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

Benefits of a Long Term Implantable Continuous Glucose Monitoring System for Adults With Diabetes - France Randomized Clinical Trial

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]).

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Device: Eversense XL CGM System; Device: Usual SMBG or FGM device used by participants

• Study Type: Interventional
• Enrollment (Actual): 239
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80054
    • CHU Amiens Picardie
  • Caen, France, 14033
    • CHU Caen Normandie
  • La Tronche, France, 38700
    • Chu Grenoble Alpes
  • Le Creusot, France, 71200
    • Hopital Hotel Dieu - Creusot
  • Lille, France, 59037
    • CHRU de Lille
  • Marseille, France, 13274
    • APHM - Hôpital Sainte-Marguerite
  • Montpellier, France, 34295
    • CHU de Montpellier
  • Nimes, France, 30900
    • Hopital Caremeau-CHU Nimes
  • Paris, France, 75475
    • Paris Lariboisière
  • Paris, France, 75679
    • APHP Groupe Hospitalier Cochin (Paris)
  • Pierre Benite, France, 69310
    • Centre Hospitalier Lyon Sud
  • Poitiers, France, 86021
    • CHU de Poitiers
  • Reims Cedex, France, 51092
    • Chu Reims
  • Rouen, France, 76100
    • CHU Rouen
  • St Herblain, France, 44800
    • CHU de Nantes
  • Strasbourg, France, 67091
    • CHRU de Strasbourg
  • Toulouse, France, 31059
    • Chu de Toulouse
  • Vandoeuvre Les Nancy, France, 54511
    • Chu de Nancy
  • Venissieux, France, 69200
    • Groupe hospitalier les Portes du Sud
  • Vernouillet, France, 28500
    • Institut de diabétologie et Nutrition du Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Device: 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).
ACTIVE_COMPARATOR: 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.	Device: 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).; Device: 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.
EXPERIMENTAL: 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.	Device: 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).
ACTIVE_COMPARATOR: 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.	Device: 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).; Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants, whether or not related to the investigational medical device. AEs were coded using the MedDRA dictionary version 20.1. All AEs were assessed by the investigator for relation to the device, seriousness (according to serious AE criteria), and severity (i.e., intensity of the event: mild, moderate, or severe). AEs of hypoglycemia were identified using a Standardized MedDRA Query (SMQ) for a list of Preferred Terms; all terms for hypoglycemia reported in the AE forms were considered symptomatic hypoglycemia. 'Severe hypoglycemia' included all serious and severe/life-threatening events of the SMQ for hypoglycemia. Serious diabetic ketoacidosis was identified in the AE forms using a set list of MedDRA terms. Adverse device effects (ADEs) included all AEs that were pre-specified in the electronic Case Report Form (eCRF).	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	The results show an analysis of covariance (ANCOVA) comparing the percentage of time participants in each treatment arm of Cohorts 1 and 2 spent in euglycemia with a blood glucose level ≥70 mg/dL to ≤180 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 centre (and diabetes type for Cohort 1) as fixed classification effects and the time in euglycemia at baseline (i.e. percentage of time spent in euglycemia 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
Percentage of Time Spent in Hyperglycemia (>250mg/dL) From Day 90 to Day 120	The results show an analysis of covariance (ANCOVA) comparing the percentage of time participants in each treatment arm of Cohorts 1 and 2 spent in hyperglycemia with a blood glucose level >250 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 (and diabetes type for Cohort 1) as fixed classification effects and the level of hyperglycemia at baseline (i.e. percentage of time spent in hyperglycemia >250 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
Percentage of Time Spent in Hyperglycemia (>180mg/dL) From Day 90 to Day 120	The results show an analysis of covariance (ANCOVA) comparing the percentage of time participants in each treatment arm of Cohorts 1 and 2 spent in hyperglycemia with a blood glucose level >180 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 (and diabetes type for Cohort 1) as fixed classification effects and the level of hyperglycemia at baseline (i.e. percentage of time spent in hyperglycemia >180 mg/dL between the Day 0 and Day 30 visits) as baseline covariate. Adjusted means with their 95% confidence intervals are provided.	From Day 90 to Day 120
Percentage of Time Spent in Hypoglycemia (<70mg/dL) From Day 90 to Day 120	The results show an analysis of covariance (ANCOVA) comparing the percentage of time participants in each treatment arm of Cohort 1 spent in hypoglycemia with a blood glucose level <70 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 (and diabetes type for Cohort 1) as fixed classification effects and the level of hypoglycemia at baseline (i.e. percentage of time spent in hypoglycemia <70 mg/dL between the Day 0 and Day 30 visits) as baseline covariate. Adjusted means with their 95% confidence intervals are provided.	From Day 90 to Day 120
