Clinical trial NCT03895515: Effect of Fiasp® in Type 1 Diabetes Treatment
Official title: The Effect of Fiasp® (Fast-acting Insulin Aspart) in Type 1 Diabetes Patients Using Continuous Glucose Monitoring / Flash Glucose Monitoring in Real-world Clinical Practice in Sweden. A Non-interventional, Retrospective Chart and Database Review Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2019-03-29
Enrollment: 178
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with type 1 diabetes

Brief summary: Fiasp® is a meal-time insulin that has been available in Sweden since June 2017. This study will investigate the effectiveness of Fiasp® in treating Type 1 Diabetes Mellitus. The study will be based on blood sugar measurements that the participants have uploaded to the Diasend® database and on existing data in their electronic medical records. The study does not require any additional visits to the study doctor.


Eligibility criteria: Inclusion criteria:

* Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study (beyond identification of potential participants by searching for patients with type 1 Diabetes diagnosis, Fiasp® prescription information and electronic medical record (EMR) data to identify continuous glucose monitoring (CGM)/flash glucose monitoring (FGM) use
* Age greater than or equal to 18 years at the time of signing informed consent
* Switched to a basal-bolus insulin regimen with Fiasp® as the bolus insulin, from a basal-bolus insulin regimen with any other bolus insulin. Switch must have occurred greater than or equal to 26 weeks prior to data collection and during 01 September 2017 to 31 August 2018
* Treated with basal-bolus insulin regimen throughout the 26 weeks prior to Fiasp® initiation
* Treated with the same basal insulin, i.e. no records of switching the basal insulin, during the 26 weeks prior to Fiasp® initiation or the 26 weeks after Fiasp® initiation
* Diagnosed with type 1 diabetes for greater than or equal to 12 months prior to Fiasp® initiation
* Use of CGM/FGM during the 26 weeks prior to Fiasp® initiation and the 26 weeks after Fiasp® initiation
* Use of the same CGM/FGM device during the full 26-week period after Fiasp® initiation.

Exclusion criteria:

* Previous participation in this study. Participation is defined as signed informed consent
* Participation in clinical study with receipt of any investigational medicinal product known to affect glucose control during the 26-week period prior to Fiasp® initiation or the 26-week period after Fiasp® initiation
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
* Patients prescribed any other glucose-lowering drugs than insulins (anatomical therapeutic chemical \[ATC\] class A10B), including oral and injectable drugs, as addition to their insulin treatment during the 26-week period prior to Fiasp® initiation or the 26-week period after Fiasp® initiation
* Use of Fiasp® as bolus insulin during the 26-week period prior to Fiasp® initiation
* Use of any insulin with an insulin pump (i.e. continuous subcutaneous insulin infusion) during the 26-week period prior to Fiasp® initiation or the 26-week period after Fiasp® initiation.

Primary outcomes:
measure: Change in percentage of time spent in glycaemic target range (TIR)
timeFrame: Two-week period closest to and before index date, Two-week period closest to Week 26
Secondary outcomes:
measure: Change in mean sensor glucose
timeFrame: Two-week period closest to and before index date, Two-week period closest to Week 26
measure: Change in glycaemic variability (GV) (measured as coefficient of variation [CV])
timeFrame: Two-week period closest to and before index date, Two-week period closest to Week 26
measure: Change in percentage of time spent in level 1 hyperglycaemia (greater than 10.0 mmol/L)
timeFrame: Two-week period closest to and before index date, Two-week period closest to Week 26
measure: Change in percentage of time spent in level 2 hyperglycaemia (greater than 13.9 mmol/L)
timeFrame: Two-week period closest to and before index date, Two-week period closest to Week 26
measure: Change in percentage of time spent in level 2 hypoglycaemia (lesser than 3.0 mmol/L)
timeFrame: Two-week period closest to and before index date, Two-week period closest to Week 26
measure: Change in percentage of time spent in level 1 hypoglycaemia (lesser than 3.9 mmol/L)
timeFrame: Two-week period closest to and before index date, Two-week period closest to Week 26
measure: Proportion with CV lesser than 36%
timeFrame: Two-week period closest to Week 26
measure: Change in Glycated Haemoglobin A1c (HbA1c)
timeFrame: Latest measurement between Week -12 and index date, measurement closest to Week 26
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosure 1452
role: STUDY_DIRECTOR
References: