Status:
COMPLETED
MD-Logic Artificial Pancreas for Automatic Type 1 Diabetes Meals Management
Lead Sponsor:
Rabin Medical Center
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
14-25 years
Phase:
NA
Brief Summary
The MDLAP (MD-Logic Artificial Pancreas)system is as an automatic system to regulate glucose levels by delivery of insulin operable in clinical trial settings. The safety of the system was proved in p...
Eligibility Criteria
Inclusion
- Diabetes type 1
- Age 14-25 years
- \>1yr since diagnosis
- Insulin infusion pump therapy for at least 3 months
- HbA1c at inclusion ≤10%
- BMI \< 95th percentile for age and sex
- Patients willing to follow study instructions
Exclusion
- Any condition that influence intestinal absorption or motility such as diabetic gastroparesis, celiac disease or malabsorptive states that could affect postprandial glucose absorption.
- any episode of diabetic ketoacidosis within the month prior to study entry and/or severe hypoglycaemia resulting in seizure or loss of consciousness in the month prior to enrolment
- any concomitant disease that may influence metabolic control
- participation in any other interventional study
- known or suspected allergy to trial products
- any significant diseases (such as preexisting seizures or epilepsy) or conditions including psychiatric disorders, eating disorder and substance abuse that in the opinion of the investigator is likely to affect the subjects ability to complete the study or compromise patients safety
- Female subject who is pregnant or planning to become pregnant within the planned study duration.
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01901913
Start Date
October 1 2013
End Date
April 1 2015
Last Update
April 16 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Schneider Children's Medical Center
Petah Tikva, Petah-Tikva, Israel, 49202