Ignite Creation Date:
2024-05-06 @ 7:23 AM
Last Modification Date:
2024-10-26 @ 11:47 AM
Study NCT ID:
NCT02523131
Status:
COMPLETED
Last Update Posted:
2018-03-13
First Post:
2015-08-09
Brief Title:
Home Testing of Day and Night Closed Loop With Pump Suspend Feature
Sponsor:
University of Cambridge
Organization:
University of Cambridge
Study Overview
Official Title:
An Open-label Multi-centre Randomised Single-period Parallel Design Study to Assess the Efficacy Safety Utility and Psychosocial Effect of 12 Week Day and Night Automated Closed Loop Glucose Control Combined With Pump Suspend Feature Compared to Sensor Augmented Insulin Pump Therapy in Youth and Adults With Type 1 Diabetes With Sub-optimal Glucose Control Under Free Living Conditions
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
APCam11
Brief Summary:
The main study objective is to determine whether day and night automated closed loop glucose control combined with pump suspend feature will improve glucose control and reduce the burden of hypoglycaemia compared to sensor augmented insulin pump therapy alone
This is an open-label multi-centre multi-national single-period randomised parallel group design study involving a three-month period of home study during which day and night glucose levels will be controlled either by a closed loop system combined with pump suspend feature intervention group or by sensor augmented insulin pump therapy control group
It is expected that up to 100 subjects aiming for 84 randomised subjects 42 youth 6 to 21 years and 42 adults 22 years and older with type 1 diabetes will be recruited through paediatric and adult outpatient diabetes clinics in each of the investigation centres Subjects who drop out within the first four weeks of the intervention may be replaced Participants will all be on subcutaneous insulin pump therapy and will have proven competencies both in the use of the study insulin pump and the study CGM device
Subjects in the intervention group will receive appropriate training in the safe use of closed loop insulin delivery system and pump suspend feature All subjects will have regular contact with the study team during the home study phase including 247 telephone support The primary outcome is between group differences in the time spent in the target glucose range from 39 to 100 mmoll 70 to 180mgdl based on CGM glucose levels during the 12 week free living phase Secondary outcomes are HbA1 at the end of treatment period the 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 of severe hypoglycaemic episodes
This is an open-label multi-centre multi-national single-period randomised parallel group design study involving a three-month period of home study during which day and night glucose levels will be controlled either by a closed loop system combined with pump suspend feature intervention group or by sensor augmented insulin pump therapy control group
It is expected that up to 100 subjects aiming for 84 randomised subjects 42 youth 6 to 21 years and 42 adults 22 years and older with type 1 diabetes will be recruited through paediatric and adult outpatient diabetes clinics in each of the investigation centres Subjects who drop out within the first four weeks of the intervention may be replaced Participants will all be on subcutaneous insulin pump therapy and will have proven competencies both in the use of the study insulin pump and the study CGM device
Subjects in the intervention group will receive appropriate training in the safe use of closed loop insulin delivery system and pump suspend feature All subjects will have regular contact with the study team during the home study phase including 247 telephone support The primary outcome is between group differences in the time spent in the target glucose range from 39 to 100 mmoll 70 to 180mgdl based on CGM glucose levels during the 12 week free living phase Secondary outcomes are HbA1 at the end of treatment period the 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 of severe hypoglycaemic episodes
Detailed Description:
Purpose of the study
To determine whether day and night automated closed loop glucose control combined with pump suspend feature will improve glucose control as measured by glycated haemoglobin and reduce the burden of hypoglycaemia compared to sensor augmented insulin pump therapy
Study objectives
1 EFFICACY The objective is to assess efficacy of day and night automated closed loop glucose control combined with pump suspend feature in maintaining glucose levels within the target range from 39 to 100mmoll 70 to 180mgdl based on subcutaneous continuous glucose monitoring CGM as compared to sensor augmented insulin pump therapy
2 SAFETY The objective is to evaluate the safety of day and night automated closed loop glucose control combined with pump suspend feature in terms of episodes of severe hypoglycaemia and other adverse events
3 UTILITY The objective is to determine the frequency and duration of the use of the automated closed loop system
4 PSYCHOSOCIAL Subjects and family members perception in terms of life-style change diabetes management and fear of hypoglycaemia will be assessed using validated questionnaires and semi-structured qualitative interviews Cognitive functions will be assessed using validated computerized cognitive tests
Study design
An open-label multi-centre multi-national randomised single-period parallel group study contrasting day and night automated closed loop glucose control combined with pump suspend feature with sensor augmented insulin pump therapy
Population
84 participants randomised 42 youth and 42 adults Each centre will aim to recruit between 05 and 20 participants
Maximum duration of study for a subject
18 weeks
Recruitment
The subjects will be recruited through the paediatric and adult diabetes outpatient clinics at each centre
Consent
Written consentassent will be obtained from participants andor guardians according to RECIRB requirements
Screening assessment
Eligible participants will undergo a screening evaluation where blood samples for full blood count renal liver thyroid function and anti-transglutaminase antibodies with IgA levels will be taken if not done in the previous 3 months Random C-peptide glucose and HbA1c will also be measured and a urine pregnancy test in females of child-bearing potential
Questionnaires investigating participants quality of life psychosocial functioning and response to their current treatment will be distributed Cognitive assessment will be made using validated computerized cognitive tests
Study Training
Training sessions on the use of study CGM insulin pump and closed loop system for those randomised to the intervention group will be provided by the research team Training session on the use of real-time CGM and on how to interpret real-time and retrospective stored data will be provided to all subjectscarers using written material
Run-in Period
During a 4 week run-in period subjects will use study CGM and insulin pump The research team will contact subject once weekly during the run-in period and subjects will also be able to contact the research team for support and treatment optimisation as necessary For compliance and to assess the ability of the subject to use the CGM and study pump safely at least 12 days of CGM data need to be recorded and safe use of study insulin pump demonstrated during the last 14 days of run-in period
Competency assessment
Competency on the use of study insulin pump and study CGM 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 real-time CGM and pump suspend feature combined with day and night closed loop or to sensor augmented insulin pump therapy
1 Automated day and night closed loop insulin delivery intervention arm combined with pump suspend feature interventional arm
At the start a blood sample will be taken for the measurement of HbA1c and a urine pregnancy test in females of child-bearing potential
A subset of participants will be interviewed to enable their historical diabetes management practices everyday work and family lives and their initial expectations of using closed loop technology to be captured and explored in-depth
Subjects will be admitted to the clinical facility on Day 1 Training on the use of closed loop and pump suspend feature will be provided by the research team During the next 2-4 hours patient will operate the system under the supervision of the clinical team Competency on the use of closed loop system will be evaluated Subjects will use closed loop and pump suspend feature for 12 weeks
2 Sensor augmented insulin pump therapy control arm
A blood sample will be taken for the measurement of HbA1c and a urine pregnancy test in females of child-bearing potential Subjects will use sensor augmented insulin pump therapy without pump suspend feature for 12 weeks
End of study assessments
A blood sample will be taken for measurement of HbA1c
Validated questionnaires evaluating the impact of the devices employed on life change diabetes management will be completed
Cognitive assessment will be made using validated computerized cognitive tests
Follow-up interviews will be undertaken with the subset of participantsfamily members at the end of the closed loop intervention
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
Subjects will be asked to test and record blood or urine ketones if their finger prick glucose is above 140mmoll 250mgdl in the morning on waking as part of the safety assessment for hyperglycaemia
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 patients on safety grounds
A subject parent or guardian 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 benefitrisk ratio Possible reasons are
1 Serious adverse events
2 Significant protocol violation or non-compliance
3 Failure to satisfy competency assessment
4 Decision by the investigator or the sponsor that termination is in the subjects best medical interest
5 Pregnancy planned pregnancy or breast feeding
6 Allergic reaction to insulin
7 Technical grounds eg subject relocates
To determine whether day and night automated closed loop glucose control combined with pump suspend feature will improve glucose control as measured by glycated haemoglobin and reduce the burden of hypoglycaemia compared to sensor augmented insulin pump therapy
Study objectives
1 EFFICACY The objective is to assess efficacy of day and night automated closed loop glucose control combined with pump suspend feature in maintaining glucose levels within the target range from 39 to 100mmoll 70 to 180mgdl based on subcutaneous continuous glucose monitoring CGM as compared to sensor augmented insulin pump therapy
2 SAFETY The objective is to evaluate the safety of day and night automated closed loop glucose control combined with pump suspend feature in terms of episodes of severe hypoglycaemia and other adverse events
3 UTILITY The objective is to determine the frequency and duration of the use of the automated closed loop system
4 PSYCHOSOCIAL Subjects and family members perception in terms of life-style change diabetes management and fear of hypoglycaemia will be assessed using validated questionnaires and semi-structured qualitative interviews Cognitive functions will be assessed using validated computerized cognitive tests
Study design
An open-label multi-centre multi-national randomised single-period parallel group study contrasting day and night automated closed loop glucose control combined with pump suspend feature with sensor augmented insulin pump therapy
Population
84 participants randomised 42 youth and 42 adults Each centre will aim to recruit between 05 and 20 participants
Maximum duration of study for a subject
18 weeks
Recruitment
The subjects will be recruited through the paediatric and adult diabetes outpatient clinics at each centre
Consent
Written consentassent will be obtained from participants andor guardians according to RECIRB requirements
Screening assessment
Eligible participants will undergo a screening evaluation where blood samples for full blood count renal liver thyroid function and anti-transglutaminase antibodies with IgA levels will be taken if not done in the previous 3 months Random C-peptide glucose and HbA1c will also be measured and a urine pregnancy test in females of child-bearing potential
Questionnaires investigating participants quality of life psychosocial functioning and response to their current treatment will be distributed Cognitive assessment will be made using validated computerized cognitive tests
Study Training
Training sessions on the use of study CGM insulin pump and closed loop system for those randomised to the intervention group will be provided by the research team Training session on the use of real-time CGM and on how to interpret real-time and retrospective stored data will be provided to all subjectscarers using written material
Run-in Period
During a 4 week run-in period subjects will use study CGM and insulin pump The research team will contact subject once weekly during the run-in period and subjects will also be able to contact the research team for support and treatment optimisation as necessary For compliance and to assess the ability of the subject to use the CGM and study pump safely at least 12 days of CGM data need to be recorded and safe use of study insulin pump demonstrated during the last 14 days of run-in period
Competency assessment
Competency on the use of study insulin pump and study CGM 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 real-time CGM and pump suspend feature combined with day and night closed loop or to sensor augmented insulin pump therapy
1 Automated day and night closed loop insulin delivery intervention arm combined with pump suspend feature interventional arm
At the start a blood sample will be taken for the measurement of HbA1c and a urine pregnancy test in females of child-bearing potential
A subset of participants will be interviewed to enable their historical diabetes management practices everyday work and family lives and their initial expectations of using closed loop technology to be captured and explored in-depth
Subjects will be admitted to the clinical facility on Day 1 Training on the use of closed loop and pump suspend feature will be provided by the research team During the next 2-4 hours patient will operate the system under the supervision of the clinical team Competency on the use of closed loop system will be evaluated Subjects will use closed loop and pump suspend feature for 12 weeks
2 Sensor augmented insulin pump therapy control arm
A blood sample will be taken for the measurement of HbA1c and a urine pregnancy test in females of child-bearing potential Subjects will use sensor augmented insulin pump therapy without pump suspend feature for 12 weeks
End of study assessments
A blood sample will be taken for measurement of HbA1c
Validated questionnaires evaluating the impact of the devices employed on life change diabetes management will be completed
Cognitive assessment will be made using validated computerized cognitive tests
Follow-up interviews will be undertaken with the subset of participantsfamily members at the end of the closed loop intervention
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
Subjects will be asked to test and record blood or urine ketones if their finger prick glucose is above 140mmoll 250mgdl in the morning on waking as part of the safety assessment for hyperglycaemia
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 patients on safety grounds
A subject parent or guardian 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 benefitrisk ratio Possible reasons are
1 Serious adverse events
2 Significant protocol violation or non-compliance
3 Failure to satisfy competency assessment
4 Decision by the investigator or the sponsor that termination is in the subjects best medical interest
5 Pregnancy planned pregnancy or breast feeding
6 Allergic reaction to insulin
7 Technical grounds eg subject relocates
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None