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.
• Patients living with Type 1 diabetes:
‣ adults aged 18 to 75 years old (included)
⁃ children/adolescents aged 7 or older
• Total daily dose of insulin ≥ 10 units per day \& weighing \>22 Kg
• Patient and their parent(s)/guardian(s) trained and able to count carb
• Current or previous insulin pump user or patient treated with multiple insulin injections
• Patient glycaemic target is not achieved or suboptimal according to international consensus: HbA1c level equal and greater than 7% and less than 12% at the time of enrolment, or TIR \< 70%, or TBR \>4%
• Any type of rapid insulin with a total daily insulin in the range of 10-60 IU (unauthorized use of insulin supplements by pen injector): Humalog™, Lyumjev (insulin lispro injection), Novorapid (insulin aspart) or FIASP® ( faster insulin aspart )
• Subject and their parent(s)/guardian(s) able to receive and understand study information, give written informed consent, and easily participate to the trial
• Subject and their parent(s)/guardian(s) affiliated to the French social security system
• Subject and their parent(s)/guardian(s) have the cognitive ability and can successfully operate all study devices and can adhere to the protocol