Cohort 1: Percentage of Time Spent in Hypoglycemia (<54mg/dL) From Day 90 to Day 120	The results show an analysis of covariance (ANCOVA) comparing the percentage of time participants in each treatment arm of Cohort 1 spent in hypoglycemia with a blood glucose level <54 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, center, and diabetes type 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 covariate. Adjusted means with their 95% confidence intervals are provided.	From Day 90 to Day 120
Percentage of Time Spent in the Euglycemic Range (70mg/dL-180mg/dL) From Day 150 to Day 180	The results show an analysis of covariance (ANCOVA) comparing the percentage of time participants in each treatment arm of Cohorts 1 and 2 spent in euglycemia with a blood glucose level ≥70 mg/dL to ≤180 mg/dL between the Day 150 and Day 180 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 (and diabetes type for Cohort 1) as fixed classification effects and the level of hypoglycemia at baseline (i.e. percentage of time spent in euglycemia between the Day 0 and Day 30 visits) as baseline covariate. Adjusted means with their 95% confidence intervals are provided.	From Day 150 to Day 180
Percentage of Time Spent in Hyperglycemia (>250mg/dL) From Day 150 to Day 180	The results show an analysis of covariance (ANCOVA) comparing the percentage of time participants in each treatment arm of Cohorts 1 and 2 spent in hyperglycemia with a blood glucose level >250 mg/dL between the Day 150 and Day 180 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 (and diabetes type for Cohort 1) as fixed classification effects and the level of hypoglycemia at baseline (i.e. percentage of time spent in hyperglycemia >250 mg/dL between the Day 0 and Day 30 visits) as baseline covariates. Adjusted means with their 95% confidence intervals are provided.	From Day 150 to Day 180
Percentage of Time Spent in Hyperglycemia (>180mg/dL) From Day 150 to Day 180	The results show an analysis of covariance (ANCOVA) comparing the percentage of time participants in each treatment arm of Cohorts 1 and 2 spent in hyperglycemia with a blood glucose level >180 mg/dL between the Day 150 and Day 180 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 (and diabetes type for Cohort 1) as fixed classification effects and the level of hypoglycemia at baseline (i.e. percentage of time spent in hyperglycemia >180 mg/dL between the Day 0 and Day 30 visits) as baseline covariate. Adjusted means with their 95% confidence intervals are provided.	From Day 150 to Day 180
Percentage of Time Spent in Hypoglycemia (<70mg/dL) From Day 150 to Day 180	The results show an analysis of covariance (ANCOVA) comparing the percentage of time participants in each treatment arm of Cohorts 1 and 2 spent in hypoglycemia with a blood glucose level <70 mg/dL between the Day 150 and Day 180 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 (and diabetes type for Cohort 1) as fixed classification effects and the level of hypoglycemia at baseline (i.e. percentage of time spent in hypoglycemia <70 mg/dL between the Day 0 and Day 30 visits) as baseline covariate. Adjusted means with their 95% confidence intervals are provided.	From Day 150 to Day 180
Percentage of Time Spent in Hypoglycemia (<54mg/dL) From Day 150 to Day 180	The results show an analysis of covariance (ANCOVA) comparing the percentage of time participants in each treatment arm of Cohorts 1 and 2 spent in hypoglycemia with a blood glucose level <54 mg/dL between the Day 150 and Day 180 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 (and diabetes type for Cohort 1) 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 covariate. Adjusted means with their 95% confidence intervals are provided.	From Day 150 to Day 180
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	The results show an analysis of covariance (ANCOVA) comparing the percentage of time participants in the Enabled arm of Cohort 2 spent in hypoglycemia with a blood glucose level <54 mg/dL over two different time periods (between the Days 90-120 and Days 150-180), based on the total duration of time with available CGM data (i.e., excluding temporary discontinuations). The statistical model included the time period 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 covariate. Adjusted means with their 95% confidence intervals are provided.	Day 90 to Day 120; Day 150 to Day 180
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	The results show an analysis of covariance (ANCOVA) comparing the percentage of time participants in the Cohort 2, Control arm spent in hypoglycemia with a blood glucose level <54 mg/dL with a different intervention over each of the two time periods (the control period, using their usual glucose monitoring system: Days 90-120, and the enabled period, using the Eversense XL CGM system: Days 150-180), based on the total duration of time with available CGM data (i.e., excluding temporary discontinuations). The statistical model included the time period 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 covariate. Adjusted means with their 95% confidence intervals are provided.	For Cohort 2, Control arm: Day 90 to Day 120; For Cohort 2, Switch from Control to Enabled arm: Day 150 to Day 180
Glucose Variability From Day 90 to Day 120, as Estimated With a Coefficient of Variation	Glucose variability was estimated with a unitless coefficient of variation, expressed as a percentage, which was computed using CGM data with the following formula: the sum of the ratios of standard deviation of daily glycemia to the mean of daily glycemia divided by the number of days with available data for the period of interest (Days 90 to 120). According to Monnier et al. Diabetes Care 2017, a coefficient of variation threshold set to 36% allows to distinguish between stable and unstable glycemia.	From Day 90 to Day 120
Glucose Variability From Day 150 to Day 180, as Estimated by a Coefficient of Variation	Glucose variability was estimated with a unitless coefficient of variation, expressed as a percentage, which was computed using CGM data with the following formula: the sum of the ratios of standard deviation of daily glycemia to the mean of daily glycemia divided by the number of days with available data for the period of interest (Days 150 to 180). According to Monnier et al. Diabetes Care 2017, a coefficient of variation threshold set to 36% allows to distinguish between stable and unstable glycemia.	From Day 150 to Day 180
HbA1c (%) Levels at Day 120	The results show 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 120 visit between the Enabled and Control arms for Cohorts 1 and 2. The statistical model included the randomization arm and center (and diabetes type for Cohort 1) as fixed classification effects, and HbA1c (%) at Day 0 as baseline covariates. Adjusted means with their 95% confidence interval are provided.	Day 120
Cohort 2: HbA1c (%) Levels at Day 180	The analysis of this secondary outcome measure for Cohort 2 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 and center as fixed classification effects, and HbA1c (%) at Day 0 as baseline covariates. Adjusted means with their 95% confidence interval are provided.	Day 180
Number of Participants With the First Sensor Operating at Day 150 and Day 180	This measure assesses sensor life by counting the number of participants with their first inserted CGM sensor still operating at 150 days and at 180 days post-insertion. The assessment was based on the lifespan of the first sensor: for example, if lifespan of the first sensor was ≥150 days and ≥180 days, then the participant was counted as having their first sensor operating at 150 days and 180 days, respectively. The lifespan of the first inserted CGM sensor for each participant, measured in days, was calculated as the date of the last glucose measurement by the sensor minus the date of the first glucose measurement by the sensor (+1 day).	From Day 0 up to Day 150 and Day 180
Mean Lifespan of the First Sensor	The lifespan of the first inserted CGM sensor for each participant, measured in days, was calculated as the date of the last glucose measurement by the sensor minus the date of the first glucose measurement by the sensor (+1 day).	From Day 0 up to Day 180
Median Number of Sensors Used by Each Participant During the Study		From Day 0 to Day 180
Number of Participants With the First Transmitter Operating at Day 150 and Day 180	This measure assesses transmitter wear time by counting the number of participants with their first CGM transmitter still operating at 150 days and at 180 days after first use. The assessment was based on the lifespan of the first transmitter: for example, if lifespan of the first transmitter was ≥150 days and ≥180 days, then the participant was counted as having their first transmitter operating at 150 days and 180 days, respectively. The lifespan of the first CGM transmitter for each participant, measured in days, was calculated as the date of the last glucose measurement with the transmitter minus the date of the first glucose measurement with the transmitter (+1 day).	From Day 0 up to Day 150 and Day 180
Mean Lifespan of the First Transmitter	The lifespan of the first CGM transmitter for each participant, measured in days, was calculated as the date of the last glucose measurement with the transmitter minus the date of the first glucose measurement with the transmitter (+1 day).	From Day 0 up to Day 180
Median Number of Transmitters Used by Each Participant During the Study		From Day 0 to Day 180
Number of Participants Who Accessed CGM Application Pages at Days 60, 120, and 180	This was a descriptive analysis of the number of participants in the Eversense XL CGM System Enabled groups who accessed the various CGM application (app) pages/functions at study Days 60, 120, and 180. The data were collected in the electronic Case Report Form.	At Days 60, 120, and 180
