NCT06919029Recruiting
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)
Assessing the Effect of Advanced Hybrid Closed Loop System, MiniMed 780G With GS4 Glucose Sensor 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): a Single Arm Open- Label Prospective Observational Study Protocol
Source: ClinicalTrials.gov · Last updated 9 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 30 (estimated)
- First submitted
- 2 Apr 2025
- Start date
- Apr 2025
- Primary completion date
- Dec 2025
- Lead sponsor
- National and Kapodistrian University of Athens
- Diseases
- Type 1 diabetes
- NCT number
- NCT06919029
What you commit to
- Study type: Observational
- Planned participants: 30
- From Apr 2025 to the primary completion date, Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Illicit drugs abuse.
- Sickle cell disease, haemoglobinopathy, receiving red blood cell transfusion or erythropoietin within 3 months prior to time of enrollment.
Other illness
- Type 2 diabetes mellitus or MODY diabetes
- Any untreated comorbidities of type 1 diabetes
- 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.
- Severe visual or hearing impairment.
- Medically documented allergy to the adhesive of plasters or unable to tolerate tape adhesive around sensor placement.
- Eating disorder including anorexia/bulimia.
- Milk protein allergy.
Lab values
- Medication affecting metabolic control or interfering in the interpretation of HbA1c
- Serious skin lesions at areas of the body used for insertion of the glucose sensor.
Other
- Pregnancy
- Regular use of acetaminophen.
- Lack of reliable telephone facility for contact.
- Living alone.
- Alcohol abuse.
Who the study is looking for
- 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.
- Willing to follow study-specific instructions.
- Total daily insulin dose greater than 8.0 units over 1 week period
- Willing and able (access to internet from home) to download information into the Medtronic CareLink software
- Clinically eligible to start the AHCL system
Age in the registry: 7 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| First Department of Pediatrics, National and Kapodistrian University of Athens, Medical School, "Aghia Sophia" Children's Hospital Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.