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

NCT03417466 | Completed Results FDA Device

• 1 other identifier: CIP313
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 3

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.

Conditions

Diabetes Mellitus

Keywords

Diabetes Type I Type II

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Enlite Sensor Accuracy Mean Absolute Relative Difference (MARD)

  YSI FST days (Day 1, 3-4, or 6 of sensor wear)

• Clarke Error Grid Analysis of Paired Sensor and YSI Plasma Glucose Values

  YSI FST days (Day 1, 3-4, or 6 of sensor wear)

• Consensus Error Grid Analysis of Paired Sensor and YSI Plasma Glucose Values

  YSI FST days (Day 1, 3-4, or 6 of sensor wear)

Study Arms (1)

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).

Device: Enlite 1 connected to iPro2 recorder

Interventions

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.

Study arm

Eligibility Criteria

• Age: 14 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Diabetes: lead

Study Sites (3)

PLA Army General Hospital

Beijing, 100700, China

Location

Sir Run Run Shaw Hospital School of Medicine Zhejiang University

Hangzhou, 310016, China

Location

Shanghai Sixth People's Hospital

Shanghai, 200233, China

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Fen Peng, Biostatistician
• Organization: Medtronic Minimed

fen.peng@medtronic.com

8185763253

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2018
• First Posted: January 31, 2018
• Study Start: June 28, 2018
• Primary Completion: September 20, 2018
• Study Completion: September 20, 2018
• Last Updated: August 20, 2019
• Results First Posted: August 20, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)