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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UNKNOWN
NA
60 participants
INTERVENTIONAL
2021-07-01
2021-10-31
Brief Summary
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Detailed Description
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The telemedicine system contains a mobile phone-based nutrition diary, bluetooth-related wrist activity meter, weight scale, blood pressure monitor, blood glucose meter, and IT system for transmitting and displaying data from these devices.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Active group
This group gets the telemedicine system, with the devices, and gets life-style guide by telephone consultation/ visits, during 3 months
Telemedicine system users
Telemonitoring by medical devices connected to a software system with a router.
Comparator group
This group gets the normal, evidence based therapy, without extra visits.
No interventions assigned to this group
Interventions
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Telemedicine system users
Telemonitoring by medical devices connected to a software system with a router.
Eligibility Criteria
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Inclusion Criteria
* Patient with Diabetes who needs intensified insulin therapy HbA1c\> = 8%
* IT proficiency is at least basic for cell phones (answering / making a voice call).
* Signing a informed consent
* For women with childbearing potential, by definition, all women who who are physiologically able to conceive are twofold use of contraception
* The subject communicates well with the investigator and is able to perform the test to understand and help comply with the requirements of the protocol
Exclusion Criteria
* Planned invasive cardiac intervention (catheter vasodilation or surgical coronary artery bypass grafting, keyboard surgery or replacement)
* Tumor disease
* Pregnant or lactating women
* Any medical condition that does not allow participation
18 Years
75 Years
ALL
No
Sponsors
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Szeged University
OTHER
Responsible Party
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Locations
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University of Szeged
Szeged, , Hungary
Countries
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Central Contacts
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Facility Contacts
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István Kósa, MD Ph.D.
Role: primary
Other Identifiers
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TMED_INZULIN_001
Identifier Type: -
Identifier Source: org_study_id