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
Verified date | July 2017 |
Source | Jessa Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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: |
Country | Name | City | State |
---|---|---|---|
Belgium | Jessa Hospital | Hasselt |
Lead Sponsor | Collaborator |
---|---|
Jessa Hospital |
Belgium,
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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