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A Study to Evaluate a Multiple Model Probabilistic Predictive Controller (MMPPC) for Closed Loop Insulin Delivery
Not Recruiting
Trial ID: NCT01492062
Purpose
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 and uses that information to tell an insulin infusion pump how much
insulin to deliver. The primary purpose of this study is to gain experience with insulin
delivery algorithms or programs program (algorithm) provides the best regulation of glucose
levels so that there are no severe low blood glucose reactions and blood glucose levels are
generally between 70 to 180 mg/dl.
Official Title
A Study to Evaluate a Multiple Model Probabilistic Predictive Controller (MMPPC) for Closed Loop Insulin Delivery
Stanford Investigator(s)
Bruce Buckingham
Professor of Pediatrics (Endocrinology) at the Lucile Salter Packard Children's Hospital, Emeritus
Eligibility
Inclusion Criteria:
Eligibility
To be eligible for the study, all subjects must meet the following criteria:
1. 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.
2. Age 21 years to less than 45.0 years
3. Subject has used a downloadable insulin pump for at least 3 months
4. Subject understands the study protocol and agrees to comply with it
5. Informed Consent Form signed
6. A Personal Home computer with internet access (must have access to a PC for uploading,
not a Mac).
Exclusion Criteria:
Exclusion
Subjects who meet any of the following criteria are not eligible for the study:
1. 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.
2. 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
3. Inpatient psychiatric treatment in the past 6 months
4. 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.
5. Pregnancy, breast feeding, or intention of becoming pregnant in the next 2 months.
6. Weight less than 26 kg
7. Renal failure or peritoneal dialysis
8. History of heart disease
9. The use of beta-blockers
10. History of cerebrovascular disease, or non-hypoglycemic seizures, or intolerance of
glucagon treatment.
11. History of a hypoglycemic seizure within 6 months of enrollment.
Intervention(s):
device: Multiple Model Predictive Controller
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Paula Clinton
6507362313