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
- Conditions
- Diabetes Mellitus, Type 1
- Interventions
- Device: Switching to the Medtronic 780G insulin pump
- Registration Number
- NCT06326489
- Lead Sponsor
- ELIAS Emergency University Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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 < 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 780G Switching to the Medtronic 780G insulin pump Patients in this arm will receive a 780G for three months.
- Primary Outcome Measures
Name Time Method Variations in HbA1c Three months Variations in HbA1c between baseline visit (V1 - 740G) and assessment visit following three months of 780G insulin pump therapy (V2 - 780G)
- Secondary Outcome Measures
Name Time Method changes in insulin requirements Three months changes in insulin requirements between baseline visit (V1 - 740G) and assessment visit following three months of 780G insulin pump therapy (V2 - 780G)
changes in time below range (TBR) Three months changes in time below range (TBR) between baseline visit (V1 - 740G) and assessment visit following three months of 780G insulin pump therapy (V2 - 780G)
changes in coefficient of variation (CV) Three months changes in coefficient of variation (CV) between baseline visit (V1 - 740G) and assessment visit following three months of 780G insulin pump therapy (V2 - 780G)
changes in time in range (TIR) levels Three months changes in time in range (TIR) levels between baseline visit (V1 - 740G) and assessment visit following three months of 780G insulin pump therapy (V2 - 780G)
changes in frequency of severe hypoglycemic and hyperglycemic events requiring hospitalization Three months changes in frequency of severe hypoglycemic and hyperglycemic events requiring hospitalization between baseline visit (V1 - 740G) and assessment visit following three months of 780G insulin pump therapy (V2 - 780G)
changes in The Pediatric Quality of Life Inventory™ 4.0 Short Form 15 Generic Core Scales questionnaire scores Three months changes in The Pediatric Quality of Life Inventory™ 4.0 Short Form 15 Generic Core Scales questionnaire scores between baseline visit (V1 - 740G) and assessment visit following three months of 780G insulin pump therapy (V2 - 780G). Scores are transformed on a scale from 0 to 100. Higher scores = Better Quality of Life
Trial Locations
- Locations (1)
Elias University Emergency Hospital
🇷🇴Bucharest, Sector 1, Romania