Number of Participants Issued at Least One Type of Alarm or Alert by the CGM System During the Study	This outcome measure is a descriptive analysis of the number of participants who were issued various types of alarms and alerts by the Eversense XL CGM System through the mobile medical application. The alarms listed in the results table are a higher level classification for the different types of alerts that immediately follow it, until the next type of alarm is listed (for example, the 'Calibration' alarm included both 'Calibrate Now' and 'Calibration Past Due' alerts). Only participants in the Enabled groups of both cohorts actually received these alarms/alerts because the CGM remained in blinded mode for participants in the Control groups.	From Day 0 up to Day 180
Diabetes Treatment Satisfaction Questionnaire - Original Status (DTSQs) Treatment Satisfaction Score at Baseline, Day 60, and Day 180	The DTSQs questionnaire contains eight items scored on a 7-point scale (i.e. each item is scored from 0 to 6). Six items measure Treatment Satisfaction, dealing with: satisfaction with current treatment; convenience of the treatment; flexibility; satisfaction with own understanding of participant's diabetes; how likely to recommend their present treatment; and how satisfied to continue with their present treatment. These are summed to produce a total Treatment Satisfaction score, with a minimum value of 0 and a maximum value of 36; a higher score indicates greater treatment satisfaction. In case of missing items, the overall score was calculated as the mean of the available items.	Baseline (Day 0), Day 60, and Day 180
Change From Baseline in the DTSQs Treatment Satisfaction Score at Day 60 and Day 180	The DTSQs questionnaire contains eight items scored on a 7-point scale (i.e. each item is scored from 0 to 6). Six items measure Treatment Satisfaction (dealing with: satisfaction with current treatment; convenience of the treatment; flexibility; satisfaction with own understanding of participant's diabetes; how likely to recommend their present treatment; and how satisfied to continue with their present treatment). These are summed to produce a total Treatment Satisfaction score, with a minimum value of 0 and a maximum value of 36; a higher score indicates greater treatment satisfaction. For the change from baseline analysis, a positive value indicates an improvement in treatment satisfaction. In case of missing items, the overall score was calculated as the mean of the available items.	Baseline (Day 0), Day 60, and Day 180
Diabetes Treatment Satisfaction Questionnaire - Change Version (DTSQc) Treatment Satisfaction Score at Day 180	The DTSQc questionnaire contains eight items scored on a 7-point scale (i.e. each item is scored from -3 to +3). Six items measure Treatment Satisfaction (dealing with: satisfaction with current treatment; convenience of the treatment; flexibility; satisfaction with own understanding of participant's diabetes; how likely to recommend their present treatment; and how satisfied to continue with their present treatment). These are summed to produce a total Treatment Satisfaction score, with a minimum value of -18 and a maximum value of +18; a higher score indicates greater treatment satisfaction. In case of missing items, the overall score was calculated as the mean of the available items.	Day 180
Audit of Diabetes-Dependent Quality of Life (ADDQoL) Score at Baseline and Day 180	The ADDQoL measures the impact of diabetes and its treatment on 19 specific aspects of life. The scale ranges from -3 to +1 for 19 life domains (impact rating) and from 0 to +3 in attributed importance (importance rating). A weighted score for each domain is calculated as a multiplier of impact rating and importance rating (ranging from -9 to +3). Finally, a mean weighted impact score (ADDQOL score) is calculated for the entire scale across all applicable domains; a higher score indicates greater quality of life.	Baseline (Day 0) and Day 180
Change From Baseline in the Audit of Diabetes-Dependent Quality of Life (ADDQoL) Score at Day 180	The ADDQoL measures the impact of diabetes and its treatment on 19 specific aspects of life. The scale ranges from -3 to +1 for 19 life domains (impact rating) and from 0 to +3 in attributed importance (importance rating). A weighted score for each domain is calculated as a multiplier of impact rating and importance rating (ranging from -9 to +3). Finally, a mean weighted impact score (ADDQOL score) is calculated for the entire scale across all applicable domains; a higher score indicates greater quality of life. For the change from baseline analysis, a positive value indicates an improvement in quality of life.	Baseline (Day 0) and Day 180
The Continuous Glucose Monitoring Satisfaction (CGM-SAT) Questionnaire Overall Score at Day 60 and Day 180	The CGM-SAT questionnaire comprises 44 item scales assessing experiences with CGM over the previous 6 months. The scale is designed to measure the impact of CGM on diabetes management and family relationships, plus on satisfaction with emotional, behavioral and cognitive effects of CGM use. The responses were rated on a 5-point scale from '1 = strongly agree' to '5 = strongly disagree'. The overall score corresponds to the mean of the 44 items of potential positive or negative effects of using the CGM device; a higher score reflects more favorable impact of, and satisfaction with CGM. In case of missing items, the overall score was calculated as the mean of the available items.	Day 60 and Day 180
