search
Back to results

Comparison of Day and Night Closed-loop With Faster-acting Insulin Aspart With Insulin Aspart (AP-MFT-01)

Primary Purpose

Diabetes Mellitus, Type 1

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
FIASP + closed loop device
Insulin aspart (standard of care insulin) + closed loop device
Sponsored by
Manchester University NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes Mellitus, Type 1

Eligibility Criteria

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

Inclusion Criteria:

  1. The subject is 18 years and older
  2. The subject has type 1 diabetes, as defined by WHO for at least 1 year or is confirmed C-peptide negative
  3. The subject will have been an insulin pump user for at least 3 months
  4. The subject is treated with any of the rapid acting insulin analogues
  5. The subject is willing to adhere to study procedures
  6. HbA1c ≥ 7.0% (53 mmol/mol) and ≤ 10 % (86mmol/mol) based on analysis from local laboratory or equivalent within 3 months prior to enrolment
  7. The subject is literate in English

Exclusion Criteria:

  • 1. Non-type 1 diabetes mellitus including those secondary to chronic disease 2. Any other physical or psychological disease likely to interfere with the normal conduct of the study 3. Untreated celiac disease or hypothyroidism 4. Current treatment with drugs known to interfere with glucose metabolism, e.g. systemic corticosteroids, Metformin, SGLT2 inhibitors, non-selective beta-blockers and MAO inhibitors etc.

    5. Known or suspected allergy against insulin 6. Subjects with clinical significant nephropathy, neuropathy or proliferative retinopathy as judged by the investigator 7. Total daily insulin dose > 2 U/kg/day 8. Total daily insulin dose < 10 U/day 9. Pregnancy, planned pregnancy, or breast feeding

Sites / Locations

  • Manchester University Hospitals NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FIASP + closed loop device

Insulin aspart (standard of care insulin) + closed loop device

Arm Description

Subjects randomised to FIASP and closed loop device will be invited to have blood samples taken at baseline, CGM training, competency assessment, and optimisation of treatment. This is followed by inpatient stay where patients will be using FIASP + closed loop intervention for 24 hours. Participants will be advised to change their usual insulin to the corresponding study visit insulin formulation, 24 hours prior to admission. (For example; if the participant is on insulin aspart, this will be changed to faster-acting aspart 24-hour prior to the admission for closed loop with faster-acting aspart and vice versa).

Subjects randomised to insulin aspart (standard of care insulin) and closed loop device will be invited to have blood samples taken at baseline, CGM training, competency assessment, and optimisation of treatment. This is followed by inpatient stay where patients will be using insulin aspart (standard of care insulin) + closed loop intervention for 24 hours.Participants will be advised to change their usual insulin to the corresponding study visit insulin formulation, 24 hours prior to admission. (For example; if the participant is on insulin aspart, this will be changed to faster-acting aspart 24-hour prior to the admission for closed loop with faster-acting aspart and vice versa).

Outcomes

Primary Outcome Measures

Time spent in the target glucose range
Time spent in the target glucose range between 3.9 to 10.0 mmol/l (70 to 180mg/dl) based on sensor glucose levels between the hours of 19:00 on day 1 and 18:00 hours on day 2 of the inpatient stay.

Secondary Outcome Measures

Time spent in the target glucose range within 4 hours of each meal
Time spent in the target glucose range between 3.9 to 10.0 mmol/l (70 to 180mg/dl) based on sensor glucose levels during the first 4 hours following each meal
Incremental area under the curve of sensor glucose level within 4 hours of each meal
Incremental area under the curve of sensor glucose level during the first 4 hours after each meal
Time spent below target glucose
Time spent below target glucose (<3.9mmol/l) (<70mg/dl)
Time spent above target glucose
Time spent above target glucose (10.0 mmol/l) (180 mg/dl)
Average, coefficient of variation and standard deviation glucose levels
Average, coefficient of variation and standard deviation glucose levels
The time with sensor glucose levels < 3.5 mmol/l (63 mg/dl)
The time with sensor glucose levels < 3.5 mmol/l (63 mg/dl)
The time with sensor glucose levels <3.0 (54mg/dl)
The time with sensor glucose levels <3.0 (54mg/dl)
The time with sensor glucose levels <2.8 mmol/l (50 mg/dl)
The time with sensor glucose levels <2.8 mmol/l (50 mg/dl)
The time with sensor glucose levels in the significant hyperglycaemia
The time with sensor glucose levels in the significant hyperglycaemia (glucose levels > 16.7 mmol/l) (300mg/dl)
Total, basal and bolus insulin dose
Total, basal and bolus insulin dose
AUC of glucose below 3.0mmol/l (54mg/dl)
AUC of glucose below 3.0mmol/l (54mg/dl)

Full Information

First Posted
June 25, 2018
Last Updated
August 19, 2022
Sponsor
Manchester University NHS Foundation Trust
Collaborators
Novo Nordisk A/S
search

1. Study Identification

Unique Protocol Identification Number
NCT03579615
Brief Title
Comparison of Day and Night Closed-loop With Faster-acting Insulin Aspart With Insulin Aspart
Acronym
AP-MFT-01
Official Title
An Open-label, Single-centre, Randomised, Two-period, Cross-over Study to Assess the Efficacy and Safety of Day and Night Automated Closed-loop Glucose Control for 24 Hours in Adults With Type 1 Diabetes Comparing Faster-acting Insulin Aspart With Insulin Aspart
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
December 23, 2020 (Actual)
Primary Completion Date
February 24, 2022 (Actual)
Study Completion Date
August 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Manchester University NHS Foundation Trust
Collaborators
Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The main objective of the study is to determine whether automated closed-loop using faster-acting insulin aspart will improve glucose control and reduce the burden of hypoglycaemia over a 23-hour period compared to insulin aspart under conditions mimicking under-estimation of meal carbohydrate content or missed meal bolus. Faster-acting insulin aspart (FIASP) is a novel formulation of insulin aspart in which two additional excipients (L-arginine and Niacinamide) have been added, resulting in accelerated initial absorption and more than double the glucose lowering effect in the first 30 minutes after subcutaneous administration using insulin pump. To date, no closed-loop study has been performed to evaluate the benefit of faster-acting aspart over insulin aspart during closed-loop system use.
Detailed Description
This is an open-label, single-centre, two-period, randomised, cross over study. The study involves a screening visit to assess participant eligibility and two 24 hour in-patient stays at the clinical research facility during which day and night glucose levels will be controlled by the closed-loop system with either faster-acting insulin aspart or insulin aspart. Up to 22 adults with type 1 diabetes and treated with continuous subcutaneous insulin infusion will be recruited, aiming for 16 completed participants. Recruitment will take place at Manchester Diabetes Centre, Manchester Royal Infirmary, Manchester, UK. Participants will attend the Manchester Clinical Research Facility (MCRF), Manchester, on two occasions. In random order, they will undergo two closed-loop study days using either faster-acting insulin aspart or insulin aspart. During the study days, the closed-loop control algorithm will automatically modulate d insulin infusion rate based on real-time subcutaneous glucose sensor measurements. Participants will receive standardised meals with half usual meal bolus for the evening meal and no meal bolus for lunch time meal during each study day.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
An open-label, single-centre, randomised, two-period, cross-over study
Masking
None (Open Label)
Masking Description
FIASP vs standard of care insulin
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FIASP + closed loop device
Arm Type
Experimental
Arm Description
Subjects randomised to FIASP and closed loop device will be invited to have blood samples taken at baseline, CGM training, competency assessment, and optimisation of treatment. This is followed by inpatient stay where patients will be using FIASP + closed loop intervention for 24 hours. Participants will be advised to change their usual insulin to the corresponding study visit insulin formulation, 24 hours prior to admission. (For example; if the participant is on insulin aspart, this will be changed to faster-acting aspart 24-hour prior to the admission for closed loop with faster-acting aspart and vice versa).
Arm Title
Insulin aspart (standard of care insulin) + closed loop device
Arm Type
Active Comparator
Arm Description
Subjects randomised to insulin aspart (standard of care insulin) and closed loop device will be invited to have blood samples taken at baseline, CGM training, competency assessment, and optimisation of treatment. This is followed by inpatient stay where patients will be using insulin aspart (standard of care insulin) + closed loop intervention for 24 hours.Participants will be advised to change their usual insulin to the corresponding study visit insulin formulation, 24 hours prior to admission. (For example; if the participant is on insulin aspart, this will be changed to faster-acting aspart 24-hour prior to the admission for closed loop with faster-acting aspart and vice versa).
