Trial Search Results

A Study to Evaluate a Multiple Model Probabilistic Predictive Controller (MMPPC) for Closed Loop Insulin Delivery

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Stanford Investigator(s):

Intervention(s):

  • Device: Multiple Model Predictive Controller

Phase:

N/A

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.

Ages Eligible for Study

21 Years - 45 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Paula Clinton
6507362313
Not Recruiting