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Published Online: 22 December 2010

The SWITCH Study (Sensing With Insulin pump Therapy to Control HbA1c): Design and Methods of a Randomized Controlled Crossover Trial on Sensor-Augmented Insulin Pump Efficacy in Type 1 Diabetes Suboptimally Controlled with Pump Therapy

Publication: Diabetes Technology & Therapeutics
Volume 13, Issue Number 1

Abstract

Background: Studies investigating the effect of real-time continuous glucose monitoring (CGM) combined with pump therapy on glycemic outcomes in type 1 diabetes are increasing. Pump therapy is well established as a “gold standard” for insulin delivery, offering improvements over multiple daily insulin injections. However, there is still a proportion of subjects using continuous subcutaneous insulin infusion in whom goals for metabolic control are far from achieved or benefits of this type of insulin therapy are transient. The SWITCH (Sensing With Insulin pump Therapy to Control HbA1c [hemoglobin A1c]) study is a multicenter, randomized, controlled, crossover study to evaluate if adding CGM to experienced pump patients with suboptimal metabolic control will provide additional insight enabling clinical and therapeutic benefit.
Methods: Subjects meeting the inclusion criteria were randomized to Sensor On or Sensor Off arms for 6 months, after a 1-month run-in period. Following a 4-month washout period, the subjects crossed over to the other study arm for 6 months. The primary end point was the between arm difference in HbA1c levels. Among others, additional end points include time spent in different glycemic ranges, percentage of patients with HbA1c <7%, number of hypoglycemic events, glucose variability parameters, safety outcomes, treatment satisfaction, and quality of life.
Results: Recruitment occurred between January 2008 and February 2009. A total of 153 patients were randomized. Study completion is anticipated in July 2010.
Conclusions: The results will establish if adding CGM to existing, capable, insulin pump users can enable better metabolic control.

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Information & Authors

Information

Published In

cover image Diabetes Technology & Therapeutics
Diabetes Technology & Therapeutics
Volume 13Issue Number 1January 2011
Pages: 49 - 54
PubMed: 21175271

History

Published in print: January 2011
Published online: 22 December 2010

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Affiliations

Ignacio Conget
Endocrinology and Diabetes Unit, Biomedical Research Institute “August Pi i Sunyer,” Biomedical Research Centre on Diabetes and Associated Metabolic Diseases, and University Clinical Hospital, Barcelona, Spain.
Tadej Battelino
University Medical Center, Ljubljana, Slovenia.
Marga Giménez
Endocrinology and Diabetes Unit, Biomedical Research Institute “August Pi i Sunyer,” Biomedical Research Centre on Diabetes and Associated Metabolic Diseases, and University Clinical Hospital, Barcelona, Spain.
Hannah Gough
Medtronic International Trading Sarl, Tolochenaz, Switzerland.
J. Castañeda
Medtronic Bakken Research Center, Maastricht, The Netherlands.
Jan Bolinder on behalf of the SWITCH Study Group
Karolinska Institute, Stockholm, Sweden.

Notes

Address correspondence to:Ignacio Conget, M.D., Ph.D.Endocrinology and Diabetes UnitHospital Clínic I UniversitariInstitut d'Investigacions Biomèdiques August Pi i SunyerVillarroel 17008036 Barcelona,Spain
E-mail: [email protected]

Author Disclosure Statement

I.C. reports receiving lectures and consulting fees from Medtronic Inc., Bayer AG, GSK, Eli Lilly & Co., NovoNordisk A/S, Sanofi-Aventis, Novartis, and MSD. T.B. reports receiving consulting fees from Medtronic Inc. and Bayer AG, speaking fees from Bayer AG, Eli Lilly & Co., Medtronic Inc., and Novo Nordisk A/S, and research grants from Abbott Diabetes Care. M.G. reports receiving lectures fees from Medtronic Inc, GSK, NovoNordisk A/S, Sanofi-Aventis, Novartis, and MSD. H.G. and J.C. are fulltime employees of Medtronic Inc. J.B. reports receiving lectures fees from Medtronic Inc., Abbot Diabetes Care, Sanofi-Aventis, and MSD and consulting fees from Abbot Diabetes Care, Sanofi-Aventis, MSD, and Astra-Zeneca.

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