Type 1 DiabetesNCT01238406
Overnight MD-Logic
A study testing MD-logic Artificial Pancreas (MDLAP) and Standard treatment with insulin pump in people with Type 1 Diabetes, run by Rabin Medical Center at 3 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 65 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- MD-logic Artificial Pancreas (MDLAP) and Standard treatment with insulin pump
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Mar 2011to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject with Type 1 diabetes (>1yr since diagnosis)
- Insulin infusion pump therapy for at least 3 months
- Patients whom uses continuous glucose sensor for at least 2 weeks(for segment 5) or will undergo run-in period of 2 weeks of glucose sensor wear before continue to baseline assessment (only for patients participating at segment 3 and 4)
- Age ≥ 10 years until 65 years
- HbA1c at inclusion ≥ 6.5 and <10
- Patients willing to follow trail instructions
Show all 10Show fewer
- Patients live with at least one other adult person (segment 3, 5, and 6 only)
- BMI Standard Deviation Score - below the 97th percentile for age(in segment 5 and 6 BMI SDS - below the 95th percentile for age)
- An internet connection at patient's home (only for patients participating at segment 3 and 6)
- Patients with care givers who are capable of operating a computer based system
Who cannot join
- Concomitant diseases that influence metabolic control
- Participation in any other interventional study
- Known or suspected allergy to trial products
- Any significant diseases or conditions including psychiatric disorders and substance abuse that, in the opinion of the investigator, is likely to affect the subject's ability to complete the study, or compromise patient safety
- Diabetic ketoacidosis in the past 1 month.
- Severe hypoglycemia resulting in seizure or loss of consciousness in the month prior to enrollment.
- Current use of oral glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study.
- Subject is participating in another drug or device study that could affect glucose measurements or glucose management.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
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 (MDLAP)System in Patients With Type 1 Diabetes
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.
Read more
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.
Read the 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 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
- Conditions
- Type 1 Diabetes
- Being tested
- MD-logic Artificial Pancreas (MDLAP), Standard treatment with insulin pump
- Keywords
- Type 1 diabetes, Closed loop, Artificial Pancreas
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MD-logic Artificial Pancreas (MDLAP)Device
Treatment with the closed loop MD-logic Artificial Pancreas(MDLAP)System
Standard treatment with insulin pumpDevice
Standard treatment with sensor augmented pump therapy
| Study group | Role | What they receive |
|---|---|---|
| MD-logic Artificial Pancreas (MDLAP) system | Experimental | Use of the closed loop MD-logic Artificial Pancreas(MDLAP)System Receives: Device: MD-logic Artificial Pancreas (MDLAP) |
| Standard treatment with insulin pump | Active comparator | Standard treatment with sensor augmented pump therapy Receives: Device: Standard treatment with insulin pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of hypoglycemic events
Number of overnight hypoglycemic events below 63 mg/dl, between bed time to 07:00
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: final visit (after7 months for participants at segment 5 part 2A)
Secondary outcomes (34)
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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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).
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: day 20 for participants in segment 4 part 2 and day 56 for participants in segment 6
Number of readings below 70 mg/dl
Measured: 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
Measured: final visit (after 7 months for participants at segment 5 part 2)
number of research team intervention
Measured: final visit (after 7 months for participants at segment 5 part 2)
HbA1c
Measured: 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
Measured: 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
Measured: final visit (after 7 months for participants at segment 5 part 2A
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2010 (estimated)
- Study startMar 2011
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Moshe Phillip, Prof, Principal investigator, Schenider Children's Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01238406
- Sponsor's protocol ID
- rmc006000ctil
- Status last verified
- Jan 2017
- First submitted
- 9 Nov 2010
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Biester T, Nir J, Remus K, Farfel A, Muller I, Biester S, Atlas E, Dovc K, Bratina N, Kordonouri O, Battelino T, Philip M, Danne T, Nimri R. DREAM5: An open-label, randomized, cross-over study to evaluate the safety and efficacy of day and night closed-loop control by comparing the MD-Logic automated insulin delivery system to sensor augmented pump therapy in patients with type 1 diabetes at home. Diabetes Obes Metab. 2019 Apr;21(4):822-828. doi: 10.1111/dom.13585. Epub 2018 Dec 21.
PubMed 30478937Nimri R, Muller I, Atlas E, Miller S, Fogel A, Bratina N, Kordonouri O, Battelino T, Danne T, Phillip M. MD-Logic overnight control for 6 weeks of home use in patients with type 1 diabetes: randomized crossover trial. Diabetes Care. 2014 Nov;37(11):3025-32. doi: 10.2337/dc14-0835. Epub 2014 Jul 30.
PubMed 25078901Nimri R, Danne T, Kordonouri O, Atlas E, Bratina N, Biester T, Avbelj M, Miller S, Muller I, Phillip M, Battelino T. The "Glucositter" overnight automated closed loop system for type 1 diabetes: a randomized crossover trial. Pediatr Diabetes. 2013 May;14(3):159-67. doi: 10.1111/pedi.12025. Epub 2013 Feb 28.
