Inpatient Evaluation of the MD-Logic Artificial Pancreas System in Patients With Type 1 Diabetes (MD-Logic- Cont)
Primary Purpose
Diabetes Type 1
Status
Withdrawn
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
MD-logic artificial pancreas system
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Type 1 focused on measuring Diabetes Type 1, Artificial Pancreas
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of type 1 diabetes for at least one year and using an insulin pump for at least 6 months
- Age 12 to 65 years
- Hemoglobin A1c (HbA1c) between 5.0% and 10.5%, as measured with DCA2000 or equivalent device
- For females, not currently known to be pregnant
- Demonstration of proper mental status and cognition for the study
- An understanding of and willingness to follow the protocol and sign the informed consent or assent
Exclusion Criteria:
- Diabetic ketoacidosis in the past 6 months
- Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
- History of a seizure disorder (except hypoglycemic seizure).
- Coronary artery disease or heart failure.
- Cystic fibrosis
- Active infection
- A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol
- A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the exercise protocol
- Current use of a beta blocker medication
- Hematocrit <30%
- Use of pseudoephedrine 48 hours prior to Clinical Research Center (CRC) admission
Sites / Locations
- Schneider children's Medical center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Closed Loop Control- MD-Logic
Arm Description
The MD-Logic artificial pancreas system will be used in conjunction with continuous glucose monitoring and insulin pump delivery to manage the subject's blood glucose.
Outcomes
Primary Outcome Measures
Percent of glucose values 71-180 mg/dL of combined day and night readings during the first admission visit
Percent of subjects with blood glucose reading of 71-180 mg/dL 4 hours following the breakfast with a missed meal bolus
Success is defined as >=40% subjects with a blood glucose in the 71-180 mg/dL range.
Percent of subjects with blood glucose reading of 71-180 mg/dL 5 hours following the breakfast with a meal bolus 30% more than the recommended bolus amount
Success is defined as >=50% subjects with a blood glucose in the 71-180 mg/dL range.
Percent of subjects with a blood glucose nadir <=60 mg/dL following exercise
Success is defined as less than 25% of subjects with a blood glucose nadir <=60 mg/dL.
Overall frequency of hypoglycemia
Success defined as no subjects with severe hypoglycemia with a low blood glucose resulting in seizure, unconsciousness or the inability to treat oneself.
Overall frequency of hyperglycemia
Success defined as no subjects with diabetic ketoacidosis (DKA).
Percent of subjects with a peak blood glucose >400 mg/dL following the breakfast with a meal bolus 30% more than the recommended bolus amount
Success is defined as less than 5% of subjects have a peak blood glucose >400 mg/dL
Secondary Outcome Measures
Percent of blood glucose values 71-180 mg/dL during the day (9:00AM-11:00PM) of the first admission visit
Percent of blood glucose values 70-180 mg/dL during the night (11:00PM-8:00AM) of the first admission visit
Percent of blood glucose values >400 mg/dL during the first admission visit
Individual success is defined as no blood glucose values >400 mg/dL.
Percent of blood glucose values <=60 mg/dL during the first admission visit
No more than 33% of visits with blood glucose <=60 mg/dL
Percent of subjects with a peak blood glucose >400 mg/dL following the breakfast with a missed meal bolus
Success is defined as less than 5% of subjects have a peak blood glucose >400 mg/dL
Percent of subjects with a nadir blood glucose <=60 mg/dL following the breakfast with a missed meal bolus
Success is defined as less than 15% of subjects have a nadir blood glucose <=60 mg/dL
Percent of subjects with a nadir blood glucose <=60 mg/dL following the breakfast with a meal bolus 30% more than the recommended bolus amount
Success is defined as less than 25% of subjects have a nadir blood glucose <=60 mg/dL
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01501032
Brief Title
Inpatient Evaluation of the MD-Logic Artificial Pancreas System in Patients With Type 1 Diabetes
Acronym
MD-Logic- Cont
Official Title
Inpatient Evaluation of the MD-Logic Artificial Pancreas System in Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Withdrawn
Study Start Date
October 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rabin Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this feasibility study is to evaluate the MDLAP (MD-Logic Artificial Pancreas system)automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes. The study will include 3 inpatient admissions (12-24 hr), which will include overnight sleep, over-bolus meal, under-bolus meal and exercise.
