Effect of Fiasp® in Type 1 Diabetes Treatment

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Drug: Fiasp®

• Registration Number: NCT03895515
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-03-27
• Study First Submitted QC: 2019-03-27
• Study First Posted: 2019-03-29
• Study Start: 2020-01-03
• Primary Completion: 2020-12-21
• Study Completion: 2020-12-21
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-06
• Last Update Posted: 2022-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 178

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fiasp®	Fiasp®	Participants with type 1 diabetes who have switched to a basal-bolus insulin regimen with Fiasp® as the bolus insulin, from a basal-bolus insulin regimen with any other bolus insulin.

Primary Outcome Measures

Name	Time	Method
Change in percentage of time spent in glycaemic target range (TIR)	Two-week period closest to and before index date, Two-week period closest to Week 26	Measured in percentage point.; The change in percentage of TIR was defined as a blood glucose level of 3.9 to 10.0 mmol/L after initiation of Fiasp® treatment. Index date is first Fiasp® prescription between 01 Sep 2017 and 01 Sep 2018.; Time frame description: From: Closest continuous two-week period during the four weeks before the index date To: Continuous two-week period available closest to Week 26 during a period ranging between 20 weeks after index date to 32 weeks after index date. Measurements will, irrespective of analysis, only be considered if the patient is concomitantly on Fiasp® treatment.

Secondary Outcome Measures

Name	Time	Method
Change in glycaemic variability (GV) (measured as coefficient of variation [CV])	Two-week period closest to and before index date, Two-week period closest to Week 26	Measured in percentage point; Index date is first Fiasp® prescription between 01 Sep 2017 and 01 Sep 2018.; Time frame description: From: Closest continuous two-week period during the four weeks before the index date To: Continuous two-week period available closest to Week 26 during a period ranging between 20 weeks after index date to 32 weeks after index date. Measurements will, irrespective of analysis, only be considered if the patient is concomitantly on Fiasp® treatment.
Proportion with CV lesser than 36%	Two-week period closest to Week 26	Proportion of participants with/without GV corresponding to a CV lesser than 36%; Time frame description: Continuous two-week period available closest to Week 26 during a period ranging between 20 weeks after index date to 32 weeks after index date. Measurements will, irrespective of analysis, only be considered if the patient is concomitantly on Fiasp® treatment.
Change in Glycated Haemoglobin A1c (HbA1c)	Latest measurement between Week -12 and index date, measurement closest to Week 26	Measured in mmol/mol; Index date is first Fiasp® prescription between 01 Sep 2017 and 01 Sep 2018.; Measurement closest to Week 26 will be identified from a period ranging between 12 weeks after index date and 32 weeks after index date
Change in mean sensor glucose	Two-week period closest to and before index date, Two-week period closest to Week 26	Measured in mmol/L; Index date is first Fiasp® prescription between 01 Sep 2017 and 01 Sep 2018.; Time frame description: From: Closest continuous two-week period during the four weeks before the index date To: Continuous two-week period available closest to Week 26 during a period ranging between 20 weeks after index date to 32 weeks after index date. Measurements will, irrespective of analysis, only be considered if the patient is concomitantly on Fiasp® treatment.
Change in percentage of time spent in level 1 hyperglycaemia (greater than 10.0 mmol/L)	Two-week period closest to and before index date, Two-week period closest to Week 26	Measured in percentage point; Index date is first Fiasp® prescription between 01 Sep 2017 and 01 Sep 2018.; Time frame description: From: Closest continuous two-week period during the four weeks before the index date To: Continuous two-week period available closest to Week 26 during a period ranging between 20 weeks after index date to 32 weeks after index date. Measurements will, irrespective of analysis, only be considered if the patient is concomitantly on Fiasp® treatment.
Change in percentage of time spent in level 2 hyperglycaemia (greater than 13.9 mmol/L)	Two-week period closest to and before index date, Two-week period closest to Week 26	Measured in percentage point; Index date is first Fiasp® prescription between 01 Sep 2017 and 01 Sep 2018.; Time frame description: From: Closest continuous two-week period during the four weeks before the index date To: Continuous two-week period available closest to Week 26 during a period ranging between 20 weeks after index date to 32 weeks after index date. Measurements will, irrespective of analysis, only be considered if the patient is concomitantly on Fiasp® treatment.
Change in percentage of time spent in level 2 hypoglycaemia (lesser than 3.0 mmol/L)	Two-week period closest to and before index date, Two-week period closest to Week 26	Measured in percentage point; Index date is first Fiasp® prescription between 01 Sep 2017 and 01 Sep 2018.; Time frame description: From: Closest continuous two-week period during the four weeks before the index date To: Continuous two-week period available closest to Week 26 during a period ranging between 20 weeks after index date to 32 weeks after index date. Measurements will, irrespective of analysis, only be considered if the patient is concomitantly on Fiasp® treatment.
Change in percentage of time spent in level 1 hypoglycaemia (lesser than 3.9 mmol/L)	Two-week period closest to and before index date, Two-week period closest to Week 26	Measured in percentage point; Index date is first Fiasp® prescription between 01 Sep 2017 and 01 Sep 2018.; Time frame description: From: Closest continuous two-week period during the four weeks before the index date To: Continuous two-week period available closest to Week 26 during a period ranging between 20 weeks after index date to 32 weeks after index date. Measurements will, irrespective of analysis, only be considered if the patient is concomitantly on Fiasp® treatment.

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇸🇪 Stockholm, Sweden