Actively 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)
Led by National and Kapodistrian University of Athens · Updated on 2025-04-09
30
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
N
National and Kapodistrian University of Athens
Lead Sponsor
A
Aghia Sophia Children's Hospital of Athens
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 directly upon T1D diagnosis in combination with continuous glucose monitoring system (CGMS) compared with those treated with MDI retrieved from historical data- in a single- arm open-label prospective observational study, assessed at 3 months. After the initial study period there will be a 3month extension phase of the study.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of type 1 diabetes based on WHO criteria
- Age between 7 and 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 a 1 week period
- Willing and able to download data using Medtronic CareLink software with home internet access
- Clinically eligible to start the AHCL system
You will not qualify if you...
- Type 2 diabetes mellitus or MODY diabetes
- Untreated comorbidities of type 1 diabetes
- Taking medication that affects metabolic control or HbA1c interpretation
- Pregnancy
- Untreated diabetic retinopathy or other conditions preventing participation
- Known or suspected allergy to insulin
- Regular use of acetaminophen
- No reliable telephone contact
- Living alone
- Severe visual or hearing impairment
- Allergy to adhesive of plasters or unable to tolerate tape adhesive around sensor
- Serious skin lesions at sensor insertion sites
- Illicit drug abuse
- Alcohol abuse
- Sickle cell disease, haemoglobinopathy, recent blood transfusion or erythropoietin use
- Eating disorders such as anorexia or bulimia
- Milk protein allergy
AI-Screening
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Trial Site Locations
Total: 1 location
1
First Department of Pediatrics, National and Kapodistrian University of Athens, Medical School, "Aghia Sophia" Children's Hospital
Athens, Greece, 11527
Actively Recruiting
Research Team
C
Christina Kanaka- Gantenbein, Professor
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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