Brief Summary

The purpose of the study is to evaluate the efficacy in glycemic control and the impact on the quality of life of patients using the MiniMed™ 780G System for the treatment of Type 1 diabetes, in real life settings in France.

Trial Health

On Track

Trial Health Score

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

Enrollment

306

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Feb 2021

Geographic Reach

1 country

32 active sites

Status

completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.7 years study duration

First Submitted

Initial submission to the registry

March 11, 2020

Completed

5 days until next milestone

First Posted

Study publicly available on registry

March 16, 2020

Completed

11 months until next milestone

Study Start

First participant enrolled

February 15, 2021

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2022

Completed

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2022

Completed

1.7 years until next milestone

Results Posted

Study results publicly available

July 8, 2024

Completed

Last Updated

July 8, 2024

Status Verified

January 1, 2024

Enrollment Period

1.3 years

First QC Date

March 11, 2020

Results QC Date

May 19, 2023

Last Update Submit

January 9, 2024

Conditions

Type 1 Diabetes

Keywords

780G, T1D

Outcome Measures

Primary Outcomes (1)

Time in Range 70-180 mg/dL (TIR)
The change in (%) the time spent within range, defined as the proportion of sensor glucose concentration within the target range of 70-180 mg/dL, between baseline and 6 months.
0-6 months

Secondary Outcomes (11)

Satisfaction Score
0-6 months
Quality of Life Change
0-6 months
Fear of Hypoglycemic Events Change
0-6 months
Treatment Satisfaction Score
0-6 months
Glycemic Parameters Changes
0-6 months
+6 more secondary outcomes

Study Arms (1)

MiniMed™ 780G System

Subject will use the MiniMed™ 780G System as per standard of care.

Device: MiniMed™ 780G System

Interventions

MiniMed™ 780G SystemDEVICE

Subject enrolled in the study will start using the MiniMed™ 780G pump in Auto Mode after a run-in period of two weeks in Manual Mode (with no SmartGuard™ functions). Study phase in Automode will follow a 6 and 12 months follow- up as per standard of care.

MiniMed™ 780G System

Eligibility Criteria

Age7 Years+

Sexall

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Subjects 7 years of age or older with T1D and under Continuous Subcutaneous Insulin Infusion (CSII) therapy (with or without CGM)

You may qualify if:

Subject is ≥7 years of age.
Subject has a clinical diagnosis of type 1 diabetes for more than 1 year as determined via medical records or source documentation by an individual qualified to make a medical diagnosis.
Subject has a HbA1c value greater than 6.5% and less than 12% at time of enrolment visit.
Subject is under Continuous Subcutaneous Insulin Infusion (CSII) therapy (with or without Continuous Glucose Monitoring) ≥ 6 months before enrolment.
Subject requires ≥8 units of insulin per day.
Subjects and their parent(s)/guardian(s) must be able to speak and be literate in French as verified by the investigator.
Subjects and their parent(s)/guardian(s) are willing to participate in the study and sign the Data Release Form (DRF).
Subjects who are ≥18 years of age should be able to provide consent.

You may not qualify if:

Subject has MiniMed™ 780G System IFU contraindication(s).
Subject uses Predictive Low-Glucose Management (PLGM) System (i.e. MiniMed™ 640G with SmartGuard) in the last 6 months before the enrolment.
Subject uses Low Glucose suspend (LGS) feature (i.e. MiniMed™ Paradigm Veo Pump) in the last 6 months before the enrolment.
Subject under Multiple-Daily Injections (MDI) treatment in the 6 months before the enrolment.
Subject has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Medtronic Diabeteslead

Study Sites (32)

CHU Angers

Angers, France

Location

CHU Besançon

Besançon, France

Location

APHP Avicenne

Bobigny, France

Location

CHU Bordeaux (Saint-André)

Bordeaux, France

Location

CH Boulogne-Sur-Mer

Boulogne-sur-Mer, France

Location

CHU Brest

Brest, France

Location

HCL Groupement Hospitalier Est

Bron, France

Location

CHU Caen

Caen, France

Location

Ch Sud Francilien

Corbeil-Essonnes, France

Location

CHU Dijon

Dijon, France

Location

CHRU La Rochelle

La Rochelle, France

Location

CHU Grenoble

La Tronche, France

Location

CHU Lille

Lille, France

Location

CHU Limoges

Limoges, France

Location

HCL DIAB-eCARE

Lyon, France

Location

IDNC Chartres

Mainvilliers, France

Location

APHM Marseille (Hôpital de la Conception)

Marseille, France

Location

APHM Marseille (La Timone)

Marseille, France

Location

GHEF (Centre Hospitalier de Meaux)

Meaux, France

Location

CHU Montpellier (Lapeyronie)

Montpellier, France

Location

CHU Nantes

Nantes, France

Location

CHU Nice

Nice, France

Location

CHU Nîmes

Nîmes, France

Location

APHP Bichat

Paris, France

Location

APHP Cochin

Paris, France

Location

Ch Lariboisiere

Paris, France

Location

CH Perpignan

Perpignan, France

Location

CH Périgueux

Périgueux, France

Location

CHU Rennes

Rennes, France

Location

CHU Strasbourg

Strasbourg, France

Location

CHU Toulouse (Rangueil)

Toulouse, France

Location

CHU Tours

Tours, France

Location

Related Publications (1)

Kessler L, Thivolet C, Penfornis A, Gouet D, Coffin C, Moret M, Borot S, Bekka S, Sonnet E, Joubert M, Lablanche S, Burtin G, Di Piazza F, van den Heuvel T, Cohen O. Advanced Hybrid Closed Loop Algorithm Use in Type 1 Diabetes: The French MiniMed Glycemic Control and Quality of Life Study. Diabetes Ther. 2025 Mar;16(3):413-427. doi: 10.1007/s13300-024-01673-9. Epub 2024 Dec 17.
PMID: 39688775DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Results Point of Contact

Title: Fabio Di Piazza
Organization: Medtronic Diabetes

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 11, 2020

First Posted

March 16, 2020

Study Start

February 15, 2021

Primary Completion

May 19, 2022

Study Completion

October 27, 2022

Last Updated

July 8, 2024

Results First Posted

July 8, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing: Will not share

Locations

FR(32)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (11)

Study Arms (1)

MiniMed™ 780G System

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (32)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Publication Agreements

Study Design

Study Record Dates

Data Sharing

Locations