Use of MiniMed 780G System in Children and Adolescents

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05591690
• Other study ID #: RECHMPL22_0420
• Status: Completed
• Start date: November 1, 2020
• Est. completion date: August 31, 2022

Study information

• Verified date: October 2022
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 31, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycated hemoglobin	Percentage of glycated hemoglobin measured by the MiniMed 780G system	1 year
Primary	Time spent in range Level with glucose levels within the norm	Time spent with glucose levels between 70 and 180 mg/dL	1 year
Primary	Time spent with glucose levels below range	Time spent with glucose levels inferior to 70mg/dL	1 year
Primary	Time spent with glucose levels above range	Time spent with glucose levels superior to 180 mg/dL	1 year