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The purpose of this study is to demonstrate the performance of the Disposable Sensor (DS5) in subjects age 2 - 80 years, for the span of 170 hours (7 days).
The purpose of this study is to demonstrate the performance of the Disposable Sensor (DS5) in subjects age 2 - 80 years, for the span of 170 hours (7 days).
This is a multi-center study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with diabetes wearing DS5 | Experimental | Subjects wearing DS5 over 7 days and participating in FSTs. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Glucose Monitoring | Device | CGM 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 (YSI™*) reference value (within 20 mg/dL [1.1 mmol/L] when sensor values < 80 mg/dL) [4.4 mmol/L]) by age groups and DS5 insertion locations. Note Self-Monitoring Blood Glucose (SMBG) was used for age 2-6, instead of YSI. Zero calibration sensor algorithm applied to raw sensor data. | 7 days (170 hours) |
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Inclusion Criteria:
Individual is 2 - 80 years of age at time of enrollment.
Subject has a clinical diagnosis of type 1 or type 2 diabetes:
If subject is participating in YSI™* FST , subject has adequate venous access as assessed by investigator or appropriate staff.
Subjects participating in the high and low glucose challenges must have an insulin carbohydrate ratio(s) and insulin sensitivity factor(s). Subjects without ratios may participate under observation only.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AMCR Institute | Escondido | California | 92025 | United States | ||
| Sansum Diabetes Research Institute |
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317 subjects (175 adult subjects, 141 pediatric subjects, and 1 age-unknown subject) consented and enrolled in the overall study. Of them, 7 subjects were screening failure and 310 subjects (172 adult subjects and 138 pediatric subjects) participated in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Adult Subjects (Age 18-80) Wearing DS5 | Adult subjects (age 18-80) wearing DS5 over 7 days: Continuous Glucose Monitoring and frequent sample testing |
| FG001 | Pediatric Subjects (Age 2-17) Wearing DS5 |
| 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 | Mar 31, 2022 | Apr 26, 2023 |
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| Santa Barbara |
| California |
| 93105 |
| United States |
| SoCal Diabetes | Torrance | California | 90505 | United States |
| Diablo Clinical Research, Inc. | Walnut Creek | California | 94598 | United States |
| Barbara Davis Center for Childhood Diabetes | Aurora | Colorado | 80045 | United States |
| Barbara Davis Center for Diabetes | Aurora | Colorado | 80045 | United States |
| University of South Florida | Tampa | Florida | 33612 | United States |
| Atlanta Diabetes Associates | Atlanta | Georgia | 30318 | United States |
| Rocky Mountain Diabetes and Osteoporosis Center | Idaho Falls | Idaho | 83404 | United States |
| AM Diabetes and Endocrinology Center | Bartlett | Tennessee | 38133 | United States |
| Texas Diabetes & Endocrinology | Austin | Texas | 78749 | United States |
| University of Virginia Center for Diabetes Technology | Charlottesville | Virginia | 22903 | United States |
| Rainier Clinical Research Center, Inc. | Renton | Washington | 98057 | United States |
| Nanjing First Hospital | Nanjing | Jiangsu | 210008 | China |
| Dalian Municiple Central Hospital | Dalian | Liaoning | 116089 | China |
| Shanghai Sixth People's Hospital | Shanghai | Shanghai Municipality | 200233 | China |
| Children's Hospital of Fudan University | Shanghai | Shanghai Municipality | 201102 | China |
| The Children's Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310005 | China |
Pediatric subjects (age 2-17) wearing DS5 over 7 days: 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) Wearing DS5 | Adult subjects (age 18-80) wearing DS5 over 7 days: Continuous Glucose Monitoring and frequent sample testing |
| BG001 | Pediatric Subjects (Age 2-17) Wearing DS5 | Pediatric subjects (age 2-17) wearing DS5 over 7 days: Continuous Glucose Monitoring and frequent sample testing |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| 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 |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| BMI (kg/m2) | Mean | Standard Deviation | kg/m^2 |
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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 (YSI™*) reference value (within 20 mg/dL [1.1 mmol/L] when sensor values < 80 mg/dL) [4.4 mmol/L]) by age groups and DS5 insertion locations. Note Self-Monitoring Blood Glucose (SMBG) was used for age 2-6, instead of YSI. Zero calibration sensor algorithm applied to raw sensor data. | Subjects with at least 1 sensor-YSI (or sensor-SMBG for subjects 2-6 years) paired point during the sensor wear | Posted | Mean | 90% Confidence Interval | percentage of readings | 7 days (170 hours) |
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Throughout the course of the study, up to approximately 90 days (including an up to 7-day training period and a 7-day study period)
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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) Wearing DS5 | Adult subjects (age 18-80) wearing DS5 over 7 days: Continuous Glucose Monitoring and frequent sample testing | 0 | 172 | 1 | 172 | 27 | 172 |
| EG001 | Pediatric Subjects (Age 2-17) Wearing DS5 | Pediatric subjects (age 2-17) wearing DS5 over 7 days: Continuous Glucose Monitoring and frequent sample testing | 0 | 138 | 0 | 138 | 23 | 138 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| BILATERAL HYDRONEPHROSIS | Renal and urinary disorders | MedDRA 25.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alcoholic ketoacidosis | Metabolism and nutrition disorders | MedDRA25.0 | Systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA25.0 | Systematic Assessment |
| |
| Asymptomatic bacteriuria | Infections and infestations | MedDRA25.0 | Systematic Assessment |
| |
| Autoimmune thyroiditis | Endocrine disorders | MedDRA25.0 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA25.0 | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA25.0 | Systematic Assessment |
| |
| Carotid arteriosclerosis | Nervous system disorders | MedDRA25.0 | Systematic Assessment |
| |
| Cerebral artery occlusion | Nervous system disorders | MedDRA25.0 | Systematic Assessment |
| |
| Cerebral artery stenosis | Nervous system disorders | MedDRA25.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA25.0 | Systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA25.0 | Systematic Assessment |
| |
| Diabetic ketosis | Metabolism and nutrition disorders | MedDRA25.0 | Systematic Assessment |
| |
| Diabetic nephropathy | Renal and urinary disorders | MedDRA25.0 | Systematic Assessment |
