The RealTrend Study: Effect on Metabolic Control in Poorly Controlled Type 1 Diabetes Using Properly the Paradigm REAL-Time System vs. Conventional Blood Glucose Self-Monitoring and Continuous Subcutaneous Insulin Infusion
Abstract Number: 205-OR
Authors: DENIS RACCAH, VERONIQUE SULMONT, YVES REZNICK, BRUNO GUERCI, ERIC RENARD, HELENE HANAIRE, NATHALIE JEANDIDIER, MARC NICOLINO
Institutions: Marseille, France, Reims, France, Caen, France, Nancy, France, Montpellier, France, Toulouse, France, Strasbourg, France, Lyon, France
Results: Efficacy of continuous glucose monitoring (CGM) versus standard self-monitoring of blood glucose to adapt insulin doses with an insulin pump has not been determined.
In this randomized, controlled, multi-centre trial, 132 adults and children insufficiently treated with multiple daily insulin injections (A1c> 8%) were assigned to a 6 months treatment in one of 2 study arms: PRT arm, fitted with the Paradigm REAL Time System (Medtronic insulin pump with integrated CGM), or CSII arm, fitted with an insulin pump and conventional blood glucose self-monitoring. In the PRT arm, patients wore glucose sensors for training 9 days before baseline A1c. Primary endpoint: change in A1c in the 2 study arms between baseline and end of study. Secondary endpoints included hyper- and hypoglycemia parameters measured by CGM: average glucose, time spent above and below hyper- and hypoglycemia limits, and respective area under the curve.
A1c was analyzable for 115 patients (46 children, 69 adults) of the full analysis population (FAS) and improved between baseline and study end in the two groups (PRT, n=55, -0.81%±1.09; CSII, n=60, -0.57%±0.94; p=0.087). A per protocol (PP) analysis of 91 patients (35 children, 56 adults) who wore sensors over 70 % of the time (inclusion criteria) showed a significant difference in A1c reduction between groups (PRT, n=32: -0.96%±0.93; CSII, n=59: -0.55%±0.93, p=0.004). In PRT group,CGM hyperglycemia parameters decreased in line with A1c, without increased hypoglycemia.
In both FAS and PP populations A1c improved significantly after treatment was changed from MDI to CSII or PRT. Patients treated with the PRT and wearing the sensor at least 70% of the time improved their A1c significantly more than the corresponding CSII arm. [figure1]