Detailed Description
The purpose of this feasibility study is to evaluate the MDLAP (MD-Logic artificial pancreas system)automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes. The study will include 3 inpatient admissions (12-24 hr), which will include overnight sleep, over-bolus meal, under-bolus meal and exercise. During the the visits, meal boluses will be semi-automated, with manual meal announcement by the physician/nurse, automated bolus recommendation by the system, and automated delivery of the bolus following confirmation of the recommendation. Between-meal insulin dosing will be fully automated. Bolus confirmation by the physician/nurse will be requested by the closed loop controller only when it determines that carbohydrates may be necessary to avoid hypoglycemia following the bolus.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Type 1
Keywords
Diabetes Type 1, Artificial Pancreas
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Closed Loop Control- MD-Logic
Arm Type
Experimental
Arm Description
The MD-Logic artificial pancreas system will be used in conjunction with continuous glucose monitoring and insulin pump delivery to manage the subject's blood glucose.
Intervention Type
Device
Intervention Name(s)
MD-logic artificial pancreas system
Intervention Description
The MD-logic artificial pancreas system is a closed loop control system using continuous glucose monitoring (CGM)and subcutaneous insulin pump infusion to mange glucose control in individuals with type 1 diabetes
Primary Outcome Measure Information:
Title
Percent of glucose values 71-180 mg/dL of combined day and night readings during the first admission visit
Time Frame
Day 1
Title
Percent of subjects with blood glucose reading of 71-180 mg/dL 4 hours following the breakfast with a missed meal bolus
Description
Success is defined as >=40% subjects with a blood glucose in the 71-180 mg/dL range.
Time Frame
Day 1
Title
Percent of subjects with blood glucose reading of 71-180 mg/dL 5 hours following the breakfast with a meal bolus 30% more than the recommended bolus amount
Description
Success is defined as >=50% subjects with a blood glucose in the 71-180 mg/dL range.
Time Frame
Day 2
Title
Percent of subjects with a blood glucose nadir <=60 mg/dL following exercise
Description
Success is defined as less than 25% of subjects with a blood glucose nadir <=60 mg/dL.
Time Frame
Day 3
Title
Overall frequency of hypoglycemia
Description
Success defined as no subjects with severe hypoglycemia with a low blood glucose resulting in seizure, unconsciousness or the inability to treat oneself.
Time Frame
day 3
Title
Overall frequency of hyperglycemia
Description
Success defined as no subjects with diabetic ketoacidosis (DKA).
Time Frame
Day 3
Title
Percent of subjects with a peak blood glucose >400 mg/dL following the breakfast with a meal bolus 30% more than the recommended bolus amount
Description
Success is defined as less than 5% of subjects have a peak blood glucose >400 mg/dL
Time Frame
day 2
Secondary Outcome Measure Information:
Title
Percent of blood glucose values 71-180 mg/dL during the day (9:00AM-11:00PM) of the first admission visit
Time Frame
Day 1
Title
Percent of blood glucose values 70-180 mg/dL during the night (11:00PM-8:00AM) of the first admission visit
Time Frame
Day 1
Title
Percent of blood glucose values >400 mg/dL during the first admission visit
Description
Individual success is defined as no blood glucose values >400 mg/dL.
Time Frame
Day 1
Title
Percent of blood glucose values <=60 mg/dL during the first admission visit
Description
No more than 33% of visits with blood glucose <=60 mg/dL
Time Frame
Day 1
Title
Percent of subjects with a peak blood glucose >400 mg/dL following the breakfast with a missed meal bolus
Description
Success is defined as less than 5% of subjects have a peak blood glucose >400 mg/dL
Time Frame
Day 1
Title
Percent of subjects with a nadir blood glucose <=60 mg/dL following the breakfast with a missed meal bolus
Description
Success is defined as less than 15% of subjects have a nadir blood glucose <=60 mg/dL
Time Frame
Day 1
Title
Percent of subjects with a nadir blood glucose <=60 mg/dL following the breakfast with a meal bolus 30% more than the recommended bolus amount
Description
Success is defined as less than 25% of subjects have a nadir blood glucose <=60 mg/dL
Time Frame
Day 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of type 1 diabetes for at least one year and using an insulin pump for at least 6 months
Age 12 to 65 years
Hemoglobin A1c (HbA1c) between 5.0% and 10.5%, as measured with DCA2000 or equivalent device
For females, not currently known to be pregnant
Demonstration of proper mental status and cognition for the study
An understanding of and willingness to follow the protocol and sign the informed consent or assent
Exclusion Criteria:
Diabetic ketoacidosis in the past 6 months
Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
History of a seizure disorder (except hypoglycemic seizure).
Coronary artery disease or heart failure.
Cystic fibrosis
Active infection
A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol
A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the exercise protocol
Current use of a beta blocker medication
Hematocrit <30%
Use of pseudoephedrine 48 hours prior to Clinical Research Center (CRC) admission
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moshe Phillip, Prof
Organizational Affiliation
Rabin Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schneider children's Medical center
City
Petah-tikva
ZIP/Postal Code
49202
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Inpatient Evaluation of the MD-Logic Artificial Pancreas System in Patients With Type 1 Diabetes
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