diabetes Study (GLADIS).

Abstract

To investigate the best glucose monitoring strategy for maintaining euglycaemia by comparing self-monitoring of blood glucose with continuous glucose monitoring, with or without an alarm function. A 100-day, randomized controlled study was conducted at four European centres, enrolling 160 patients with Type 1 or Type 2 diabetes, on multiple daily insulin injections or continuous subcutaneous insulin infusion. Participants were randomized to continuous glucose monitoring without alarms (n=48), continuous glucose monitoring with alarms (n=49) or self-monitoring of blood glucose (n=48). Time spent outside the glucose target during days 80-100 was 9.9h/day for the continuous glucose monitoring without alarms group, 9.7h/day for the continuous glucose monitoring with alarms group and 10.6h/day for the self-monitoring of blood glucose group (P=0.18 and 0.08 compared with continuous glucose monitoring without and with alarms, respectively).The continuous glucose monitoring with alarms group spent less time in hypoglycaemia compared with the self-monitoring of blood glucose group (1.0h/day and 1.6h/day, respectively; 95% CI -1.2 to -0.1; P=0.030). Among those treated with continuous subcutaneous insulin infusion, time spent outside the glucose target was significantly different when comparing continuous glucose monitoring without alarms and self-monitoring of blood glucose (-1.9h/day; 95% CI -3.8 to 0.0; P=0.0461) and when comparing continuous glucose monitoring with alarms and self-monitoring of blood glucose (-2.4h/day; 95% CI -4.1 to -0.5; P=0.0134). There was no difference in HbA1c reduction from baseline in the three groups; however, the proportion of participants with a reduction of≥6mmol/mol (≥0.5%) was higher in the continuous glucose monitoring without alarms (27%) and continuous glucose monitoring with alarms groups (25%) than in the self-monitoring of blood glucose group (10.6%). This study shows that the use of continuous glucose monitoring reduces time spent outside glucose targets compared with self-monitoring of blood glucose, especially among users of insulin pumps.