Study design: Multicenter,randomized, 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 segment,9-20 eligible patients will be enrolled at the Israeli center only.Each 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 sessions,one 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.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.This segment will consist of two parts. At part 1 each subject will participate in 4weeks-1.5 months period of over nights either using closed-loop with MDLAP or using sensor augmented pump (SAP) therapy.At the end of the first 4 weeks-1.5 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-1.5 months.In case it will be decided to extend the study, additional 4 weeks-1.5 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-1.5 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 parts.In 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 settings,at a diabetes camp and finally at patient's home.
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 settings,at diabetes camp settings and finally at patient's 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, Israel;Ljubljana, 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 center.Data 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 segment,9-20 eligible patients will be enrolled at the Israeli center only.Each 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.In 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 sessions,one 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 patient's 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-1.5 months period of over nights either using closed-loop with MDLAP or using sensor augmented pump (SAP) therapy.At the end of the first 4 weeks-1.5 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-1.5 months.In case it will be decided to extend the study, additional 4 weeks-1.5 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-1.5 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 parts.In 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
151
Treatment with the closed loop MD-logic Artificial Pancreas(MDLAP)System
Standard treatment with sensor augmented pump therapy
Diabetes -Zentrum fuer kinder und jugendliche
Hanover, Germany
Schneider Children's Medical center
Petah Tikva, Israel
University Children's Hospital
Ljubljana, Slovenia
Number of hypoglycemic events
Number of overnight hypoglycemic events below 63 mg/dl, between bed time to 07:00
Time frame: final visit (day 26 for participants at segment 1, day 14 for participants in segment 2 and 4 and day 20 for participants in segment 3)
Time spent in hypoglycemia
Reduction of time spent in hypoglycemia defined as sensor glucose level below 60 mg/dL at segments 1\&2 below 63 mg/dl at segment 3 and below 70 mg/dl in segment 5
Time frame: final visit (day 26 for participants at segment 1 , day 14 for participants in segment 2 and day 20 for participants in segment 3, 4 weeks-1.5 months for participants in segment 5)
Reduction in overnight mean glucose level
Reduction in overnight mean glucose level
Time frame: final visit (day 26 for participants at segment 1 and day 14 for participants in segment 2)
Increase in time spent in the target range
Increase in time spent in the target range defined as sensor glucose level within 63 to 140 mg/dl (3.5 to 7.8 mmol/l)
Time frame: day 14 for participants in segment 4
Increase in time spent in the target range of sensor glucose level within 70-180 mg/dl
Increase in time spent in the target range of sensor glucose level within 70-180 mg/dl
Time frame: day 20 for participants in segment 4 part 2 and day 56 for participants in segment 6
Sleep efficacy
Sleep efficacy as measured by Actigraph
Time frame: final visit (after7 months for participants at segment 5 part 2A)
Percentage of time spent in the target range
Percentage of time spent in the target range,defined as sensor glucose level within 63 to 140 mg/dl (3.5 to 7.8 mmol/l)and between 70 to 140 mg/dl(3.9 to 7.8 mmol/L)
Time frame: final visit (day 26 for participants at segment 1 , day 14 for participants in segment 2 and 4 and day 20 for participants in segment 3)
Percentage of time spent in the tight target range
Percentage of time spent in the target range, defined as sensor glucose level within 80 to 120 mg/dl (3.5 to 7.8 mmol/l)
Time frame: final visit (day 26 for participants at segment 1, day 14 for participants in segment 2 and 4 and day 20 for participants in segment 3)
Average (SD) of blood glucose levels
Average (SD) of blood glucose levels
Time frame: final visit (day 26 for participants at segment 1and 4 and day 14 for participants in segment 2, day 20 for participants in segment 3, day 20 for participants in segment 4 part 2 and day 56 for participants in segment 6)
Percentage of time spent below 60 mg/dl and below 70 mg/dl
Percentage of time spent below 60 mg/dl and below 70 mg/dl
Time frame: final visit (day 26 for participants at segment 1, day 14 for participants in segment 2 and 4 and day 20 for participants in segment 3)
Percentage of time spent above 140, 180, 250 mg/dl (7.8, 10, 13.9 mmol/l)
Percentage of time spent above 140, 180, 250 mg/dl (7.8, 10, 13.9 mmol/l)
Time frame: final visit (day 26 for participants at segment 1, day 14 for participants in segment 2 and 4 and day 20 for participants in segment 3 )
Glucose variability
Glucose variability
Time frame: final visit (day 26 for participants at segment 1, day 14 for participants in segment 2 and 4 and day 20 for participants in segment 3 )
Control Variability Grid Analysis (CVGA)
Control Variability Grid Analysis (CVGA)
Time frame: final visit (day 26 for participants at segment 1 and day 14 for participants in segment 2)
number of accurate alerts related to the remote safety and control diabetes management system
number of accurate alerts related to the remote safety and control diabetes management system
Time frame: final visit (day 26 for participants at segment 1 and day 14 for participants in segment 2)
Number of hypoglycemic events below 60 and 70 mg/dl (3.3, 3.9 mmol/l)
Number of hypoglycemic events below 60 and 70 mg/dl (3.3, 3.9 mmol/l)
Time frame: final visit (day 26 for participants at segment 1, day 14 for participants in segment 2 and 4 and day 20 for participants in segment 3)
Area under the curve <60,<63,<70,>140,>180,>250 mg/dl(3.3,3.5,3.9,7.8,10,13.9)
Area under the curve \<60,\<63,\<70,\>140,\>180,\>250 mg/dl(3.3,3.5,3.9,7.8,10,13.9)
Time frame: final visit (day 26 for participants at segment 1, day 14 for participants in segment 2 and 4 and day 20 for participants in segment 3)
• The percentage of nights mean overnight sensor glucose levels was within 90-140mg/dl (5-7.8 mmol/l)
Time frame: final visit (day 14 ) for participants in segment 4 only
Postprandial peak blood glucose and 2 hours postprandial blood glucose (segment 4 and 6 only)
Time frame: Final visit (day 14 ) for participants in segment 4 part 1, day 20 for participants in segment 4 part 2 and day 56 for participants in segment 6
Artificial Pancreas technical performance, defined as the total frequency of failures
Artificial Pancreas technical performance, defined as The total frequency of failures (number of failures/night) of each following system components: sensor communication, pump communication, controller, user interface
Time frame: Final visit (day 14 ) for participants in segment 4 only
Analysis of the number of sensor data point not received to the artificial pancreas device divided by the total number of possible data points to be received.
