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The purpose of this clinical investigation is to evaluate the accuracy of the Senseonics Continuous Glucose Monitoring System (Senseonics CGM System) measurements when compared with reference standard measurements The investigation will also evaluate safety of the Senseonics CGM System usage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Accuracy assessment, CGMS | Experimental | To determine accuracy of the Senseonics Continuous Glucose Monitoring System measurements through approximately 90 days post-insertion. Manipulation of glucose levels during multiple clinic days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Glucose Monitoring System | Device | Accuracy and safety assessment of a continuous glucose monitoring device |
|
| Measure | Description | Time Frame |
|---|---|---|
| CGM Relative Difference to Laboratory Reference Reported as MARD | Mean absolute relative difference (MARD) for paired Sensor and reference measurements through 90 days post-insertion for reference glucose values from 40-400 mg/dL will be calculated for comparison. | 90 days |
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| Measure | Description | Time Frame |
|---|---|---|
| CGM System Agreement With Reference Control | The percentage of system readings within ±15 mg/dL or 15% of YSI reference values (15/15%) | 90 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Christiansen, MD | Diablo Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John Muir Physician Network Clinical Research Center | Concord | California | 94520 | United States | ||
| AMCR Institute |
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| ID | Title | Description |
|---|---|---|
| FG000 | Accuracy Assessment, CGMS | To determine accuracy of the Senseonics Continuous Glucose Monitoring System measurements through approximately 90 days post-insertion. Manipulation of glucose levels during multiple clinic days Continuous Glucose Monitoring System: Accuracy and safety assessment of a continuous glucose monitoring device |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Accuracy Assessment, CGMS | To determine accuracy of the Senseonics Continuous Glucose Monitoring System measurements through approximately 90 days post-insertion. Manipulation of glucose levels during multiple clinic days Continuous Glucose Monitoring System: Accuracy and safety assessment of a continuous glucose monitoring device |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | CGM Relative Difference to Laboratory Reference Reported as MARD | Mean absolute relative difference (MARD) for paired Sensor and reference measurements through 90 days post-insertion for reference glucose values from 40-400 mg/dL will be calculated for comparison. | Posted | Mean | 95% Confidence Interval | percent | 90 days |
|
|
90 days post insertion or sensor removal and follow-up
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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 | Accuracy Assessment, CGMS | To determine accuracy of the Senseonics Continuous Glucose Monitoring System measurements through approximately 90 days post-insertion. Manipulation of glucose levels during multiple clinic days Continuous Glucose Monitoring System: Accuracy and safety assessment of a continuous glucose monitoring device |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Surgical procedure to remove sensor | Surgical and medical procedures | Systematic Assessment | PI requested assistance from a general surgeon for removal of sensor through outpatient surgery who then elected to place the patient under general anesthesia. The sensor was removed intact without incident |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Food poisoning | Injury, poisoning and procedural complications | Systematic Assessment | Not related to Study device or insertion/removal procedure |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Clinical Sciences | Senseonics | 3015157260 | katherine.tweden@senseonics.com |
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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 |
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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 |
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| Escondido |
| California |
| 92025 |
| United States |
| Diablo Clinical Research | Walnut Creek | California | 94598 | United States |
| Atlanta Diabetes Care | Atlanta | Georgia | 30318 | United States |
| Mount Sinai Diabetes Center | New York | New York | 10029 | United States |
| Worldwide Clinical Trials | San Antonio | Texas | 78217 | United States |
| Clinical Trials of Texas | San Antonio | Texas | 78229 | United States |
| UVA Diabetes and Endocrine Clinic | Charlottesville | Virginia | 22903 | United States |
| Rainier Clinical Research | Renton | Washington | 98057 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| Dominant Hand | Count of Participants | Participants |
|
| Body mass Index | Count of Participants | Participants |
|
| Years since diabetes diagnosis | Mean | Standard Deviation | years |
|
| Diabetes Type | Count of Participants | Participants |
|
| Type of insulin therapy | Count of Participants | Participants |
|
| History of | Count of Participants | Participants |
|
| Participants |
|
|
| Other Pre-specified | CGM System Agreement With Reference Control | The percentage of system readings within ±15 mg/dL or 15% of YSI reference values (15/15%) | Posted | Number | percent of readings within 15/15% | 90 days |
|
|
|
| 0 |
| 90 |
| 1 |
| 90 |
| 43 |
| 90 |
|
|
| Syncope | Vascular disorders | Systematic Assessment | Related or Possibly related to Study Procedure |
|
| Carpal tunnel | Nervous system disorders | Systematic Assessment | Not related to Study device or insertion/removal procedure |
|
| Dizziness | Nervous system disorders | Systematic Assessment | Not related to Study device or insertion/removal procedure |
|
