Ignite Creation Date:
2024-05-05 @ 11:01 PM
Last Modification Date:
2024-10-26 @ 10:27 AM
Study NCT ID:
NCT01238406
Status:
COMPLETED
Last Update Posted:
2017-01-11
First Post:
2010-11-09
Brief Title:
Overnight MD-Logic
Sponsor:
Rabin Medical Center
Organization:
Rabin Medical Center
Study Overview
Official Title:
Multicenter Prospective Open Label Cross Over Pilot Trial to Evaluate Blood Glucose Control Overnight Under Closed-loop Insulin Delivery With MD Logic Artificial Pancreas MDLAPSystem in Patients With Type 1 Diabetes
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:
Study design Multicenterrandomized prospective open label cross over six segments pilot trial to evaluate blood glucose control overnight under closed-loop insulin delivery with MD-Logic Artificial Pancreas MDLAP system in patients with type 1 diabetes
on the first segment 15 eligible subjects will be enrolled from the three participating centers 5 patients at each center All 15 patients will participate in the overnight closed loop session in the hospital settings
On the second segment 54 eligible subjects will be enrolled 18 at each center Each subject will participate in the two consecutive overnight sessions in diabetes camp settings one under closed-loop with MDLAP and one under sensor augmented pump therapy
In the third segment9-20 eligible patients will be enrolled at the Israeli center onlyEach subject will participate in up to four consecutive overnight under closed loop with MDLAP and up to four additional overnight under regular sensor augmented pump therapy at home
On the fourth segment 45-60 patients will be enrolled at the Israeli center only This segment will be conducted at a diabetes camp and will consist of two main parts In part 1 15-20 patients will be randomized to participate in one of the two groups 2-4 nights under closed loop control while the MD-Logic learning algorithm is activated or 2-4 nights under closed loop control without activating the MD-Logic learning algorithm In part 2 of the forth segment 30-40 patients will participate in two consecutive24-48 hours sessionsone under closed loop control and the second under sensor augmented pump therapy
On the fifth segment 40-80 eligible patients will be enrolled at the Israeli center onlyThe first 10 patients will participate in a pilot session and data gathered at this pilot session will not be used at the final analysisThis segment will consist of two parts At part 1 each subject will participate in 4weeks-15 months period of over nights either using closed-loop with MDLAP or using sensor augmented pump SAP therapyAt the end of the first 4 weeks-15 months of the study statistical analysis will be performed in order to decide whether to extend the study with an optional period of extra 4 weeks-15 monthsIn case it will be decided to extend the study additional 4 weeks-15 months intervention period following completion of final visit activities will be offered to participants Subjects that have participated in the control group sensor augmented pump therapy will be offered the opportunity to continue to 4 weeks-15 months of closed-loop control and the study group will be offered to switch to sensor augmented pump therapy In segment 5 part 2 up to 40 patients will be enrolled Each patient will participate in 3 months study period either using overnight closed loop under MDLAP or sensor augmented pump therapyParticipants in segment 5 part 2 will be offered to participate in part 2A At this part sleep quality assessment will be made by using actigraf and sleep questionnaire At the end of this period an optional 3 months extension period will be offered with the other arm cross-over
Segment 6 will be consist of two main partsIn part 1 up to 40 eligible patients will be enrolled at the Israeli center only Each subject will participate in up to 72 hours of closed-loop with MDLAP at home and up to 72 hours under regular sensor augmented pump therapy The sequence of the treatment intervention will be randomly assigned The sequence of the treatment intervention will be randomly assigned In part 2 of this segment 40 eligible patients will enrolled at the Israeli center only Each subject will participate in up to 2 weeks of closed loop with MDLAP at home and up to 2 weeks under regular sensor augmented pump therapy The sequence of the treatment intervention will be randomly assigned
Objectives The objective of this feasibility study is to evaluate the safety and efficacy of blood glucose control using the MD-Logic Artificial Pancreas System in individuals with type 1 diabetes in the hospital settingsat a diabetes camp and finally at patients home
on the first segment 15 eligible subjects will be enrolled from the three participating centers 5 patients at each center All 15 patients will participate in the overnight closed loop session in the hospital settings
On the second segment 54 eligible subjects will be enrolled 18 at each center Each subject will participate in the two consecutive overnight sessions in diabetes camp settings one under closed-loop with MDLAP and one under sensor augmented pump therapy
