Clinical Trials Directory

Trials / Completed

CompletedNCT05591690

Use of MiniMed 780G System in Children and Adolescents

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

Status
Completed
Phase
Study type
Observational
Enrollment
32 (actual)
Sponsor
University Hospital, Montpellier · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2020-11-01
Primary completion
2022-06-01
Completion
2022-08-31
First posted
2022-10-24
Last updated
2022-10-24

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT05591690. Inclusion in this directory is not an endorsement.