Status:
RECRUITING
Effect of Advanced Hybrid Closed Loop System, MiniMed 780G in Newly Diagnosed Children and Adolescents With Type 1 Diabetes on Glycemic Control and Patient Reported Outcomes Compared to Standard Insulin Therapy Historical Data (AHCL in New Onset T1D Children Study)
Lead Sponsor:
National and Kapodistrian University of Athens
Collaborating Sponsors:
Aghia Sophia Children's Hospital of Athens
Conditions:
Diabetes Mellitus, Type I
Eligibility:
All Genders
7-17 years
Brief Summary
The objective of this study is to evaluate glycemic control of users of the AHCL system MiniMed 780G with GS4 calibration-free sensor in children and adolescents with newly diagnosed T1D implemented d...
Eligibility Criteria
Inclusion
- Clinical diagnosis of type 1 diabetes (WHO criteria). Diagnosis of type 1 diabetes is based on international criteria and the investigator's judgment; C peptide level and 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 the Medtronic CareLink software
- Clinically eligible to start the AHCL system
Exclusion
- 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 tape adhesive 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 or erythropoietin within 3 months prior to time of enrollment.
- Eating disorder including anorexia/bulimia.
- Milk protein allergy.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06919029
Start Date
April 1 2025
End Date
April 1 2026
Last Update
April 9 2025
Active Locations (1)
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1
First Department of Pediatrics, National and Kapodistrian University of Athens, Medical School, "Aghia Sophia" Children's Hospital
Athens, Greece, 11527