In the third segment9-20 eligible patients will be enrolled at the Israeli center onlyEach subject will participate in up to four consecutive overnight under closed loop with MDLAP and up to four additional overnight under regular sensor augmented pump therapy at home
On the fourth segment 45-60 patients will be enrolled at the Israeli center only This segment will be conducted at a diabetes camp and will consist of two main parts In part 1 15-20 patients will be randomized to participate in one of the two groups 2-4 nights under closed loop control while the MD-Logic learning algorithm is activated or 2-4 nights under closed loop control without activating the MD-Logic learning algorithm In part 2 of the forth segment 30-40 patients will participate in two consecutive24-48 hours sessionsone under closed loop control and the second under sensor augmented pump therapy
On the fifth segment 40-80 eligible patients will be enrolled at the Israeli center onlyThe first 10 patients will participate in a pilot session and data gathered at this pilot session will not be used at the final analysisThis segment will consist of two parts At part 1 each subject will participate in 4weeks-15 months period of over nights either using closed-loop with MDLAP or using sensor augmented pump SAP therapyAt the end of the first 4 weeks-15 months of the study statistical analysis will be performed in order to decide whether to extend the study with an optional period of extra 4 weeks-15 monthsIn case it will be decided to extend the study additional 4 weeks-15 months intervention period following completion of final visit activities will be offered to participants Subjects that have participated in the control group sensor augmented pump therapy will be offered the opportunity to continue to 4 weeks-15 months of closed-loop control and the study group will be offered to switch to sensor augmented pump therapy In segment 5 part 2 up to 40 patients will be enrolled Each patient will participate in 3 months study period either using overnight closed loop under MDLAP or sensor augmented pump therapyParticipants in segment 5 part 2 will be offered to participate in part 2A At this part sleep quality assessment will be made by using actigraf and sleep questionnaire At the end of this period an optional 3 months extension period will be offered with the other arm cross-over
Segment 6 will be consist of two main partsIn part 1 up to 40 eligible patients will be enrolled at the Israeli center only Each subject will participate in up to 72 hours of closed-loop with MDLAP at home and up to 72 hours under regular sensor augmented pump therapy The sequence of the treatment intervention will be randomly assigned The sequence of the treatment intervention will be randomly assigned In part 2 of this segment 40 eligible patients will enrolled at the Israeli center only Each subject will participate in up to 2 weeks of closed loop with MDLAP at home and up to 2 weeks under regular sensor augmented pump therapy The sequence of the treatment intervention will be randomly assigned
Objectives The objective of this feasibility study is to evaluate the safety and efficacy of blood glucose control using the MD-Logic Artificial Pancreas System in individuals with type 1 diabetes in the hospital settingsat a diabetes camp and finally at patients home
Detailed Description:
In the last two decades remarkable technological progress has been made with the development of continuous glucose sensors miniature devices implantable pumps and sensors and wireless communications interest in the closed-loop insulin delivery was revived
Control trails that evaluate the clinical benefits of continuous glucose sensor have shown improved HbA1c with no significant increase in sever hypoglycemia trend towards lower hypoglycemic episodes although not significant and no significant change in sever hypoglycemia One of the main drawbacks of continuous glucose sensor is noncompliant of the patient the flow of information and the need to act accordingly makes this devise a burden for some patients Theoretically subcutaneous insulin pumps and glucose sensors attached to an artificial pancreas in a closed-loop system can mimic the activity of functioning pancreatic beta cells with strict control of blood glucose levels Such a system may also offer an opportunity to free the patients from the daily burden of dealing with their diabetes
We developed the MD-Logic Artificial Pancreas MDLAP which is based on a model which imitates the logic of diabetes care givers
We aimed to evaluate blood glucose control overnight under closed- loop insulin delivery with MD-Logic Artificial Pancreas MDLAP system in patients with type 1 diabetes in the hospital settingsat diabetes camp settings and finally at patients home
Study Objectives To determine the safety and efficacy of using the MDLAP system to automatically control blood glucose in type 1 diabetic patients
Study Scope This is a three center prospective pilot trail to evaluate blood glucose control under closed-loop insulin delivery with MD-Logic Artificial Pancreas MDLAP system in patients with type 1 diabetes being conducted in Tel Aviv IsraelLjubljana Slovenia and Hannover Germany
Study will be consist from six segments
In segment 1 15 eligible patients will be enrolled for the pilot study 5 patients will be recruited at each centerData generated from the first patient at each center will not be included at the final statistical analysis and will be used to assess logistical and training issues only
On the second segment 54 eligible subjects will be enrolled 18 at each center Each subject will participate in the two consecutive overnight sessions in diabetes camp settings one under closed-loop with MDLAP and one under sensor augmented pump therapy Staying at a camp can represent the home setting but has on site the support of a medical team trained in diabetes A remote safety and control diabetes management system will be utilized at this segment to enable the supervising personnel to alert the patient and intervene in cases of impending hypoglycemia long standing hyperglycemia and technical faults of any component of the AP system
In the third segment9-20 eligible patients will be enrolled at the Israeli center onlyEach subject will participate in up to four consecutive overnight under closed loop with MDLAP and up to four additional overnight under regular sensor augmented pump therapy at homeIn similar to segment 2 we will use also at segment 3 the remote safety and control diabetes management system which enable the supervising personnel to alert the patient or parents and intervene in cases of impending hypoglycemia long standing hyperglycemia and technical faults of any component of the AP system
On the fourth segment 45-60 patients will be enrolled at the Israeli center only This segment will be conducted at a diabetes camp and will consist of two main parts In part 1 15-20 patients will be randomized to participate in one of the two groups 2-4 nights under closed loop control while the MD-Logic learning algorithm is activated or 2-4 nights under closed loop control without activating the MD-Logic learning algorithm In part 2 of the forth segment 30-40 patients will participate in two consecutive 24-48 hours sessionsone under closed loop control and the second under sensor augmented pump therapy
On the fifth segment 40-80 eligible patients will be enrolled at the Israeli center only and will be conducted at patients home This segment will consist of two main parts The first 10 patients will participate in a pilot session and data gathered at this pilot session will not be used at the final analysis At part 1 each subject will participate in 4 weeks-15 months period of over nights either using closed-loop with MDLAP or using sensor augmented pump SAP therapyAt the end of the first 4 weeks-15 months of the study statistical analysis will be performed in order to decide whether to extend the study with an optional period of extra 4 weeks-15 monthsIn case it will be decided to extend the study additional 4 weeks-15 months intervention period following completion of final visit activities will be offered to participants Subjects that have participated in the control group sensor augmented pump therapy will be offered the opportunity to continue to 4 weeks-15 months of closed-loop control and the study group will be offered to switch to sensor augmented pump therapy In segment 5 part 2 up to 40 patients will be enrolled Each patient will participate in 3 months study period either using overnight closed loop under MDLAP or sensor augmented pump therapy Participants in segment 5 part 2 will be offered to participate in part 2A At this part sleep quality assessment will be made by using actigraf and sleep questionnaire At the end of this period an optional 3 months extension period will be offered with the other arm cross-over
Segment 6 will be consist of two main partsIn part 1 up to 40 eligible patients will be enrolled at the Israeli center only Each subject will participate in up to 72 hours of closed-loop with MDLAP at home and up to 72 hours under regular sensor augmented pump therapy The sequence of the treatment intervention will be randomly assigned In part 2 of this segment 40 eligible patients will enrolled at the Israeli center only Each subject will participate in up to 2 weeks of closed loop with MDLAP at home and up to 2 weeks under regular sensor augmented pump therapy The sequence of the treatment intervention will be randomly assigned
Control trails that evaluate the clinical benefits of continuous glucose sensor have shown improved HbA1c with no significant increase in sever hypoglycemia trend towards lower hypoglycemic episodes although not significant and no significant change in sever hypoglycemia One of the main drawbacks of continuous glucose sensor is noncompliant of the patient the flow of information and the need to act accordingly makes this devise a burden for some patients Theoretically subcutaneous insulin pumps and glucose sensors attached to an artificial pancreas in a closed-loop system can mimic the activity of functioning pancreatic beta cells with strict control of blood glucose levels Such a system may also offer an opportunity to free the patients from the daily burden of dealing with their diabetes
