Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
20 participants
OBSERVATIONAL
2017-07-05
2018-07-04
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Target group
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
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of type 1 diabetes mellitus
* Treatment is an insulin pump and wearing a FreeStyle Flash Libre glucosesensor
Exclusion Criteria
5 Years
18 Years
ALL
No
Sponsors
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Jessa Hospital
OTHER
Responsible Party
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Principal Investigators
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Guy Massa, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Jessa Hospital, hasselt, Belgium
Locations
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Jessa Hospital
Hasselt, , Belgium
Countries
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Other Identifiers
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JessaH_B243201732756
Identifier Type: -
Identifier Source: org_study_id
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