Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04759144
Status:
COMPLETED
Last Update Posted:
2023-03-14
First Post:
2021-02-13
Brief Title:
FASter Insulin in Closed-loop Technology in Children
Sponsor:
University of Cambridge
Organization:
University of Cambridge
Study Overview
Official Title:
A Randomised Crossover Study Comparing Hybrid Closed-loop Insulin Delivery Using Ultra-rapid Acting Insulin to Hybrid Closed-loop Insulin Delivery Using Standard Rapid-acting Insulin in Children With Type 1 Diabetes in the Home Setting FAST-Kids
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FAST-Kids
Brief Summary:
The main objective of this study is to determine whether 247 hybrid closed-loop insulin delivery under free living conditions applying faster insulin aspart FiAsp is superior to 247 hybrid closed-loop insulin delivery applying standard insulin aspart in very young children with type 1 diabetes
The closed-loop system consists of three components the continuous glucose monitor CGM the insulin pump and a smartphone Application or App that translates in real-time sensor glucose levels received from the glucose monitoring device and calculates the amount of insulin to be delivered by the coupled insulin pump
This is a double-blind multi-centre randomised crossover design study involving a run-in period followed by two 8-week study periods during which glucose levels will be controlled by a hybrid closed-loop system using either standard insulin aspart or faster insulin aspart in random order
Participants aged 2-6 years with type 1 diabetes on insulin pump therapy will be recruited through paediatric diabetes outpatient clinics at participating clinical centres Enrolment will target up to 30 children aiming for 6-14 participants per centre to allow for dropouts during run-in
Prior to the use of study devices participants and parentsguardians will receive appropriate training by the research team on the safe use of the study pump and CGM device and the hybrid closed-loop insulin delivery system Parentsguardians at nurseyschool may also receive training by the study team if required Participants will have regular contact with the study team during the study including 247 telephone support Parentsguardians will be asked to complete validated questionnaires at the start and end of the study to assess quality of life measures including sleep
The primary outcome is the between group difference in time spent in target range between 39 and 100 mmoll as recorded by CGM during the study Secondary outcomes are time spent with glucose levels above and below target as recorded by CGM and other CGM-based metrics Safety evaluation comprises assessment of the frequency and severity of hypoglycaemic episodes and diabetic ketoacidosis DKA
The closed-loop system consists of three components the continuous glucose monitor CGM the insulin pump and a smartphone Application or App that translates in real-time sensor glucose levels received from the glucose monitoring device and calculates the amount of insulin to be delivered by the coupled insulin pump
This is a double-blind multi-centre randomised crossover design study involving a run-in period followed by two 8-week study periods during which glucose levels will be controlled by a hybrid closed-loop system using either standard insulin aspart or faster insulin aspart in random order
Participants aged 2-6 years with type 1 diabetes on insulin pump therapy will be recruited through paediatric diabetes outpatient clinics at participating clinical centres Enrolment will target up to 30 children aiming for 6-14 participants per centre to allow for dropouts during run-in
Prior to the use of study devices participants and parentsguardians will receive appropriate training by the research team on the safe use of the study pump and CGM device and the hybrid closed-loop insulin delivery system Parentsguardians at nurseyschool may also receive training by the study team if required Participants will have regular contact with the study team during the study including 247 telephone support Parentsguardians will be asked to complete validated questionnaires at the start and end of the study to assess quality of life measures including sleep
The primary outcome is the between group difference in time spent in target range between 39 and 100 mmoll as recorded by CGM during the study Secondary outcomes are time spent with glucose levels above and below target as recorded by CGM and other CGM-based metrics Safety evaluation comprises assessment of the frequency and severity of hypoglycaemic episodes and diabetic ketoacidosis DKA
Detailed Description:
Purpose of clinical trial
To compare hybrid closed-loop applying faster insulin aspart to hybrid closed-loop applying standard insulin aspart over 8 weeks
Study objectives
The study objective is to compare hybrid closed-loop glucose control using faster insulin aspart with hybrid closed-loop control using standard insulin aspart in very young children with type 1 diabetes
1 EFFICACY The objective is to assess the ability of a hybrid closed-loop system applying faster insulin aspart to maintain CGM glucose levels within the target range from 39 to 100 mmoll in comparison to a hybrid closed-loop system applying standard insulin aspart in very young children with type 1 diabetes
2 SAFETY The objective is to evaluate the safety of closed-loop glucose control using faster insulin aspart compared to standard insulin aspart in terms of episodes and severity of hypoglycaemia frequency of diabetic ketoacidosis DKA and nature and severity of other adverse events
3 UTILITY The objective is to determine the acceptability and duration of use of the closed-loop system
4 HUMAN FACTORS The objective is to assess emotional and behavioural characteristics of parentsguardians and their response to the closed-loop system and clinical trial using validated surveys
Participating clinical centres
1 Addenbrookes Hospital Cambridge University Hospitals NHS Foundation Trust Cambridge
2 John Radcliffe Hospital Oxford University Hospitals NHS Foundation Trust Oxford
3 Nottingham Childrens Hospital Nottingham
4 Alder Hey Childrens Hospital Liverpool
Sample Size
24 children randomised 6-14 participants per centre
Maximum duration of study for a subject
6 months
Recruitment
Participants will be recruited through the paediatric diabetes outpatient clinics at participating clinical centres see above Enrolment will target up to 30 participants aiming for 6-14 participants per centre to allow for dropouts during run-in
Consent
Written informed consent will be obtained from all parentsguardians
Screening and baseline Assessment
Eligible participants will undergo a baseline assessment including a blood sample for the measurement of HbA1c Height and weight will be recorded Validated questionnaires will be completed by parentsguardians
Pre-Study Training and Run-in
Training sessions on the use of the study CGM insulin pump and hybrid closed-loop insulin delivery will be provided by the research team During the closed-loop training session parentsguardians will operate the system under the supervision of the clinical research team Participants and parentsguardians will use the study CGM insulin pump and hybrid closed-loop insulin delivery during a 2-4 week run-in period For compliance and to assess the ability of the participant to use the study devices safely at least 8 days of CGM data need to be recorded and safe use of study insulin pump and hybrid closed-loop insulin delivery demonstrated during the last 14 days of the run-in period The CGM data will also be used to assess baseline glucose control and may be used for treatment optimisation as necessary
Competency Assessment
Competency on the use of study pumpstudy CGM and hybrid closed-loop insulin delivery will be evaluated by the research team Training may be repeated if required
Randomisation
Eligible participants will be randomised using randomisation software to the initial use of faster insulin aspart with the hybrid closed-loop system or to standard insulin aspart with the hybrid closed-loop system for 8 weeks before crossing over to the other treatment arm
1 Faster insulin aspart with hybrid closed-loop
Participants and their parentsguardians will use the hybrid closed-loop system with faster insulin aspart for 8 weeks at home The participant parentsguardians and the research team will be blinded to the intervention
Crossover assessment
At the end of the first study arm validated questionnaires will be completed by the parentsguardians
2 Standard insulin aspart with hybrid closed-loop
Participants and their parentsguardians will use the hybrid closed-loop system with standard insulin aspart for 8 weeks at home The participant parentsguardians and the research team will be blinded to the intervention
Study contacts
Participants and parentsguardians will be contacted 24 hours after starting each study arm to ensure there are no concerns regarding the study devices Participants will be contacted by the study team emailphone 2 and 4 weeks after the start of each study arm in order to record any adverse events device deficiencies and changes in insulin settings other medical conditions andor medication
In case of any problems related to the technical devices or diabetes management participants and parentsguardians will be able to contact a 24-hour telephone helpline to the local research team The local research team will have access to central 24 hour advice on technical issues
End of study assessments
Height and weight will be recorded Validated questionnaires will be completed by parentsguardians Participants will resume usual care using their pre-study insulin pump
Procedures for safety monitoring during trial
Standard operating procedures for monitoring and reporting of all adverse events will be in place including serious adverse events SAE serious adverse device effects SADE and specific adverse events AE such as severe hypoglycaemia
A data safety and monitoring board DSMB will be informed of all serious adverse events and any unanticipated serious adverse device effects that occur during the study and will review compiled adverse event data at periodic intervals
Criteria for withdrawal of subjects on safety grounds
A participant and parentguardian 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 participant after consideration of the benefitrisk ratio Possible reasons are
1 Serious adverse events
2 Serious protocol violation
3 Non-compliance
4 Failure to satisfy competency assessment
5 Decision by the investigator or the Sponsor that termination is in the participants best medical interest
6 Allergic reaction to insulin
To compare hybrid closed-loop applying faster insulin aspart to hybrid closed-loop applying standard insulin aspart over 8 weeks
Study objectives
The study objective is to compare hybrid closed-loop glucose control using faster insulin aspart with hybrid closed-loop control using standard insulin aspart in very young children with type 1 diabetes
1 EFFICACY The objective is to assess the ability of a hybrid closed-loop system applying faster insulin aspart to maintain CGM glucose levels within the target range from 39 to 100 mmoll in comparison to a hybrid closed-loop system applying standard insulin aspart in very young children with type 1 diabetes
2 SAFETY The objective is to evaluate the safety of closed-loop glucose control using faster insulin aspart compared to standard insulin aspart in terms of episodes and severity of hypoglycaemia frequency of diabetic ketoacidosis DKA and nature and severity of other adverse events
3 UTILITY The objective is to determine the acceptability and duration of use of the closed-loop system
4 HUMAN FACTORS The objective is to assess emotional and behavioural characteristics of parentsguardians and their response to the closed-loop system and clinical trial using validated surveys
Participating clinical centres
1 Addenbrookes Hospital Cambridge University Hospitals NHS Foundation Trust Cambridge
2 John Radcliffe Hospital Oxford University Hospitals NHS Foundation Trust Oxford
3 Nottingham Childrens Hospital Nottingham
4 Alder Hey Childrens Hospital Liverpool
Sample Size
24 children randomised 6-14 participants per centre
Maximum duration of study for a subject
6 months
Recruitment
Participants will be recruited through the paediatric diabetes outpatient clinics at participating clinical centres see above Enrolment will target up to 30 participants aiming for 6-14 participants per centre to allow for dropouts during run-in
Consent
Written informed consent will be obtained from all parentsguardians
Screening and baseline Assessment
Eligible participants will undergo a baseline assessment including a blood sample for the measurement of HbA1c Height and weight will be recorded Validated questionnaires will be completed by parentsguardians
Pre-Study Training and Run-in
Training sessions on the use of the study CGM insulin pump and hybrid closed-loop insulin delivery will be provided by the research team During the closed-loop training session parentsguardians will operate the system under the supervision of the clinical research team Participants and parentsguardians will use the study CGM insulin pump and hybrid closed-loop insulin delivery during a 2-4 week run-in period For compliance and to assess the ability of the participant to use the study devices safely at least 8 days of CGM data need to be recorded and safe use of study insulin pump and hybrid closed-loop insulin delivery demonstrated during the last 14 days of the run-in period The CGM data will also be used to assess baseline glucose control and may be used for treatment optimisation as necessary
Competency Assessment
Competency on the use of study pumpstudy CGM and hybrid closed-loop insulin delivery will be evaluated by the research team Training may be repeated if required
Randomisation
Eligible participants will be randomised using randomisation software to the initial use of faster insulin aspart with the hybrid closed-loop system or to standard insulin aspart with the hybrid closed-loop system for 8 weeks before crossing over to the other treatment arm
1 Faster insulin aspart with hybrid closed-loop
Participants and their parentsguardians will use the hybrid closed-loop system with faster insulin aspart for 8 weeks at home The participant parentsguardians and the research team will be blinded to the intervention
Crossover assessment
At the end of the first study arm validated questionnaires will be completed by the parentsguardians
2 Standard insulin aspart with hybrid closed-loop
Participants and their parentsguardians will use the hybrid closed-loop system with standard insulin aspart for 8 weeks at home The participant parentsguardians and the research team will be blinded to the intervention
Study contacts
Participants and parentsguardians will be contacted 24 hours after starting each study arm to ensure there are no concerns regarding the study devices Participants will be contacted by the study team emailphone 2 and 4 weeks after the start of each study arm in order to record any adverse events device deficiencies and changes in insulin settings other medical conditions andor medication
In case of any problems related to the technical devices or diabetes management participants and parentsguardians will be able to contact a 24-hour telephone helpline to the local research team The local research team will have access to central 24 hour advice on technical issues
End of study assessments
Height and weight will be recorded Validated questionnaires will be completed by parentsguardians Participants will resume usual care using their pre-study insulin pump
Procedures for safety monitoring during trial
Standard operating procedures for monitoring and reporting of all adverse events will be in place including serious adverse events SAE serious adverse device effects SADE and specific adverse events AE such as severe hypoglycaemia
A data safety and monitoring board DSMB will be informed of all serious adverse events and any unanticipated serious adverse device effects that occur during the study and will review compiled adverse event data at periodic intervals
Criteria for withdrawal of subjects on safety grounds
A participant and parentguardian 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 participant after consideration of the benefitrisk ratio Possible reasons are
1 Serious adverse events
2 Serious protocol violation
3 Non-compliance
4 Failure to satisfy competency assessment
5 Decision by the investigator or the Sponsor that termination is in the participants best medical interest
6 Allergic reaction to insulin
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None