Intervention Type
Device
Intervention Name(s)
FIASP + closed loop device
Intervention Description
Participants will be advised to change their usual insulin to the corresponding study visit insulin formulation, 24 hours prior to admission. (For example; if the participant is on insulin aspart, this will be changed to faster-acting aspart 24-hour prior to the admission for closed loop with faster-acting aspart and vice versa).
Intervention Type
Device
Intervention Name(s)
Insulin aspart (standard of care insulin) + closed loop device
Intervention Description
Participants will be advised to maintain their usual insulin 24 hours prior to admission.
Primary Outcome Measure Information:
Title
Time spent in the target glucose range
Description
Time spent in the target glucose range between 3.9 to 10.0 mmol/l (70 to 180mg/dl) based on sensor glucose levels between the hours of 19:00 on day 1 and 18:00 hours on day 2 of the inpatient stay.
Time Frame
23 hours
Secondary Outcome Measure Information:
Title
Time spent in the target glucose range within 4 hours of each meal
Description
Time spent in the target glucose range between 3.9 to 10.0 mmol/l (70 to 180mg/dl) based on sensor glucose levels during the first 4 hours following each meal
Time Frame
4 hours
Title
Incremental area under the curve of sensor glucose level within 4 hours of each meal
Description
Incremental area under the curve of sensor glucose level during the first 4 hours after each meal
Time Frame
4 hours
Title
Time spent below target glucose
Description
Time spent below target glucose (<3.9mmol/l) (<70mg/dl)
Time Frame
23 hours
Title
Time spent above target glucose
Description
Time spent above target glucose (10.0 mmol/l) (180 mg/dl)
Time Frame
23 hours
Title
Average, coefficient of variation and standard deviation glucose levels
Description
Average, coefficient of variation and standard deviation glucose levels
Time Frame
23 hours
Title
The time with sensor glucose levels < 3.5 mmol/l (63 mg/dl)
Description
The time with sensor glucose levels < 3.5 mmol/l (63 mg/dl)
Time Frame
23 hours
Title
The time with sensor glucose levels <3.0 (54mg/dl)
Description
The time with sensor glucose levels <3.0 (54mg/dl)
Time Frame
23 hours
Title
The time with sensor glucose levels <2.8 mmol/l (50 mg/dl)
Description
The time with sensor glucose levels <2.8 mmol/l (50 mg/dl)
Time Frame
23 hours
Title
The time with sensor glucose levels in the significant hyperglycaemia
Description
The time with sensor glucose levels in the significant hyperglycaemia (glucose levels > 16.7 mmol/l) (300mg/dl)
Time Frame
23 hours
Title
Total, basal and bolus insulin dose
Description
Total, basal and bolus insulin dose
Time Frame
23 hours
Title
AUC of glucose below 3.0mmol/l (54mg/dl)
Description
AUC of glucose below 3.0mmol/l (54mg/dl)
Time Frame
23 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The subject is 18 years and older The subject has type 1 diabetes, as defined by WHO for at least 1 year or is confirmed C-peptide negative The subject will have been an insulin pump user for at least 3 months The subject is treated with any of the rapid acting insulin analogues The subject is willing to adhere to study procedures HbA1c ≥ 7.0% (53 mmol/mol) and ≤ 10 % (86mmol/mol) based on analysis from local laboratory or equivalent within 3 months prior to enrolment The subject is literate in English Exclusion Criteria: 1. Non-type 1 diabetes mellitus including those secondary to chronic disease 2. Any other physical or psychological disease likely to interfere with the normal conduct of the study 3. Untreated celiac disease or hypothyroidism 4. Current treatment with drugs known to interfere with glucose metabolism, e.g. systemic corticosteroids, Metformin, SGLT2 inhibitors, non-selective beta-blockers and MAO inhibitors etc. 5. Known or suspected allergy against insulin 6. Subjects with clinical significant nephropathy, neuropathy or proliferative retinopathy as judged by the investigator 7. Total daily insulin dose > 2 U/kg/day 8. Total daily insulin dose < 10 U/day 9. Pregnancy, planned pregnancy, or breast feeding
Facility Information:
Facility Name
Manchester University Hospitals NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M13 WL
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Comparison of Day and Night Closed-loop With Faster-acting Insulin Aspart With Insulin Aspart

We'll reach out to this number within 24 hrs