MedPath

Use of MiniMed 780G System in Children and Adolescents

Completed
Conditions
Diabetes
Registration Number
NCT05591690
Lead Sponsor
University Hospital, Montpellier
Brief Summary

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

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
32
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Time spent with glucose levels below range1 year

Time spent with glucose levels inferior to 70mg/dL

Time spent with glucose levels above range1 year

Time spent with glucose levels superior to 180 mg/dL

Glycated hemoglobin1 year

Percentage of glycated hemoglobin measured by the MiniMed 780G system

Time spent in range Level with glucose levels within the norm1 year

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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Uhmontpellier

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Montpellier, France

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