Evaluating a new insulin delivery system for children with newly diagnosed type 1 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the effectiveness of the Advanced Hybrid Closed Loop (AHCL) system MiniMed 780G in managing glycemic control in children and adolescents aged 7 to 17 who have recently been diagnosed with type 1 diabetes. Participants will use the AHCL system in conjunction with continuous glucose monitoring, and their outcomes will be compared to historical data from patients treated with multiple daily injections. The study will be conducted as a single-arm open-label observational study over a period of three months, with a potential three-month extension phase. The goal is to gather data on glycemic control and patient-reported outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Study coordinator: Christina Kanaka- Gantenbein, Professor
• Email: ckanaka@med.uoa.gr
• Phone: 00302132013244

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.