Ignite Creation Date:
2024-05-06 @ 8:35 AM
Last Modification Date:
2024-10-26 @ 12:02 PM
Study NCT ID:
NCT02776696
Status:
COMPLETED
Last Update Posted:
2019-12-27
First Post:
2016-05-16
Brief Title:
Comparison of Two Closed-Loop Strategies for Glucose Control in Type 1 Diabetes The DREMED Trail- 2
Sponsor:
Rabin Medical Center
Organization:
Rabin Medical Center
Study Overview
Official Title:
Comparison of Two Closed-Loop Strategies for Glucose Control in Type 1 Diabetes The DREMED Trail- 2
Status:
COMPLETED
Status Verified Date:
2018-09
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:
None
Brief Summary:
The purpose of the study is to compare two closed-loop strategies in terms of glycemic control in Type 1 Diabetes during a camp setting
The proposed study is a four-segment feasibility study One segment is a proof of concept study with two parts conducted as in-patient clinic study the second segment is two-arms cross-over randomized and single-center and the third segment is four-arms parallel randomized and single-center in diabetes camp study in subjects with type 1 diabetes on insulin pump therapy and the forth segment is a single arm feasibility in a diabetes camp setting followed by a 3 weeks period at home
Segment 1 will be divided into two parts part 1 is a single arm pilot study aim to asses logistical and safety issues in 12 patients and part 2 is a randomized cross over study aim to evaluate glucose performance using closed-loop control Part 2-is a randomized cross-over two arms in-patient study A total of 12 patients will participate in this part of the study Following the run-in period subjects will be randomized to participate in two periods of closed-loop treatment each period will last 36 hours in hospital setting During the first period glycemic control will be controlled by the Hybrid closed-loop system and during the second period by Hybrid Logic closed-loop system The sequence of treatment first period HCL therapy than AHCL or vice versa will be randomly assigned
Segment 2 is a randomized cross-over two arms Camp Study including up to 30 patients Following the run-in period subjects will be randomized to participate in two periods of closed-loop treatment each period will last 2days in a camp setting the total duration of the camp will be up to 6 days In one period glycemic control will be controlled by the Hybrid closed-loop system and another period by Hybrid Logic closed-loop system The sequence of treatment first period HCL therapy than AHCL or vice versa will be randomly assigned
Segment 3 is a randomized parallel four arm Camp Study including up to 80 patients Following the run-in period subjects will be randomized to participate in one of 4 intervention arms of closed-loop treatment in camp settings The duration of the camp will be 12 days in which glycemic control will be controlled by one of 4 versions of closed-loop system Hybrid Closed Loop HCL or one of 3 versions of Advanced Hybrid Closed Loop AHCL
Segment 4 is a single arm feasibility study in a diabetes camp setting followed by a three week period at home After the completion of segments 1-3 the AHCL system will be optimized and a new version of the system will be created for use in segment 4 Up to 20 subjects will participate in this part of the study Following a minimum of 5 days run-in period subjects will be placed in a camp setting and closed loop will be initiated Subjects will remain in closed loop for 5 days and will have 3 days of challenges including missed meal bolus late meal bolus and moderate-intensity exercise At the conclusion of the camp subjects will continue to use the system at home in Auto Mode for a period of 21 days
The proposed study is a four-segment feasibility study One segment is a proof of concept study with two parts conducted as in-patient clinic study the second segment is two-arms cross-over randomized and single-center and the third segment is four-arms parallel randomized and single-center in diabetes camp study in subjects with type 1 diabetes on insulin pump therapy and the forth segment is a single arm feasibility in a diabetes camp setting followed by a 3 weeks period at home
Segment 1 will be divided into two parts part 1 is a single arm pilot study aim to asses logistical and safety issues in 12 patients and part 2 is a randomized cross over study aim to evaluate glucose performance using closed-loop control Part 2-is a randomized cross-over two arms in-patient study A total of 12 patients will participate in this part of the study Following the run-in period subjects will be randomized to participate in two periods of closed-loop treatment each period will last 36 hours in hospital setting During the first period glycemic control will be controlled by the Hybrid closed-loop system and during the second period by Hybrid Logic closed-loop system The sequence of treatment first period HCL therapy than AHCL or vice versa will be randomly assigned
Segment 2 is a randomized cross-over two arms Camp Study including up to 30 patients Following the run-in period subjects will be randomized to participate in two periods of closed-loop treatment each period will last 2days in a camp setting the total duration of the camp will be up to 6 days In one period glycemic control will be controlled by the Hybrid closed-loop system and another period by Hybrid Logic closed-loop system The sequence of treatment first period HCL therapy than AHCL or vice versa will be randomly assigned
Segment 3 is a randomized parallel four arm Camp Study including up to 80 patients Following the run-in period subjects will be randomized to participate in one of 4 intervention arms of closed-loop treatment in camp settings The duration of the camp will be 12 days in which glycemic control will be controlled by one of 4 versions of closed-loop system Hybrid Closed Loop HCL or one of 3 versions of Advanced Hybrid Closed Loop AHCL
Segment 4 is a single arm feasibility study in a diabetes camp setting followed by a three week period at home After the completion of segments 1-3 the AHCL system will be optimized and a new version of the system will be created for use in segment 4 Up to 20 subjects will participate in this part of the study Following a minimum of 5 days run-in period subjects will be placed in a camp setting and closed loop will be initiated Subjects will remain in closed loop for 5 days and will have 3 days of challenges including missed meal bolus late meal bolus and moderate-intensity exercise At the conclusion of the camp subjects will continue to use the system at home in Auto Mode for a period of 21 days
Detailed Description:
None
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