Controlled Insulin Delivery: Combining Technology With Treatment

Completed · Early Phase 1

Conditions studied: Diabetes Mellitus, Type 1

In brief

Hypothesis: Closed-loop control systems for an artificial pancreas using multi-parametric model predictive control can be developed and evaluated safely in patients with Type 1 Diabetes Mellitus (T1DM) to control blood glucose concentrations. This study seeks to combine real-time continuous glucose sensing with automated insulin delivery in a closed-loop system that will achieve euglycemia in patients with T1DM. The end result of this line of research will be an artificial pancreas that will provide around-the-clock glucose regulation through controlled insulin delivery in response to detected patterns of change in glucose levels.

Key facts

Study ID

NCT01484457

Run by

Sansum Diabetes Research Institute

People needed

19

Starts

2008-07-01

Expected to finish

2010-01-01

Last updated by the study team

2021-03-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Willing to sign the consent form
• Type 1 diabetes for at least 1 year prior to the study
• Using continuous subcutaneous insulin infusion pump
• Above 21 years of age
• Willing to follow the study requirements

You may not qualify if…

• Allergy to the sensor or to one of its components
• Psychiatric disorders
• Reported diabetic ketoacidosis within last 3 months
• Abnormal liver function (Transaminase > 2 times the upper limit of normal)
• Heart failure
• Any carcinogenic disease
• Any other chronic abnormality
• Unwilling to perform or to follow the research protocol
• Participation in any other study concurrent with the proposed study
• Creatinine concentration above the upper limit of normal for age and sex
• Active coronary artery disease
• Active gastroparesis
• History of uncontrolled seizures
• Pregnancy
• Untreated adrenal insufficiency
• Hypokalemia
• Uncontrolled thyroid disease.
• Condition, which in the opinion of the investigator, would interfere with patient safety

Where it is running

• Sansum Diabetes Research Institute — Santa Barbara, California, United States
• Schneider Children's Medical Center of Israel — Petah Tikva, Israel

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.