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)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-30

Study Completion Date

2026-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type I

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Advanced 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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. 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.
2. Age range 7 to 17 years.
3. Literate in Greek or English.
4. Willing to wear study devices.
5. Willing to follow study-specific instructions.
6. Total daily insulin dose greater than 8.0 units over 1 week period
7. Willing and able (access to internet from home) to download information into the Medtronic CareLink software
8. Clinically eligible to start the AHCL system

Exclusion Criteria

* 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.

Minimum Eligible Age

7 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Christina Kanaka-Gantenbein

Professor Pediatrics- Pediatric Endocrinology, Director First Department of Pediatrics, National and Kapodistrian University of Athens, Medical School, "Aghia Sophia" Children's Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR