Type 1 DiabetesAP@Home04_P3NCT04055480
Closing the Loop in Adults With Type 1 Diabetes Under Free Living Conditions
A study testing Closed-loop using standard rapid-acting insulin and Closed-loop using faster insulin aspart in people with Type 1 Diabetes, run by University of Cambridge at 4 sites in 3 countries.
Trial summary
The main objective of this study is to determine whether home use of day and night closed loop insulin delivery under free living conditions applying faster insulin aspart (FiAsp) is non-inferior to home use of closed-loop applying standard insulin aspart. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Closed-loop using standard rapid-acting insulin and Closed-loop using faster insulin aspart
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 10 Aug 2019to 30 Aug 2020
- 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 has type 1 diabetes as defined by WHO
- The subject is 18 years of age or older
- The subject will have been on an insulin pump for at least 6 months with good knowledge of insulin self-adjustment including carbohydrate counting
- The subject is treated with one of the rapid acting or ultra-rapid acting insulin analogues (Insulin Aspart, faster acting insulin Aspart, Insulin Lispro or Insulin Glulisine)
- HbA1c <10% (86mmol/mol) for phase 3, based on analysis from central laboratory or equivalent
- The subject is willing to perform regular finger-prick blood glucose monitoring, with at least 2 measurements per day
Show all 10Show fewer
- The subject is willing to wear closed-loop system at home and at work place
- The subject is willing to follow study specific instructions including the use of bolus calculator for all meals / snacks
- The subject is willing to upload pump and CGM data at regular intervals
- Female subjects of child bearing age should be on effective contraception and must have a negative urine-HCG pregnancy test at screening.
Who cannot join
- Non-type 1 diabetes mellitus
- Subjects who are living alone
- Any other physical or psychological disease or condition likely to interfere with the normal conduct of the study and interpretation of the study results
- Current treatment with drugs known to have significant interference with glucose metabolism, such as systemic corticosteroids, as judged by the investigator
- Known or suspected allergy against insulin or previous reaction to FiAsp
- Subjects with clinically significant nephropathy (eGFR < 45ml/min), neuropathy or active retinopathy (defined as presence of maculopathy or more than background diabetic retinopathy changes) as judged by the investigator
Show all 17Show fewer
- More than one episode of severe hypoglycaemia as defined by American Diabetes Association (42) in preceding 12 months (Severe hypoglycaemia is defined as an event requiring assistance of another person to actively administer carbohydrates, glucagon, or take other corrective actions including episodes of hypoglycaemia severe enough to cause unconsciousness, seizures or attendance at hospital.)
- Total daily insulin dose > 2 IU/kg/day
- Subject is pregnant or breast feeding or planning pregnancy within next 10 months
- Severe visual impairment
- Severe hearing impairment
- Lack of reliable telephone facility for contact
- Subject not proficient in English (UK), French (Switzerland) or German (Germany, Switzerland and Austria)
- Additional exclusion criteria specific for Austria
- Positive results on urine drug screen (amphetamines/metamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).
- Positive alcohol breath test.
- Positive reaction to any of the following tests: hepatitis B surface (HBs) antigen, anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus (HIV) 1 antibodies, anti-HIV2 antibodies.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
United Kingdom2 sites
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ
Manchester Royal Infirmary, Central Manchester University Hospitals NHS Foundation Trust
Manchester
About this study
Official title: A Multi-centre, Randomised, Two-period, Crossover Study to Evaluate Home Use of Closed-loop Applying Faster Insulin Aspart Versus Standard Insulin Aspart
The main objective of this study is to determine whether home use of day and night closed loop insulin delivery under free living conditions applying faster insulin aspart (FiAsp) is non-inferior to home use of closed-loop applying standard insulin aspart.
This is a double-blind, multi-centre, randomised, crossover design study, involving a run-in period followed by two study periods during which glucose levels will be controlled either by an automated closed-loop system using standard rapid acting insulin analogue or by an automated closed-loop system using faster insulin aspart in random order.
Read more
Subjects will receive appropriate training in the safe use of closed-loop insulin delivery system. Subjects will have regular contact with the study team during the home study phase including 24/7 telephone support.
The primary outcome is time spent in target range between 3.9 and 10.0 mmol/L as recorded by CGM during home stay. Secondary outcomes are the HbA1c, time spent with glucose levels above and below target, as recorded by CGM, and other CGM based metrics.
Read the detailed description
Purpose of clinical trial The purpose is to determine whether home use of day and night closed loop applying faster insulin aspart is not inferior to home use of closed loop applying standard insulin aspart.
Study objectives The study objective is to compare day and night automated closed-loop glucose control using faster acting insulin aspart with closed loop control using standard insulin aspart.
- EFFICACY: The objective is to assess the efficacy of day and night automated closed-loop glucose control applying standard rapid-acting insulin analogue in maintaining CGM glucose levels within the target range from 3.9 to 10.0 mmol/l, as compared to day and night closed-loop using faster acting insulin aspart
- SAFETY: The objective is to evaluate the safety of day and night automated closed-loop glucose control in terms of episodes of severe hypoglycaemia, hyperglycaemia and other adverse events and adverse device effects.
- UTILITY: The objective is to determine the percentage of time when closed-loop was operational, and usability and acceptance of the closed-loop system.
Study Design A double-blind, multi-centre, randomised, two-period crossover study, contrasting day and night automated closed-loop glucose control applying standard rapid acting insulin analogue with day and night closed-loop control applying faster acting insulin aspart.
Study Efficacy Endpoints The primary outcome is the time spent in the target glucose range from 3.9 to 10.0 mmol/l based on CGM glucose levels during the free living phase.
Secondary outcomes include time spent above and below the target glucose range, based on CGM levels.
Safety Evaluation Frequency of severe hypoglycaemic episodes as defined by American Diabetes Association, frequency of severe hyperglycaemia (>20 mmol/l) and / or significant ketosis (plasma ketones >3mmol/l) and nature and severity of other adverse events.
Utility Evaluation Percentage of time spent in closed-loop. Usability and acceptance of the closed-loop system will be assessed using a patient experience questionnaire at the end of the second intervention. Additionally, human factor questionnaires will be administered following recruitment and at the end of each intervention arm.
Sample Size 24 adults completing the study. Up to 30 subjects will be recruited to allow for dropouts.
Maximum duration of study for a subject 20 weeks (5 months)
Recruitment The subjects will be recruited through the adult diabetes outpatient clinics or other established methods at participating centres.
Consent Participants will be asked to provide written informed consent.
Baseline Assessment Eligible subjects will undergo a baseline evaluation including a blood sample for the measurement of HbA1c, renal, liver functions, full blood count, thyroid functions and coeliac antibody screen (if not done in the previous 3 months). Urine pregnancy test will be done in females. Additional centre specific assessments will also be undertaken. Human factor questionnaires will be administered.
Study Training and Run-in Period Training sessions on the use of study CGM, insulin pump and closed-loop system will be provided by the research team. During the 2-4 weeks run-in period, subjects will use study CGM and insulin pump and will have regular contact with the research team. At the end of the run-in period, for compliance and to assess the ability of the subject to use the CGM and study pump safely, before the start of the first home study phase, at least 7 days of CGM data need to be recorded and safe use of study insulin pump demonstrated. CGM and insulin pump data during the run-in period will be used to assess baseline glucose control and optimise treatment before the start of the first home study phase.
Competency Assessment Competency on the use of study insulin pump, study CGM and closed-loop system will be evaluated using a competency assessment tool developed by the research team. Further training may be delivered as required.
Randomisation Eligible subjects will be randomised using randomisation software to the use of closed-loop with faster acting aspart or to closed-loop with standard insulin aspart.
Automated closed-loop Training on the use of closed-loop will be provided by the research team. Automated closed-loop control will be commenced and during the 2-3 hour training the participant will operate the system under the supervision of the clinical team. Competency on the use of closed-loop system will be evaluated. Subjects will be advised to use automated closed-loop system for next 8 weeks
Cross-over Assessment At the end of the first intervention human factor questionnaires will be administered.
There will be no washout period in phase 3 extension.
End of study assessments A patient experience questionnaire will be given at the end of the second intervention. Additionally human factor questionnaires will be administered.
Procedures for safety monitoring during trial Standard operating procedures for monitoring and reporting of all adverse events and adverse device events will be in place, including serious adverse events (SAE), serious adverse device effects (SADE) and specific adverse events (AE) such as severe hypoglycaemia.
Subjects will be asked to test and record blood ketones if their finger-stick glucose is above 14 mmol/l as part of the safety assessment for hyperglycaemia.
A data monitoring and ethics committee (DMEC) will be informed of all serious adverse events and any unanticipated adverse device/method effects that occur during the study and will review compiled adverse event data at periodic intervals.
Criteria for withdrawal of patients on safety grounds
A subject may terminate participation in the study at any time without necessarily giving a reason and without any personal disadvantage. An investigator can stop the participation of a subject after consideration of the benefit/risk ratio. Possible reasons are:
- Serious adverse events
- Significant protocol violation or noncompliance
- Failure to satisfy competency assessment
- Decision by the investigator, or the sponsor, that termination is in the subject's best medical interest
- Pregnancy, planned pregnancy, or breast feeding
- Allergic reaction to insulin
- Technical grounds (e.g. subject relocates)
- Conditions
- Type 1 Diabetes
- Being tested
- Closed-loop using standard rapid-acting insulin, Closed-loop using faster insulin aspart
- Keywords
- closed-loop, artificial pancreas, insulin
- Medical subject headings
- Diabetes Mellitus, Type 1, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed-loop using standard rapid-acting insulinDevice
Closed-loop using standard rapid-acting insulin
Closed-loop using faster insulin aspartDevice
Closed-loop using faster insulin aspart
| Study group | Role | What they receive |
|---|---|---|
| Closed-loop using standard rapid-acting insulin | Active comparator | Unsupervised home use of day and night hybrid closed loop insulin delivery system (CamAPS FX) for 8 weeks using standard rapid-acting insulin
The CamAPS FX closed-loop system comprises
Dana insulin pump (Diabecare, Sooil, Seoul, South Korea) Dexcom G6 real-time CGM sensor (Dexcom, Northridge, CA, USA) An Android smartphone hosting CamAPS FX Application with the Cambridge model predictive control algorithm and communicating wirelessly with the insulin pump Glooko/Diasend cloud upload system to monitor CGM/insulin data. Receives: Device: Closed-loop using standard rapid-acting insulin |
| Closed-loop using faster insulin aspart | Experimental | Unsupervised home use of day and night hybrid closed loop insulin delivery system (CamAPS FX) for 8 weeks using faster insulin aspart
The CamAPS FX closed-loop system comprises
Dana insulin pump (Diabecare, Sooil, Seoul, South Korea) Dexcom G6 real-time CGM sensor (Dexcom, Northridge, CA, USA) An Android smartphone hosting CamAPS FX Application with the Cambridge model predictive control algorithm and communicating wirelessly with the insulin pump Glooko/Diasend cloud upload system to monitor CGM/insulin data. Receives: Device: Closed-loop using faster insulin aspart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time spent in the target glucose range from 3.9 to 10.0 mmol/l based on subcutaneous glucose monitoring (CGM).
Measured: 8 week intervention period
Secondary outcomes (7)
Time spent above target glucose (3.9 to 10.0 mmol/l) based on continuous subcutaneous glucose monitoring (CGM)
Measured: 8 week intervention period
Time spent below target glucose (3.9 to 10.0 mmol/l) based on continuous subcutaneous glucose monitoring (CGM)
Measured: 8 week intervention period
Average, standard deviation and coefficient of variation of glucose levels based on continuous subcutaneous glucose monitoring
Measured: 8 week intervention period
The time with glucose levels < 3.5 mmol/l <3.0mmol/l and <2.8 mmol/l based on continuous subcutaneous glucose monitoring
Measured: 8 week intervention period
The time with glucose levels in the significant hyperglycaemia, as based on continuous subcutaneous glucose monitoring (glucose levels > 16.7 mmol/l)
Measured: 8 week intervention period
Low Blood Glucose Index (LBGI) based on continuous subcutaneous glucose monitoring
Measured: 8 week intervention period
Total, basal and bolus insulin dose
Measured: 8 week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start10 Aug 2019
- Primary completion15 Jun 2020
- Study completion30 Aug 2020
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 Type 1 DiabetesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cambridge
- Sponsor type
- University, hospital or other
- Collaborators
- Manchester University NHS Foundation Trust, Insel Gruppe AG, University Hospital Bern, Medical University of Graz
- Responsible party
- Principal investigator, Dr Roman Hovorka, University of Cambridge
- Investigators
- Roman Hovorka, Principal investigator, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04055480
- Sponsor's protocol ID
- 136248_APHome04
- Acronym
- AP@Home04_P3
- Status last verified
- Aug 2020
- First submitted
- 6 Aug 2019
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol, statistical analysis plan and fully anonymised individual participant data that underlie the results reported in the manuscript will be available 6 months following publication and ending 36 months following manuscript publication to investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose, to achieve aims in the approved proposal. Proposals should be directed to rh347@cam.ac.uk and may be submitted up to 36 months following article publication. To gain access, data requestors will need to sign a data access agreement. Fully anonymised data may be shared with third parties (EU or non-EU based) for the purposes of advancing management and treatment of diabetes.
Publications
Haliloglu B, Boughton CK, Lakshman R, Ware J, Nwokolo M, Thabit H, Mader JK, Bally L, Leelarathna L, Wilinska ME, Allen JM, Hartnell S, Evans ML, Hovorka R. Postprandial Glucose Excursions with Ultra-Rapid Insulin Analogs in Hybrid Closed-Loop Therapy for Adults with Type 1 Diabetes. Diabetes Technol Ther. 2024 Jul;26(7):449-456. doi: 10.1089/dia.2023.0509. Epub 2024 Feb 27.
PubMed 38315506
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Randomised, Two-period, Crossover Study to Evaluate Home Use of Closed-loop Applying Faster Insulin Aspart Versus Standard Insulin Aspart
- ClinicalTrials.gov ID
- NCT04055480
- Acronym / sponsor ID
- AP@Home04_P3 / 136248_APHome04
- Conditions
- Type 1 Diabetes
- Keywords
- closed-loop, artificial pancreas, insulin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of CambridgeUniversity, hospital or other
- Collaborators
- Manchester University NHS Foundation Trust, Insel Gruppe AG, University Hospital Bern, Medical University of Graz
- Study start
- 10 Aug 2019 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 13 Aug 2019 (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 this study is to determine whether home use of day and night closed loop insulin delivery under free living conditions applying faster insulin aspart (FiAsp) is non-inferior to home use of closed-loop applying standard insulin aspart.
This is a double-blind, multi-centre, randomised, crossover design study, involving a run-in period followed by two study periods during which glucose levels will be controlled either by an automated closed-loop system using standard rapid acting insulin analogue or by an automated closed-loop system using faster insulin aspart in random order.
Subjects will receive appropriate training in the safe use of closed-loop insulin delivery system. Subjects will have regular contact with the study team during the home study phase including 24/7 telephone support.
The primary outcome is time spent in target range between 3.9 and 10.0 mmol/L as recorded by CGM during home stay. Secondary outcomes are the HbA1c, time spent with glucose levels above and below target, as recorded by CGM, and other CGM based metrics.
Detailed description
Purpose of clinical trial The purpose is to determine whether home use of day and night closed loop applying faster insulin aspart is not inferior to home use of closed loop applying standard insulin aspart.
Study objectives The study objective is to compare day and night automated closed-loop glucose control using faster acting insulin aspart with closed loop control using standard insulin aspart.
- EFFICACY: The objective is to assess the efficacy of day and night automated closed-loop glucose control applying standard rapid-acting insulin analogue in maintaining CGM glucose levels within the target range from 3.9 to 10.0 mmol/l, as compared to day and night closed-loop using faster acting insulin aspart
- SAFETY: The objective is to evaluate the safety of day and night automated closed-loop glucose control in terms of episodes of severe hypoglycaemia, hyperglycaemia and other adverse events and adverse device effects.
- UTILITY: The objective is to determine the percentage of time when closed-loop was operational, and usability and acceptance of the closed-loop system.
Study Design A double-blind, multi-centre, randomised, two-period crossover study, contrasting day and night automated closed-loop glucose control applying standard rapid acting insulin analogue with day and night closed-loop control applying faster acting insulin aspart.
Study Efficacy Endpoints The primary outcome is the time spent in the target glucose range from 3.9 to 10.0 mmol/l based on CGM glucose levels during the free living phase.
Secondary outcomes include time spent above and below the target glucose range, based on CGM levels.
Safety Evaluation Frequency of severe hypoglycaemic episodes as defined by American Diabetes Association, frequency of severe hyperglycaemia (>20 mmol/l) and / or significant ketosis (plasma ketones >3mmol/l) and nature and severity of other adverse events.
Utility Evaluation Percentage of time spent in closed-loop. Usability and acceptance of the closed-loop system will be assessed using a patient experience questionnaire at the end of the second intervention. Additionally, human factor questionnaires will be administered following recruitment and at the end of each intervention arm.
Sample Size 24 adults completing the study. Up to 30 subjects will be recruited to allow for dropouts.
Maximum duration of study for a subject 20 weeks (5 months)
Recruitment The subjects will be recruited through the adult diabetes outpatient clinics or other established methods at participating centres.
Consent Participants will be asked to provide written informed consent.
Baseline Assessment Eligible subjects will undergo a baseline evaluation including a blood sample for the measurement of HbA1c, renal, liver functions, full blood count, thyroid functions and coeliac antibody screen (if not done in the previous 3 months). Urine pregnancy test will be done in females. Additional centre specific assessments will also be undertaken. Human factor questionnaires will be administered.
Study Training and Run-in Period Training sessions on the use of study CGM, insulin pump and closed-loop system will be provided by the research team. During the 2-4 weeks run-in period, subjects will use study CGM and insulin pump and will have regular contact with the research team. At the end of the run-in period, for compliance and to assess the ability of the subject to use the CGM and study pump safely, before the start of the first home study phase, at least 7 days of CGM data need to be recorded and safe use of study insulin pump demonstrated. CGM and insulin pump data during the run-in period will be used to assess baseline glucose control and optimise treatment before the start of the first home study phase.
Competency Assessment Competency on the use of study insulin pump, study CGM and closed-loop system will be evaluated using a competency assessment tool developed by the research team. Further training may be delivered as required.
Randomisation Eligible subjects will be randomised using randomisation software to the use of closed-loop with faster acting aspart or to closed-loop with standard insulin aspart.
Automated closed-loop Training on the use of closed-loop will be provided by the research team. Automated closed-loop control will be commenced and during the 2-3 hour training the participant will operate the system under the supervision of the clinical team. Competency on the use of closed-loop system will be evaluated. Subjects will be advised to use automated closed-loop system for next 8 weeks
Cross-over Assessment At the end of the first intervention human factor questionnaires will be administered.
There will be no washout period in phase 3 extension.
End of study assessments A patient experience questionnaire will be given at the end of the second intervention. Additionally human factor questionnaires will be administered.
Procedures for safety monitoring during trial Standard operating procedures for monitoring and reporting of all adverse events and adverse device events will be in place, including serious adverse events (SAE), serious adverse device effects (SADE) and specific adverse events (AE) such as severe hypoglycaemia.
Subjects will be asked to test and record blood ketones if their finger-stick glucose is above 14 mmol/l as part of the safety assessment for hyperglycaemia.
A data monitoring and ethics committee (DMEC) will be informed of all serious adverse events and any unanticipated adverse device/method effects that occur during the study and will review compiled adverse event data at periodic intervals.
Criteria for withdrawal of patients on safety grounds
A subject may terminate participation in the study at any time without necessarily giving a reason and without any personal disadvantage. An investigator can stop the participation of a subject after consideration of the benefit/risk ratio. Possible reasons are:
- Serious adverse events
- Significant protocol violation or noncompliance
- Failure to satisfy competency assessment
- Decision by the investigator, or the sponsor, that termination is in the subject's best medical interest
- Pregnancy, planned pregnancy, or breast feeding
- Allergic reaction to insulin
- Technical grounds (e.g. subject relocates)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Closed-loop using standard rapid-acting insulin | Active comparator | Device: Closed-loop using standard rapid-acting insulinUnsupervised home use of day and night hybrid closed loop insulin delivery system (CamAPS FX) for 8 weeks using standard rapid-acting insulin The CamAPS FX closed-loop system comprises Dana insulin pump (Diabecare, Sooil, Seoul, South Korea) Dexcom G6 real-time CGM sensor (Dexcom, Northridge, CA, USA) An Android smartphone hosting CamAPS FX Application with the Cambridge model predictive control algorithm and communicating wirelessly with the insulin pump Glooko/Diasend cloud upload system to monitor CGM/insulin data. |
| Closed-loop using faster insulin aspart | Experimental | Device: Closed-loop using faster insulin aspartUnsupervised home use of day and night hybrid closed loop insulin delivery system (CamAPS FX) for 8 weeks using faster insulin aspart The CamAPS FX closed-loop system comprises Dana insulin pump (Diabecare, Sooil, Seoul, South Korea) Dexcom G6 real-time CGM sensor (Dexcom, Northridge, CA, USA) An Android smartphone hosting CamAPS FX Application with the Cambridge model predictive control algorithm and communicating wirelessly with the insulin pump Glooko/Diasend cloud upload system to monitor CGM/insulin data. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The subject has type 1 diabetes as defined by WHO
- The subject is 18 years of age or older
- The subject will have been on an insulin pump for at least 6 months with good knowledge of insulin self-adjustment including carbohydrate counting
- The subject is treated with one of the rapid acting or ultra-rapid acting insulin analogues (Insulin Aspart, faster acting insulin Aspart, Insulin Lispro or Insulin Glulisine)
- HbA1c <10% (86mmol/mol) for phase 3, based on analysis from central laboratory or equivalent
Key exclusion criteria (17 listed)
- Non-type 1 diabetes mellitus
- Subjects who are living alone
- Any other physical or psychological disease or condition likely to interfere with the normal conduct of the study and interpretation of the study results
- Current treatment with drugs known to have significant interference with glucose metabolism, such as systemic corticosteroids, as judged by the investigator
- Known or suspected allergy against insulin or previous reaction to FiAsp
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 |
|---|---|---|
| Closed-loop using standard rapid-acting insulinClosed-loop using standard rapid-acting insulin | Device | Closed-loop using standard rapid-acting insulin |
| Closed-loop using faster insulin aspartClosed-loop using faster insulin aspart | Device | Closed-loop using faster insulin aspart |
Primary outcome
Time spent in the target glucose range from 3.9 to 10.0 mmol/l based on subcutaneous glucose monitoring (CGM).
Time frame: 8 week intervention period
7 secondary outcomes
Time spent above target glucose (3.9 to 10.0 mmol/l) based on continuous subcutaneous glucose monitoring (CGM)
Time frame: 8 week intervention period
Time spent below target glucose (3.9 to 10.0 mmol/l) based on continuous subcutaneous glucose monitoring (CGM)
Time frame: 8 week intervention period
Average, standard deviation and coefficient of variation of glucose levels based on continuous subcutaneous glucose monitoring
Time frame: 8 week intervention period
The time with glucose levels < 3.5 mmol/l <3.0mmol/l and <2.8 mmol/l based on continuous subcutaneous glucose monitoring
Time frame: 8 week intervention period
The time with glucose levels in the significant hyperglycaemia, as based on continuous subcutaneous glucose monitoring (glucose levels > 16.7 mmol/l)
Time frame: 8 week intervention period
Low Blood Glucose Index (LBGI) based on continuous subcutaneous glucose monitoring
Time frame: 8 week intervention period
Total, basal and bolus insulin dose
Time frame: 8 week intervention period
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 2 Sep 2020.
- Derived from this study: PubMed 38315506Haliloglu B, Boughton CK, Lakshman R, Ware J, Nwokolo M, Thabit H, Mader JK, Bally L, Leelarathna L, Wilinska ME, Allen JM, Hartnell S, Evans ML, Hovorka R. Postprandial Glucose Excursions with Ultra-Rapid Insulin Analogs in Hybrid Closed-Loop Therapy for Adults with Type 1 Diabetes. Diabetes Technol Ther. 2024 Jul;26(7):449-456. doi: 10.1089/dia.2023.0509. Epub 2024 Feb 27.
- Individual participant dataSharing planned: Yes. Study protocol, statistical analysis plan and fully anonymised individual participant data that underlie the results reported in the manuscript will be available 6 months following publication and ending 36 months following manuscript publication to investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose, to achieve aims in the approved proposal. Proposals should be directed to rh347@cam.ac.uk and may be submitted up to 36 months following article publication. To gain access, data requestors will need to sign a data access agreement. Fully anonymised data may be shared with third parties (EU or non-EU based) for the purposes of advancing management and treatment of diabetes.
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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.
Roman Hovorka principal investigator
University of Cambridge
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closed-loop using standard rapid-acting insulin and Closed-loop using faster insulin aspart in people with Type 1 Diabetes, run by University of Cambridge at 4 sites in 3 countries.
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 10 inclusion and 17 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 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom, Austria, Switzerland. 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 from 3.9 to 10.0 mmol/l based on subcutaneous glucose monitoring (CGM). (time frame: 8 week intervention period). 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 NCT04055480, 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 2 Sep 2020.