Incremental Value of Continuous Glucose Monitoring When Starting Pump Therapy in Patients With Poorly Controlled Type 1 Diabetes
The RealTrend study *
Denis Raccah , MD, PHD 1 ,
Véronique Sulmont , MD 2 ,
Yves Reznik , MD, PHD 3 ,
Bruno Guerci , MD, PHD 4 ,
Eric Renard , MD, PHD 5 ,
Hélène Hanaire , MD, PHD 6 ,
Nathalie Jeandidier , MD, PHD 7 and
Marc Nicolino , MD, PHD 8
1 University Hospital Sainte Marguerite, Marseille, France;
2 American Memorial Hospital, Children's Hospital, Reims, France;
3 Côte de Nacre Hospital, Caen, France;
4 Centre Hospitalier Universitaire de Nancy and University of Nancy, Nancy, France;
5 Centre Hospitalier Universitaire de Montpellier and University of Montpellier, Montpellier, France;
6 Centre Hospitalier Universitaire de Toulouse and University of Toulouse, Toulouse, France;
7 University Louis Pasteur Hospital, Strasbourg, France;
8 Hospital Femme-Mère-Enfant, Lyon, France.
Corresponding author: Denis Raccah, denis.raccah{at}mail.ap-hm.fr .
Abstract
OBJECTIVE To compare the improvements in glycemic control associated with transitioning to insulin pump therapy in patients using continuous
glucose monitoring versus standard blood glucose self-monitoring.
RESEARCH DESIGN AND METHODS The RealTrend study was a 6-month, randomized, parallel-group, two-arm, open-label study of 132 adults and children with
uncontrolled type 1 diabetes (A1C ≥8%) being treated with multiple daily injections. One group was fitted with the Medtronic
MiniMed Paradigm REAL-Time system (PRT group), an insulin pump with integrated continuous subcutaneous glucose monitoring
(CGM) capability, with instructions to wear CGM sensors at least 70% of the time. Conventional insulin pump therapy was initiated
in the other group (continuous subcutaneous insulin infusion [CSII] group). Outcome measures included A1C and glycemic variability.
RESULTS A total of 115 patients completed the study. Between baseline and trial end, A1C improved significantly in both groups (PRT
group −0.81 ± 1.09%, P < 0.001; CSII group −0.57 ± 0.94%, P < 0.001), with no significant difference between groups. When the 91 patients who were fully protocol-compliant (including
CGM sensor wear ≥70% of the time) were considered, A1C improvement was significantly greater in the PRT group ( P = 0.004) (PRT group −0.96 ± 0.93%, P < 0.001; CSII group −0.55 ± 0.93%, P < 0.001). Hyperglycemia parameters decreased in line with improvements in A1C with no impact on hypoglycemia.
CONCLUSIONS CGM-enabled insulin pump therapy improves glycemia more than conventional pump therapy during the first 6 months of pump
use in patients who wear CGM sensors at least 70% of the time.
Footnotes
Clinical trial registry no. NCT00441129, clinicaltrials.gov .
↵ *Additional study investigators are listed in the appendix .
The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore
be hereby marked “advertisement” in accordance with 18 U.S.C. Section 1734 solely to indicate this fact.
Received April 21, 2009.
Accepted August 29, 2009.
© 2009 by the American Diabetes Association.