Use of MiniMed 780G System in Children and Adolescents

NCT ID: NCT05591690

Last Updated: 2022-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-01

Study Completion Date

2022-08-31

Brief Summary

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Hybrid closed-loop technology have shown that it improves glycemic control parameters, but the investigators do not have sufficient data at more than 6 months of follow-up, allowing us to describe the effectiveness of these systems in the long term.

All MiniMed 780G system users from November 2020 to March 2022 were included (n=32) For every time points, there was a significant difference in Time In Range between the pre-AHCL and post-AHCL. Noted difference were +14.5% and, +10.8% at respectively 3 months and 1 year. No more hypoglycemia were identified.

This "real-life" analysis shows that the algorithm is effective in improvement of metabolic control for T1 diabetic children and adolescents, at one year of follow-up.

However, an effect of breathlessness is observed which underlined the need for a solid therapeutic education program.

Detailed Description

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Conditions

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Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

All children with type 1 diabetes in whom a Medtronic G780 closed-loop pump was placed between November 2020 and March 2022 in our center were included.

Exclusion Criteria

Participant opposition
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fabienne Dalla Vale, PH

Role: STUDY_DIRECTOR

University Hospital, Montpellier

Locations

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Uhmontpellier

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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RECHMPL22_0420

Identifier Type: -

Identifier Source: org_study_id

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