The MiniMed™ 780G Glycemic Control and Quality of Life Study for the Treatment of Pediatric and Adult Subjects With Type 1 Diabetes in France.

Type 1 Diabetes Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04308291
• Other study ID #: CIP328
• Status: Completed
• Start date: February 15, 2021
• Est. completion date: October 27, 2022

Study information

• Verified date: November 2022
• Source: Medtronic Diabetes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 306
• Est. completion date: October 27, 2022
• Est. primary completion date: May 19, 2022
• Gender: All
• Age group: 7 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Device:
• 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.

Locations

Country	Name	City	State
France	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 Périgueux	Périgueux
France	CH Perpignan	Perpignan
France	CHU Rennes	Rennes
France	CHU Strasbourg	Strasbourg
France	CHU Toulouse (Rangueil)	Toulouse
France	CHU Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Diabetes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time in range (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.	0-6months
Secondary	Satisfaction score	To evaluate the change from baseline in satisfaction score based on the Diabetes Treatment Satisfaction Questionnaire change (DTSQc)	0-6months
Secondary	Quality of Life Change	To evaluate the change in quality of life based on the Diabetes Quality of life questionnaire (DQoL)	0-6 months
Secondary	Fear of hypoglycemic events Change	To evaluate the change from baseline in the fear of hypoglycemic events based on the Hypoglycemia Fear Survey (HFS)	0-6 months
Secondary	Treatment satisfaction score	To evaluate the treatment satisfaction score based on the Diabetes Treatment Satisfaction Questionnaire status (DTSQs)	0-6 months
Secondary	Glycemic parameters changes	To evaluate the change in glycemic parameters: mean time of sensor glucose values below 70mg/dL	0-6 months
Secondary	Glycemic parameters changes	To evaluate the change in glycemic parameters: mean time of sensor glucose values below 54mg/dL	0-6 months
Secondary	Glycemic parameters changes	To evaluate the change in glycemic parameters: mean time of sensor glucose values above 180mg/dL	0-6 months
Secondary	Glycemic parameters changes	To evaluate the change in glycemic parameters: mean time of sensor glucose values above above 250mg/dL	0-6 months
Secondary	Glycemic parameters changes	To evaluate the change in glycosylated haemoglobin (HbA1c)	0-6 months