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OpenTrials
Completed

NCT Number: NCT05591690

Use of MiniMed 780G System in Children and Adolescents

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.

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Glycated hemoglobin

    Time frame: 1 year

    Percentage of glycated hemoglobin measured by the MiniMed 780G system

  2. Time spent in range Level with glucose levels within the norm

    Time frame: 1 year

    Time spent with glucose levels between 70 and 180 mg/dL

  3. Time spent with glucose levels below range

    Time frame: 1 year

    Time spent with glucose levels inferior to 70mg/dL

  4. Time spent with glucose levels above range

    Time frame: 1 year

    Time spent with glucose levels superior to 180 mg/dL

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Use of MiniMed 780G System in Children and Adolescents, a French Real Life Observational Study

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 24, 2022
Registry last updated
Oct 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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