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
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus, Type 1
- Sponsor
- ELIAS Emergency University Hospital
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Variations in HbA1c
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Ioacara Sorin
Assoc. Prof. Dr.
ELIAS Emergency University Hospital
Eligibility 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)
Outcomes
Primary Outcomes
Variations in HbA1c
Time Frame: Three months
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(Three months)
- changes in time below range (TBR)(Three months)
- changes in coefficient of variation (CV)(Three months)
- changes in time in range (TIR) levels(Three months)
- changes in frequency of severe hypoglycemic and hyperglycemic events requiring hospitalization(Three months)
- changes in The Pediatric Quality of Life Inventory™ 4.0 Short Form 15 Generic Core Scales questionnaire scores(Three months)