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Evaluation of the MiniMed 780 System in Paediatric Subjects

NCT05574062 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2025-06-19

Study results available
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Summary

The purpose of this study is to demonstrate the safety and performance of the MiniMed™ 780G system in pediatric subjects (2-6 years old) with type 1 diabetes in a home setting.

The objective of this study is to evaluate the safety and performance of the MiniMed™ 780G system in Auto Mode firstly in comparison to the MiniMed™ 780G system in Manual Mode with Suspend before low activated (currently available standard therapy) and secondly in comparison to the new MiniMed™ 780G BLE 2.0 system with DS5 sensor in Auto Mode among pediatric population (2-6 years old).

Conditions

  • Diabetes type1
  • Children, Only

Interventions

DEVICE

MiniMed 780G Auto Mode with G4S sensor

MiniMed™ 780G system in Auto Mode with G4S sensor.

DEVICE

MiniMed 780G Manual Mode with G4S sensor

MiniMed™ 780G system in Manual Mode.

DEVICE

MiniMed 780G Auto Mode with DS5 sensor

MiniMed 780G Auto Mode with DS5 sensor

Sponsors & Collaborators

  • Medtronic Diabetes

    lead INDUSTRY

Principal Investigators

  • Ohad Cohen, MD · Medtronic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
2 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-24
Primary Completion
2024-04-22
Completion
2024-11-15
FDA Device
Yes

Countries

  • Finland
  • Italy
  • Slovenia
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05574062 on ClinicalTrials.gov