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

Withdrawn before enrolling · Not applicable

Conditions studied: Type 1 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT01492062

Run by

Stanford University

People needed

0

Starts

2011-02-01

Expected to finish

2013-11-01

Last updated by the study team

2015-04-02

Who can join

Age: 21 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• CTRU located in Blake Wilbur — Stanford, California, United States
• Stanford University School of Medicine — Stanford, California, United States

Full record on ClinicalTrials.gov

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