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Fast-Acting Insulin Aspart and Insulin Pump Settings

Primary Purpose

Type 1 Diabetes

Status

Unknown status

Phase

Phase 4

Locations

Denmark

Study Type

Interventional

Intervention

Insulin aspart

Fast-acting insulin aspart

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Insulin pump

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Type 1 diabetes for ≥ 5 years
HbA1c 53-75 mmol/mol (7.0-9.0%)
Insulin pump treatment for ≥ 6 months (all insulin pump makes except hybrid closed-loop systems are eligible for inclusion)
CGM use for ≥ 6 months (all CGM makes are eligible for inclusion)
Carbohydrate counting for all snacks and meals
Use of the insulin pump bolus calculator for all meals and snacks

Exclusion Criteria:

Breast-feeding, pregnant, planning to become pregnant or of child-bearing potential and not using adequate contraceptive methods
Gastroparesis (clinical assessment)
Shift work
Changing insulin needs throughout the menstrual cycle that requires different basal rate patterns
Use of a hybrid closed-loop system
Use of flash glucose monitoring
Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start
Chronic paracetamol use
Alcohol or drug abuse
Severe cardiac disease or retinopathy contraindicating HbA1c below 53 mmol/mol
Impaired renal function (eGFR< 60 ml/min/1.73 m2)
History of local skin reactions to Fiasp and/or Iasp
Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation
Lack of compliance with key study procedures at the discretion of the investigator
Unacceptable adverse events at the discretion of the investigator
Less than 40 weeks guarantee remaining on insulin pump

Sites / Locations

Steno Diabetes Center CopenhagenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Iasp-Fiasp

Fiasp-Iasp

Arm Description

First period: Insulin pump with Iasp Second period: Insulin pump with Fiasp

First period: Insulin pump with Fiasp Second period: Insulin pump with Iasp

Outcomes

Primary Outcome Measures

Time in range

Difference in time spent with glucose values in the range 3.9-10.0 mmol/l between Fiasp and Iasp treatment assessed by continuous glucose monitoring

Secondary Outcome Measures

Mean glucose

Difference in mean glucose between Fiasp and Iasp treatment assessed by continuous glucose monitoring

Coefficient of variation

Difference in coefficient of variation between Fiasp and Iasp treatment assessed by continuous glucose monitoring

Time below range level 1

Difference in time spent with glucose values below 3.9 mmol/l between Fiasp and Iasp treatment assessed by continuous glucose monitoring

Time below range level 2

Difference in time spent with glucose values below 3.0 mmol/l between Fiasp and Iasp treatment assessed by continuous glucose monitoring

Time above range level 1

Difference in time spent with glucose values above 10.0 mmol/l between Fiasp and Iasp treatment assessed by continuous glucose monitoring

Time above range level 2

Difference in time spent with glucose values above 13.9 mmol/l between Fiasp and Iasp treatment assessed by continuous glucose monitoring

Fructosamine

Difference in change in fructosamine between Fiasp and Iasp treatment

Total daily insulin dose

Difference between Fiasp and Iasp treatment in total daily insulin dose

Total daily basal insulin dose

Difference between Fiasp and Iasp treatment in total daily basal insulin dose

Total daily bolus insulin dose

Difference between Fiasp and Iasp treatment in total daily bolus insulin dose

Severe hypoglycemia

Difference between Fiasp and Iasp treatment in number of severe hypoglycemia events

Ketoacidosis

Difference between Fiasp and Iasp treatment in number of ketoacidosis events

Full Information

NCT ID

NCT04620967

First Posted

November 3, 2020

Last Updated

February 12, 2021

Sponsor

Kirsten Nørgaard

1. Study Identification

Unique Protocol Identification Number

NCT04620967

Brief Title

Fast-Acting Insulin Aspart and Insulin Pump Settings

Official Title

Fast-Acting Insulin Aspart and Insulin Pump Settings: THE FAST PUMP SETTING STUDY

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Unknown status

Study Start Date

February 1, 2021 (Actual)

Primary Completion Date

June 30, 2022 (Anticipated)

Study Completion Date

June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Kirsten Nørgaard

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

To clarify the role of fast-acting insulin aspart (Fiasp) in insulin pump-treated type 1 diabetes more research is needed. The aim of this study is twofold: to compare the effects of Fiasp and Iasp in adults with type 1 diabetes who are using insulin pump and CGM and who are attending a diabetes out-patient clinic with extensive expertise in insulin pump and CGM therapy. to determine differences in insulin pump settings when insulin pumps are optimally adjusted to each of the two insulin types.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes

Keywords

Insulin pump

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Model Description

A randomized, double-blind, cross-over study with two 16-week intervention periods separated by a 3-week washout period comparing Fiasp with Iasp in adults with type 1 diabetes treated with insulin pump and CGM.

Masking

ParticipantCare ProviderInvestigator

Masking Description

Group allocation is concealed to participants as well as investigators until all participants have completed the study. The allocation for a participant may be revealed in a medical emergency if knowledge about the treatment allocation would influence the treatment of the person.

