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The purpose of this study is to demonstrate the performance and safety of the Enlite Sensor over 144 hours (6 days) when inserted in the abdomen and used with the iPro2 in subjects age 14 - 75 years.
This study is a multi-center, randomized, prospective single-sample correlational design without controls. Up to 72 subjects will be enrolled in order to have approximately 60 subjects complete the study. Three investigational centers in China will be used during this study.
Each subject will wear the following devices:
• Two Enlite Sensors each connected to an iPro2 for approximately 6 days
Sensor Location:
• The 2 Enlite Sensors will be worn in the abdomen area. Investigational center staff will insert sensors and connect to the iPro2s.
During the study, each subject will be randomized and undergo one Yellow Springs Instrument (YSI™) frequent sample testing (FST) (Day 1, 3-4, or 6).
During the study, subjects will continue with their current diabetes regimen independent of the study devices. Subjects will be instructed by the investigational center that they are not to use the study devices (except for the study meter) for the management of their diabetes. The Study Meter may be used for treatment decisions and calibration of Enlite Sensor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study arm | Experimental | Use Enlite Sensor over 144 hours (6 days) when inserted in the abdomen and used with the iPro2 and undergo one Yellow Springs Instrument (YSI™) frequent sample testing (FST) (Day 1, 3-4, or 6). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enlite 1 connected to iPro2 recorder | Device | Use Enlite Sensor over 144 hours (6 days) when inserted in the abdomen and used with the iPro2 in subjects age 14 - 75 years. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percentage of Enlite Sensor Values That Are Within 20% Agreement of Gold Standard (Yellow Springs Instrument (YSI) YSI Plasma Glucose Values) | Primary endpoint is the mean percentage of Enlite Sensor Values from primary sensor that are within 20% agreement of YSI plasma glucose values (within 20 mg/dL if YSI <= 80 mg/dL) during YSI frequent sampling testing (FST) days. | YSI FST days (Day 1, 3-4, or 6 of sensor wear) |
| Measure | Description | Time Frame |
|---|---|---|
| Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD) | Enlite sensor values from primary sensor were compared to YSI plasma glucose values during YSI FST days (Day 1, 3-4, or 6). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Therefore, the unit of MARD is percentage (%). | YSI FST days (Day 1, 3-4, or 6 of sensor wear) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jian Zhou, MD | Shanghai 6th People's Hospital | Principal Investigator |
| Xiaofeng Lv, MD | PLA Army General Hospital | Principal Investigator |
| Hong Li, MD | Sir Run Run Shaw Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PLA Army General Hospital | Beijing | 100700 | China | |||
| Sir Run Run Shaw Hospital School of Medicine Zhejiang University |
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A total of 72 subjects signed the informed consent form and completed the screening. Five subjects failed the screening. One subject withdrew before wearing the sensor.
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Arm | Use Enlite Sensor over 144 hours (6 days) when inserted in the abdomen and used with the iPro2 and undergo one Yellow Springs Instrument (YSI™) frequent sample testing (FST) (Day 1, 3-4, or 6) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Arm | Use Enlite Sensor over 144 hours (6 days) when inserted in the abdomen and used with the iPro2 and undergo one Yellow Springs Instrument (YSI™) frequent sample testing (FST) (Day 1, 3-4, or 6) |
| 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 | Mean Percentage of Enlite Sensor Values That Are Within 20% Agreement of Gold Standard (Yellow Springs Instrument (YSI) YSI Plasma Glucose Values) | Primary endpoint is the mean percentage of Enlite Sensor Values from primary sensor that are within 20% agreement of YSI plasma glucose values (within 20 mg/dL if YSI <= 80 mg/dL) during YSI frequent sampling testing (FST) days. | Subjects who have Enlite sensor inserted and have at least one paired Enlite sensor and YSI measurement. 66 subjects have Enlite sensor inserted, of which one subject has no paired Enlite sensor and YSI measurement. | Posted | Mean | Standard Deviation | percentage of paired readings | YSI FST days (Day 1, 3-4, or 6 of sensor wear) |
|
