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.
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.
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
This study is a single-center open-label, single arm, trial, comparing advanced hybrid closed-loop (AHCL) insulin delivery and standard insulin therapy with multiple daily injections (MDI) (historical data- control) over a period of 3 months in newly diagnosed type 1 diabetes children and adolescents hospitalized and followed at the Diabetes center of the First Department of Pediatrics of the Medical School of the National and Kapodistrian University of Athens, Athens, Greece. After the initial 3 months, there will be an extension phase of the study, for another 3 months (total 6 months). A total of 30-35 individuals (aged 7-17 years) will be enrolled to reach 25-30 individuals who will complete the 3-months' study. The expected number of participants is based on the last 3 years data of our Diabetes Center, where the total number of newly diagnosed children/ adolescents with T1D (and those over 7 years of age) in our Center was as follows, in 2022: 56 (36), in 2023: 63 (47), in 2024.
Cohort
Prospective
Advanced Hybrid Closed Loop from onset of type 1 diabetes in children
DeviceThe 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.
CGMS metrics
CGMS metrics including Time in Range (70-180 mg/dl) during the 3 months' study period, i.e. from baseline to 3 months (90 days) extracted from the CGMS data from both the study group and children and adolescents in MDI- FGM/CGM group (historical data from age and sex matched children and adolescents followed in the same Diabetes Center). The same metrics will be evaluated in the extension phase of the study, namely at 6-months post initiation of the study.
HbA1c
HbA1c
Acceptance of AHCL
Assess the percentage of the study participants willing to continue their therapy with AHCL as shown by prescribing the 780G insulin pump after the 3 months' time of their participation to the study.
TAR (Time Above Range) (>180mg/dl)
Time Above Range (\>180mg/dl) from baseline to 3 months (90 days) extracted from the CGMS data from both the study group and children and adolescents in MDI- FGM/CGM group (historical data from age and sex matched children and adolescents followed in the same Diabetes Center). The same metrics will be evaluated in the extension phase of the study, namely at 6-months post initiation of the study.
TBR (Time Below Range) (<70mg/dl)
TBR (Time Below Range) during the 3 months' study period, i.e. from baseline to 3 months (90 days) extracted from the CGMS data from both the study group and children and adolescents in MDI- FGM/CGM group (historical data from age and sex matched children and adolescents followed in the same Diabetes Center). The same metrics will be evaluated in the extension phase of the study, namely at 6-months post initiation of the study.
AHCL use
Advanced Hybrid Closed Loop use during the 3 months' study period, i.e. from baseline to 3 months (90 days) extracted from AHCL data. The same metric will be evaluated in the extension phase of the study, namely at 6-months post initiation of the study.
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National and Kapodistrian University of Athens
Lead sponsor
Aghia Sophia Children's Hospital of Athens
Collaborator