| Headache | Nervous system disorders | Systematic Assessment | Related or Possibly related to Study Procedure |
|
| Paresthesia | Nervous system disorders | Systematic Assessment | Related or Possibly related to the study device or Insertion/Removal Procedure |
|
| Syncope-Vasovagal | Vascular disorders | Systematic Assessment | Related or Possibly related to the study device or Insertion/Removal Procedure |
|
| Sciatica | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to Study device or insertion/removal procedure |
|
| Shoulder pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to Study device or insertion/removal procedure |
|
| Neck strain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to Study device or insertion/removal procedure |
|
| Broken toe | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to Study device or insertion/removal procedure |
|
| Rib injury | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to Study device or insertion/removal procedure |
|
| Sensor location site- Pain/discomfort | Musculoskeletal and connective tissue disorders | Systematic Assessment | Related or Possibly related to the study device or Insertion/Removal Procedure |
|
| Ankle sprain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to Study device or insertion/removal procedure |
|
| Nephrolithiasis | Renal and urinary disorders | Systematic Assessment | Not related to Study device or insertion/removal procedure |
|
| Urinary tract infection | Renal and urinary disorders | Systematic Assessment | Not related to Study device or insertion/removal procedure |
|
| Candidiasis vaginal | Reproductive system and breast disorders | Systematic Assessment | Not related to Study device or insertion/removal procedure |
|
| Dyslipidemia | Metabolism and nutrition disorders | Systematic Assessment | Not related to Study device or insertion/removal procedure |
|
| Fever | General disorders | Systematic Assessment | Not related to Study device or insertion/removal procedure |
|
| Common cold | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Not related to Study device or insertion/removal procedure |
|
| Sore throat | Gastrointestinal disorders | Systematic Assessment | Not related to Study device or insertion/removal procedure |
|
| Cracked tooth | Injury, poisoning and procedural complications | Systematic Assessment | Not related to Study device or insertion/removal procedure |
|
| Infection-Tooth | Infections and infestations | Systematic Assessment | Not related to Study device or insertion/removal procedure |
|
| Laryngitis | Infections and infestations | Systematic Assessment | Not related to Study device or insertion/removal procedure |
|
| Cataracts | Eye disorders | Systematic Assessment | Not related to Study device or insertion/removal procedure |
|
| Infection-Upper Respiratory | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Not related to Study device or insertion/removal procedure |
|
| Blepharoplasty | Surgical and medical procedures | Systematic Assessment | Not related to Study device or insertion/removal procedure |
|
| Broken tooth | Injury, poisoning and procedural complications | Systematic Assessment | Not related to Study device or insertion/removal procedure |
|
| TMJ pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Not related to Study device or insertion/removal procedure |
|
| Device Fragement not recovered | Surgical and medical procedures | Systematic Assessment | Related or Possibly related to the study device or Insertion/Removal Procedure |
|
| Fatigue | General disorders | Systematic Assessment | Not related to Study device or insertion/removal procedure |
|
| Bruising | Skin and subcutaneous tissue disorders | Systematic Assessment | Related or Possibly related to the study device or Insertion/Removal Procedure |
|
| Erythema, removal site | Skin and subcutaneous tissue disorders | Systematic Assessment | Related or Possibly related to the study device or Insertion/Removal Procedure |
|
| Sensor location site- Pain/discomfort | General disorders | Systematic Assessment | Related or Possibly related to the study device or Insertion/Removal Procedure |
|
| IV site pain | Injury, poisoning and procedural complications | Systematic Assessment | Related or Possibly related to Study Procedure |
|
| Dermatitis | Immune system disorders | Systematic Assessment | Not related to Study device or insertion/removal procedure |
|
| Cellulitis | Infections and infestations | Systematic Assessment | Not related to Study device or insertion/removal procedure |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | Systematic Assessment | Not related to Study device or insertion/removal procedure |
|
| IV site Erythema | Injury, poisoning and procedural complications | Systematic Assessment | Related or Possibly related to Study Procedure |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Not related to Study device or insertion/removal procedure |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Not related to Study device or insertion/removal procedure |
|
| Sleep apnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Not related to Study device or insertion/removal procedure |
|
| Gastroenteritis | Gastrointestinal disorders | Systematic Assessment | Not related to Study device or insertion/removal procedure |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment | Not related to Study device or insertion/removal procedure |
|
| Gastric ulcer | Gastrointestinal disorders | Systematic Assessment | Not related to Study device or insertion/removal procedure |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment | Not related to Study device or insertion/removal procedure |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment | Not related to Study device or insertion/removal procedure |
|
| Erythema, Arm | Skin and subcutaneous tissue disorders | Systematic Assessment | Related or Possibly related to Study Procedure |
|
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |