A French Study to Evaluate the Usefulness of an Implantable Continuous Glucose Monitoring (CGM) Sensor to Improve Glycemic Control in Participants With Diabetes Mellitus
NCT ID: NCT03445065
Last Updated: 2021-09-10
Study Results
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View full resultsBasic Information
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COMPLETED
NA
239 participants
INTERVENTIONAL
2018-02-28
2020-08-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Cohort 1, Enabled - Eversense XL CGM System
Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.
Eversense XL CGM System
The Eversense XL Continuous Glucose Monitoring (CGM) System consists of an implantable sensor inserted under the skin, an external transmitter, and a Mobile Medical Application (MMA) for display of glucose information that runs on a Handheld Device (HHD).
Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM)
Cohort 1 included patients with clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and had an HbA1c \>8%. All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode.
Eversense XL CGM System
The Eversense XL Continuous Glucose Monitoring (CGM) System consists of an implantable sensor inserted under the skin, an external transmitter, and a Mobile Medical Application (MMA) for display of glucose information that runs on a Handheld Device (HHD).
Usual SMBG or FGM device used by participants
Commercially available products in France for self-monitoring of blood glucose (SMBG) or flash glucose monitoring (FGM) were considered as comparators for this study.
Cohort 2, Enabled - Eversense XL CGM System
Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Enabled group were trained and allowed to use the Eversense XL system for continuous glucose monitoring (CGM). They were not allowed to use another CGM or FGM system.
Eversense XL CGM System
The Eversense XL Continuous Glucose Monitoring (CGM) System consists of an implantable sensor inserted under the skin, an external transmitter, and a Mobile Medical Application (MMA) for display of glucose information that runs on a Handheld Device (HHD).
Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM)
Cohort 2 included patients with Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending \>1.5 hours per day with a sensor mean glucose of \<70 mg/dL for at least 28 days (time in hypoglycemia). All participants had the Eversense XL Glucose Sensor subcutaneously implanted into their arm of choice. Those randomized into the Control group were to continue using their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]), and the implanted Eversense XL CGM System remained in blinded mode.
Eversense XL CGM System
The Eversense XL Continuous Glucose Monitoring (CGM) System consists of an implantable sensor inserted under the skin, an external transmitter, and a Mobile Medical Application (MMA) for display of glucose information that runs on a Handheld Device (HHD).
Usual SMBG or FGM device used by participants
Commercially available products in France for self-monitoring of blood glucose (SMBG) or flash glucose monitoring (FGM) were considered as comparators for this study.
Interventions
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Eversense XL CGM System
The Eversense XL Continuous Glucose Monitoring (CGM) System consists of an implantable sensor inserted under the skin, an external transmitter, and a Mobile Medical Application (MMA) for display of glucose information that runs on a Handheld Device (HHD).
Usual SMBG or FGM device used by participants
Commercially available products in France for self-monitoring of blood glucose (SMBG) or flash glucose monitoring (FGM) were considered as comparators for this study.
Eligibility Criteria
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Inclusion Criteria
* Clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and an HbA1c \> 8% (Cohort 1)
* Clinically confirmed diagnosis of Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending more than more than 1.5 hour with sensor glucose \<70 mg/dl per day including excursions below 54 mg/dl as a mean for at least 28 days (Cohort 2)
* Participant is willing to comply with protocol
Exclusion Criteria
* A condition preventing or complicating the placement, operation or removal of the Sensor or wearing of transmitter, including upper extremity deformities or skin condition
* History of hepatitis B, hepatitis C, or HIV
* Currently receiving (or likely to need during the study period): immunosuppressant therapy; chemotherapy; anticoagulant/antithrombotic therapy (excluding aspirin \< 2000 mg per day); antibiotics for chronic infection (e.g. osteomyelitis, endocarditis)
* A condition requiring or likely to require magnetic resonance imaging (MRI)
* Known topical or local anesthetic allergy
* Known allergy to glucocorticoids or using systemic glucocorticoids (excluding topical, optical or nasal but including inhaled)
* Any condition that in the investigator's opinion would make the participant unable to complete the study or would make it not in the participant's best interest to participate in the study. Conditions include, but are not limited to, psychiatric conditions, known current or recent alcohol abuse or drug abuse by participant history, a condition that may increase the risk of induced hypoglycemia or risk related to repeated blood testing. Investigator will supply rationale for exclusion
* Participation in another clinical investigation (drug or device) within 2 weeks prior to screening or intent to participate during the study period
* Legal incompetence or limited legal competence
* Dependency on sponsor or Investigator (e.g. co-worker or family member)
* The presence of any other active implanted device
18 Years
ALL
No
Sponsors
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Roche Diabetes Care
INDUSTRY
Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Cecile Berteau
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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CHU Amiens Picardie
Amiens, , France
CHU Caen Normandie
Caen, , France
CHU Grenoble Alpes
La Tronche, , France
Hopital Hotel Dieu - Creusot
Le Creusot, , France
CHRU de Lille
Lille, , France
APHM - Hopital Sainte-Marguerite
Marseille, , France
CHU de Montpellier
Montpellier, , France
Hopital Caremeau-CHU Nimes
Nîmes, , France
Paris Lariboisière
Paris, , France
APHP Groupe Hospitalier Cochin (Paris)
Paris, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
CHU de Poitiers
Poitiers, , France
CHU Reims
Reims, , France
CHU Rouen
Rouen, , France
CHU de Nantes
Saint-Herblain, , France
CHRU de Strasbourg
Strasbourg, , France
CHU de Toulouse
Toulouse, , France
CHU de Nancy
Vandœuvre-lès-Nancy, , France
Institut de diabétologie et Nutrition du Centre
Vernouillet, , France
Groupe hospitalier Les Portes du Sud
Vénissieux, , France
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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RD003329
Identifier Type: -
Identifier Source: org_study_id
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