The MiniMed™ 780G Glycemic Control and Quality of Life Study for the Treatment of Pediatric and Adult Subjects With Type 1 Diabetes in France.
NCT ID: NCT04308291
Last Updated: 2024-07-08
Study Results
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View full resultsBasic Information
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COMPLETED
306 participants
OBSERVATIONAL
2021-02-15
2022-10-27
Brief Summary
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Detailed Description
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The study is conducted according to the same schedule as the routine follow-up of patients:
1. RUN-IN PHASE: Subject will start a run-in phase in an out of hospital setting, as per standard practice of the site. The objective of the run-in phase is to train the subjects on the MiniMed™ 780G insulin pump, assess subjects' compliance and ability to comprehend the study procedures and tolerance of wearing the sensor and transmitter continuously. It is expected that during the run-in phase the MiniMed™ 780G insulin pump will be set in Manual mode and all the algorithms are switched off, and baseline Continuous Glucose Monitoring (CGM) data will be collected. The expected duration of the run-in phase is approximately 2 weeks. At the end of the run-in phase the MiniMed™ 780G insulin pump will be set in Auto Mode and the date of activation will be collected and identified as a start of the study phase. Data from the MiniMed™ 780G insulin pump will be uploaded in the CareLink™ as per standard practice, before Auto Mode activation.
2. 6 AND 12 MONTHS FOLLOW UP: Follow-up visits will be performed according to the therapy management standard of care at 6 and 12 months after Auto Mode activation in the study.
Approximately 300 patients (children and adults) will be enrollment in the study in approximately 32 sites in France.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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MiniMed™ 780G System
Subject will use the MiniMed™ 780G System as per standard of care.
MiniMed™ 780G System
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.
Interventions
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MiniMed™ 780G System
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.
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. Subject has a HbA1c value greater than 6.5% and less than 12% at time of enrolment visit.
4. Subject is under Continuous Subcutaneous Insulin Infusion (CSII) therapy (with or without Continuous Glucose Monitoring) ≥ 6 months before enrolment.
5. Subject requires ≥8 units of insulin per day.
6. Subjects and their parent(s)/guardian(s) must be able to speak and be literate in French as verified by the investigator.
7. Subjects and their parent(s)/guardian(s) are willing to participate in the study and sign the Data Release Form (DRF).
8. Subjects who are ≥18 years of age should be able to provide consent.
Exclusion Criteria
2. Subject uses Predictive Low-Glucose Management (PLGM) System (i.e. MiniMed™ 640G with SmartGuard) in the last 6 months before the enrolment.
3. Subject uses Low Glucose suspend (LGS) feature (i.e. MiniMed™ Paradigm Veo Pump) in the last 6 months before the enrolment.
4. Subject under Multiple-Daily Injections (MDI) treatment in the 6 months before the enrolment.
5. Subject has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
7 Years
ALL
No
Sponsors
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Medtronic Diabetes
INDUSTRY
Responsible Party
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Locations
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CHU Angers
Angers, , France
CHU Besançon
Besançon, , France
APHP Avicenne
Bobigny, , France
CHU Bordeaux (Saint-André)
Bordeaux, , France
CH Boulogne-Sur-Mer
Boulogne-sur-Mer, , France
CHU Brest
Brest, , France
HCL Groupement Hospitalier Est
Bron, , France
CHU Caen
Caen, , France
Ch Sud Francilien
Corbeil-Essonnes, , France
CHU Dijon
Dijon, , France
CHRU La Rochelle
La Rochelle, , France
CHU Grenoble
La Tronche, , France
CHU Lille
Lille, , France
CHU Limoges
Limoges, , France
HCL DIAB-eCARE
Lyon, , France
IDNC Chartres
Mainvilliers, , France
APHM Marseille (Hôpital de la Conception)
Marseille, , France
APHM Marseille (La Timone)
Marseille, , France
GHEF (Centre Hospitalier de Meaux)
Meaux, , France
CHU Montpellier (Lapeyronie)
Montpellier, , France
CHU Nantes
Nantes, , France
CHU Nice
Nice, , France
CHU Nîmes
Nîmes, , France
APHP Bichat
Paris, , France
APHP Cochin
Paris, , France
Ch Lariboisiere
Paris, , France
CH Perpignan
Perpignan, , France
CH Périgueux
Périgueux, , France
CHU Rennes
Rennes, , France
CHU Strasbourg
Strasbourg, , France
CHU Toulouse (Rangueil)
Toulouse, , France
CHU Tours
Tours, , France
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CIP328
Identifier Type: -
Identifier Source: org_study_id
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