Comparison Between Enlite and Flash Glucose Monitoring

Type1 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03249974
• Other study ID #: JessaH_B243201732756
• Status: Completed
• Start date: July 5, 2017
• Est. completion date: July 4, 2018

Study information

• Verified date: July 2017
• Source: Jessa Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 4, 2018
• Est. primary completion date: July 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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:

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type1 Diabetes Mellitus

Intervention

Device:
• 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

Locations

Country	Name	City	State
Belgium	Jessa Hospital	Hasselt

Sponsors (1)

Lead Sponsor	Collaborator
Jessa Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

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