Clinical trial NCT03450863: 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
Official title: Impact of Fiasp® on Glycaemic Control in a Real World Population With Type 1 Diabetes Mellitus Using Flash Glucose Monitoring
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1 Diabetes
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2018-03-01
Enrollment: 320
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with type 1 diabetes mellitus

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 previous insulin treatment. The study will also assess how satisfied the participants are with the treatment with Fiasp® and the impact of the treatment on quality of life. The study has also been set up to learn more about how effective Fiasp® is in controlling the glucose levels during the day and night. The duration of the study is expected to be approximately 2 years. The participation is expected to be approximately 6-8 months for each patient.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Change in Glycated Haemoglobin (HbA1c)
timeFrame: Baseline (week 0), end of study (week 24 ± 4 weeks after baseline)
Secondary outcomes:
measure: 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
timeFrame: Baseline (week 0), end of study (week 24 ± 4 weeks)
measure: Change in Patient Reported Outcomes: Treatment satisfaction measured by the overall score obtained from the Diabetes Treatment Satisfaction Questionnaire (DTSQ)
timeFrame: Baseline (week 0), end of study (week 24 ± 4 weeks)
measure: Change in fasting plasma glucose (FPG)
timeFrame: Baseline (week 0), week 12 (±4 weeks)
measure: Change in fasting plasma glucose (FPG)
timeFrame: Baseline (week 0), end of study (week 24 ±4 weeks)
Other outcomes:
Locations:
city: Schweinfurt
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosure (1452)
role: STUDY_DIRECTOR
References:
citation: Danne T, Axel Schweitzer M, Keuthage W, Kipper S, Kretzschmar Y, Simon J, Wiedenmann T, Ziegler R. Impact of Fast-Acting Insulin Aspart on Glycemic Control in Patients with Type 1 Diabetes Using Intermittent-Scanning Continuous Glucose Monitoring Within a Real-World Setting: The GoBolus Study. Diabetes Technol Ther. 2021 Mar;23(3):203-212. doi: 10.1089/dia.2020.0360. Epub 2020 Oct 21.