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)

ConditionDiabetes Mellitus, Type I

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age7-17

SponsorNational and Kapodistrian University of Athens

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

No treatment groups listed

Sponsors and collaborators

National and Kapodistrian University of Athens

Lead sponsor

Aghia Sophia Children's Hospital of Athens

Collaborator

Source ClinicalTrials.gov