Diabetes Mellitus, Type 1AP-MFT-01NCT03579615
Comparison of Day and Night Closed-loop With Faster-acting Insulin Aspart With Insulin Aspart
A study testing FIASP + closed loop device in people with Diabetes Mellitus, Type 1, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- FIASP + closed loop device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Dec 2020to 1 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Manchester University Hospitals NHS Foundation Trust
Manchester, M13 WL
About this study
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
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- FIASP + closed loop device, Insulin aspart (standard of care insulin) + closed loop device
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FIASP + closed loop deviceDevice
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).
Insulin aspart (standard of care insulin) + closed loop deviceDevice
Participants will be advised to maintain their usual insulin 24 hours prior to admission.
| Study group | Role | What they receive |
|---|---|---|
| FIASP + closed loop device | Experimental | 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). Receives: Device: FIASP + closed loop device |
| Insulin aspart (standard of care insulin) + closed loop device | Active comparator | 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). Receives: Device: Insulin aspart (standard of care insulin) + closed loop device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 23 hours
Secondary outcomes (11)
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
Measured: 4 hours
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
Measured: 4 hours
Time spent below target glucose
Time spent below target glucose (<3.9mmol/l) (<70mg/dl)
Measured: 23 hours
Time spent above target glucose
Time spent above target glucose (10.0 mmol/l) (180 mg/dl)
Measured: 23 hours
Average, coefficient of variation and standard deviation glucose levels
Average, coefficient of variation and standard deviation glucose levels
Measured: 23 hours
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)
Measured: 23 hours
The time with sensor glucose levels <3.0 (54mg/dl)
The time with sensor glucose levels <3.0 (54mg/dl)
Measured: 23 hours
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)
Measured: 23 hours
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)
Measured: 23 hours
Total, basal and bolus insulin dose
Total, basal and bolus insulin dose
Measured: 23 hours
AUC of glucose below 3.0mmol/l (54mg/dl)
AUC of glucose below 3.0mmol/l (54mg/dl)
Measured: 23 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start23 Dec 2020
- Primary completion24 Feb 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- An open-label, single-centre, randomised, two-period, cross-over study
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03579615
- Sponsor's protocol ID
- R04695
- Acronym
- AP-MFT-01
- Status last verified
- Aug 2022
- First submitted
- 25 Jun 2018
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Thabit H, Mubita W, Rubio J, Karuppan M, Schofield J, Willinska ME, Hovorka R, Leelarathna L. Comparison of faster-acting aspart with insulin aspart under conditions mimicking underestimation or missed meal boluses in type 1 diabetes using closed-loop insulin delivery. Diabetes Obes Metab. 2023 Apr;25(4):1121-1124. doi: 10.1111/dom.14942. Epub 2022 Dec 27. No abstract available.
PubMed 36514847
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03579615
- Acronym / sponsor ID
- AP-MFT-01 / R04695
- Conditions
- Diabetes Mellitus, Type 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Collaborators
- Novo Nordisk A/S
- Study start
- 23 Dec 2020 (actual)
- Primary completion
- 24 Feb 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 6 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- An open-label, single-centre, randomised, two-period, cross-over study
| Arm | Type | Receives |
|---|---|---|
| FIASP + closed loop device | Experimental | Device: FIASP + closed loop deviceSubjects 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). |
| Insulin aspart (standard of care insulin) + closed loop device | Active comparator | Device: Insulin aspart (standard of care insulin) + closed loop deviceSubjects 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FIASP + closed loop deviceParticipants 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). | Device | FIASP + closed loop device |
| Insulin aspart (standard of care insulin) + closed loop deviceParticipants will be advised to maintain their usual insulin 24 hours prior to admission. | Device | Insulin aspart (standard of care insulin) + closed loop device |
Primary outcome
Time spent in the target glucose range
Time frame: 23 hours
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.
11 secondary outcomes
Time spent in the target glucose range within 4 hours of each meal
Time frame: 4 hours
Incremental area under the curve of sensor glucose level within 4 hours of each meal
Time frame: 4 hours
Time spent below target glucose
Time frame: 23 hours
Time spent above target glucose
Time frame: 23 hours
Average, coefficient of variation and standard deviation glucose levels
Time frame: 23 hours
The time with sensor glucose levels < 3.5 mmol/l (63 mg/dl)
Time frame: 23 hours
The time with sensor glucose levels <3.0 (54mg/dl)
Time frame: 23 hours
The time with sensor glucose levels <2.8 mmol/l (50 mg/dl)
Time frame: 23 hours
The time with sensor glucose levels in the significant hyperglycaemia
Time frame: 23 hours
Total, basal and bolus insulin dose
Time frame: 23 hours
AUC of glucose below 3.0mmol/l (54mg/dl)
Time frame: 23 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
- Derived from this study: PubMed 36514847Thabit H, Mubita W, Rubio J, Karuppan M, Schofield J, Willinska ME, Hovorka R, Leelarathna L. Comparison of faster-acting aspart with insulin aspart under conditions mimicking underestimation or missed meal boluses in type 1 diabetes using closed-loop insulin delivery. Diabetes Obes Metab. 2023 Apr;25(4):1121-1124. doi: 10.1111/dom.14942. Epub 2022 Dec 27. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FIASP + closed loop device in people with Diabetes Mellitus, Type 1, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time spent in the target glucose range (time frame: 23 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03579615, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2022.