Effect of Gain on Closed-Loop Insulin

Completed · Not applicable

Conditions studied: Type 1 Diabetes

In brief

The purpose of this study is to test the ability of an advanced external Physiologic Insulin Delivery (ePID) algorithm (a step by step process used to develop a solution to a problem) to get acceptable meal responses over a range of gain. Gain is defined as how much insulin is given in response to a change in a patient's glucose level. This study also examines the effectiveness of the external Physiologic Insulin Delivery (ePID) closed-loop insulin delivery computer software. The investigators would like to assess whether fasting target levels can be achieved as the closed-loop gain increases or decreases, and to evaluate the system's ability to produce an acceptable breakfast meal response.

Key facts

Study ID

NCT02065895

Run by

Joslin Diabetes Center

People needed

8

Starts

2013-12-01

Expected to finish

2015-04-01

Last updated by the study team

2018-05-17

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Type 1 diabetes for > 3 years
• Manage diabetes using a continuous glucose monitor and continuous subcutaneous insulin infusion pump
• Non obese (BMI < 30)
• Aged 18 - 75 years old
• HbA1c < 8 %

You may not qualify if…

• renal or hepatic failure
• cancer or lymphoma
• Malabsorption or malnourishment
• Hypercortisolism
• Alcoholism or drug abuse
• Anemia (hematocrit < 36 in females and <40 in males)
• Eating disorder
• Dietary restrictions
• Acetaminophen allergy
• Chronic acetaminophen use
• Glucocorticoid therapy
• History of gastroparesis
• Use of Beta blockers

Where it is running

• Joslin Diabetes Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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