Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06579404
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-16
Brief Title:
Closed-loop in Adults With Type 2 Diabetes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open-label Multinational Multicentre Randomised Single-period Parallel Study to Assess the Efficacy Safety and Utility of Fully Closed-loop Insulin Delivery Compared to Standard Insulin Therapy With CGM in Adults With Type 2 Diabetes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
COYOTE
Brief Summary:
The main objective of this study is to determine the efficacy safety and utility of fully closed-loop glucose control in the home setting in adults with type 2 diabetes T2D This study builds on previous and on-going studies of closed-loop systems that have been performed in Cambridge in adults with type 2 diabetes in the inpatient and in the home setting and in children and adults with type 1 diabetes
This is an open-label multi-national multi-centre randomised single-period parallel study involving a run-in period followed by a 26-week intervention period during which glucose levels will be controlled either by a fully closed-loop system or by participants usual insulin therapy with continuous glucose monitoring A total of up to 224 adults with type 2 diabetes using insulin will be recruited through outpatient diabetes clinics primary care centres social media advertising and other established methods at participating centres Participants will receive appropriate training in the safe use of the study devices
The primary outcome is the between group difference in HbA1c at 26 weeks Other key outcomes include the time spent with glucose levels within above and below the target glucose range 39-100mmolL and mean sensor glucose as recorded by CGM over the 26 weeks Insulin requirements body weight renal and liver function will also be compared Safety evaluation comprises severe hypoglycaemic episodes and other adverse and serious adverse events Human factors outcomes include CGM closed-loop usage questionnaires and semi-structured interviews
This is an open-label multi-national multi-centre randomised single-period parallel study involving a run-in period followed by a 26-week intervention period during which glucose levels will be controlled either by a fully closed-loop system or by participants usual insulin therapy with continuous glucose monitoring A total of up to 224 adults with type 2 diabetes using insulin will be recruited through outpatient diabetes clinics primary care centres social media advertising and other established methods at participating centres Participants will receive appropriate training in the safe use of the study devices
The primary outcome is the between group difference in HbA1c at 26 weeks Other key outcomes include the time spent with glucose levels within above and below the target glucose range 39-100mmolL and mean sensor glucose as recorded by CGM over the 26 weeks Insulin requirements body weight renal and liver function will also be compared Safety evaluation comprises severe hypoglycaemic episodes and other adverse and serious adverse events Human factors outcomes include CGM closed-loop usage questionnaires and semi-structured interviews
Detailed Description:
Purpose of clinical trial
To determine the efficacy safety and utility of fully closed-loop insulin delivery over 26 weeks in the home setting in adults with type 2 diabetes
Study objectives
To determine the efficacy safety and utility of fully closed-loop insulin delivery over 26 weeks in the home setting in adults with type 2 diabetes
1 EFFICACY The objective is to assess the ability of fully closed-loop insulin delivery to improve glucose control as measured by HbA1c primary endpoint and sensor glucose metrics
2 SAFETY The objective is to evaluate the safety of fully closed-loop insulin delivery in terms of episodes and severity of hypoglycaemia and nature and severity of other adverse events
3 UTILITY The objective is to determine the acceptability and duration of use of the CGM and closed-loop system
4 HUMAN FACTORS The objective is to assess cognitive emotional and behavioural characteristics of participants and their response to the closed-loop system using validated questionnaires and semi-structured interviews
Participating clinical centres
UK - Addenbrookes Hospital Cambridge University Hospitals NHS Foundation Trust - Imperial College Healthcare NHS Trust London
- Manchester Royal Infirmary Manchester University NHS Foundation Trust
- Kings College Hospital Kings College Hospital NHS Foundation Trust London
- Guys and St Thomas NHS Foundation Trust
- Norfolk and Norwich University Hospital Norfolk and Norwich University Hospitals NHS Foundation Trust
- University Hospitals of Leicester NHS Trust
Switzerland
- Inselspital Bern University Hospital Bern
France
- Centre Hospitalier Universitaire CHU de Toulouse
Germany
- Medical Center - University of Freiburg
Austria
- Medical University of Graz Graz
Czech Republic
- Diabetes Centre Institute for Clinical and Experimental Medicine Prague
Sample Size
224 participants 112 per group will be randomised Recruitment will target a minimum quota of 25 of participants using basal insulin and a minimum quota of 60 of participants using multiple daily insulin injections
Maximum duration of study for a subject 30 weeks
Recruitment
Participants will be recruited through outpatient diabetes clinics primary care centres social media advertising or other established methods at participating centres
Consent
Participants will be asked to provide written informed consent
Baseline Assessment
Eligible participants will undergo baseline evaluation involving talking a medical history including demographics heightweight waist hip ratio and blood pressure measurement and blood samples for HbA1c fasted lipid profile renal and liver function A urine albumin-creatinine ratio ACR will be performed along with a urine pregnancy test in females of child-bearing age Human factors questionnaires will be completed and a masked glucose sensor will be applied
Run-in Period
During a 2-3 week run-in period participants will use their usual insulin therapy and wear a masked CGM system At the end of the run-in period for compliance at least 10 days of CGM data needs to be recorded CGM data during the run-in period will be used to assess baseline glucose control before the start of the intervention phase
Randomisation
Eligible participants will be randomised in a 11 ratio using central randomisation software to fully closed-loop or standard insulin therapy with CGM for 26 weeks Randomisation will be stratified by site and baseline HbA1c
Fully closed loop insulin delivery intervention arm
Following randomisation participants in the closed-loop group will receive training on the study CGM study insulin pump and closed-loop App during a 1-2 hour outpatient session Competency on the use of the closed-loop system will be evaluated Further training may be delivered as required Participants will be advised to use the closed-loop system for the next 26 weeks
Standard insulin therapy with CGM control arm
