Transitioning children with Type 1 diabetes to advanced insulin pump therapy
Evaluating the Efficacy and Quality of Life Impact of Transitioning to Advanced Hybrid Closed-Loop Insulin Pump Therapy in Romanian Children With Type 1 Diabetes Mellitus
PHASE4 · ELIAS Emergency University Hospital · NCT06326489
This study tests if switching Romanian children with Type 1 diabetes to a new advanced insulin pump can help improve their blood sugar levels and overall quality of life.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 7 Years to 17 Years |
| Sex | All |
| Sponsor | ELIAS Emergency University Hospital (other) |
| Locations | 1 site (Bucharest, Sector 1) |
| Trial ID | NCT06326489 on ClinicalTrials.gov |
What this trial studies
This study evaluates the benefits of switching Romanian children with Type 1 diabetes from a predictive low glucose suspend insulin pump to an advanced hybrid closed-loop insulin pump therapy. It aims to measure changes in HbA1c levels, insulin requirements, and quality of life over a three-month period. The study will also assess the frequency of severe hypoglycemic and hyperglycemic events and overall patient satisfaction using a standardized questionnaire.
Who should consider this trial
Good fit: Ideal candidates are Romanian children aged 7 years or older currently using a predictive low glucose suspend insulin pump with an HbA1c greater than 7.5%.
Not a fit: Patients under 7 years old, those with less than one year of diabetes duration, or those with well-controlled HbA1c levels may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve glycemic control and quality of life for children with Type 1 diabetes.
How similar studies have performed: Other studies have shown promising results with advanced hybrid closed-loop insulin pump therapies, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 7 years or older at baseline * Diagnosis of type 1 diabetes * Current use of a predictive low glucose suspend insulin pump (740G) * At least 30% of subjects must have an HbA1c \> 7,5% (58 mmol/mol) Exclusion Criteria: * Age \< 7 years or ≥ 18 years at baseline * Diabetes duration \< 1 year at baseline * HbA1c ≤ 7% (53 mmol/mol) * Not meeting the Romanian national standards for closed-loop insulin pump therapy * Other criteria deemed inappropriate by the principal investigator (to be documented)
Where this trial is running
Bucharest, Sector 1
- Elias University Emergency Hospital — Bucharest, Sector 1, Romania (RECRUITING)
Study contacts
- Study coordinator: Sorin Ioacara, MD, PhD
- Email: drsorin@yahoo.com
- Phone: 0040213161600
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.
Conditions: Diabetes Mellitus, Type 1, HbA1c, insulin pumps, closed-loop