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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 (GoBolus)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03450863
Recruitment Status : Completed
First Posted : March 1, 2018
Last Update Posted : October 17, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

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.

Condition or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 1 Diabetes Drug: Fast-acting insulin aspart

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Study Type : Observational
Actual Enrollment : 323 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Fiasp® on Glycaemic Control in a Real World Population With Type 1 Diabetes Mellitus Using Flash Glucose Monitoring
Actual Study Start Date : March 22, 2018
Actual Primary Completion Date : September 4, 2019
Actual Study Completion Date : September 4, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Group/Cohort Intervention/treatment
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
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.
Other Name: Fiasp®




Primary Outcome Measures :
  1. Change in Glycated Haemoglobin (HbA1c) [ Time Frame: Baseline (week 0), end of study (week 24 ± 4 weeks after baseline) ]
    Measure in % point


Secondary Outcome Measures :
  1. 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 [ Time Frame: Baseline (week 0), end of study (week 24 ± 4 weeks) ]
    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.

  2. Change in Patient Reported Outcomes: Treatment satisfaction measured by the overall score obtained from the Diabetes Treatment Satisfaction Questionnaire (DTSQ) [ Time Frame: Baseline (week 0), end of study (week 24 ± 4 weeks) ]
    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.

  3. Change in fasting plasma glucose (FPG) [ Time Frame: Baseline (week 0), week 12 (±4 weeks) ]
    Measured in mmol/L

  4. Change in fasting plasma glucose (FPG) [ Time Frame: Baseline (week 0), end of study (week 24 ±4 weeks) ]
    Measured in mmol/L



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with type 1 diabetes mellitus
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03450863


Locations
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Germany
Novo Nordisk Investigational Site
Schweinfurt, Germany, 97421
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03450863    
Other Study ID Numbers: NN1218-4412
U1111-1204-0620 ( Other Identifier: World Health Organization (WHO) )
First Posted: March 1, 2018    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com/sharing-results

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Insulin
Insulin, Globin Zinc
Insulin Aspart
Insulin, Long-Acting
Insulin degludec, insulin aspart drug combination
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs