NCT06326489CompletedPhase 4
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
Source: ClinicalTrials.gov · Last updated 29 Sept 2026
Brief summary (registry, in English)
The proposed study aims to demonstrate the potential benefits of transitioning T1DM children from predictive low glucose suspend insulin pump therapy to advanced hybrid closed-loop insulin pump therapy in Romania. Primary Outcome: Variations in HbA1c between baseline visit (V1 - 740G) and assessment visit following three months of 780G insulin pump therapy (V2 - 780G). Secondary Outcomes: changes in insulin requirements, time in range (TIR) levels, time below range (TBR), coefficient of variation (CV), frequency of severe hypoglycemic and hyperglycemic events requiring hospitalization, and PedsQL SF15 questionnaire scores.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 17 Mar 2024
- Start date
- 11 Mar 2024
- Primary completion date
- 8 Jul 2025
- Lead sponsor
- ELIAS Emergency University Hospital
- Diseases
- Type 1 diabetes
- NCT number
- NCT06326489
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 30
- From 11 Mar 2024 to the primary completion date, 8 Jul 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
- Not meeting the Romanian national standards for closed-loop insulin pump therapy
Other illness
- Diabetes duration \< 1 year at baseline
Lab values
- HbA1c ≤ 7% (53 mmol/mol)
Age
- Age \< 7 years or ≥ 18 years at baseline
Other
- Other criteria deemed inappropriate by the principal investigator (to be documented)
Who the study is looking for
- 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)
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 |
|---|---|---|---|
| Elias University Emergency Hospital Coordinator of this site? Confirm its status | Bucharest | Romania | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.