Time frame: Final visit (day 14 ) for participants in segment 4 only
Percent time of active closed-loop control
Percent time of active closed-loop control defined as the number of minutes the MD-Logic system was functioning properly (computation of insulin infusion, and insulin actually delivered) divided by the maximum number of minutes the MD-Logic system should have been active (as per protocol)
Time frame: Final visit (day 14) for participants in segment 4 only
sensor accuracy
comparison of paired data points between capillary glucose level and Continuous Glucose Monitoring
Time frame: final visit (day 14 for participants in segment 4 only)
The time spent in hypoglycemia
The time spent in hypoglycemia below 50 mg/dl (2.8 mmol/l).
Time frame: After 4 weeks-1.5 month at segment 5 only (in addition after additional 4 weeks-1.5 months if segment 5 will be extended)
The number of hypoglycemic events below 60 and 50 mg/dl
The number of hypoglycemic events below 60 and 50 mg/dl (event defined duration of at least 20 minutes).
Time frame: After 4 weeks- 1.5 months only at segment 5(in addition after additional 4 weeks-1.5 months if segment 5 will be extended)
The time sensor glucose level spent within 70 to 140 mg/dl (3.9 to 7.8 mmol/l)
Time frame: After 4 weeks- 1.5 months only at segment 5 (in addition after additional 4 weeks-1.5 months if segment 5 will be extended)
The time spent in hyperglycemia
The time spent in hyperglycemia above 240 mg/dl (13.3 mmol/l).
Time frame: After 4 weeks-1.5 monts only at segment 5 (in addition after additional 4 weeks-1.5 months if segment 5 will be extended)
Patient's diabetes treatment satisfaction
Patient's diabetes treatment satisfaction using Diabetes Treatment Satisfaction Questionnaire
Time frame: After 4 weeks-1.5 months only at segment 5 (in addition after additional 4 weeks-1.5 months if segment 5 will be extended)
Acceptance and use intention of an Artificial Pancreas
Acceptance and use intention of an Artificial Pancreas for participant and for parents
Time frame: after 4 weeks- 1.5 months only at segment 5(in addition after additional 4 weeks-1.5 months if segment 5 will be extended)
Fear of hypoglycemia
Fear of hypoglycemia using questionaire
Time frame: After 4 weeks- 1.5 months only at segment 5 (in addition after additional 4 weeks-1.5 months if segment 5 will be extended)
Satisfaction with Artificial Pancreas
Satisfaction with Artificial Pancreas using questionaire
Time frame: After 4 weeks- 1.5 months only at segment 5 (in addition after additional 4 weeks-1.5 months if segment 5 will be extended)
Average percentage of overnight operation of the closed-loop control
Time frame: After 4 weeks-1.5 months only at segment 5 (in addition after additional 4 weeks-1.5 months if segment 5 will be extended)
Percentage of time spent below 50, 60, 70 mg/dl
Percentage of time spent below 50, 60, 70 mg/dl
Time frame: day 20 for participants in segment 4 part 2 and day 56 for participants in segment 6
Number of hypoglycemic events below 50, 60, 70 mg/dl
Number of hypoglycemic events below 50, 60, 70 mg/dl
Time frame: day 20 for participants in segment 4 part 2 and day 56 for participants in segment 6
Percentage of time spent above 180, 250 mg/dl
Percentage of time spent above 180, 250 mg/dl
Time frame: day 20 for participants in segment 4 part 2 and day 56 for participants in segment 6
Number of readings below 70 mg/dl
Time frame: day 20 for participants in segment 4 part 2 and day 56 for participants in segment 6
Automatic Caller System (ACS) technical performance and number of accurate alerts
Time frame: final visit (after 7 months for participants at segment 5 part 2)
number of research team intervention
Time frame: final visit (after 7 months for participants at segment 5 part 2)
HbA1c
Time frame: final visit (after 7 months for participants at segment 5 part 2)
Number of awake bouts per night
Number of awake bouts per night as measured by Actigraph
Time frame: final visit (after 7 months for participants at segment 5 part 2A)
Total wake up time per night
Total wake up time per night as measured by Actigraph
Time frame: final visit (after 7 months for participants at segment 5 part 2A
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