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The purpose of this clinical investigation is to evaluate the accuracy of the Eversense® continuous Glucose Monitoring System (Eversense® 180 CGM System) measurements when compared with reference standard measurements up to 180 days of sensor use.
The investigation will also evaluate safety of the Eversense® 180 CGM System usage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous Glucose Monitoring Device | Experimental | The Eversense® 180 CGM System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Glucose Monitoring System | Device | The Eversense® 180 CGM System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness Measure - Mean Absolute Relative Difference (MARD) for Paired CGM and Reference Glucose Measurements | The effectiveness endpoint is the mean absolute relative difference (MARD), calculated for paired CGM Sensor and reference glucose measurements through 180 days post-sensor insertion for reference glucose values from 40-400 mg/dL. MARD is defined as the average of absolute difference of paired Sensor and reference glucose readings divided by the reference glucose reading (reference) for reference glucose values from 40-400 mg/dL, that is: MARD = ((SUM | (Glucose)sensor - (Glucose)reference | / (Glucose)reference ) / n ) x 100%, where n is the total number of Sensor and reference glucose pairs after 180 days of sensor use (MARD is expressed as a percent). Lower MARDs indicate higher (better) accuracy. | 180 days |
| Safety Endpoint - Incidence of Device-related or Sensor Insertion/Removal Procedure-related Serious Adverse Events | Incidence of device-related or sensor insertion/removal procedure-related serious adverse events occurring up to 180 days after the insertion procedure. | 180 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Satish Garg, MD | Barbara Davis Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John Muir Physician Network Clinical Research Center | Concord | California | 94520 | United States | ||
| AMCR Institute Inc. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Continuous Glucose Monitoring Device | The Eversense® 180 CGM System Continuous Glucose Monitoring System: The Eversense® 180 CGM System |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 14, 2020 | Jun 21, 2023 |
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| Escondido |
| California |
| 92025 |
| United States |
| Diablo Clinical Research | Walnut Creek | California | 94598 | United States |
| Barbara Davis Center for Diabetes | Aurora | Colorado | 80045 | United States |
| Atlanta Diabetes Care | Atlanta | Georgia | 30318 | United States |
| Rocky mountain Diabetes Center C/O Research Department | Idaho Falls | Idaho | 83404 | United States |
| Clinical Trials of Texas | San Antonio | Texas | 78229 | United States |
| Rainier Clinical Research Center | Renton | Washington | 98057 | United States |
| Received SBA Sensor |
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| COMPLETED |
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| NOT COMPLETED |
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Subjects enrolled and inserted with the Eversense 180 CGM system.
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| ID | Title | Description |
|---|---|---|
| BG000 | The Eversense® 180 CGM System All Subject | All subjects inserted with a study sensor(s). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Body Mass Index Class | Count of Participants | Participants |
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| Years since diabetes diagnosis | Mean | Standard Deviation | years |
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| Diabetes type | Count of Participants | Participants |
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| Type of insulin therapy | Count of Participants | Participants |
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| History of ketoacidosis and hypoglycemia in past 6 months | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Effectiveness Measure - Mean Absolute Relative Difference (MARD) for Paired CGM and Reference Glucose Measurements | The effectiveness endpoint is the mean absolute relative difference (MARD), calculated for paired CGM Sensor and reference glucose measurements through 180 days post-sensor insertion for reference glucose values from 40-400 mg/dL. MARD is defined as the average of absolute difference of paired Sensor and reference glucose readings divided by the reference glucose reading (reference) for reference glucose values from 40-400 mg/dL, that is: MARD = ((SUM | (Glucose)sensor - (Glucose)reference | / (Glucose)reference ) / n ) x 100%, where n is the total number of Sensor and reference glucose pairs after 180 days of sensor use (MARD is expressed as a percent). Lower MARDs indicate higher (better) accuracy. | Posted | Mean | 95% Confidence Interval | percent | 180 days | Matched CGM and YSI pairs | Matched CGM and YSI pairs |
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| Primary | Safety Endpoint - Incidence of Device-related or Sensor Insertion/Removal Procedure-related Serious Adverse Events | Incidence of device-related or sensor insertion/removal procedure-related serious adverse events occurring up to 180 days after the insertion procedure. | Posted | Number | 95% Confidence Interval | serious adverse events | 180 days |
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Through 180 days post Sensor insertion and sensor removal 10-day follow-up (up to 190 days)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | The Eversense® 180 CGM System All Subject Evaluation | All subjects inserted with a study sensor. | 0 | 181 | 7 | 181 | 118 | 181 |
| EG001 | The Eversense® 180 CGM System SBA Subgroup | Subjects inserted with Eversense® 180 CGM system with slightly modified indicator hydrogel containing sacrificial boronic acid (referred to as SBA Sensor). | 0 | 43 | 3 | 43 | 30 | 43 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Invasive lobular carcinoma | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Post-surgical staphylococcus infection in left breast | Reproductive system and breast disorders | Systematic Assessment |
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| Humerus Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| hypoglycemic event | Endocrine disorders | Systematic Assessment | This SAE was not related to the device or procedures. |
| |
| Chronic behavioral issues | Nervous system disorders | Systematic Assessment |
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| Diabetic ketoacidosis event requiring hospitalization | Endocrine disorders | Systematic Assessment |
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| hiatal hernia | General disorders | Systematic Assessment |
