Evaluating a new insulin delivery system for children with newly diagnosed type 1 diabetes
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
This study is testing a new insulin delivery system to see if it helps children and teens with newly diagnosed type 1 diabetes manage their blood sugar better than traditional methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 7 Years to 17 Years |
| Sex | All |
| Sponsor | National and Kapodistrian University of Athens Academic / other |
| Locations | 1 site (Athens) |
| Trial ID | NCT06919029 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 7 to 17 years who have been clinically diagnosed with type 1 diabetes.
Not a fit: Patients with type 2 diabetes, untreated comorbidities, or those on medications affecting metabolic control may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved glycemic control and quality of life for children and adolescents with newly diagnosed type 1 diabetes.
How similar studies have performed: Other studies have shown promising results with advanced hybrid closed loop systems in diabetes management, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Athens
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.