Status:
COMPLETED
Controlled Insulin Delivery: Combining Technology With Treatment
Lead Sponsor:
Sansum Diabetes Research Institute
Collaborating Sponsors:
Juvenile Diabetes Research Foundation
Schneider Children's Medical Center, Israel
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
Hypothesis: Closed-loop control systems for an artificial pancreas using multi-parametric model predictive control can be developed and evaluated safely in patients with Type 1 Diabetes Mellitus (T1DM...
Detailed Description
The goal of the JDRF Artificial Pancreas Project is to produce an autonomous artificial pancreas that can safely and effectively regulate glycemia in people with type 1 diabetes mellitus. In our work,...
Eligibility Criteria
Inclusion
- Willing to sign the consent form
- Type 1 diabetes for at least 1 year prior to the study
- Using continuous subcutaneous insulin infusion pump
- Above 21 years of age
- Willing to follow the study requirements
Exclusion
- Allergy to the sensor or to one of its components
- Psychiatric disorders
- Reported diabetic ketoacidosis within last 3 months
- Abnormal liver function (Transaminase \> 2 times the upper limit of normal)
- Heart failure
- Any carcinogenic disease
- Any other chronic abnormality
- Unwilling to perform or to follow the research protocol
- Participation in any other study concurrent with the proposed study
- Creatinine concentration above the upper limit of normal for age and sex
- Active coronary artery disease
- Active gastroparesis
- History of uncontrolled seizures
- Pregnancy
- Untreated adrenal insufficiency
- Hypokalemia
- Uncontrolled thyroid disease.
- Condition, which in the opinion of the investigator, would interfere with patient safety
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01484457
Start Date
July 1 2008
End Date
January 1 2010
Last Update
March 23 2021
Active Locations (2)
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1
Sansum Diabetes Research Institute
Santa Barbara, California, United States, 93105
2
Schneider Children's Medical Center of Israel
Petah Tikva, Israel