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Type 1 DiabetesNCT04308291

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

An observational study of Type 1 Diabetes, run by Medtronic MiniMed, Inc. at 32 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 7 years and older
Conditions the study is for
Type 1 Diabetes
What is being tested?
MiniMed™ 780G System
Type of treatment
Medical device
How many people
306 participants
Where
32 sitesFrance
Study dates
15 Feb 2021to 27 Oct 2022
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 years and older
  • All sexes
  • Child, Adult, Older adult

Study population: Subjects 7 years of age or older with T1D and under Continuous Subcutaneous Insulin Infusion (CSII) therapy (with or without CGM)

Who may be able to join

  • Subject is ≥7 years of age.
  • 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.
  • Subject has a HbA1c value greater than 6.5% and less than 12% at time of enrolment visit.
  • Subject is under Continuous Subcutaneous Insulin Infusion (CSII) therapy (with or without Continuous Glucose Monitoring) ≥ 6 months before enrolment.
  • Subject requires ≥8 units of insulin per day.
  • Subjects and their parent(s)/guardian(s) must be able to speak and be literate in French as verified by the investigator.
  • Subjects and their parent(s)/guardian(s) are willing to participate in the study and sign the Data Release Form (DRF).
  • Subjects who are ≥18 years of age should be able to provide consent.

Who cannot join

  • Subject has MiniMed™ 780G System IFU contraindication(s).
  • Subject uses Predictive Low-Glucose Management (PLGM) System (i.e. MiniMed™ 640G with SmartGuard) in the last 6 months before the enrolment.
  • Subject uses Low Glucose suspend (LGS) feature (i.e. MiniMed™ Paradigm Veo Pump) in the last 6 months before the enrolment.
  • Subject under Multiple-Daily Injections (MDI) treatment in the 6 months before the enrolment.
  • Subject has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).

Trial locations and contacts

32 sites in 1 country.

32 sites in 1 country

France32 sites

  • CHU Angers

    Angers

  • CHU Besançon

    Besançon

  • APHP Avicenne

    Bobigny

  • CHU Bordeaux (Saint-André)

    Bordeaux

  • CH Boulogne-Sur-Mer

    Boulogne-sur-Mer

  • CHU Brest

    Brest

  • HCL Groupement Hospitalier Est

    Bron

  • CHU Caen

    Caen

  • Ch Sud Francilien

    Corbeil-Essonnes

  • CHU Dijon

    Dijon

  • CHRU La Rochelle

    La Rochelle

  • CHU Grenoble

    La Tronche

  • CHU Lille

    Lille

  • CHU Limoges

    Limoges

  • HCL DIAB-eCARE

    Lyon

  • IDNC Chartres

    Mainvilliers

  • APHM Marseille (Hôpital de la Conception)

    Marseille

  • APHM Marseille (La Timone)

    Marseille

  • GHEF (Centre Hospitalier de Meaux)

    Meaux

  • CHU Montpellier (Lapeyronie)

    Montpellier

  • CHU Nantes

    Nantes

  • CHU Nice

    Nice

  • CHU Nîmes

    Nîmes

  • APHP Bichat

    Paris

  • APHP Cochin

    Paris

  • Ch Lariboisiere

    Paris

  • CH Périgueux

    Périgueux

  • CH Perpignan

    Perpignan

  • CHU Rennes

    Rennes

  • CHU Strasbourg

    Strasbourg

  • CHU Toulouse (Rangueil)

    Toulouse

  • CHU Tours

    Tours

Other trials in France

About this study

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)

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.

Read the 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.

Conditions
Type 1 Diabetes
Being tested
MiniMed™ 780G System
Keywords
780G, T1D
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MiniMed™ 780G SystemDevice

    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.

Study groups in NCT04308291
Study groupRoleWhat they receive
MiniMed™ 780G SystemSubject will use the MiniMed™ 780G System as per standard of care.
Receives: Device: MiniMed™ 780G System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time in Range 70-180 mg/dL (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.

    Measured: 0-6 months

Secondary outcomes (11)

  1. Satisfaction Score

    To evaluate the change from baseline in satisfaction score based on the Diabetes Treatment Satisfaction Questionnaire change (DTSQc)

    Measured: 0-6 months

  2. Quality of Life Change

    To evaluate the change in quality of life based on the Diabetes Quality of life questionnaire (DQoL)

    Measured: 0-6 months

  3. Fear of Hypoglycemic Events Change

    To evaluate the change from baseline in the fear of hypoglycemic events based on the Hypoglycemia Fear Survey (HFS)

    Measured: 0-6 months

  4. Treatment Satisfaction Score

    To evaluate the treatment satisfaction score based on the Diabetes Treatment Satisfaction Questionnaire status (DTSQs)

    Measured: 0-6 months

  5. Glycemic Parameters Changes

    To evaluate the change in glycemic parameters: mean time of sensor glucose values below 70mg/dL

    Measured: 0-6 months

  6. Glycemic Parameters Changes

    To evaluate the change in glycemic parameters: mean time of sensor glucose values below 54mg/dL

    Measured: 0-6 months

  7. Glycemic Parameters Changes

    To evaluate the change in glycemic parameters: mean time of sensor glucose values above 180mg/dL

    Measured: 0-6 months

  8. Glycemic Parameters Changes

    To evaluate the change in glycemic parameters: mean time of sensor glucose values above above 250mg/dL

    Measured: 0-6 months

  9. HbA1c

    To evaluate the change in glycosylated haemoglobin (HbA1c), between baseline and 6 months.

    Measured: 0-6 months

  10. Time in Range of 70-180 mg/dL (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 12 months.

    Measured: 0-12 months

  11. HbA1c

    To evaluate the change in glycosylated haemoglobin (HbA1c), between baseline and 12 months.

    Measured: 0-12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2020
  2. Study start15 Feb 2021
  3. Primary completion19 May 2022
  4. Study completion27 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
306 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04308291
Sponsor's protocol ID
CIP328
Status last verified
Jan 2024
First submitted
11 Mar 2020
Last updated
8 Jul 2024
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 39688775

Questions about this trial

What is this clinical trial studying?

An observational study of Type 1 Diabetes, run by Medtronic MiniMed, Inc. at 32 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time in Range 70-180 mg/dL (TIR) (time frame: 0-6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04308291, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.

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