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

March 23, 2024 updated by: Ioacara Sorin, ELIAS Emergency University Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Romania
    • Sector 1
      • Bucharest, Sector 1, Romania, 011461
        • Recruiting
        • Elias University Emergency Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 780G
Patients in this arm will receive a 780G for three months.
Device: Switching to the Medtronic 780G insulin pump
Patients using a Medtronic 740G insulin pump will receive the 780G model for three months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Three months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ELIAS Emergency University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2024

Primary Completion (Estimated)

August 30, 2024

Study Completion (Estimated)

November 30, 2024

Study Registration Dates

First Submitted

March 17, 2024

First Submitted That Met QC Criteria

March 17, 2024

First Posted (Actual)

March 22, 2024

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 23, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 105122023-1/05.12.2023
  • ERP-2023-13520 (Other Grant/Funding Number: Medtronic)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 1

Clinical Trials on Switching to the Medtronic 780G insulin pump

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Panama

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe