Comparison Between Enlite and Flash Glucose Monitoring

A Comparative Study on the Accuracy, Ease of Use and Skin Reactions Between the Enlite Sensor With Guardian 2 Link Transmitter and the FreeStyle Libre Flash Glucose Sensor

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03249974

Enrollment

Registered

2017-08-15

Start date

2017-07-05

Completion date

2018-07-04

Last updated

2018-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type1 Diabetes Mellitus

Keywords

Enlite glucose monitoring, accuracy, usability, skin reactions, type 1 diabetes mellitus

Brief summary

1. The accuracy of the sensors (Flash vs Enlite glucose monitoring) will be evaluated with a standardized breakfast test. Patients receive a standardized breakfast. The usual insulin bolus will be administered at breakfast. After breakfast, a venous blood sample is taken for 2 hours every 15 minutes to determine the blood sugar. At the same time, the glucose value shown by the sensors will be noted. A comparison of the blood glucose value with the data recorded by the sensor can evaluate the accuracy of the sensor and also estimate the lag-time between the sensor glucose and the venous glucose. 2. Patient satisfaction will be evaluated using a questionnaire that will be completed after the Enlite sensor has been worn for 1 month. 3. The development of skin reactions will be checked by a short questionnaire, supplemented with a picture of possible skin phenomena. 4. The data recorded by the FreeStyle sensor (average glucose,% above target,% within target,% under target, amount of hypoglycemia) in the month prior to sensor switching will be compared to the same data recorded by the Enlite sensor during the first month of use.

Interventions

DEVICEEnlite sensor communicating with Minimed 640G pump

Children (5 to 18 years) with type 1 diabetes mellitus treated with an insulin pump and wearing a FreeStyle Flash Libre glucosesensor will switch to the Enlite sensor communicating with Minimed 640G pump

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

5 Years to 18 Years

Healthy volunteers

Inclusion criteria

* Children (5 to 18 years) * Diagnosis of type 1 diabetes mellitus * Treatment is an insulin pump and wearing a FreeStyle Flash Libre glucosesensor

Exclusion criteria

Design outcomes

Primary

Measure	Time frame	Description
Accuracy of Enlite sensor	2 hours	The accuracy of the sensors (flash vs enlite glucose monitoring) will be evaluated with a standardized breakfast test. Patients receive a standardized breakfast. The usual insulin bolus will be administered at breakfast. After breakfast, a venous blood sample is taken for 2 hours every 15 minutes to determine the blood sugar. At the same time, the glucose value shown by the sensors will be noted. A comparison of the blood glucose value with the data recorded by the sensor can evaluate the accuracy of the sensor and also estimate the lag-time between the sensor glucose and the venous glucose.

Secondary

Measure	Time frame	Description
Usability of Enlite sensor	1 month	Patient satisfaction will be evaluated using a questionnaire that will be completed after the Enlite sensor has been worn for 1 month.
skin reactions wih Enlite sensor	1 month	The development of skin reactions will be checked by a short questionnaire, supplemented with a picture of possible skin phenomena.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026