RecruitingNCT06919029

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)

Assessing the Effect of Advanced Hybrid Closed Loop System, MiniMed 780G With GS4 Glucose Sensor 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): a Single Arm Open- Label Prospective Observational Study Protocol


Sponsor

National and Kapodistrian University of Athens

Enrollment

30 participants

Start Date

Apr 1, 2025

Study Type

OBSERVATIONAL

Conditions

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 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.


Eligibility

Min Age: 7 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether starting newly diagnosed children and teenagers with Type 1 Diabetes immediately on an advanced automated insulin delivery system (the MiniMed 780G "closed loop" system) leads to better blood sugar control and quality of life compared to standard insulin therapy. **You may be eligible if...** - You are between 7 and 17 years old - You have just been diagnosed with Type 1 Diabetes (based on WHO criteria) - You speak Greek or English - You are willing to wear the study devices and follow study instructions - You have internet access at home to upload device data - Your total daily insulin use is more than 8 units over a week **You may NOT be eligible if...** - You have Type 2 Diabetes or a rare form of diabetes (MODY) - You have untreated diabetes complications or other serious health conditions - You are pregnant - You have a known allergy to insulin - You live alone or lack a reliable phone for contact - You have severe vision or hearing impairment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAdvanced Hybrid Closed Loop from onset of type 1 diabetes in children

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.


Locations(1)

First Department of Pediatrics, National and Kapodistrian University of Athens, Medical School, "Aghia Sophia" Children's Hospital

Athens, Greece

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NCT06919029


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