Phase
Condition
Diabetes Mellitus, Type 1
Diabetes And Hypertension
Diabetes Prevention
Treatment
Advanced Hybrid Closed Loop from onset of type 1 diabetes in children
Clinical Study ID
Ages 7-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Clinical diagnosis of type 1 diabetes (WHO criteria). Diagnosis of type 1 diabetesis based on international criteria and the investigator's judgment; C peptide leveland antibody determinations are not required.
Age range 7 to 17 years.
Literate in Greek or English.
Willing to wear study devices.
Willing to follow study-specific instructions.
Total daily insulin dose greater than 8.0 units over 1 week period
Willing and able (access to internet from home) to download information into theMedtronic CareLink software
Clinically eligible to start the AHCL system
Exclusion
Exclusion Criteria:
Type 2 diabetes mellitus or MODY diabetes
Any untreated comorbidities of type 1 diabetes
Medication affecting metabolic control or interfering in the interpretation of HbA1c
Pregnancy
Untreated diabetes retinopathy, or other causes that in the investigator's opinion,precludes the individual from participating in the trial.
Known or suspected allergy to insulin.
Regular use of acetaminophen.
Lack of reliable telephone facility for contact.
Living alone.
Severe visual or hearing impairment.
Medically documented allergy to the adhesive of plasters or unable to tolerate tapeadhesive around sensor placement.
Serious skin lesions at areas of the body used for insertion of the glucose sensor.
Illicit drugs abuse.
Alcohol abuse.
Sickle cell disease, haemoglobinopathy, receiving red blood cell transfusion orerythropoietin within 3 months prior to time of enrollment.
Eating disorder including anorexia/bulimia.
Milk protein allergy.
Study Design
Connect with a study center
First Department of Pediatrics, National and Kapodistrian University of Athens, Medical School, "Aghia Sophia" Children's Hospital
Athens, 11527
GreeceActive - Recruiting
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