Status:
COMPLETED
A French Study to Evaluate the Usefulness of an Implantable Continuous Glucose Monitoring (CGM) Sensor to Improve Glycemic Control in Participants With Diabetes Mellitus
Lead Sponsor:
Hoffmann-La Roche
Collaborating Sponsors:
Roche Diabetes Care
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study will be conducted in France and will evaluate the usefulness of using a long-term subcutaneously inserted continuous glucose monitoring (CGM) sensor (the Eversense XL CGM System) to improve...
Eligibility Criteria
Inclusion
- Male and female participants at least 18 years of age
- 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
- Female participants of childbearing capacity (defined as not surgically sterile or not menopausal for ≥ 1 year) who are lactating or pregnant, intending to become pregnant, or not practicing birth control during the course of the study
- 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
Key Trial Info
Start Date :
February 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 20 2020
Estimated Enrollment :
239 Patients enrolled
Trial Details
Trial ID
NCT03445065
Start Date
February 28 2018
End Date
August 20 2020
Last Update
September 10 2021
Active Locations (20)
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1
CHU Amiens Picardie
Amiens, France, 80054
2
CHU Caen Normandie
Caen, France, 14033
3
CHU Grenoble Alpes
La Tronche, France, 38700
4
Hopital Hotel Dieu - Creusot
Le Creusot, France, 71200