Journal article
Safety and efficacy of the predictive low glucose management system in the prevention of hypoglycaemia: Protocol for randomised controlled home trial to evaluate the Suspend before low function
MB Abraham, JA Nicholas, TT Ly, HC Roby, N Paramalingam, J Fairchild, BR King, GR Ambler, F Cameron, EA Davis, TW Jones
BMJ Open | BMJ PUBLISHING GROUP | Published : 2016
Abstract
Introduction: Innovations with sensor-augmented pump therapy (SAPT) to reduce hypoglycaemia in patients with type 1 diabetes are an ongoing area of research. The predictive low glucose management (PLGM) system incorporates continuous glucose sensor data into an algorithm and suspends basal insulin before the occurrence of hypoglycaemia. The system was evaluated in in-clinic studies, and has informed the parameters of a larger home trial to study its efficacy and safety in real life. Methods and analysis: The aim of this report is to describe the study design and outcome measures for the trial. This is a 6-month, multicentre, randomised controlled home trial to test the PLGM system in childre..
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Funding Acknowledgements
This study is funded by the Juvenile Diabetes Research Foundation funded Australian Type 1 diabetes Clinical Research Network. MA was funded by Channel 7 Telethon Research Fellowship 2014. The Jaeb Center for Health Research reviewed the protocol as part of the JDRF JDRF17-2011-664 Artificial Pancreas Consortium Network. Insulin pumps, transmitters, and glucose sensors were provided by Medtronic via an unrestricted grant. Additional pumps were also purchased through a grant from Princess Margaret Hospital foundation. Medtronic has no role in the design and conduct of the study; data collection, analysis and interpretation of the data; the preparation, review or approval of the manuscript; and decision to submit the manuscript for publication.