Comparison Between Enlite and Flash Glucose Monitoring

Completed

• Conditions: Type1 Diabetes Mellitus
• Interventions: Device: Enlite sensor communicating with Minimed 640G pump

• Registration Number: NCT03249974
• Lead Sponsor: Jessa Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-07
• Study Start: 2017-07-05
• Study First Submitted: 2017-07-10
• Study First Submitted QC: 2017-08-14
• Study First Posted: 2017-08-15
• Primary Completion: 2018-07-04
• Study Completion: 2018-07-04
• Last Update Submitted: 2018-07-10
• Last Update Posted: 2018-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Target group	Enlite 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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Jessa Hospital; 🇧🇪 Hasselt, Belgium