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The purpose of this study is to demonstrate the performance of the Guardianâ„¢ Sensor (3) with an advanced algorithm in subjects age 2 - 80 years, for the span of 170 hours (7 days).
The study is a multi-center, prospective, single-sample correlational design without controls. The purpose of this study is to demonstrate the performance of the Guardianâ„¢ Sensor (3) with an advanced algorithm in subjects age 2 - 80 years, for the span of 170 hours (7 days).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with diabetes wearing Guardianâ„¢ Sensor (3) | Other | Subjects wear Guardianâ„¢ Sensor (3) and Guardianâ„¢ Connect Transmitter over 7 days and participate in FSTs. Zero calibration sensor algorithm applied to raw sensor data. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guardianâ„¢ Sensor (3) connected to a Guardianâ„¢ Connect Transmitter | Device | Continuous Glucose Monitoring and frequent sample testing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Readings Within 20% Agreement | Mean of daily percentage of sensor values within 20% of Yellow Springs Instrument (YSIâ„¢*) reference value (within 20 mg/dL if sensor values < 80 mg/dL), across all participants and all Frequent Sample Testing (FST) days. Note Self-Monitoring Blood Glucose (SMBG) was used for age 2-6, instead of YSI. | 7 days (170 hours) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AMCR Institue | Escondido | California | 92026 | United States | ||
| Sansum Diabetes Research Institute |
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335 subjects (188 adult subjects and 147 pediatric subjects) consented and enrolled in the overall study. Of them, 311 subjects (169 adult subjects and 142 pediatric subjects) were eligible.
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| ID | Title | Description |
|---|---|---|
| FG000 | Adult Subjects (Age 18-80) With Diabetes Wearing Guardianâ„¢ Sensor (3) | Adult subjects (age 18-80) wear Guardianâ„¢ Sensor (3) over 7 days and participate in FSTs. Guardianâ„¢ Sensor (3) connected to a Guardianâ„¢ Connect Transmitter: Continuous Glucose Monitoring and frequent sample testing |
| FG001 |
| 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 26, 2019 | Mar 12, 2021 |
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| Santa Barbara |
| California |
| 93105 |
| United States |
| SoCal Diabetes | Torrance | California | 90505 | United States |
| Diablo Clinical Research | Walnut Creek | California | 92025 | United States |
| Diablo Clinical Research | Walnut Creek | California | 94598 | United States |
| Barbara Davis Center - Adults | Aurora | Colorado | 80045 | United States |
| Barbara Davis Center for Childhood Diabetes (Pediatric) | Aurora | Colorado | 80045 | United States |
| University of South Florida | Tampa | Florida | 33613 | United States |
| Rocky Mountain Diabetes and Osteoporosis Center | Idaho Falls | Idaho | 83404 | United States |
| IDERC | Des Moines | Iowa | 50265 | United States |
| Mayo Clinic (Rochester MN) | Rochester | Minnesota | 55905 | United States |
| AM Diabetes & Endocrinology Center | Bartlett | Tennessee | 38133 | United States |
| Texas Diabetes and Endocrinology | Austin | Texas | 78749 | United States |
| University of Virgina | Charlottesville | Virginia | 22903 | United States |
| Rainer Clinical Research Center | Renton | Washington | 98057 | United States |
| Pediatric Subjects (Age 2-17) With Diabetes Wearing Guardianâ„¢ Sensor (3) |
Pediatric subjects (age 2-17) wear Guardianâ„¢ Sensor (3) over 7 days and participate in FSTs. Guardianâ„¢ Sensor (3) connected to a Guardianâ„¢ Connect Transmitter: Continuous Glucose Monitoring and frequent sample testing |
| COMPLETED |
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| NOT COMPLETED |
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Demographics and other baseline characteristics were documented for eligible subjects (i.e., subjects who passed screening).
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| ID | Title | Description |
|---|---|---|
| BG000 | Adult Subjects (Age 18-80) With Diabetes Wearing Guardianâ„¢ Sensor (3) | Adult subjects (age 18-80) wear Guardianâ„¢ Sensor (3) over 7 days and participate in FSTs. Guardianâ„¢ Sensor (3) connected to a Guardianâ„¢ Connect Transmitter: Continuous Glucose Monitoring and frequent sample testing |
| BG001 | Pediatric Subjects (Age 2-17) With Diabetes Wearing Guardianâ„¢ Sensor (3) | Pediatric subjects (age 2-17) wear Guardianâ„¢ Sensor (3) over 7 days and participate in FSTs. Guardianâ„¢ Sensor (3) connected to a Guardianâ„¢ Connect Transmitter: Continuous Glucose Monitoring and frequent sample testing |
| BG002 | Total | Total of all reporting groups |
| 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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| Region of Enrollment | Number | 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 | Percentage of Readings Within 20% Agreement | Mean of daily percentage of sensor values within 20% of Yellow Springs Instrument (YSIâ„¢*) reference value (within 20 mg/dL if sensor values < 80 mg/dL), across all participants and all Frequent Sample Testing (FST) days. Note Self-Monitoring Blood Glucose (SMBG) was used for age 2-6, instead of YSI. | Subjects with at least 1 sensor-YSI (or sensor-SMBG for subjects 2-6 years) paired point during the sensor wear | Posted | Mean | 91.8% Confidence Interval | Percentage of Readings | 7 days (170 hours) |
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Throughout the course of the study, up to 91 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 | Adult Subjects (Age 18-80) With Diabetes Wearing Guardianâ„¢ Sensor (3) | Adult subjects (age 18-80) wear Guardianâ„¢ Sensor (3) over 7 days and participate in FSTs. Guardianâ„¢ Sensor (3) connected to a Guardianâ„¢ Connect Transmitter: Continuous Glucose Monitoring and frequent sample testing | 0 | 169 | 2 | 169 | 37 | 169 |
| EG001 | Pediatric Subjects (Age 2-17) With Diabetes Wearing Guardianâ„¢ Sensor (3) | Pediatric subjects (age 2-17) wear Guardianâ„¢ Sensor (3) over 7 days and participate in FSTs. Guardianâ„¢ Sensor (3) connected to a Guardianâ„¢ Connect Transmitter: Continuous Glucose Monitoring and frequent sample testing | 0 | 142 | 2 | 142 | 32 | 142 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Prostatomegaly | Reproductive system and breast disorders | MedDRA22.0 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA22.0 | Systematic Assessment |
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| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA22.0 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA22.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA22.0 | Systematic Assessment |
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| Arthropod bite | Injury, poisoning and procedural complications | MedDRA22.0 | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA22.0 | Systematic Assessment |
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| Attention deficit/hyperactivity disorder | Psychiatric disorders | MedDRA22.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA22.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA22.0 | Systematic Assessment |
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| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA22.0 | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA22.0 | Systematic Assessment |
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| Ear infection | Infections and infestations | MedDRA22.0 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA22.0 | Systematic Assessment |
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| Folliculitis | Infections and infestations | MedDRA22.0 | Systematic Assessment |
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| Foot fracture | Injury, poisoning and procedural complications | MedDRA22.0 | Systematic Assessment |
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| Fungal skin infection | Infections and infestations | MedDRA22.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA22.0 | Systematic Assessment |
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| Gastroenteritis viral | Infections and infestations | MedDRA22.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA22.0 | Systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA22.0 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA22.0 | Systematic Assessment |
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| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA22.0 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA22.0 | Systematic Assessment |
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| Infusion site pain | General disorders | MedDRA22.0 | Systematic Assessment |
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| Insulin resistance | Metabolism and nutrition disorders | MedDRA22.0 | Systematic Assessment |
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| Medical device site bruise | General disorders | MedDRA22.0 | Systematic Assessment |
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| Medical device site haemorrhage | General disorders | MedDRA22.0 | Systematic Assessment |
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| Medical device site infection | Infections and infestations | MedDRA22.0 | Systematic Assessment |
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| Medical device site pain | General disorders | MedDRA22.0 | Systematic Assessment |
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| Muscle strain | Injury, poisoning and procedural complications | MedDRA22.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA22.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA22.0 | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA22.0 | Systematic Assessment |
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| Oral herpes | Infections and infestations | MedDRA22.0 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA22.0 | Systematic Assessment |
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| Pharyngitis streptococcal | Infections and infestations | MedDRA22.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA22.0 | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA22.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA22.0 | Systematic Assessment |
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| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA22.0 | Systematic Assessment |
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| Road traffic accident | Injury, poisoning and procedural complications | MedDRA22.0 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA22.0 | Systematic Assessment |
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| Skin laceration | Injury, poisoning and procedural complications | MedDRA22.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA22.0 | Systematic Assessment |
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| Tooth infection | Infections and infestations | MedDRA22.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA22.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA22.0 | Systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA22.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA22.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robin Mottackel | Medtronic Diabetes | 8185764886 | robin.e.mottackel@medtronic.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 30, 2019 | Mar 12, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| 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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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| ANCOVA |
A generalized estimating equation model was used, considering correlation structure of day of sensor wear (1-7). |
| <0.041 |
| Intercept from ANCOVA as agreement rate |
| 87.96 |
| 2-Sided |
| 91.8 |
| 86.13 |
| 89.80 |
A group sequential study design was utilized to perform interim analysis. For the final stage, the p-value is 0.041. |
| Superiority |
| ANCOVA | A generalized estimating equation model was used, considering correlation structure of day of sensor wear (1-7). | 0.041 | Intercept from ANCOVA as agreement rate | 84.59 | 2-Sided | 91.8 | 82.02 | 87.17 | A group sequential study design was utilized to perform interim analysis. For the final stage, the p-value is 0.041. | Superiority |
| ANCOVA | A generalized estimating equation model was used, considering correlation structure of day of sensor wear (1-7). | <0.041 | Intercept from ANCOVA as agreement rate | 81.05 | 2-Sided | 91.8 | 77.58 | 84.53 | A group sequential study design was utilized to perform interim analysis. For the final stage, the p-value is 0.041. | Superiority |