NCT02423798

New Generation Enlite Accuracy Study

Accuracy and Performance Evaluation of the Medtronic New Generation Enlite Glucose Sensor in Conjunction With the Medtronic 640G System Components - in Clinic and at Home

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Medtronic MiniMed, Inc. · Industry
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The trial will investigate the accuracy and performance (i.e. the life-time) of a new sensor for CGM, the (new generation) Enlite glucose sensor, CE-marked in 2013, in conjunction with the new Medtronic 640G system components. Accuracy and life-time of the sensor are important parameters contributing to the safety of patients and patient acceptance of this still fairly new technology. The current trial investigates the accuracy of the new sensor in conjunction with the new 640G system components both in the clinic and at home. This enables us to assess the sensor accuracy in a well-controlled environment using a highly accurate laboratory glucose analyzer as reference as well as sensor accuracy during real-life conditions using a blood glucose meter as reference analyzer. The data gathered in this trial will help to understand the effect of technological advancements made and can guide future development of glucose sensor for continuous glucose monitoring.

Conditions

• Diabetes

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2015-04-22
• Last updated: 2018-01-17
• Results posted: 2017-09-25