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

NCT06326489 | Recruiting Phase 4

• 2 other identifiers: 105122023-1/05.12.2023ERP-2023-13520
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 1

Keywords

HbA1c; insulin pumps; closed-loop

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• changes in insulin requirements

  Three months

• changes in time in range (TIR) levels

  Three months

• changes in time below range (TBR)

  Three months

• changes in coefficient of variation (CV)

  Three months

• changes in frequency of severe hypoglycemic and hyperglycemic events requiring hospitalization

  Three months

Study Arms (1)

780G

EXPERIMENTAL

Patients in this arm will receive a 780G for three months.

Device: Switching to the Medtronic 780G insulin pump

Interventions

Switching to the Medtronic 780G insulin pump DEVICE

Patients using a Medtronic 740G insulin pump will receive the 780G model for three months

780G

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• ELIAS Emergency University Hospital: lead

Study Sites (1)

Elias University Emergency Hospital

Bucharest, Sector 1, 011461, Romania

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Sorin Ioacara, MD, PhD

CONTACT

0040213161600; drsorin@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr.

Model Details: The study will include 30 children with type 1 diabetes aged seven years and older who use a predictive low glucose suspend insulin pump (740G). Patients eligible for the study will receive a 780G insulin pump for three months.

Study Record Dates

• First Submitted: March 17, 2024
• First Posted: March 22, 2024
• Study Start: March 11, 2024
• Primary Completion: August 30, 2024
• Study Completion: November 30, 2024
• Last Updated: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)