Clinical trial NCT03445065: A French Study to Evaluate the Usefulness of an Implantable Continuous Glucose Monitoring (CGM) Sensor to Improve Glycemic Control in Participants With Diabetes Mellitus
Official title: Benefits of a Long Term Implantable Continuous Glucose Monitoring System for Adults With Diabetes - France Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: Roche Diabetes Care
First posted: 2018-02-26
Enrollment: 239
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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 glycemic control in patients with either Type 1 or Type 2 diabetes mellitus under insulin therapy. Participants will be enrolled into one of two cohorts (Cohorts 1 and 2). Cohort 1 will be focused on participants with Type 1 or Type 2 diabetes with hemoglobin A1C (HbA1c) \>8%. Cohort 2 will be focused on participants with Type 1 diabetes spending more than 1.5 hours per day with mean glucose \<70 mg/dL, including excursions below 54 mg/dL, for at least 28 days. Within each cohort, participants will be randomized in a 2:1 ratio to one of two groups: the Enabled and Control groups, respectively. The Enabled group will be trained to use the CGM system, whereas the Control group will continue with their usual glucose monitoring system (self-monitoring of blood glucose \[SMBG\] or flash glucose monitoring \[FGM\]).


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Cohort 1: HbA1c (%) Levels at Day 180
timeFrame: Day 180
measure: Cohort 2: Percentage of Time Spent in Hypoglycemia (<54 mg/dL) From Day 90 to Day 120
timeFrame: From Day 90 to Day 120
Secondary outcomes:
measure: Number of Participants With at Least One Pre-Specified Adverse Event That Occurred Following Sensor Insertion
timeFrame: At sensor insertion (Day 0)
measure: Number of Participants With at Least One Pre-Specified Adverse Event That Occurred Following Sensor Removal
timeFrame: At sensor removal (up to Day 180)
measure: Overall Number of Participants With at Least One Adverse Event
timeFrame: From Day 0 (Insertion) up to Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180
measure: Percentage of Time Spent in the Euglycemic Range (70mg/dL-180mg/dL) From Day 90 to Day 120
timeFrame: From Day 90 to Day 120
measure: Percentage of Time Spent in Hyperglycemia (>250mg/dL) From Day 90 to Day 120
timeFrame: From Day 90 to Day 120
measure: Percentage of Time Spent in Hyperglycemia (>180mg/dL) From Day 90 to Day 120
timeFrame: From Day 90 to Day 120
measure: Percentage of Time Spent in Hypoglycemia (<70mg/dL) From Day 90 to Day 120
timeFrame: From Day 90 to Day 120
measure: Cohort 1: Percentage of Time Spent in Hypoglycemia (<54mg/dL) From Day 90 to Day 120
timeFrame: From Day 90 to Day 120
measure: Percentage of Time Spent in the Euglycemic Range (70mg/dL-180mg/dL) From Day 150 to Day 180
timeFrame: From Day 150 to Day 180
measure: Percentage of Time Spent in Hyperglycemia (>250mg/dL) From Day 150 to Day 180
timeFrame: From Day 150 to Day 180
measure: Percentage of Time Spent in Hyperglycemia (>180mg/dL) From Day 150 to Day 180
timeFrame: From Day 150 to Day 180
measure: Percentage of Time Spent in Hypoglycemia (<70mg/dL) From Day 150 to Day 180
timeFrame: From Day 150 to Day 180
measure: Percentage of Time Spent in Hypoglycemia (<54mg/dL) From Day 150 to Day 180
timeFrame: From Day 150 to Day 180
measure: Cohort 2, Enabled Arm: Percentage of Time Spent in Hypoglycemia (<54 mg/dL) During the Day 90-120 Period Compared With the Day 150-180 Period for the Enabled Group
timeFrame: Day 90 to Day 120; Day 150 to Day 180
measure: Cohort 2, Control Arm: Percentage of Time Spent in Hypoglycemia (<54 mg/dL) During the Control Period (Days 90-120) Compared With the Enabled Period (Days 150-180) for Participants Who Switched to Use the CGM System
timeFrame: For Cohort 2, Control arm: Day 90 to Day 120; For Cohort 2, Switch from Control to Enabled arm: Day 150 to Day 180
measure: Glucose Variability From Day 90 to Day 120, as Estimated With a Coefficient of Variation
timeFrame: From Day 90 to Day 120
measure: Glucose Variability From Day 150 to Day 180, as Estimated by a Coefficient of Variation
timeFrame: From Day 150 to Day 180
measure: HbA1c (%) Levels at Day 120
