Clinical Investigation to Assess the Feasibility of a New Diabetes Management Program
NCT ID: NCT05793645
Last Updated: 2023-07-20
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
2023-05-15
2024-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Personalized care plan
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personalized care plan
Algorithm that defines personalized care plan
Interventions
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personalized care plan
Algorithm that defines personalized care plan
Eligibility Criteria
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Inclusion Criteria
* T1D diagnosis minimum 8 months prior to the Screening/Initiation visit (Visit 0).
* Equipped with Continuous Glucose Monitoring (CGM) System, intermittent or real-time, either alone or associated with an insulin pump system
* Subject and health care provider must use a Remote diabetes management platform for the upload and follow-up of CGM, pump data or HCL data (e.g.: Glooko, Diasend).
* Parent or guardian able and willing to give informed consent for the subject's participation in the investigation.
Exclusion Criteria
* Use of Medtronic insulin pump.
* Any disease or other medical condition, prior or concomitant medication /treatment
/intervention, that may affect this clinical investigation or in other ways make the subject unsuitable for participation in this investigation, according to the judgement of the Principal Investigator (PI), or authorized designee.
* Participation in any clinical investigation or study within the previous 30 days, that may affect the safety or performance of this investigation.
* Mental incapacity precluding understanding or cooperation.
* Subject not able to read and communicate in Swedish without an interpreter.
12 Years
15 Years
ALL
No
Sponsors
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Key2Compliance
INDUSTRY
NordicInfu Care AB
INDUSTRY
Air Liquide Santé International
INDUSTRY
Responsible Party
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Locations
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Helsingborg Lasarett
Helsingborg, , Sweden
Sachsska, barn- och ungdomssjukhuset
Stockholm, , Sweden
Norrlands universitetssjukhus
Umeå, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Charlotta NILSSON
Role: primary
Bjorn Rathsman
Role: primary
Elena Lundberg
Role: primary
Other Identifiers
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ALMED-22-002
Identifier Type: -
Identifier Source: org_study_id
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