Ignite Creation Date:
2024-05-06 @ 8:04 AM
Last Modification Date:
2024-10-26 @ 11:55 AM
Study NCT ID:
NCT02651181
Status:
COMPLETED
Last Update Posted:
2020-01-02
First Post:
2016-01-07
Brief Title:
Feasibility Study to Evaluate the Hybrid-Logic Closed Loop System in Type 1 Diabetes The DREAMED Trail
Sponsor:
Rabin Medical Center
Organization:
Rabin Medical Center
Study Overview
Official Title:
Feasibility Study to Evaluate the Hybrid-Logic Closed Loop System in Type 1 Diabetes -Single-arm Single-center in Clinic Study-The DREAMED Trail
Status:
COMPLETED
Status Verified Date:
2017-01
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:
Closed loop technology has been shown to reduce both hypoglycemia and hyperglycemia as well as reduce glycemic variability
Several groups around the world investigate efforts in developing closed-loop systems Investigators combined two closed-loop systems with different mode of operation in order to enhance the closed-loop system The two systems are Hybrid closed-loop system and the MD-Logic closed-loop system The combined algorithm Hybrid logic closed loop HLCL was tested In silico and was proved to be safe and effective The next step is to test the system in a clinical study in a supervised environment in a camp
The two systems were tested separately in several clinical studies and were proven to be safe and effective in a diverse population of patients with type 1 diabetes The MD-Logic system for overnight use the GlucoSitter has a CE mark
The purpose of this study is to collect data on the feasibility of the HLCL system in a camp setting
Several groups around the world investigate efforts in developing closed-loop systems Investigators combined two closed-loop systems with different mode of operation in order to enhance the closed-loop system The two systems are Hybrid closed-loop system and the MD-Logic closed-loop system The combined algorithm Hybrid logic closed loop HLCL was tested In silico and was proved to be safe and effective The next step is to test the system in a clinical study in a supervised environment in a camp
The two systems were tested separately in several clinical studies and were proven to be safe and effective in a diverse population of patients with type 1 diabetes The MD-Logic system for overnight use the GlucoSitter has a CE mark
The purpose of this study is to collect data on the feasibility of the HLCL system in a camp setting
Detailed Description:
Closed loop technology has been shown to reduce both hypoglycemia and hyperglycemia as well as reduce glycemic variability
Several groups around the world investigate efforts in developing closed-loop systems Investigators combined two closed-loop systems with different mode of operation in order to enhance the closed-loop system The two systems are Hybrid closed-loop system and the MD-Logic closed-loop system The combined algorithm Hybrid logic closed loop HLCL was tested In silico and was proved to be safe and effective The next step is to test the system in a clinical study in a supervised environment in a camp
The two systems were tested separately in several clinical studies and were proven to be safe and effective in a diverse population of patients with type 1 diabetes The MD-Logic system for overnight use the GlucoSitter has a CE mark
The primary objective of the study is to characterize the overall management of the glycemic control using this system including Safety The data collected in this study will be used to confirmdevelop the HLCL System further
Secondary objectives of this study include evaluation of the HLCL system in a monitored setting camp with the following stressesExercise high carbohydrate and high fat meals
This study is a single-arm single-center in clinic Investigation in subjects with type 1 diabetes on insulin pump therapy
Run-in Period
A total of up to 10 subjects will be enrolled age 18-40 A minimum of 6 days run-in period with sensor augmented pump will be used to collect sensors and insulin data and to allow the subject to become familiar
Study Period - Camp
Following the run-in period subjects will participate in a 5 day 4 night study period in a camp setting during which the HLCL feature will be studied
Several groups around the world investigate efforts in developing closed-loop systems Investigators combined two closed-loop systems with different mode of operation in order to enhance the closed-loop system The two systems are Hybrid closed-loop system and the MD-Logic closed-loop system The combined algorithm Hybrid logic closed loop HLCL was tested In silico and was proved to be safe and effective The next step is to test the system in a clinical study in a supervised environment in a camp
The two systems were tested separately in several clinical studies and were proven to be safe and effective in a diverse population of patients with type 1 diabetes The MD-Logic system for overnight use the GlucoSitter has a CE mark
The primary objective of the study is to characterize the overall management of the glycemic control using this system including Safety The data collected in this study will be used to confirmdevelop the HLCL System further
Secondary objectives of this study include evaluation of the HLCL system in a monitored setting camp with the following stressesExercise high carbohydrate and high fat meals
This study is a single-arm single-center in clinic Investigation in subjects with type 1 diabetes on insulin pump therapy
Run-in Period
A total of up to 10 subjects will be enrolled age 18-40 A minimum of 6 days run-in period with sensor augmented pump will be used to collect sensors and insulin data and to allow the subject to become familiar
Study Period - Camp
Following the run-in period subjects will participate in a 5 day 4 night study period in a camp setting during which the HLCL feature will be studied
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