timeFrame: Day 120
measure: Cohort 2: HbA1c (%) Levels at Day 180
timeFrame: Day 180
measure: Number of Participants With the First Sensor Operating at Day 150 and Day 180
timeFrame: From Day 0 up to Day 150 and Day 180
measure: Mean Lifespan of the First Sensor
timeFrame: From Day 0 up to Day 180
measure: Median Number of Sensors Used by Each Participant During the Study
timeFrame: From Day 0 to Day 180
measure: Number of Participants With the First Transmitter Operating at Day 150 and Day 180
timeFrame: From Day 0 up to Day 150 and Day 180
measure: Mean Lifespan of the First Transmitter
timeFrame: From Day 0 up to Day 180
measure: Median Number of Transmitters Used by Each Participant During the Study
timeFrame: From Day 0 to Day 180
measure: Number of Participants Who Accessed CGM Application Pages at Days 60, 120, and 180
timeFrame: At Days 60, 120, and 180
measure: Number of Participants Issued at Least One Type of Alarm or Alert by the CGM System During the Study
timeFrame: From Day 0 up to Day 180
measure: Diabetes Treatment Satisfaction Questionnaire - Original Status (DTSQs) Treatment Satisfaction Score at Baseline, Day 60, and Day 180
timeFrame: Baseline (Day 0), Day 60, and Day 180
measure: Change From Baseline in the DTSQs Treatment Satisfaction Score at Day 60 and Day 180
timeFrame: Baseline (Day 0), Day 60, and Day 180
measure: Diabetes Treatment Satisfaction Questionnaire - Change Version (DTSQc) Treatment Satisfaction Score at Day 180
timeFrame: Day 180
measure: Audit of Diabetes-Dependent Quality of Life (ADDQoL) Score at Baseline and Day 180
timeFrame: Baseline (Day 0) and Day 180
measure: Change From Baseline in the Audit of Diabetes-Dependent Quality of Life (ADDQoL) Score at Day 180
timeFrame: Baseline (Day 0) and Day 180
measure: The Continuous Glucose Monitoring Satisfaction (CGM-SAT) Questionnaire Overall Score at Day 60 and Day 180
timeFrame: Day 60 and Day 180
measure: Change From Day 60 in the CGM-SAT Questionnaire Overall Score at Day 180
timeFrame: Day 60 and Day 180
measure: Diabetes Distress Scale 2 (DDS2) Questionnaire Score at Baseline, Day 60, and Day 180
timeFrame: Baseline (Day 0), Day 60, and Day 180
measure: Change From Baseline in the Diabetes Distress Scale 2 (DDS2) Questionnaire Score at Day 60 and Day 180
timeFrame: Baseline (Day 0), Day 60, and Day 180
measure: Hypoglycemia Fear Survey, Part 2 (HFS2) Worry Subscale Score at Baseline, Day 60, and Day 180
timeFrame: Baseline (Day 0), Day 60, and Day 180
measure: Change From Baseline in the Hypoglycemia Fear Survey, Part 2 (HFS2) Worry Subscale Score at Day 60 and Day 180
timeFrame: Baseline (Day 0), Day 60, and Day 180
measure: Change From Baseline in the Partner Diabetes Distress Scale (Partner-DDS) Questionnaire Total and Subscale Scores at Day 60 and Day 180
timeFrame: Baseline (Day 0), Day 60, and Day 180
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
city: Caen
country: France
facility: CHU Caen Normandie
city: La Tronche
country: France
facility: CHU Grenoble Alpes
city: Le Creusot
country: France
facility: Hopital Hotel Dieu - Creusot
city: Lille
country: France
facility: CHRU de Lille
city: Marseille
country: France
facility: APHM - Hopital Sainte-Marguerite
city: Montpellier
country: France
facility: CHU de Montpellier
city: Nimes
country: France
facility: Hopital Caremeau-CHU Nimes
city: Paris
country: France
facility: Paris Lariboisière
city: Paris
country: France
facility: APHP Groupe Hospitalier Cochin (Paris)
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud
city: Poitiers
country: France
facility: CHU de Poitiers
city: Reims Cedex
country: France
facility: CHU Reims
city: Rouen
country: France
facility: CHU Rouen
city: St Herblain
country: France
facility: CHU de Nantes
city: Strasbourg
country: France
facility: CHRU de Strasbourg
city: Toulouse
country: France
facility: CHU de Toulouse
city: Vandoeuvre Les Nancy
country: France
facility: CHU de Nancy
city: Venissieux
country: France
facility: Groupe hospitalier Les Portes du Sud
city: Vernouillet
country: France
facility: Institut de diabétologie et Nutrition du Centre
Study officials:
affiliation: Hoffmann-La Roche
name: Cecile Berteau
role: STUDY_DIRECTOR
References: