Status:
COMPLETED
Study on How Fiasp® Can Influence Blood Sugar Levels of type1 Diabetic Patients in Their Daily Lives, With the Help of the Freestyle Libre® Device
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 1 Diabetes
Eligibility:
All Genders
Brief Summary
The purpose of this study is to collect information about Fiasp® to evaluate how effective Fiasp® is in treating elevated blood sugar in patients with type 1 diabetes, compared with the participant's ...
Eligibility Criteria
Inclusion
- Signed consent obtained before any study-related activities (study-related activities are any procedures related to recording of data according to protocol)
- The decision to initiate treatment with commercially available Fiasp® has been made by the patient and the treating physician before and independently from the decision to include the patient in this study
- Male or female, age greater than or equal to 18 years at the time of signing informed consent
- Diagnosed with T1DM at least 1 year prior to inclusion in the study
- Stable treatment by MDI/CSII for at least 6 months prior to inclusion in the study. Stable treatment is defined as not changing the treatment method, with dose adjustments allowed
- Regular (defined as usage on a monthly basis) user of Freestyle Libre® flash glucose monitoring for at least 6 months as the only continuous glucose monitoring (CGM) system actively used and availability of a full 2 weeks sensor download as "csv" file with 80% completeness of the data (if more sensor data are available, the 2 week data closest to baseline visit will be used)
- Latest HbA1c value measured in the 3 months prior to inclusion in the study between 7.5-9.5%
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
- Anti-diabetic treatment intensification during the last 3 months prior to inclusion in the study. Treatment intensification is defined as adding new anti-diabetic medication to previous treatment regimen
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods. Only highly effective methods of birth control are accepted (i.e. one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, certain intrauterine devices), or sexual abstinence or a vasectomised partner
Key Trial Info
Start Date :
March 22 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 4 2019
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT03450863
Start Date
March 22 2018
End Date
September 4 2019
Last Update
March 18 2020
Active Locations (1)
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1
Novo Nordisk Investigational Site
Schweinfurt, Germany, 97421