We developed the MD-Logic Artificial Pancreas MDLAP which is based on a model which imitates the logic of diabetes care givers
We aimed to evaluate blood glucose control overnight under closed- loop insulin delivery with MD-Logic Artificial Pancreas MDLAP system in patients with type 1 diabetes in the hospital settingsat diabetes camp settings and finally at patients home
Study Objectives To determine the safety and efficacy of using the MDLAP system to automatically control blood glucose in type 1 diabetic patients
Study Scope This is a three center prospective pilot trail to evaluate blood glucose control under closed-loop insulin delivery with MD-Logic Artificial Pancreas MDLAP system in patients with type 1 diabetes being conducted in Tel Aviv IsraelLjubljana Slovenia and Hannover Germany
Study will be consist from six segments
In segment 1 15 eligible patients will be enrolled for the pilot study 5 patients will be recruited at each centerData generated from the first patient at each center will not be included at the final statistical analysis and will be used to assess logistical and training issues only
On the second segment 54 eligible subjects will be enrolled 18 at each center Each subject will participate in the two consecutive overnight sessions in diabetes camp settings one under closed-loop with MDLAP and one under sensor augmented pump therapy Staying at a camp can represent the home setting but has on site the support of a medical team trained in diabetes A remote safety and control diabetes management system will be utilized at this segment to enable the supervising personnel to alert the patient and intervene in cases of impending hypoglycemia long standing hyperglycemia and technical faults of any component of the AP system
In the third segment9-20 eligible patients will be enrolled at the Israeli center onlyEach subject will participate in up to four consecutive overnight under closed loop with MDLAP and up to four additional overnight under regular sensor augmented pump therapy at homeIn similar to segment 2 we will use also at segment 3 the remote safety and control diabetes management system which enable the supervising personnel to alert the patient or parents and intervene in cases of impending hypoglycemia long standing hyperglycemia and technical faults of any component of the AP system
On the fourth segment 45-60 patients will be enrolled at the Israeli center only This segment will be conducted at a diabetes camp and will consist of two main parts In part 1 15-20 patients will be randomized to participate in one of the two groups 2-4 nights under closed loop control while the MD-Logic learning algorithm is activated or 2-4 nights under closed loop control without activating the MD-Logic learning algorithm In part 2 of the forth segment 30-40 patients will participate in two consecutive 24-48 hours sessionsone under closed loop control and the second under sensor augmented pump therapy
On the fifth segment 40-80 eligible patients will be enrolled at the Israeli center only and will be conducted at patients home This segment will consist of two main parts The first 10 patients will participate in a pilot session and data gathered at this pilot session will not be used at the final analysis At part 1 each subject will participate in 4 weeks-15 months period of over nights either using closed-loop with MDLAP or using sensor augmented pump SAP therapyAt the end of the first 4 weeks-15 months of the study statistical analysis will be performed in order to decide whether to extend the study with an optional period of extra 4 weeks-15 monthsIn case it will be decided to extend the study additional 4 weeks-15 months intervention period following completion of final visit activities will be offered to participants Subjects that have participated in the control group sensor augmented pump therapy will be offered the opportunity to continue to 4 weeks-15 months of closed-loop control and the study group will be offered to switch to sensor augmented pump therapy In segment 5 part 2 up to 40 patients will be enrolled Each patient will participate in 3 months study period either using overnight closed loop under MDLAP or sensor augmented pump therapy Participants in segment 5 part 2 will be offered to participate in part 2A At this part sleep quality assessment will be made by using actigraf and sleep questionnaire At the end of this period an optional 3 months extension period will be offered with the other arm cross-over
Segment 6 will be consist of two main partsIn part 1 up to 40 eligible patients will be enrolled at the Israeli center only Each subject will participate in up to 72 hours of closed-loop with MDLAP at home and up to 72 hours under regular sensor augmented pump therapy The sequence of the treatment intervention will be randomly assigned In part 2 of this segment 40 eligible patients will enrolled at the Israeli center only Each subject will participate in up to 2 weeks of closed loop with MDLAP at home and up to 2 weeks under regular sensor augmented pump therapy The sequence of the treatment intervention will be randomly assigned
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