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Iasp-Fiasp

Arm Type

Experimental

Arm Description

First period: Insulin pump with Iasp Second period: Insulin pump with Fiasp

Arm Title

Fiasp-Iasp

Arm Type

Experimental

Arm Description

First period: Insulin pump with Fiasp Second period: Insulin pump with Iasp

Intervention Type

Drug

Intervention Name(s)

Insulin aspart

Intervention Description

Insulin aspart (Iasp) in insulin pump

Intervention Type

Drug

Intervention Name(s)

Fast-acting insulin aspart

Intervention Description

Fast-acting insulin aspart (Fiasp) in insulin pump

Primary Outcome Measure Information:

Title

Time in range

Description

Difference in time spent with glucose values in the range 3.9-10.0 mmol/l between Fiasp and Iasp treatment assessed by continuous glucose monitoring

Time Frame

Last two weeks of the 16-week interventions

Secondary Outcome Measure Information:

Title

Mean glucose

Description

Difference in mean glucose between Fiasp and Iasp treatment assessed by continuous glucose monitoring

Time Frame

Last two weeks of the 16-week interventions

Title

Coefficient of variation

Description

Difference in coefficient of variation between Fiasp and Iasp treatment assessed by continuous glucose monitoring

Time Frame

Last two weeks of the 16-week interventions

Title

Time below range level 1

Description

Difference in time spent with glucose values below 3.9 mmol/l between Fiasp and Iasp treatment assessed by continuous glucose monitoring

Time Frame

Last two weeks of the 16-week interventions

Title

Time below range level 2

Description

Difference in time spent with glucose values below 3.0 mmol/l between Fiasp and Iasp treatment assessed by continuous glucose monitoring

Time Frame

Last two weeks of the 16-week interventions

Title

Time above range level 1

Description

Difference in time spent with glucose values above 10.0 mmol/l between Fiasp and Iasp treatment assessed by continuous glucose monitoring

Time Frame

Last two weeks of the 16-week interventions

Title

Time above range level 2

Description

Difference in time spent with glucose values above 13.9 mmol/l between Fiasp and Iasp treatment assessed by continuous glucose monitoring

Time Frame

Last two weeks of the 16-week interventions

Title

Fructosamine

Description

Difference in change in fructosamine between Fiasp and Iasp treatment

Time Frame

16 weeks

Title

Total daily insulin dose

Description

Difference between Fiasp and Iasp treatment in total daily insulin dose

Time Frame

Last two weeks of the 16-week interventions

Title

Total daily basal insulin dose

Description

Difference between Fiasp and Iasp treatment in total daily basal insulin dose

Time Frame

Last two weeks of the 16-week interventions

Title

Total daily bolus insulin dose

Description

Difference between Fiasp and Iasp treatment in total daily bolus insulin dose

Time Frame

Last two weeks of the 16-week interventions

Title

Severe hypoglycemia

Description

Difference between Fiasp and Iasp treatment in number of severe hypoglycemia events

Time Frame

16 weeks

Title

Ketoacidosis

Description

Difference between Fiasp and Iasp treatment in number of ketoacidosis events

Time Frame

16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Type 1 diabetes for ≥ 5 years HbA1c 53-75 mmol/mol (7.0-9.0%) Insulin pump treatment for ≥ 6 months (all insulin pump makes except hybrid closed-loop systems are eligible for inclusion) CGM use for ≥ 6 months (all CGM makes are eligible for inclusion) Carbohydrate counting for all snacks and meals Use of the insulin pump bolus calculator for all meals and snacks Exclusion Criteria: Breast-feeding, pregnant, planning to become pregnant or of child-bearing potential and not using adequate contraceptive methods Gastroparesis (clinical assessment) Shift work Changing insulin needs throughout the menstrual cycle that requires different basal rate patterns Use of a hybrid closed-loop system Use of flash glucose monitoring Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start Chronic paracetamol use Alcohol or drug abuse Severe cardiac disease or retinopathy contraindicating HbA1c below 53 mmol/mol Impaired renal function (eGFR< 60 ml/min/1.73 m2) History of local skin reactions to Fiasp and/or Iasp Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation Lack of compliance with key study procedures at the discretion of the investigator Unacceptable adverse events at the discretion of the investigator Less than 40 weeks guarantee remaining on insulin pump

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Signe Schmidt, MD PhD

Phone

+45 51174785

signe.schmidt@regionh.dk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kirsten Nørgaard, MD DMSc

Organizational Affiliation

Steno Diabetes Center Copenhagen

Official's Role

Principal Investigator

Facility Information:

Facility Name

Steno Diabetes Center Copenhagen

City

Gentofte

ZIP/Postal Code

2820

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Signe Schmidt, MD PhD

Phone

+45 51174785

signe.schmidt@regionh.dk

First Name & Middle Initial & Last Name & Degree

Ajenthen Ranjan, MD PhD

First Name & Middle Initial & Last Name & Degree

Hanne-Charlotte Andersen, RN

First Name & Middle Initial & Last Name & Degree

Signe Schmidt, MD PhD

12. IPD Sharing Statement

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Fast-Acting Insulin Aspart and Insulin Pump Settings

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