A Pivotal Study to Evaluate Enlite™ Sensor Performance With iPro™2 in China

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Device: Enlite 1 connected to iPro2 recorder

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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100700
    • PLA Army General Hospital
  • Hangzhou, China, 310016
    • Sir Run Run Shaw Hospital School of Medicine Zhejiang University
  • Shanghai, China, 200233
    • Shanghai Sixth People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Device: Enlite 1 connected to iPro2 recorder; Use Enlite Sensor over 144 hours (6 days) when inserted in the abdomen and used with the iPro2 in subjects age 14 - 75 years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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)
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)

Collaborators and Investigators

• Sponsor: Medtronic Diabetes
• Investigators: Principal Investigator: Jian Zhou, MD, Shanghai 6th People's Hospital; Principal Investigator: Hong Li, MD, Sir Run Run Shaw Hospital; Principal Investigator: Xiaofeng Lv, MD, PLA Army General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2018
• Primary Completion (Actual): September 20, 2018
• Study Completion (Actual): September 20, 2018

Study Registration Dates

• First Submitted: January 25, 2018
• First Submitted That Met QC Criteria: January 30, 2018
• First Posted (Actual): January 31, 2018

Study Record Updates

• Last Update Posted (Actual): August 20, 2019
• Last Update Submitted That Met QC Criteria: July 30, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Diabetes Type I Type II
• Other Study ID Numbers: CIP313

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes