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 (GoBolus)
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|ClinicalTrials.gov Identifier: NCT03450863|
Recruitment Status : Completed
First Posted : March 1, 2018
Last Update Posted : October 17, 2019
|Condition or disease||Intervention/treatment|
|Diabetes Diabetes Mellitus, Type 1 Diabetes||Drug: Fast-acting insulin aspart|
|Study Type :||Observational|
|Actual Enrollment :||323 participants|
|Official Title:||Impact of Fiasp® on Glycaemic Control in a Real World Population With Type 1 Diabetes Mellitus Using Flash Glucose Monitoring|
|Actual Study Start Date :||March 22, 2018|
|Actual Primary Completion Date :||September 4, 2019|
|Actual Study Completion Date :||September 4, 2019|
Fast-acting insulin aspart
Participants will receive fast-acting insulin aspart at the treating physician's discretion as part of the usual clinical practice. The prescription and use of fast-acting insulin aspart is completely independent of this study. Total study duration for the individual patient will be approximately 24 weeks.
Drug: Fast-acting insulin aspart
Patients will be treated with commercially available fast-acting insulin aspart as bolus insulin (multiple daily injection [MDI]) or as insulin used in the insulin pumps (continuous subcutaneous insulin infusion [CSII]). Dosing of fast-acting insulin aspart is individual and determined by the treating physician in accordance with the needs of the patient.
Other Name: Fiasp®
- Change in Glycated Haemoglobin (HbA1c) [ Time Frame: Baseline (week 0), end of study (week 24 ± 4 weeks after baseline) ]Measure in % point
- 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 [ Time Frame: Baseline (week 0), end of study (week 24 ± 4 weeks) ]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.
- Change in Patient Reported Outcomes: Treatment satisfaction measured by the overall score obtained from the Diabetes Treatment Satisfaction Questionnaire (DTSQ) [ Time Frame: Baseline (week 0), end of study (week 24 ± 4 weeks) ]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.
- Change in fasting plasma glucose (FPG) [ Time Frame: Baseline (week 0), week 12 (±4 weeks) ]Measured in mmol/L
- Change in fasting plasma glucose (FPG) [ Time Frame: Baseline (week 0), end of study (week 24 ±4 weeks) ]Measured in mmol/L
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03450863
|Novo Nordisk Investigational Site|
|Schweinfurt, Germany, 97421|
|Study Director:||Clinical Reporting Anchor and Disclosure (1452)||Novo Nordisk A/S|