A French Study to Evaluate the Usefulness of an Implantable Continuous Glucose Monitoring (CGM) Sensor to Improve Glycemic Control in Participants With Diabetes Mellitus

NCT03445065 | Completed Results FDA Device

• 1 other identifier: RD003329
• Study Type: interventional
• Target: 239
• Locations: 1 country
• Sites: 20

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 \[FGM\]).

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• Cohort 1: HbA1c (%) Levels at Day 180

  The analysis of the primary outcome measure for Cohort 1 was an analysis of covariance (ANCOVA) comparing the HbA1c (%), defined as the percentage of hemoglobin proteins that are glycated (i.e., chemically linked to a sugar), at the Day 180 visit between the Enabled and Control arms. The statistical model included the randomization arm, center, and diabetes type as fixed classification effects, and HbA1c (%) at Day 0 as baseline covariates. Adjusted means with their 95% confidence intervals are provided.

  Day 180

• Cohort 2: Percentage of Time Spent in Hypoglycemia (<54 mg/dL) From Day 90 to Day 120

  The analysis of the primary outcome measure for Cohort 2 was an analysis of covariance (ANCOVA) comparing the percentage of time participants in each treatment arm spent in hypoglycemia with a blood glucose level \<54 milligrams per decilitre (mg/dL) between the Day 90 and Day 120 visits, based on the total duration of time with available CGM data (i.e., excluding temporary discontinuations). The statistical model included the randomization arm and center as fixed classification effects and the level of hypoglycemia at baseline (i.e. percentage of time spent in hypoglycemia \<54 mg/dL between the Day 0 and Day 30 visits) as baseline covariates. Adjusted means with their 95% confidence intervals are provided.

  From Day 90 to Day 120

Secondary Outcomes (39)

• Number of Participants With at Least One Pre-Specified Adverse Event That Occurred Following Sensor Insertion

  At sensor insertion (Day 0)

• Number of Participants With at Least One Pre-Specified Adverse Event That Occurred Following Sensor Removal

  At sensor removal (up to Day 180)

• Overall Number of Participants With at Least One Adverse Event

  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

• Percentage of Time Spent in the Euglycemic Range (70mg/dL-180mg/dL) From Day 90 to Day 120

  From Day 90 to Day 120

• Percentage of Time Spent in Hyperglycemia (>250mg/dL) From Day 90 to Day 120

  From Day 90 to Day 120

Study Arms (4)

Cohort 1, Enabled - Eversense XL CGM System

EXPERIMENTAL

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.

Device: Eversense XL CGM System

Cohort 1, Control - Usual Glucose Monitoring System (SMBG or FGM)

ACTIVE COMPARATOR

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.

Device: Eversense XL CGM System; Device: Usual SMBG or FGM device used by participants

Cohort 2, Enabled - Eversense XL CGM System

EXPERIMENTAL

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.

Device: Eversense XL CGM System

Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM)

ACTIVE COMPARATOR

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.

Device: Eversense XL CGM System; Device: Usual SMBG or FGM device used by participants

Interventions

Eversense XL CGM System DEVICE

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, Enabled - Eversense XL CGM System; Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM); Cohort 2, Enabled - Eversense XL CGM System

Usual SMBG or FGM device used by participants DEVICE

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 1, Control - Usual Glucose Monitoring System (SMBG or FGM); Cohort 2, Control - Usual Glucose Monitoring System (SMBG or FGM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead
• Roche Diabetes Care: collaborator

Study Sites (20)

CHU Amiens Picardie

Amiens, 80054, France

Location

CHU Caen Normandie

Caen, 14033, France

Location

CHU Grenoble Alpes

La Tronche, 38700, France

Location

Hopital Hotel Dieu - Creusot

Le Creusot, 71200, France

Location

CHRU de Lille

Lille, 59037, France

Location

APHM - Hopital Sainte-Marguerite

Marseille, 13274, France

Location

CHU de Montpellier

Montpellier, 34295, France

Location

Hopital Caremeau-CHU Nimes

Nîmes, 30900, France

Location

Paris Lariboisière

Paris, 75475, France

Location

APHP Groupe Hospitalier Cochin (Paris)

Paris, 75679, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69310, France

Location

CHU de Poitiers

Poitiers, 86021, France

Location

CHU Reims

Reims, 51092, France

Location

CHU Rouen

Rouen, 76100, France

Location

CHU de Nantes

Saint-Herblain, 44800, France

Location

CHRU de Strasbourg

Strasbourg, 67091, France

Location

CHU de Toulouse

Toulouse, 31059, France

Location

CHU de Nancy

Vandœuvre-lès-Nancy, 54511, France

Location

Institut de diabétologie et Nutrition du Centre

Vernouillet, 28500, France

Location

Groupe hospitalier Les Portes du Sud

Vénissieux, 69200, France

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800-821-8590

Study Officials

• Cecile Berteau

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2018
• First Posted: February 26, 2018
• Study Start: February 28, 2018
• Primary Completion: August 20, 2020
• Study Completion: August 20, 2020
• Last Updated: September 10, 2021
• Results First Posted: September 10, 2021

Record last verified: 2021-08

Locations

FR (20)