6 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 | Study Arm | Use Enlite Sensor over 144 hours (6 days) when inserted in the abdomen and used with the iPro2 and undergo one Yellow Springs Instrument (YSI™) frequent sample testing (FST) (Day 1, 3-4, or 6) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Fen Peng, Biostatistician | Medtronic Minimed | 8185763253 | fen.peng@medtronic.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 14, 2018 | Jun 7, 2019 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Sep 18, 2017 | Jun 7, 2019 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Clarke Error Grid Analysis of Paired Sensor and YSI Plasma Glucose Values | Clarke Error Grid compared the paired primary sensor and YSI reference glucose values. Zone A represents a region where sensor values that are within 20% of YSI reference values, or both sensor and YSI reference values are less than 70 mg/dL. Values in Zone A are "clinically accurate in that they would lead to clinically correct treatment decisions". Zone B represents sensor values that deviate YSI reference values by more than 20%, but "would lead to benign or no treatment". Ideal situation is 100% in Zone A + B. | YSI FST days (Day 1, 3-4, or 6 of sensor wear) |
| Consensus Error Grid Analysis of Paired Sensor and YSI Plasma Glucose Values | Consensus Error Grid (or Parkes error grid) compared the paired primary sensor and YSI reference glucose values. Zone A is defined in the Parkes error grid as the zone of "clinical accurate measurements with no effect on clinical action", Zone B as "altered clinical action with little or no effect on clinical outcome". Ideal situation is 100% in Zone A + B. | YSI FST days (Day 1, 3-4, or 6 of sensor wear) |
| Hangzhou |
| 310016 |
| China |
| Shanghai Sixth People's Hospital | Shanghai | 200233 | China |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD) | Enlite sensor values from primary sensor were compared to YSI plasma glucose values during YSI FST days (Day 1, 3-4, or 6). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) * 100). Therefore, the unit of MARD is percentage (%). | Subjects who have Enlite sensor inserted and have at least one paired Enlite sensor and YSI measurement. 66 subjects have Enlite sensor inserted, of which one subject has no paired Enlite sensor and YSI measurement. | Posted | Mean | Standard Deviation | percentage of difference | YSI FST days (Day 1, 3-4, or 6 of sensor wear) |
|
|
|
| Secondary | Clarke Error Grid Analysis of Paired Sensor and YSI Plasma Glucose Values | Clarke Error Grid compared the paired primary sensor and YSI reference glucose values. Zone A represents a region where sensor values that are within 20% of YSI reference values, or both sensor and YSI reference values are less than 70 mg/dL. Values in Zone A are "clinically accurate in that they would lead to clinically correct treatment decisions". Zone B represents sensor values that deviate YSI reference values by more than 20%, but "would lead to benign or no treatment". Ideal situation is 100% in Zone A + B. | Subjects who have Enlite sensor inserted and have at least one paired Enlite sensor and YSI measurement. 66 subjects have Enlite sensor inserted, of which one subject has no paired Enlite sensor and YSI measurement. | Posted | Mean | 95% Confidence Interval | percentage of paired readings | YSI FST days (Day 1, 3-4, or 6 of sensor wear) |
|
|
|
| Secondary | Consensus Error Grid Analysis of Paired Sensor and YSI Plasma Glucose Values | Consensus Error Grid (or Parkes error grid) compared the paired primary sensor and YSI reference glucose values. Zone A is defined in the Parkes error grid as the zone of "clinical accurate measurements with no effect on clinical action", Zone B as "altered clinical action with little or no effect on clinical outcome". Ideal situation is 100% in Zone A + B. | Subjects who have Enlite sensor inserted and have at least one paired Enlite sensor and YSI measurement. 66 subjects have Enlite sensor inserted, of which one subject has no paired Enlite sensor and YSI measurement. | Posted | Mean | 95% Confidence Interval | percentage of paired readings | YSI FST days (Day 1, 3-4, or 6 of sensor wear) |
|
|
|
| 0 |
| 66 |
| 0 |
| 66 |
| 5 |
| 66 |
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Haemorrhage | Vascular disorders | Non-systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
Investigators are required to submit any proposed publications to the study sponsor for review and approval at least 60 days prior to submitting the materials for external publication.