NCT06919029 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)
| NCT ID | NCT06919029 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National and Kapodistrian University of Athens |
| Condition | Diabetes Mellitus, Type I |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-04 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2025-04 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06919029 clinical trial?
This trial is open to participants of all sexes, aged 7 Years or older, up to 17 Years, studying Diabetes Mellitus, Type I. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06919029 currently recruiting?
Yes, NCT06919029 is actively recruiting participants. Contact the research team at ckanaka@med.uoa.gr for enrollment information.
Where is the NCT06919029 trial being conducted?
This trial is being conducted at Athens, Greece.
Who is sponsoring the NCT06919029 clinical trial?
NCT06919029 is sponsored by National and Kapodistrian University of Athens. The trial plans to enroll 30 participants.
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