Overnight MD-Logic

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Rabin Medical Center
Sponsor:
Information provided by (Responsible Party):
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01238406
First received: November 9, 2010
Last updated: May 4, 2014
Last verified: May 2014
  Purpose

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. At the end of this period an optional 3 months extension period will be offered with the other arm (cross-over)

On segment 6, 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.

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.


Condition Intervention
Type 1 Diabetes
Device: MD-logic Artificial Pancreas (MDLAP)
Device: Standard treatment with insulin pump

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: No ]
    Reduction in overnight mean glucose level

  • Increase in time spent in the target range [ Time Frame: day 14 for participants in segment 4 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Increase in time spent in the target range of sensor glucose level within 70-180 mg/dl


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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)

  • 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) ] [ Designated as safety issue: No ]
    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)

  • 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) ] [ Designated as safety issue: No ]
    Average (SD) of blood glucose levels

  • 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) ] [ Designated as safety issue: Yes ]
    Percentage of time spent below 60 mg/dl and below 70 mg/dl

  • 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 ) ] [ Designated as safety issue: No ]
    Percentage of time spent above 140, 180, 250 mg/dl (7.8, 10, 13.9 mmol/l)

  • 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 ) ] [ Designated as safety issue: No ]
    Glucose variability

  • Control Variability Grid Analysis (CVGA) [ Time Frame: final visit (day 26 for participants at segment 1 and day 14 for participants in segment 2) ] [ Designated as safety issue: No ]
    Control Variability Grid Analysis (CVGA)

  • 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) ] [ Designated as safety issue: Yes ]
    number of accurate alerts related to the remote safety and control diabetes management system

  • 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) ] [ Designated as safety issue: Yes ]
    Number of hypoglycemic events below 60 and 70 mg/dl (3.3, 3.9 mmol/l)

  • 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) ] [ Designated as safety issue: No ]
    Area under the curve <60,<63,<70,>140,>180,>250 mg/dl(3.3,3.5,3.9,7.8,10,13.9)

  • • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Artificial Pancreas technical performance, defined as the total frequency of failures [ Time Frame: Final visit (day 14 ) for participants in segment 4 only ] [ Designated as safety issue: No ]
    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

  • 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 ] [ Designated as safety issue: No ]
  • Percent time of active closed-loop control [ Time Frame: Final visit (day 14) for participants in segment 4 only ] [ Designated as safety issue: No ]
    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)

  • sensor accuracy [ Time Frame: final visit (day 14 for participants in segment 4 only) ] [ Designated as safety issue: No ]
    comparison of paired data points between capillary glucose level and Continuous Glucose Monitoring

  • The time spent in hypoglycemia [ Time Frame: After 4 weeks-1.5 month at segment 5 only (in addition after 4 weeks-1.5 months if segment 5 will be extended) ] [ Designated as safety issue: Yes ]
    The time spent in hypoglycemia below 50 mg/dl (2.8 mmol/l).

  • 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 4 weeks-1.5 months if segment 5 will be extended) ] [ Designated as safety issue: Yes ]
    The number of hypoglycemic events below 60 and 50 mg/dl (event defined duration of at least 20 minutes).

  • 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 4 weeks-1.5 months if segment 5 will be extended) ] [ Designated as safety issue: No ]
  • The time spent in hyperglycemia [ Time Frame: After 4 weeks-1.5 monts only at segment 5 (in addition after 4 weeks-1.5 months if segment 5 will be extended) ] [ Designated as safety issue: Yes ]
    The time spent in hyperglycemia above 240 mg/dl (13.3 mmol/l).

  • Patient's diabetes treatment satisfaction [ Time Frame: After 4 weeks-1.5 months only at segment 5 (in addition after 4 weeks-1.5 months if segment 5 will be extended) ] [ Designated as safety issue: No ]
    Patient's diabetes treatment satisfaction using Diabetes Treatment Satisfaction Questionnaire

  • Acceptance and use intention of an Artificial Pancreas [ Time Frame: after 4 weeks- 1.5 months only at segment 5(in addition after 4 weeks-1.5 months if segment 5 will be extended) ] [ Designated as safety issue: No ]
    Acceptance and use intention of an Artificial Pancreas for participant and for parents

  • Fear of hypoglycemia [ Time Frame: After 4 weeks- 1.5 months only at segment 5 (in addition after 4 weeks-1.5 months if segment 5 will be extended) ] [ Designated as safety issue: No ]
    Fear of hypoglycemia using questionaire

  • Satisfaction with Artificial Pancreas [ Time Frame: After 4 weeks- 1.5 months only at segment 5 (in addition after 4 weeks-1.5 months if segment 5 will be extended) ] [ Designated as safety issue: No ]
    Satisfaction with Artificial Pancreas using questionaire

  • 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 4 weeks-1.5 months if segment 5 will be extended) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
    Percentage of time spent 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 ] [ Designated as safety issue: Yes ]
    Number of hypoglycemic events below 50, 60, 70 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 ] [ Designated as safety issue: No ]
    Percentage of time spent above 180, 250 mg/dl

  • 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 ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: No ]
  • number of research team intervention [ Time Frame: final visit (after 7 months for participants at segment 5 part 2) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 223
Study Start Date: March 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MD-logic Artificial Pancreas (MDLAP) system
Use of the closed loop MD-logic Artificial Pancreas(MDLAP)System
Device: MD-logic Artificial Pancreas (MDLAP)
Treatment with the closed loop MD-logic Artificial Pancreas(MDLAP)System
Active Comparator: Standard treatment with insulin pump
Standard treatment with sensor augmented pump therapy
Device: Standard treatment with insulin pump
Standard treatment with sensor augmented pump therapy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   10 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01238406

Contacts
Contact: Moshe Phillip, Prof 972-3-9253747 mosheph@clalit.org.il
Contact: Alona Hamou, Msc 972-3-9253778 alonah@clalit.org.il

Locations
Germany
Diabetes -Zentrum fuer kinder und jugendliche Active, not recruiting
Hannover, Germany, 30173
Israel
Schneider Children's Medical center Recruiting
Petach-Tikva, Israel, 49202
Contact: Moshe Phillip, Prof    972-3-9253747    mosheph@clalit.org.il   
Principal Investigator: Moshe Phillip, Prof         
Sub-Investigator: Revital Nimri, Dr         
Sub-Investigator: Eran Atlas, Msc         
Sub-Investigator: Eli A Grunberg, Bsc         
Sub-Investigator: Shahar Miller, Bsc         
Sub-Investigator: Shlomit Shalitin, Dr         
Sub-Investigator: Yael Lebenthal, Dr         
Sub-Investigator: Liora Lazar, Dr.         
Sub-Investigator: Liat de Vries, Dr         
Sub-Investigator: Tal Ben Ari, Dr         
Sub-Investigator: Tal Oron, Dr         
Sub-Investigator: Ariel Tenenbaum, Dr         
Sub-Investigator: Eran Mel, Dr         
Sub-Investigator: Nitzan Dror, Dr         
Sub-Investigator: Alon Pharfel, Dr         
Slovenia
University Children's Hospital Active, not recruiting
Ljubljana, Slovenia, SI-1000
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Moshe Phillip, Prof Schenider Children's Medical
  More Information

No publications provided by Rabin Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01238406     History of Changes
Other Study ID Numbers: rmc006000ctil
Study First Received: November 9, 2010
Last Updated: May 4, 2014
Health Authority: Israel: Ministry of Health

Keywords provided by Rabin Medical Center:
Type 1 diabetes
Closed loop
Artificial Pancreas

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Pancreatin
Pancrelipase
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014