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Comparison Between Enlite and Flash Glucose Monitoring

J

Jessa Hospital

Status

Completed

Conditions

Type1 Diabetes Mellitus

Treatments

Device: Enlite sensor communicating with Minimed 640G pump

Study type

Observational

Funder types

Other

Identifiers

NCT03249974
JessaH_B243201732756

Details and patient eligibility

About

  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.

Enrollment

20 patients

Sex

All

Ages

5 to 18 years old

Volunteers

No 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

Trial design

20 participants in 1 patient group

Target group
Description:
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
Treatment:
Device: Enlite sensor communicating with Minimed 640G pump

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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