PubMed 23448393Phillip M, Battelino T, Atlas E, Kordonouri O, Bratina N, Miller S, Biester T, Stefanija MA, Muller I, Nimri R, Danne T. Nocturnal glucose control with an artificial pancreas at a diabetes camp. N Engl J Med. 2013 Feb 28;368(9):824-33. doi: 10.1056/NEJMoa1206881.
PubMed 23445093
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 (MDLAP)System in Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT01238406
- Acronym / sponsor ID
- rmc006000ctil
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 diabetes, Closed loop, Artificial Pancreas
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 10 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MD-logic Artificial Pancreas (MDLAP) system | Experimental | Device: MD-logic Artificial Pancreas (MDLAP)Use of the closed loop MD-logic Artificial Pancreas(MDLAP)System |
| Standard treatment with insulin pump | Active comparator | Device: Standard treatment with insulin pumpStandard treatment with sensor augmented pump therapy |
Who may qualify
- Ages
- 10 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Subject with Type 1 diabetes (>1yr since diagnosis)
- Insulin infusion pump therapy for at least 3 months
- Patients whom uses continuous glucose sensor for at least 2 weeks(for segment 5) or will undergo run-in period of 2 weeks of glucose sensor wear before continue to baseline assessment (only for patients participating at segment 3 and 4)
- Age ≥ 10 years until 65 years
- HbA1c at inclusion ≥ 6.5 and <10
Key exclusion criteria (8 listed)
- Concomitant diseases that influence metabolic control
- Participation in any other interventional study
- Known or suspected allergy to trial products
- Any significant diseases or conditions including psychiatric disorders and substance abuse that, in the opinion of the investigator, is likely to affect the subject's ability to complete the study, or compromise patient safety
- Diabetic ketoacidosis in the past 1 month.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MD-logic Artificial Pancreas (MDLAP)Treatment with the closed loop MD-logic Artificial Pancreas(MDLAP)System | Device | MD-logic Artificial Pancreas (MDLAP) system |
| Standard treatment with insulin pumpStandard treatment with sensor augmented pump therapy | Device | Standard treatment with insulin pump |
Primary outcome
Number of hypoglycemic events
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)
Number of overnight hypoglycemic events below 63 mg/dl, between bed time to 07:00
Time spent in hypoglycemia
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 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
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)
Reduction in overnight mean glucose level
Increase in time spent in the target range
Time frame: day 14 for participants in segment 4
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)
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
Increase in time spent in the target range of sensor glucose level within 70-180 mg/dl
Sleep efficacy
Time frame: final visit (after7 months for participants at segment 5 part 2A)
Sleep efficacy as measured by Actigraph
34 secondary outcomes
Percentage of time spent in the target range
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
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
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
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)
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
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)
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
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)
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)
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
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
Time frame: Final visit (day 14) for participants in segment 4 only
sensor accuracy
Time frame: final visit (day 14 for participants in segment 4 only)
The time spent in hypoglycemia
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
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
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
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
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
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
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
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
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
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
Time frame: final visit (after 7 months for participants at segment 5 part 2A)
Total wake up time per night
Time frame: final visit (after 7 months for participants at segment 5 part 2A
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.
- Derived from this study: PubMed 30478937Biester T, Nir J, Remus K, Farfel A, Muller I, Biester S, Atlas E, Dovc K, Bratina N, Kordonouri O, Battelino T, Philip M, Danne T, Nimri R. DREAM5: An open-label, randomized, cross-over study to evaluate the safety and efficacy of day and night closed-loop control by comparing the MD-Logic automated insulin delivery system to sensor augmented pump therapy in patients with type 1 diabetes at home. Diabetes Obes Metab. 2019 Apr;21(4):822-828. doi: 10.1111/dom.13585. Epub 2018 Dec 21.
- Derived from this study: PubMed 25078901Nimri R, Muller I, Atlas E, Miller S, Fogel A, Bratina N, Kordonouri O, Battelino T, Danne T, Phillip M. MD-Logic overnight control for 6 weeks of home use in patients with type 1 diabetes: randomized crossover trial. Diabetes Care. 2014 Nov;37(11):3025-32. doi: 10.2337/dc14-0835. Epub 2014 Jul 30.
- Derived from this study: PubMed 23448393Nimri R, Danne T, Kordonouri O, Atlas E, Bratina N, Biester T, Avbelj M, Miller S, Muller I, Phillip M, Battelino T. The "Glucositter" overnight automated closed loop system for type 1 diabetes: a randomized crossover trial. Pediatr Diabetes. 2013 May;14(3):159-67. doi: 10.1111/pedi.12025. Epub 2013 Feb 28.
- Derived from this study: PubMed 23445093Phillip M, Battelino T, Atlas E, Kordonouri O, Bratina N, Miller S, Biester T, Stefanija MA, Muller I, Nimri R, Danne T. Nocturnal glucose control with an artificial pancreas at a diabetes camp. N Engl J Med. 2013 Feb 28;368(9):824-33. doi: 10.1056/NEJMoa1206881.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moshe Phillip, Prof principal investigator
Schenider Children's Medical
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MD-logic Artificial Pancreas (MDLAP) and Standard treatment with insulin pump in people with Type 1 Diabetes, run by Rabin Medical Center at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Israel, Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of hypoglycemic events (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 study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01238406, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2017.