First Clinical Evaluation of a Novel Glucose Non-invasive Sensor Technology in Patients With Type 1 Diabetes
NCT ID: NCT05771090
Last Updated: 2023-06-29
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
NA
10 participants
INTERVENTIONAL
2023-04-01
2023-06-16
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
DEVICE_FEASIBILITY
NONE
Study Groups
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Study arm
Participants in the study arm will undergo the study procedure which are different induced glycaemic states.
Sokru device
Different induced glycaemic states in people living with diabetes (PwD).
Interventions
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Sokru device
Different induced glycaemic states in people living with diabetes (PwD).
Eligibility Criteria
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Inclusion Criteria
* T1D with MDI or CSII therapy \>1 year
* Age 18 - 50 (inclusive)
* Caucasian ethnicity
* BMI between 18.5 and 24.9 kg/m2 (inclusive)
* Usage of a continuous glucose monitoring (CGM)
Exclusion Criteria
* History of cardiovascular diseases
* Diabetes-related comorbidities
* HbA1c \>9 %
* Epilepsy
* Known sensitivity to medical grade adhesives or other skin-related complications, which might influence the outcome
* Known sensitivity to Latex
* Participation in another investigation with an investigational drug within the 30 days preceding and during the present investigation
18 Years
50 Years
ALL
No
Sponsors
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Insel Gruppe AG, University Hospital Bern
OTHER
DCB Research AG
OTHER
Responsible Party
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Principal Investigators
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Derek Brandt
Role: STUDY_CHAIR
DCB Research AG
Locations
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Universitätsklinik für Diabetologie, Endokrinologie, Ernährungsmedizin & Metabolismus (UDEM) Inselspital, Universitätsspital
Bern, , Switzerland
Countries
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Other Identifiers
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VAARA study
Identifier Type: -
Identifier Source: org_study_id
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