| Trial ID: | L4338 |
| Source ID: | NCT03450863
|
| Associated Drug: |
Fast-Acting Insulin Aspart
|
| Title: |
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
|
| Acronym: |
GoBolus
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes|Diabetes Mellitus, Type 1 Diabetes
|
| Interventions: |
DRUG: Fast-acting insulin aspart
|
| Outcome Measures: |
Primary: Change in Glycated Haemoglobin (HbA1c), Measure in % point, Baseline (week 0), end of study (week 24 ± 4 weeks after baseline) | Secondary: Change in Patient Reported Outcome: Impact of treatment measured by the overall score obtained from the Treatment Related Impact Measure For Diabetes (TRIM-D) questionnaire, The TRIM-D Device is an eight item measure with two domains assessing Device Bother and Device Function. This captures information on the ease of use, convenience, and handling of the device(s) used to take diabetes medication. The measure has acceptable reliability, validity and ability to detect change., Baseline (week 0), end of study (week 24 ± 4 weeks)|Change in Patient Reported Outcomes: Treatment satisfaction measured by the overall score obtained from the Diabetes Treatment Satisfaction Questionnaire (DTSQ), The DTSQs questionnaire will be used to assess subject's treatment satisfaction. This instrument contains 8 items and measures the treatment for your diabetes (including insulin, tablets and/or diet) in terms of convenience, flexibility and general feelings regarding treatment., Baseline (week 0), end of study (week 24 ± 4 weeks)|Change in fasting plasma glucose (FPG), Measured in mmol/L, Baseline (week 0), week 12 (±4 weeks)|Change in fasting plasma glucose (FPG), Measured in mmol/L, Baseline (week 0), end of study (week 24 ±4 weeks)
|
| Sponsor/Collaborators: |
Sponsor: Novo Nordisk A/S
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
320
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2018-03-22
|
| Completion Date: |
2019-09-04
|
| Results First Posted: |
|
| Last Update Posted: |
2020-03-18
|
| Locations: |
Novo Nordisk Investigational Site, Schweinfurt, 97421, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT03450863
|
