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The purpose of this multi-center, prospective clinical study is to evaluate the performance of a novel, implanted Senseonics continuous glucose monitoring system (Senseonics CGM System) compared to Yellow Springs Instrument (YSI) glucose analyzer reference standard measurements using a next generation transmitter and algorithm. Other measures evaluated will be the effects of compression on performance and the safety of the Senseonics CGM system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous Glucose Monitoring Device | Experimental | Senseonics continuous glucose monitoring system |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous glucose monitoring system | Device | Implanted continuous glucose monitoring system |
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| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of CGM System Through 90 Days Post-Insertion (MARD for Paired CGM and Reference Glucose Measurements) | The effectiveness endpoint is the mean absolute relative difference (MARD), calculated for all paired Senseonics CGM System and reference glucose measurements through 90 days of Sensor use. MARD is defined as the average of absolute difference of paired Senseonics CGM System and reference glucose readings divided by the reference glucose reading (reference) for all reference glucose values, that is: MARD = ((SUM | (Glucose)sensor - (Glucose)reference | / (Glucose)reference ) / n ) x 100%, where n is the total number of CGM and reference glucose pairs after 90 days of sensor use (MARD is a percentage). Lower MARDs indicate higher (better) accuracy. | 90 days |
| Safety Endpoint | Incidence of device-related or sensor insertion/removal procedure-related serious adverse events through 90 days post-insertion. | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
History of severe hypoglycemia in the previous 6 months. Severe hypoglycemia is defined as hypoglycemia resulting in loss of consciousness or seizure
History of diabetic ketoacidosis requiring emergency room visit or hospitalization in the previous 6 months
Female subjects 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.
Symptomatic coronary artery disease; unstable angina; myocardial infarction, transient ischemic attack or stroke in the past 6 months; uncontrolled hypertension (systolic>160 mm Hg or diastolic >100 mm Hg at time of screening); current congestive heart failure; history of cardiac arrhythmia (benign Premature Atrial Contractions (PACs) and Premature Ventricular Contractions (PVCs) allowed).
Subjects with asymptomatic coronary artery disease (e,g, coronary artery bypass graft (CABG), stent placement or angioplasty) may participate if negative stress test within 1 year prior to screening and written clearance from Cardiologist documented.
Hematocrit <30% or >55%
History of hepatitis B, hepatitis C, or HIV
Current treatment for a seizure disorder unless written clearance by neurologist to participate in study
History of adrenal insufficiency
Currently receiving (or likely to need during the study period):
immunosuppressant therapy; chemotherapy; anticoagulant/antithrombotic therapy (excluding aspirin); glucocorticoids (excluding ophthalmic or nasal). This exclusion does include the use of inhaled glucocorticoids and the use of topical glucocorticoids (over sensor site only); antibiotic 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
Any condition that in the investigator's opinion would make the subject unable to complete the study or would make it not in the subject'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 subject 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
The presence of any other active implanted device (as defined further in protocol)
The presence of any other CGM sensor or transmitter located in upper arm (other location is acceptable)
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| Name | Affiliation | Role |
|---|---|---|
| Mark Christiansen, MD | Diablo Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AMCR Institute Inc. | Escondido | California | 92025 | United States | ||
| Diablo Clinical Research |
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| ID | Title | Description |
|---|---|---|
| FG000 | Continuous Glucose Monitoring Device | Continuous glucose monitoring system: Implanted with Senseonics Eversense® Continuous Glucose Monitoring (CGM) System (Eversense® 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 | Sep 29, 2017 | Jun 21, 2023 |
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| Walnut Creek |
| California |
| 94598 |
| United States |
| Rainier Clinical Research Center | Renton | Washington | 98057 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Continuous Glucose Monitoring Device | Senseonics continuous glucose monitoring system Continuous glucose monitoring system: Implanted continuous glucose monitoring system |
| 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 |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index Class: Normal, Overweight, Obese | Mean | Standard Deviation | kg/m2 |
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| Dominant Hand: Right, Left | Number | participants |
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| Diabetes Type: Type I, Type II | Count of Participants | Participants |
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| Years Since Diabetes Diagnosis | Mean | Standard Deviation | years |
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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 | Accuracy of CGM System Through 90 Days Post-Insertion (MARD for Paired CGM and Reference Glucose Measurements) | The effectiveness endpoint is the mean absolute relative difference (MARD), calculated for all paired Senseonics CGM System and reference glucose measurements through 90 days of Sensor use. MARD is defined as the average of absolute difference of paired Senseonics CGM System and reference glucose readings divided by the reference glucose reading (reference) for all reference glucose values, that is: MARD = ((SUM | (Glucose)sensor - (Glucose)reference | / (Glucose)reference ) / n ) x 100%, where n is the total number of CGM and reference glucose pairs after 90 days of sensor use (MARD is a percentage). Lower MARDs indicate higher (better) accuracy. | Posted | Mean | 95% Confidence Interval | percent | 90 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 through 90 days post-insertion. | Posted | Number | 95% Confidence Interval | serious adverse events | 90 days |
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Through 90 days post Sensor insertion and sensor removal 10-day follow-up (up to 100 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 | Continuous Glucose Monitoring Device | Continuous glucose monitoring system: Implanted with Senseonics Eversense® Continuous Glucose Monitoring (CGM) System (Eversense® CGM System). | 0 | 35 | 3 | 35 | 15 | 35 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Other - Gastroenteritis | Gastrointestinal disorders | Systematic Assessment |
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| Hypoglycemic episode | Endocrine disorders | Systematic Assessment |
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| Other - Wound infection left foot, grade 4 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Common Cold | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Sensor Location Site - Pain/Discomfort | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Other - Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Other - Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Other - Pilonidal cyst | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Other - Difficulty removing sensor | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Adhesive Patch Location Site - Irritation including redness, excoriation or ulceration | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Other - Darkening of skin at proximal end of sensor | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Other - Vaginal Infection | Reproductive system and breast disorders | Systematic Assessment |
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| Other - Dental Caries | General disorders | Systematic Assessment |
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| Other - Arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katherine Tweden, PhD | Senseonics, Incorporated | 651.335.2205 | Katherine.Tweden@senseonics.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 21, 2023 | 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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| Asian |
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| American Indian or Alaska Native |
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| Native Hawaiian or Other Pacific Islander |
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| More than One Race |
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| Hispanic |
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| Non-Hispanic |
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| Continuous insulin infusion pump |
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| Title | Denominators | Categories |
|---|
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