Clinical trial NCT04308291: The MiniMed™ 780G Glycemic Control and Quality of Life Study for the Treatment of Pediatric and Adult Subjects With Type 1 Diabetes in France.
Official title: The MiniMed™ 780G Glycemic Control and Quality of Life Study for the Treatment of Pediatric and Adult Subjects With Type 1 Diabetes in France (EQOL Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Keywords: 780G, T1D
Lead sponsor: Medtronic Diabetes
Sponsor class: INDUSTRY
First posted: 2020-03-16
Enrollment: 306
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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)

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.

Detailed description: Local, post-market, non-interventional, prospective, single-arm, multi-center study of patients pediatric and adult.

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.

Eligibility criteria: Inclusion Criteria:

1. Subject is ≥7 years of age.
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:

1. Subject has MiniMed™ 780G System IFU contraindication(s).
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).

Primary outcomes:
measure: Time in Range 70-180 mg/dL (TIR)
timeFrame: 0-6 months
Secondary outcomes:
measure: Satisfaction Score
timeFrame: 0-6 months
measure: Quality of Life Change
timeFrame: 0-6 months
measure: Fear of Hypoglycemic Events Change
timeFrame: 0-6 months
measure: Treatment Satisfaction Score
timeFrame: 0-6 months
measure: Glycemic Parameters Changes
timeFrame: 0-6 months
measure: Glycemic Parameters Changes
timeFrame: 0-6 months
measure: Glycemic Parameters Changes
timeFrame: 0-6 months
measure: Glycemic Parameters Changes
timeFrame: 0-6 months
measure: HbA1c
timeFrame: 0-6 months
measure: Time in Range of 70-180 mg/dL (TIR)
timeFrame: 0-12 months
measure: HbA1c
timeFrame: 0-12 months
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Besançon
country: France
facility: CHU Besançon
city: Bobigny
country: France
facility: APHP Avicenne
city: Bordeaux
country: France
facility: CHU Bordeaux (Saint-André)
city: Boulogne-sur-Mer
country: France
facility: CH Boulogne-Sur-Mer
city: Brest
country: France
facility: CHU Brest
city: Bron
country: France
facility: HCL Groupement Hospitalier Est
city: Caen
country: France
facility: CHU Caen
city: Corbeil-Essonnes
country: France
facility: Ch Sud Francilien
city: Dijon
country: France
facility: CHU Dijon
city: La Rochelle
country: France
facility: CHRU La Rochelle
city: La Tronche
country: France
facility: CHU Grenoble
city: Lille
country: France
facility: CHU Lille
city: Limoges
country: France
facility: CHU Limoges
city: Lyon
country: France
facility: HCL DIAB-eCARE
city: Mainvilliers
country: France
facility: IDNC Chartres
city: Marseille
country: France
facility: APHM Marseille (Hôpital de la Conception)
city: Marseille
country: France
facility: APHM Marseille (La Timone)
city: Meaux
country: France
facility: GHEF (Centre Hospitalier de Meaux)
city: Montpellier
country: France
facility: CHU Montpellier (Lapeyronie)
city: Nantes
country: France
facility: CHU Nantes
city: Nice
country: France
facility: CHU Nice
city: Nîmes
country: France
facility: CHU Nîmes
city: Paris
country: France
facility: APHP Bichat
city: Paris
country: France
facility: APHP Cochin
city: Paris
country: France
facility: Ch Lariboisiere
city: Perpignan
country: France
facility: CH Perpignan
city: Périgueux
country: France
facility: CH Périgueux
city: Rennes
country: France
facility: CHU Rennes
city: Strasbourg
country: France
facility: CHU Strasbourg
city: Toulouse
country: France
facility: CHU Toulouse (Rangueil)
city: Tours
country: France
facility: CHU Tours
Study officials:
References: