Impact of Fiasp® on Glycaemic Control in a Real World Population With Type 1 Diabetes Mellitus Using Flash Glucose Monitoring
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 320
- Locations
- 1
- Primary Endpoint
- Change in Glycated Haemoglobin (HbA1c)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Fast-acting insulin aspart (Drug)
Outcomes
Primary Outcomes
Change in Glycated Haemoglobin (HbA1c)
Time Frame: Baseline (week 0), end of study (week 24 ± 4 weeks after baseline)
Measure in % point
Secondary Outcomes
- 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(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)(Baseline (week 0), end of study (week 24 ± 4 weeks))
- Change in fasting plasma glucose (FPG)(Baseline (week 0), end of study (week 24 ±4 weeks))