Type 1 Diabetes Clinical Trial
Official title:
Evaluation of Security and Efficacy of Medtrum Hybrid Closed Loop System in Children, Adolescents and Adults With Type 1 Diabetes
The purpose of this study is to evaluate the safety and effectiveness of the MEDTRUM Hybrid Closed Loop (HCL) System in children, adolescents, and adults with type 1 diabetes (7-75 years old) in a home setting and to test the function of meal announcement in an extend study. The main question it aims to answer is : • Is the Hybrid Closed Loop system superior at increasing the time spent in the target glucose range of 70-180 mg/dL when compared to the Open (manual) Loop system ? Participants will be : - Trained into the use of the Insulin pump MEDTRUM A8 TouchCare® Insulin Management system - Randomized to the Open Loop or Closed Loop group - Respond to self administered questionnaires : the Hypoglycaemia Fear Survey, the Diabetes Quality of Life Questionnaire, and the Diabetes treatment Satisfaction Questionnaire status Researchers will compare the time spent in the target glucose range of 70-180 mg/mL during the last 12 weeks of the study between the patients randomised to the Open Loop group and those randomised to the Closed Loop group.
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