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

Diabetes Clinical Trial

— GoBolus  

Official title:

Impact of Fiasp® on Glycaemic Control in a Real World Population With Type 1 Diabetes Mellitus Using Flash Glucose Monitoring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03450863
• Other study ID #: NN1218-4412
• Secondary ID: U1111-1204-0620
• Status: Completed
• Start date: March 22, 2018
• Est. completion date: September 4, 2019

Study information

• Verified date: March 2020
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: September 4, 2019
• Est. primary completion date: September 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 1 Diabetes

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Schweinfurt

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Glycated Haemoglobin (HbA1c)	Measure in % point	Baseline (week 0), end of study (week 24 ± 4 weeks after baseline)
Secondary	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	The TRIM-D Device is an eight item measure with two domains assessing Device Bother and Device Function. This captures information on the ease of use, convenience, and handling of the device(s) used to take diabetes medication. The measure has acceptable reliability, validity and ability to detect change.	Baseline (week 0), end of study (week 24 ± 4 weeks)
Secondary	Change in Patient Reported Outcomes: Treatment satisfaction measured by the overall score obtained from the Diabetes Treatment Satisfaction Questionnaire (DTSQ)	The DTSQs questionnaire will be used to assess subject's treatment satisfaction. This instrument contains 8 items and measures the treatment for your diabetes (including insulin, tablets and/or diet) in terms of convenience, flexibility and general feelings regarding treatment.	Baseline (week 0), end of study (week 24 ± 4 weeks)
Secondary	Change in fasting plasma glucose (FPG)	Measured in mmol/L	Baseline (week 0), week 12 (±4 weeks)
Secondary	Change in fasting plasma glucose (FPG)	Measured in mmol/L	Baseline (week 0), end of study (week 24 ±4 weeks)