A Study to Evaluate a Multiple Model Probabilistic Predictive Controller (MMPPC) for Closed Loop Insulin Delivery
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.
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. If the system is working properly, you would not need to
 enter the amount of food you were eating, give an insulin bolus, or change your basal rates
 while wearing the device. You would need to periodically check to be sure the continuous
 glucose sensor was functioning properly and you would need to respond to alarms that might
 occur if your blood glucose was too high, too low, or the glucose sensor or pump were not
 working well. In addition to this the investigators will also gain experience with insulin
 delivery algorithms to minimize the number of glucose readings which are above or below
 target. It is our intention to modify the algorithms during these studies.

 In this study the investigators plan to use a commercially available insulin infusion pump
 (OmniPod) to deliver lispro (Humalog) insulin. The investigators will use Navigator
 continuous glucose sensors both to monitor glucose levels (sensor 1) and provide the glucose
 concentration for the closed loop algorithm (sensor 2). The signal from the second Navigator
 will be sent by serial cable to a computer which will be at the patient's bedside. A control
 algorithm will reside on the computer, and the amount of insulin to be delivered will be
 transmitted to the OmniPod Personal Device Manager which will then send a radiofrequency (rf)
 signal to the Omnipod pump residing on the subject. A health care provider will be in
 attendance and monitoring discrete blood glucose levels (YSI, GlucoScout, or HemoCue
 measurements) at least every 30 minutes. While the Navigator and Omnipod are commercially
 available they will be used in this study as part of an investigational system while you are
 in the hospital, an investigational system is one that is not approved for use by the FDA.
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.