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| hyperglycemia | Endocrine disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin irritation, adhesive patch location (including erythema, pruritus, rash, contact dermatitis) | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Skin irritation, not device related (including abrasion, laceration, redness, tear, rash, contact de | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hypopigmentation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Infection (not related) | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Skin atrophy | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Skin cancer (left forearm, scalp, ear, nose) | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Infection (insertion/removal site, under adhesive patch) | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Contact dermatitis/Rash (drape adhesive, heat related) | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Burn | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Erythema, insertion site | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Seroma, removal site | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Influenzas | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Chest congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Chest pain with tachycardia, dizziness | Cardiac disorders | Systematic Assessment |
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| Lower extremity edema, bilateral | Vascular disorders | Systematic Assessment |
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| Sinus tachycardia | Cardiac disorders | Systematic Assessment |
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| Nausea/Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Abdominal pain/discomfort | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Gastroenteritis | Gastrointestinal disorders | Systematic Assessment |
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| Headache (1 w/ dizziness) | Nervous system disorders | Systematic Assessment |
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| Pain | Nervous system disorders | Systematic Assessment |
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| Migraine with nausea | Nervous system disorders | Systematic Assessment |
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| Arm Numbness | Nervous system disorders | Systematic Assessment |
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| Tremor | Nervous system disorders | Systematic Assessment |
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| Pain (back, forehead, hand, neck, etc. ) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Muscle/Connective tissue injury | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Bone Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Sprain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Arthritis/Osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Carpal tunnel | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Trigger finger | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Puncture wound, right foot | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| UTI | Renal and urinary disorders | Systematic Assessment |
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| HSV flare | General disorders | Systematic Assessment |
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| Vaginal candidiasis | Infections and infestations | Systematic Assessment |
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| Hyperglycemia/DKA | Endocrine disorders | Systematic Assessment |
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| Hypoglycemic episode | Endocrine disorders | Systematic Assessment |
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| Hyperthyroidism | Endocrine disorders | Systematic Assessment |
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| Bruising | Blood and lymphatic system disorders | Systematic Assessment |
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| Bleeding | Blood and lymphatic system disorders | Systematic Assessment |
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| Iron Deficiency | Blood and lymphatic system disorders | Systematic Assessment |
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| Ecchymosis, IV site | Blood and lymphatic system disorders | Systematic Assessment |
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| Fever | General disorders | Systematic Assessment |
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| Antibiotic allergy | General disorders | Systematic Assessment |
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| Food/Drink allergy | General disorders | Systematic Assessment |
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| Seasonal allergy | General disorders | Systematic Assessment |
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| Dental work/issues | General disorders | Systematic Assessment |
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| Cataract | Eye disorders | Systematic Assessment |
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| Otitis media | Ear and labyrinth disorders | Systematic Assessment |
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| Sinus infection | Infections and infestations | Systematic Assessment |
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| Pharyngitis | Infections and infestations | Systematic Assessment |
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| Retinopathy | Eye disorders | Systematic Assessment |
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| Cold sores | Infections and infestations | Systematic Assessment |
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| Corneal ulcer | Eye disorders | Systematic Assessment |
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| Lipoplasty, lower extremities | General disorders | Systematic Assessment |
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| Bariatric surgery | General disorders | Systematic Assessment |
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| Malaise | General disorders | Systematic Assessment |
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| Thumb tip cut off, right | General disorders | Systematic Assessment |
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| Steristrips did not hold, replaced | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Clinical Sciences | Senseonics | 301-515-7260 | katherine.tweden@senseonics.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 11, 2020 | Jun 21, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000095583 | Continuous Glucose Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Obese (>30) |
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| Continuous insulin infusion pump |
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| Other (Basal only or 1 injection per day) |
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