Status:
WITHDRAWN
A Study to Evaluate a Multiple Model Probabilistic Predictive Controller (MMPPC) for Closed Loop Insulin Delivery
Lead Sponsor:
Stanford University
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
21-45 years
Phase:
NA
Brief Summary
You are invited to participate in a research study for the development of an artificial pancreas. An artificial pancreas uses a program which takes information from a continuous blood glucose monitor ...
Detailed Description
You are invited to participate in a research study for the development of an artificial pancreas. An artificial pancreas uses a program which takes information from a continuous blood glucose monitor ...
Eligibility Criteria
Inclusion
- Eligibility
- To be eligible for the study, all subjects must meet the following criteria:
- Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year. The diagnosis of type 1 diabetes is based on the investigator's judgment; Cpeptide level and antibody determinations are not needed.
- Age 21 years to less than 45.0 years
- Subject has used a downloadable insulin pump for at least 3 months
- Subject understands the study protocol and agrees to comply with it
- Informed Consent Form signed
- A Personal Home computer with internet access (must have access to a PC for uploading, not a Mac).
Exclusion
- Exclusion
- Subjects who meet any of the following criteria are not eligible for the study:
- The presence of a significant medical disorder that in the judgment of the investigator will affect the wearing of the sensors or the completion of any aspect of the protocol.
- The presence of any of the following diseases:
- Asthma if treated with systemic or inhaled corticosteroids in the last 6 months
- Cystic fibrosis
- Other major illness that in the judgment of the investigator might interfere with the completion of the protocol Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment
- Inpatient psychiatric treatment in the past 6 months
- Current use of oral/inhaled glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study.
- Pregnancy, breast feeding, or intention of becoming pregnant in the next 2 months.
- Weight less than 26 kg
- Renal failure or peritoneal dialysis
- History of heart disease
- The use of beta-blockers
- History of cerebrovascular disease, or non-hypoglycemic seizures, or intolerance of glucagon treatment.
- History of a hypoglycemic seizure within 6 months of enrollment.
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01492062
Start Date
February 1 2011
End Date
November 1 2013
Last Update
April 2 2015
Active Locations (2)
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1
CTRU located in Blake Wilbur
Stanford, California, United States, 94305
2
Stanford University School of Medicine
Stanford, California, United States, 94305