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

NCT ID: NCT03450863

Last Updated: 2020-03-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 320 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-03-22
• Study Completion Date: 2019-09-04

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.

Conditions

Diabetes; Diabetes Mellitus, Type 1 Diabetes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Fast-acting insulin aspart

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Fiasp®

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Reporting Anchor and Disclosure (1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Novo Nordisk Investigational Site

Schweinfurt, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 32924568 (View on PubMed)

Other Identifiers

U1111-1204-0620

Identifier Type: OTHER

Identifier Source: secondary_id

NN1218-4412

Identifier Type: -

Identifier Source: org_study_id