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

NCT03450863 | Completed

• 2 other identifiers: NN1218-4412U1111-1204-0620
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in Glycated Haemoglobin (HbA1c)

  Measure in % point

  Baseline (week 0), end of study (week 24 ± 4 weeks after baseline)

Secondary Outcomes (4)

• 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), week 12 (±4 weeks)

• Change in fasting plasma glucose (FPG)

  Baseline (week 0), end of study (week 24 ±4 weeks)

Study Arms (1)

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

Interventions

Fast-acting insulin aspart 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.

Also known as: Fiasp®

Fast-acting insulin aspart

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with type 1 diabetes mellitus

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Schweinfurt, 97421, Germany

Location

Related Publications (1)

• 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.

  PMID: 32924568 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1

Interventions

Insulin Aspart

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Clinical Reporting Anchor and Disclosure (1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2018
• First Posted: March 1, 2018
• Study Start: March 22, 2018
• Primary Completion: September 4, 2019
• Study Completion: September 4, 2019
• Last Updated: March 18, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)