Status:
WITHDRAWN
Inpatient Evaluation of the MD-Logic Artificial Pancreas System in Patients With Type 1 Diabetes
Lead Sponsor:
Rabin Medical Center
Conditions:
Diabetes Type 1
Eligibility:
All Genders
12-65 years
Phase:
PHASE1
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 insul...
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 insul...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01501032
Start Date
October 1 2013
End Date
December 1 2014
Last Update
March 19 2015
Active Locations (1)
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1
Schneider children's Medical center
Petah Tikva, Israel, 49202