Clinical trial NCT03417466: A Pivotal Study to Evaluate Enlite™ Sensor Performance With iPro™2 in China
Official title: A Pivotal Study to Evaluate Enlite™ Sensor Performance With iPro™2 in China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Diabetes Type I Type II
Lead sponsor: Medtronic Diabetes
Sponsor class: INDUSTRY
First posted: 2018-01-31
Enrollment: 72
Sex: ALL
Minimum age (years): 14
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Subject is 14 - 75 years of age at time of screening
2. Subject has a clinical diagnosis of type 1 or 2 diabetes as determined via medical record or source documentation by an individual qualified to make a medical diagnosis
3. Subject has adequate venous access as assessed by investigator or appropriate staff
4. Subject is willing to follow the study procedures and willing to come to study visits.
5. Subject is willing to perform at least 4 self-monitoring of blood glucose (SMBG) per day for 6 days

Exclusion Criteria:

1. Subject will not tolerate tape adhesive in the area of Enlite Sensor placement as assessed by qualified individual.
2. Subject has any unresolved adverse skin condition in the area of study device or device placement (e.g., psoriasis, rash, Staphylococcus infection)
3. Subject is actively participating in an investigational study (drug or device) wherein they have received treatment from an investigational study (drug or device) in the last 2 weeks
4. Subject is female and has a positive pregnancy screening test
5. Females of child bearing age and who are sexually active should be excluded if they are not using a form of contraception deemed reliable by investigator
6. Subject is female and plans to become pregnant during the course of the study
7. Subject has a hematocrit (Hct) lower than the normal reference range
8. Subject may not be on the research staff of those performing this study

Primary outcomes:
measure: Mean Percentage of Enlite Sensor Values That Are Within 20% Agreement of Gold Standard (Yellow Springs Instrument (YSI) YSI Plasma Glucose Values)
timeFrame: YSI FST days (Day 1, 3-4, or 6 of sensor wear)
Secondary outcomes:
measure: Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD)
timeFrame: YSI FST days (Day 1, 3-4, or 6 of sensor wear)
measure: Clarke Error Grid Analysis of Paired Sensor and YSI Plasma Glucose Values
timeFrame: YSI FST days (Day 1, 3-4, or 6 of sensor wear)
measure: Consensus Error Grid Analysis of Paired Sensor and YSI Plasma Glucose Values
timeFrame: YSI FST days (Day 1, 3-4, or 6 of sensor wear)
Other outcomes:
Locations:
city: Beijing
country: China
facility: PLA Army General Hospital
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital School of Medicine Zhejiang University
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
Study officials:
affiliation: Shanghai 6th People's Hospital
name: Jian Zhou, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: PLA Army General Hospital
name: Xiaofeng Lv, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sir Run Run Shaw Hospital
name: Hong Li, MD
role: PRINCIPAL_INVESTIGATOR
References: