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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03249974
Other study ID # JessaH_B243201732756
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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:

Study Design


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
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