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

January 9, 2024 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Périgueux
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

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

Accepts Healthy Volunteers

No

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time in Range 70-180 mg/dL (TIR)
Time Frame: 0-6 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Satisfaction Score
Time Frame: 0-6 months
To evaluate the change from baseline in satisfaction score based on the Diabetes Treatment Satisfaction Questionnaire change (DTSQc)
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
HbA1c
Time Frame: 0-6 months
To evaluate the change in glycosylated haemoglobin (HbA1c), between baseline and 6 months.
0-6 months
Time in Range of 70-180 mg/dL (TIR)
Time Frame: 0-12 months
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 12 months.
0-12 months
HbA1c
Time Frame: 0-12 months
To evaluate the change in glycosylated haemoglobin (HbA1c), between baseline and 12 months.
0-12 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 19, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 27, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

Yes

product manufactured in and exported from the U.S.

Yes

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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