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)

Last updated: April 2, 2025
Sponsor: National and Kapodistrian University of Athens
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Mellitus, Type 1

Diabetes And Hypertension

Diabetes Prevention

Treatment

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

Clinical Study ID

NCT06919029
6267/14.3.2025
  • Ages 7-17
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Clinical diagnosis of type 1 diabetes (WHO criteria). Diagnosis of type 1 diabetesis based on international criteria and the investigator's judgment; C peptide leveland 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 theMedtronic CareLink software

  8. Clinically eligible to start the AHCL system

Exclusion

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 tapeadhesive 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 orerythropoietin within 3 months prior to time of enrollment.

  • Eating disorder including anorexia/bulimia.

  • Milk protein allergy.

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Advanced Hybrid Closed Loop from onset of type 1 diabetes in children
Phase:
Study Start date:
April 01, 2025
Estimated Completion Date:
April 30, 2026

Connect with a study center

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

    Athens, 11527
    Greece

    Active - Recruiting

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