NCT05591690

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 24, 2022

Completed
Last Updated

October 24, 2022

Status Verified

October 1, 2022

Enrollment Period

1.6 years

First QC Date

September 21, 2022

Last Update Submit

October 21, 2022

Conditions

Diabetes

Keywords

Advanced hybrid closed looppediatricsreal-worldtime in range

Outcome Measures

Primary Outcomes (4)

  • Glycated hemoglobin

    Percentage of glycated hemoglobin measured by the MiniMed 780G system

    1 year

  • Time spent in range Level with glucose levels within the norm

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

    1 year

  • Time spent with glucose levels below range

    Time spent with glucose levels inferior to 70mg/dL

    1 year

  • Time spent with glucose levels above range

    Time spent with glucose levels superior to 180 mg/dL

    1 year

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Diabetic minors treated with closed-loop insulin pumps

You may qualify if:

  • 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.

You may not qualify if:

  • Participant opposition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Fabienne Dalla Vale, PH

    University Hospital, Montpellier

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2022

First Posted

October 24, 2022

Study Start

November 1, 2020

Primary Completion

June 1, 2022

Study Completion

August 31, 2022

Last Updated

October 24, 2022

Record last verified: 2022-10

Locations

FR(1)