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New Generation Enlite Accuracy Study

NCT02423798 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-01-17

Study results available
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Summary

The trial will investigate the accuracy and performance of a new sensor for continuous glucose monitoring (CGM), the (new generation) Enlite, CE-marked in 2013, in conjunction with the new Medtronic 640G system components.

To evaluate the accuracy and performance of the new generation Enlite sensor. This is a postmarket, interventional, open-label, non-randomized, single center clinical research trial.

The trial will adopt a prospective single-sample design using the Yellow Spring Instruments (YSI) plasma glucose reference sampling procedure in the clinic and self-monitoring of blood glucose (SMBG) plasma glucose reference sampling procedure at home.

Conditions

Interventions

DEVICE

Glucose sensor (Enlite)

This is a postmarket, interventional, open-label, non-randomized, single center clinical research trial. The trial will adopt a prospective single-sample design using the Yellow Spring Instruments (YSI) plasma glucose reference sampling procedure in the clinic and selfmonitoring of blood glucose (SMBG) plasma glucose reference sampling procedure at home. The trial will consist of 6 visits to the investigational site: a visit for informed consent procedures (Visit 0), a screening visit (Visit 1), 3 study visits (Visit 2-4) and a final examination (Visit 5).

Sponsors & Collaborators

  • Profil Institut für Stoffwechselforschung GmbH

    collaborator INDUSTRY

  • Medtronic Diabetes

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2015-09-30
Completion
2015-09-30

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02423798 on ClinicalTrials.gov