Short-term continuous glucose monitoring: effects on glucose and treatment satisfaction in patients with type 1 diabetes mellitus; a randomized controlled trial

Objective: To assess whether 4 weeks use of a continuous glucose monitoring (CGM) system improves glucose control, treatment satisfaction or health status, as compared to intensified conventional finger-prick measurements (ICFM) in patients with type 1 diabetes mellitus (DM1). Method: Thirty patients suffering from DM1 for more than three years and treated with either insulin pumps or multiple daily insulin injections, were included in a randomised controlled cross-over trial. They were Caucasians of both genders, between 18 and 50 years, and had moderately well controlled diabetes. The participants performed either ICFM or CGM for 4 weeks, followed by an 8 weeks observation period. Thereafter they were crossed over to the opposite intervention. HbA1c, hypoglycaemic episodes, treatment satisfaction and health status were assessed at all meetings, although HbA1c was the primary endpoint. Results: At inclusion mean HbA1c was 7.8 +/- 0.9 %. The mean change in HbA1c was -0.2 +/- 0.1% and -0.2 +/- 0.1% for the CGM and the ICFM periods, accordingly (p = 0.91). The mean changes in HbA1c during the combined treatment and observation periods were -0.1 +/- 0.1% and -0.2 +/- 0.1% for the CGM and the ICFM period, accordingly (p = 0.86). The frequency of severe hypoglycaemic episodes, treatment satisfaction and health status was also equal between the two interventions. No adverse events were observed.