Change From Day 60 in the CGM-SAT Questionnaire Overall Score at Day 180	The CGM-SAT questionnaire comprises 44 item scales assessing experiences with CGM over the previous 6 months. The scale is designed to measure the impact of CGM on diabetes management and family relationships, plus on satisfaction with emotional, behavioral and cognitive effects of CGM use. The responses were rated on a 5-point scale from '1 = strongly agree' to '5 = strongly disagree'. The overall score corresponds to the mean of the 44 items of potential positive or negative effects of using the CGM device; a higher score (or positive change from baseline score) reflects more favorable impact of, and satisfaction with CGM. In case of missing items, the overall score was calculated as the mean of the available items.	Day 60 and Day 180
Diabetes Distress Scale 2 (DDS2) Questionnaire Score at Baseline, Day 60, and Day 180	The DDS2 is a 2-item diabetes distress screening instrument asking respondents to rate on a 6-point scale (from 1 = 'Not a problem' to 6 = 'A very serious problem') the degree to which the following items caused distress: (1) feeling overwhelmed by the demands of living with diabetes, and (2) feeling that I am often failing with my diabetes regimen. The DDS2 score is the mean of the two items (ranging from 1 to 6). A lower DDS2 score (or a negative change from baseline score) indicates a lower level of distress. If one item was missing, then no score was computed.	Baseline (Day 0), Day 60, and Day 180
Change From Baseline in the Diabetes Distress Scale 2 (DDS2) Questionnaire Score at Day 60 and Day 180	The DDS2 is a 2-item diabetes distress screening instrument asking respondents to rate on a 6-point scale (from 1 = 'Not a problem' to 6 = 'A very serious problem') the degree to which the following items caused distress: (1) feeling overwhelmed by the demands of living with diabetes, and (2) feeling that I am often failing with my diabetes regimen. The DDS2 score is the mean of the two items (ranging from 1 to 6). A lower DDS2 score (or a negative change from baseline score) indicates a lower level of distress. If one item was missing, then no score was computed.	Baseline (Day 0), Day 60, and Day 180
Hypoglycemia Fear Survey, Part 2 (HFS2) Worry Subscale Score at Baseline, Day 60, and Day 180	HFS2 Worry items describe specific concerns that patients may have about their hypoglycemic episodes (e.g., being alone, episodes occurring during sleep, or having an accident). The 5-point Likert scale for each item ranges from 0 (never) to 4 (almost always), and the HFS2 Worry subscale score is the sum of all 18 items (ranging from 0 to 72). A lower HFS2 Worry subscale score (or a negative change from baseline score) indicates a lower level of fear of hypoglycemia. There was no plan to replace missing items: if one item was missing, the score was not computed.	Baseline (Day 0), Day 60, and Day 180
Change From Baseline in the Hypoglycemia Fear Survey, Part 2 (HFS2) Worry Subscale Score at Day 60 and Day 180	HFS2 Worry items describe specific concerns that patients may have about their hypoglycemic episodes (e.g., being alone, episodes occurring during sleep, or having an accident). The 5-point Likert scale for each item ranges from 0 (never) to 4 (almost always), and the HFS2 Worry subscale score is the sum of all 18 items (ranging from 0 to 72). A lower HFS2 Worry subscale score (or a negative change from baseline score) indicates a lower level of fear of hypoglycemia. There was no plan to replace missing items: if one item was missing, the score was not computed.	Baseline (Day 0), Day 60, and Day 180
Change From Baseline in the Partner Diabetes Distress Scale (Partner-DDS) Questionnaire Total and Subscale Scores at Day 60 and Day 180	The Partner-DDS is a 21-item self-report scale that highlights four critical dimensions of partner-related distress: "my partner's diabetes management", "how best to help", "diabetes and me", and "hypoglycemia". The scale ranges from 0 (not at all) to 4 (a great deal). The Partner-DDS yields a total diabetes distress score plus 4 subscale scores: Total Partner-DDS Score = Mean of the 21 items; My partner's diabetes management = Mean of item 3, 4, 10, 12, 14, 15 and 20; How best to help = Mean of item 2, 6, 7, 11 and 13; Diabetes and me = Mean of items 5, 8, 9, 16 and 21; Hypoglycemia = Mean of items 1, 17, 18 and 19. A lower Partner-DDS score (or a negative change from baseline score) indicates a lower level of distress.	Baseline (Day 0), Day 60, and Day 180

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Collaborators: Roche Diabetes Care France SAS
• Investigators: Study Director: Cecile Berteau, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 28, 2018
• Primary Completion (ACTUAL): August 20, 2020
• Study Completion (ACTUAL): August 20, 2020

Study Registration Dates

• First Submitted: February 2, 2018
• First Submitted That Met QC Criteria: February 19, 2018
• First Posted (ACTUAL): February 26, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 10, 2021
• Last Update Submitted That Met QC Criteria: August 13, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: RD003329

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes