Status:
COMPLETED
A Pivotal Study to Evaluate Enlite™ Sensor Performance With iPro™2 in China
Lead Sponsor:
Medtronic Diabetes
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
14-75 years
Phase:
NA
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 st...
Eligibility Criteria
Inclusion
- Subject is 14 - 75 years of age at time of screening
- 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
- Subject has adequate venous access as assessed by investigator or appropriate staff
- Subject is willing to follow the study procedures and willing to come to study visits.
- Subject is willing to perform at least 4 self-monitoring of blood glucose (SMBG) per day for 6 days
Exclusion
- Subject will not tolerate tape adhesive in the area of Enlite Sensor placement as assessed by qualified individual.
- Subject has any unresolved adverse skin condition in the area of study device or device placement (e.g., psoriasis, rash, Staphylococcus infection)
- 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
- Subject is female and has a positive pregnancy screening test
- 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
- Subject is female and plans to become pregnant during the course of the study
- Subject has a hematocrit (Hct) lower than the normal reference range
- Subject may not be on the research staff of those performing this study
Key Trial Info
Start Date :
June 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 20 2018
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT03417466
Start Date
June 28 2018
End Date
September 20 2018
Last Update
August 20 2019
Active Locations (3)
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1
PLA Army General Hospital
Beijing, China, 100700
2
Sir Run Run Shaw Hospital School of Medicine Zhejiang University
Hangzhou, China, 310016
3
Shanghai Sixth People's Hospital
Shanghai, China, 200233