Following randomisation participants in the control group will use their usual insulin therapy and the study CGM Training on the use of the CGM will be provided Participants will use standard insulin therapy and CGM for the next 26 weeks
3 month study visit Weight waist hip ratio and blood pressure will be measured and a blood sample will be taken for measurement of HbA1c fasted lipid profile renal and liver function Data from the closed-loop system and CGM system will be reviewed Human factors questionnaires will be completed
End of study assessments
Weight waist hip ratio and blood pressure will be measured and a blood sample will be taken for measurement of HbA1c fasted lipid profile renal and liver function Urinary ACR will be measured Human factors questionnaires will be completed and a subset of participants will participate in interviews Study devices will be returned and participants will resume their usual insulin therapy and standard glucose monitoring
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
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 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
Participant is unable to demonstrate safe use of study devices as judged by the investigator
Serious adverse events
Significant protocol violation or non-compliance
Decision by the investigator or the Sponsor that termination is in the participants best medical interest
Pregnancy planned pregnancy or breast feeding
Allergic reaction to insulin or severe allergic reaction to adhesive surface of infusion set or glucose sensor
Technical grounds eg participant relocates
To determine the efficacy safety and utility of fully closed-loop insulin delivery over 26 weeks in the home setting in adults with type 2 diabetes
Study objectives
To determine the efficacy safety and utility of fully closed-loop insulin delivery over 26 weeks in the home setting in adults with type 2 diabetes
1 EFFICACY The objective is to assess the ability of fully closed-loop insulin delivery to improve glucose control as measured by HbA1c primary endpoint and sensor glucose metrics
2 SAFETY The objective is to evaluate the safety of fully closed-loop insulin delivery in terms of episodes and severity of hypoglycaemia and nature and severity of other adverse events
3 UTILITY The objective is to determine the acceptability and duration of use of the CGM and closed-loop system
4 HUMAN FACTORS The objective is to assess cognitive emotional and behavioural characteristics of participants and their response to the closed-loop system using validated questionnaires and semi-structured interviews
Participating clinical centres
UK - Addenbrookes Hospital Cambridge University Hospitals NHS Foundation Trust - Imperial College Healthcare NHS Trust London
- Manchester Royal Infirmary Manchester University NHS Foundation Trust
- Kings College Hospital Kings College Hospital NHS Foundation Trust London
- Guys and St Thomas NHS Foundation Trust
- Norfolk and Norwich University Hospital Norfolk and Norwich University Hospitals NHS Foundation Trust
- University Hospitals of Leicester NHS Trust
Switzerland
- Inselspital Bern University Hospital Bern
France
- Centre Hospitalier Universitaire CHU de Toulouse
Germany
- Medical Center - University of Freiburg
Austria
- Medical University of Graz Graz
Czech Republic
- Diabetes Centre Institute for Clinical and Experimental Medicine Prague
Sample Size
224 participants 112 per group will be randomised Recruitment will target a minimum quota of 25 of participants using basal insulin and a minimum quota of 60 of participants using multiple daily insulin injections
Maximum duration of study for a subject 30 weeks
Recruitment
Participants will be recruited through outpatient diabetes clinics primary care centres social media advertising or other established methods at participating centres
Consent
Participants will be asked to provide written informed consent
Baseline Assessment
Eligible participants will undergo baseline evaluation involving talking a medical history including demographics heightweight waist hip ratio and blood pressure measurement and blood samples for HbA1c fasted lipid profile renal and liver function A urine albumin-creatinine ratio ACR will be performed along with a urine pregnancy test in females of child-bearing age Human factors questionnaires will be completed and a masked glucose sensor will be applied
Run-in Period
During a 2-3 week run-in period participants will use their usual insulin therapy and wear a masked CGM system At the end of the run-in period for compliance at least 10 days of CGM data needs to be recorded CGM data during the run-in period will be used to assess baseline glucose control before the start of the intervention phase
Randomisation
Eligible participants will be randomised in a 11 ratio using central randomisation software to fully closed-loop or standard insulin therapy with CGM for 26 weeks Randomisation will be stratified by site and baseline HbA1c
Fully closed loop insulin delivery intervention arm
Following randomisation participants in the closed-loop group will receive training on the study CGM study insulin pump and closed-loop App during a 1-2 hour outpatient session Competency on the use of the closed-loop system will be evaluated Further training may be delivered as required Participants will be advised to use the closed-loop system for the next 26 weeks
Standard insulin therapy with CGM control arm
Following randomisation participants in the control group will use their usual insulin therapy and the study CGM Training on the use of the CGM will be provided Participants will use standard insulin therapy and CGM for the next 26 weeks
3 month study visit Weight waist hip ratio and blood pressure will be measured and a blood sample will be taken for measurement of HbA1c fasted lipid profile renal and liver function Data from the closed-loop system and CGM system will be reviewed Human factors questionnaires will be completed
End of study assessments
Weight waist hip ratio and blood pressure will be measured and a blood sample will be taken for measurement of HbA1c fasted lipid profile renal and liver function Urinary ACR will be measured Human factors questionnaires will be completed and a subset of participants will participate in interviews Study devices will be returned and participants will resume their usual insulin therapy and standard glucose monitoring
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
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 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
Participant is unable to demonstrate safe use of study devices as judged by the investigator
Serious adverse events
Significant protocol violation or non-compliance
Decision by the investigator or the Sponsor that termination is in the participants best medical interest
Pregnancy planned pregnancy or breast feeding
Allergic reaction to insulin or severe allergic reaction to adhesive surface of infusion set or glucose sensor
Technical grounds eg participant 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