| |
| Diabetic neuropathy | Nervous system disorders | MedDRA25.0 | Systematic Assessment |
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| Dry eye | Eye disorders | MedDRA25.0 | Systematic Assessment |
| |
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA25.0 | Systematic Assessment |
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| Gallbladder polyp | Hepatobiliary disorders | MedDRA25.0 | Systematic Assessment |
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| Giant cell tumour of tendon sheath | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA25.0 | Systematic Assessment |
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| Growth retardation | Musculoskeletal and connective tissue disorders | MedDRA25.0 | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA25.0 | Systematic Assessment |
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| Helicobacter gastritis | Infections and infestations | MedDRA25.0 | Systematic Assessment |
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| Hepatic cyst | Hepatobiliary disorders | MedDRA25.0 | Systematic Assessment |
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| Hepatic function abnormal | Hepatobiliary disorders | MedDRA25.0 | Systematic Assessment |
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| Hepatic mass | Hepatobiliary disorders | MedDRA25.0 | Systematic Assessment |
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| Hepatic steatosis | Hepatobiliary disorders | MedDRA25.0 | Systematic Assessment |
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| Humerus fracture | Injury, poisoning and procedural complications | MedDRA25.0 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA25.0 | Systematic Assessment |
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| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA25.0 | Systematic Assessment |
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| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA25.0 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA25.0 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA25.0 | Systematic Assessment |
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| Infusion site infection | Infections and infestations | MedDRA25.0 | Systematic Assessment |
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| Infusion site pain | General disorders | MedDRA25.0 | Systematic Assessment |
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| Ketosis | Metabolism and nutrition disorders | MedDRA25.0 | Systematic Assessment |
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| Left atrial enlargement | Cardiac disorders | MedDRA25.0 | Systematic Assessment |
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| Medical device site bruise | General disorders | MedDRA25.0 | Systematic Assessment |
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| Medical device site pain | General disorders | MedDRA25.0 | Systematic Assessment |
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| Medical device site rash | General disorders | MedDRA25.0 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA25.0 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA25.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA25.0 | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA25.0 | Systematic Assessment |
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| Non-alcoholic fatty liver | Hepatobiliary disorders | MedDRA25.0 | Systematic Assessment |
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| Otitis media | Infections and infestations | MedDRA25.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA25.0 | Systematic Assessment |
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| Peripheral arterial occlusive disease | Vascular disorders | MedDRA25.0 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA25.0 | Systematic Assessment |
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| Pleural mesothelioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA25.0 | Systematic Assessment |
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| Poor quality sleep | Psychiatric disorders | MedDRA25.0 | Systematic Assessment |
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| Postoperative wound infection | Infections and infestations | MedDRA25.0 | Systematic Assessment |
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| Prostatic calcification | Reproductive system and breast disorders | MedDRA25.0 | Systematic Assessment |
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| Proteinuria | Renal and urinary disorders | MedDRA25.0 | Systematic Assessment |
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| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA25.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA25.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA25.0 | Systematic Assessment |
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| Renal cyst | Renal and urinary disorders | MedDRA25.0 | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA25.0 | Systematic Assessment |
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| Serum ferritin decreased | Investigations | MedDRA25.0 | Systematic Assessment |
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| Skin infection | Infections and infestations | MedDRA25.0 | Systematic Assessment |
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| Thyroid mass | Endocrine disorders | MedDRA25.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA25.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA25.0 | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA25.0 | Systematic Assessment |
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| Vitamin D decreased | Investigations | MedDRA25.0 | Systematic Assessment |
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| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA25.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA25.0 | 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 | Mar 31, 2022 | Mar 21, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| 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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| 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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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| China |
|
A generalized estimating equation model was used, considering correlation structure of day of sensor wear (1-7).
| <0.05 |
| Intercept from ANCOVA as agreement rate |
| 87.5 |
| 2-Sided |
| 90 |
| 85.4 |
| 89.7 |
| Superiority |
| ANCOVA | A generalized estimating equation model was used, considering correlation structure of day of sensor wear (1-7). | <0.05 | Intercept from ANCOVA as agreement rate | 87.9 | 2-Sided | 90 | 85.8 | 89.9 | Superiority |