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670G IN CHILDREN SMALLER THAN LABELLED: THE HANNOVER SMARTHOME STUDY

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Abstract

Background Insulin pump therapy and continuous glucose monitoring users with T1D are rising more and more in pediatric age group. According to newest consensus statements (ATTD), the outcomes of CGM systems get into focus more than e.g. HbA1c. The newest combination system is Minimed670G by Medtronic, which is is the first system that allows an automated adaption of insulin dosage due to actual sensor glucose values. As it is actually labeled only above seven years of age and 8 U of Insulin as total daily dose, one should evaluate if the system is feasible in working also in smaller children. Method In this monocentric, randomized cross-over study, 20 kids between 2 and <9 and 20 between 9 and 14 used the 670G system 4 weeks in auto mode and 4 weeks in SAP mode respectively (Fig.1). Inclusion criteria are T1D >1 year and at least 3 months of CSII experience Primary endpoint is the time in range (TIR) [%] 70-180 mg/dl in a period comparison. Secondary, the number of hypoglycemic events, ketosis events as well as TIR <70, TIR<54, TIR>160 mg/dl will be assessed. Conclusion As new technologies always take long scientific and regulatory processes until the are available to patients for daily life, it is necessary to start clinical studies as soon as possible in all age groups, to provide all patients the best available therapy options.

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© Copyright 2019 Morressier GmbH.
All rights reserved.