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

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06326489
• Other study ID #: 105122023-1/05.12.2023
• Secondary ID: ERP-2023-13520
• Status: Recruiting
• Phase: Phase 4
• Start date: March 11, 2024
• Est. completion date: November 30, 2024

Study information

• Verified date: March 2024
• Source: ELIAS Emergency University Hospital
• Contact: Sorin Ioacara, MD, PhD
• Phone: 0040213161600
• Email: drsorin[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Device:
• Switching to the Medtronic 780G insulin pump
Patients using a Medtronic 740G insulin pump will receive the 780G model for three months

Locations

Country	Name	City	State
Romania	Elias University Emergency Hospital	Bucharest	Sector 1

Sponsors (1)

Lead Sponsor	Collaborator
ELIAS Emergency University Hospital

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variations in HbA1c	Variations in HbA1c between baseline visit (V1 - 740G) and assessment visit following three months of 780G insulin pump therapy (V2 - 780G)	Three months
Secondary	changes in insulin requirements	changes in insulin requirements between baseline visit (V1 - 740G) and assessment visit following three months of 780G insulin pump therapy (V2 - 780G)	Three months
Secondary	changes in time in range (TIR) levels	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)	Three months
Secondary	changes in time below range (TBR)	changes in time below range (TBR) between baseline visit (V1 - 740G) and assessment visit following three months of 780G insulin pump therapy (V2 - 780G)	Three months
Secondary	changes in coefficient of variation (CV)	changes in coefficient of variation (CV) between baseline visit (V1 - 740G) and assessment visit following three months of 780G insulin pump therapy (V2 - 780G)	Three months
Secondary	changes in frequency of severe hypoglycemic and hyperglycemic events requiring hospitalization	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)	Three months
Secondary	changes in The Pediatric Quality of Life Inventory™ 4.0 Short Form 15 Generic Core Scales questionnaire scores	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	Three months