Effect of Fiasp® in Type 1 Diabetes Treatment

April 6, 2022 updated by: Novo Nordisk A/S

The Effect of Fiasp® (Fast-acting Insulin Aspart) in Type 1 Diabetes Patients Using Continuous Glucose Monitoring / Flash Glucose Monitoring in Real-world Clinical Practice in Sweden. A Non-interventional, Retrospective Chart and Database Review Study

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

178

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Stockholm, Sweden, 141 86
        • Novo Nordisk INvestigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants with type 1 diabetes

Description

Inclusion criteria:

  • Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study (beyond identification of potential participants by searching for patients with type 1 Diabetes diagnosis, Fiasp® prescription information and electronic medical record (EMR) data to identify continuous glucose monitoring (CGM)/flash glucose monitoring (FGM) use
  • Age greater than or equal to 18 years at the time of signing informed consent
  • Switched to a basal-bolus insulin regimen with Fiasp® as the bolus insulin, from a basal-bolus insulin regimen with any other bolus insulin. Switch must have occurred greater than or equal to 26 weeks prior to data collection and during 01 September 2017 to 31 August 2018
  • Treated with basal-bolus insulin regimen throughout the 26 weeks prior to Fiasp® initiation
  • Treated with the same basal insulin, i.e. no records of switching the basal insulin, during the 26 weeks prior to Fiasp® initiation or the 26 weeks after Fiasp® initiation
  • Diagnosed with type 1 diabetes for greater than or equal to 12 months prior to Fiasp® initiation
  • Use of CGM/FGM during the 26 weeks prior to Fiasp® initiation and the 26 weeks after Fiasp® initiation
  • Use of the same CGM/FGM device during the full 26-week period after Fiasp® initiation.

Exclusion criteria:

  • Previous participation in this study. Participation is defined as signed informed consent
  • Participation in clinical study with receipt of any investigational medicinal product known to affect glucose control during the 26-week period prior to Fiasp® initiation or the 26-week period after Fiasp® initiation
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
  • Patients prescribed any other glucose-lowering drugs than insulins (anatomical therapeutic chemical [ATC] class A10B), including oral and injectable drugs, as addition to their insulin treatment during the 26-week period prior to Fiasp® initiation or the 26-week period after Fiasp® initiation
  • Use of Fiasp® as bolus insulin during the 26-week period prior to Fiasp® initiation
  • Use of any insulin with an insulin pump (i.e. continuous subcutaneous insulin infusion) during the 26-week period prior to Fiasp® initiation or the 26-week period after Fiasp® initiation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Participants receive treatment with Fiasp® according to routine clinical practice. All treatment decisions, including assignment of participants to Fiasp® treatment, were made independently of the study and prior to the participants' inclusion in the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in percentage of time spent in glycaemic target range (TIR)
Time Frame: 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.

Two-week period closest to and before index date, Two-week period closest to Week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in mean sensor glucose
Time Frame: 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.

Two-week period closest to and before index date, Two-week period closest to Week 26
Change in glycaemic variability (GV) (measured as coefficient of variation [CV])
Time Frame: 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.

Two-week period closest to and before index date, Two-week period closest to Week 26
Change in percentage of time spent in level 1 hyperglycaemia (greater than 10.0 mmol/L)
Time Frame: 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.

Two-week period closest to and before index date, Two-week period closest to Week 26
Change in percentage of time spent in level 2 hyperglycaemia (greater than 13.9 mmol/L)
Time Frame: 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.

Two-week period closest to and before index date, Two-week period closest to Week 26
Change in percentage of time spent in level 2 hypoglycaemia (lesser than 3.0 mmol/L)
Time Frame: 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.

Two-week period closest to and before index date, Two-week period closest to Week 26
Change in percentage of time spent in level 1 hypoglycaemia (lesser than 3.9 mmol/L)
Time Frame: 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.

Two-week period closest to and before index date, Two-week period closest to Week 26
Proportion with CV lesser than 36%
Time Frame: 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.

Two-week period closest to Week 26
Change in Glycated Haemoglobin A1c (HbA1c)
Time Frame: 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

Latest measurement between Week -12 and index date, measurement closest to Week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 3, 2020

Primary Completion (ACTUAL)

December 21, 2020

Study Completion (ACTUAL)

December 21, 2020

Study Registration Dates

First Submitted

March 27, 2019

First Submitted That Met QC Criteria

March 27, 2019

First Posted (ACTUAL)

March 29, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 7, 2022

Last Update Submitted That Met QC Criteria

April 6, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • NN1218-4510
  • U1111-1228-4256 (OTHER: World Health Organisation (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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