Status:
COMPLETED
Remote Study Collecting Blood Glucose Values and Activity Data in Patients With Type 2 Diabetes on Different Treatments
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Brief Summary
Earlier protocol ID was NN1250-4630, protocol ID is changed to NN1535-7774. The purpose of this study is to collect blood glucose values and activity data in patients with type 2 diabetes for approxim...
Eligibility Criteria
Inclusion
- Willingness to consent via the e-consent process before any study-related activities takes place (study-related activities are any procedure related to recording of data according to the protocol)
- Male or female, age above or equal to 18 years at the time of signing informed consent
- Diagnosed T2DM for more than 3 months prior to signing the informed consent
- On one of the following treatments for T2DM:
- Metformin ± other OADs
- Basal insulin ± OADs
- GLP-1 ± Basal insulin (loose and fixed combination) ± OADs
- Willingness to, and capable of applying and using the study devices
- Willingness to follow study procedures
- Fluent in Danish both oral, reading and in writing
- In possession of a compatible smartphone throughout the study, meaning that the smartphone fulfils the criteria to the operating system for using the devices needed for the study
Exclusion
- Previous participation in this study. Participation is defined as having given informed consent in this study
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- Participation in any other study investigating diabetes.
- Patients who do not have a blood glucose meter at home
Key Trial Info
Start Date :
April 30 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 7 2025
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT04809311
Start Date
April 30 2024
End Date
January 7 2025
Last Update
March 21 2025
Active Locations (1)
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1
Digital/virtual site
Copenhegan, Denmark