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

November 22, 2022 updated by: Medtronic Diabetes

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

306

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France
        • CHU Angers
      • Besançon, France
        • CHU Besançon
      • Bobigny, France
        • APHP Avicenne
      • Bordeaux, France
        • CHU Bordeaux (Saint-André)
      • Boulogne-sur-Mer, France
        • CH Boulogne-sur-Mer
      • Brest, France
        • CHU Brest
      • Bron, France
        • HCL Groupement Hospitalier Est
      • Caen, France
        • CHU caen
      • Corbeil-Essonnes, France
        • CH SUd Francilien
      • Dijon, France
        • CHU Dijon
      • La Rochelle, France
        • CHRU La Rochelle
      • La Tronche, France
        • CHU Grenoble
      • Lille, France
        • CHU Lille
      • Limoges, France
        • Chu Limoges
      • Lyon, France
        • HCL DIAB-eCARE
      • Mainvilliers, France
        • IDNC Chartres
      • Marseille, France
        • APHM Marseille (Hôpital de la Conception)
      • Marseille, France
        • APHM Marseille (La Timone)
      • Meaux, France
        • GHEF (Centre Hospitalier de Meaux)
      • Montpellier, France
        • CHU Montpellier (Lapeyronie)
      • Nantes, France
        • CHU Nantes
      • Nice, France
        • CHU Nice
      • Nîmes, France
        • CHU Nîmes
      • Paris, France
        • APHP Bichat
      • Paris, France
        • Aphp Cochin
      • Paris, France
        • CH Lariboisière
      • Perpignan, France
        • CH Perpignan
      • Périgueux, France
        • Ch Perigueux
      • Rennes, France
        • Chu Rennes
      • Strasbourg, France
        • CHU Strasbourg
      • Toulouse, France
        • CHU Toulouse (Rangueil)
      • Tours, France
        • Chu Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MiniMed™ 780G System
Subject will use the MiniMed™ 780G System as per standard of care.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time in range (TIR)
Time Frame: 0-6months
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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Diabetes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2021

Primary Completion (Actual)

May 19, 2022

Study Completion (Actual)

October 27, 2022

Study Registration Dates

First Submitted

March 11, 2020

First Submitted That Met QC Criteria

March 11, 2020

First Posted (Actual)

March 16, 2020

Study Record Updates

Last Update Posted (Actual)

November 23, 2022

Last Update Submitted That Met QC Criteria

November 22, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP328

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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