Closed Loop Insulin Pump Therapy After Islet Auto-Transplantation



Status:Completed
Conditions:Gastrointestinal, Gastrointestinal, Diabetes
Therapuetic Areas:Endocrinology, Gastroenterology
Healthy:No
Age Range:21 - 64
Updated:4/21/2016
Start Date:February 2014
End Date:December 2015

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Efficacy and Feasibility of Fully Automated Closed Loop Insulin Pump Therapy After Islet Auto-Transplantation

The purpose of this study is to determine the effectiveness of closed loop insulin pump
therapy to control blood sugar following total pancreatectomy and islet auto-transplantation
(TPIAT).

OBJECTIVES AND HYPOTHESES The main objective of this study is to determine if a closed loop
insulin system can successfully achieve tighter blood sugar control than the current
multiple daily injection regimen. The investigators hypothesize that the average blood
glucose will be lower in the closed loop group than the control group, there will be less
glucose variability in the closed loop group than the control group, and there will be less
total time spent in hyperglycemia and hypoglycemia in the closed loop group than in the
control group. The investigators also will investigate insulin requirements and islet
function in the first 6 months post-transplant in the closed loop group The investigators
hypothesize that the insulin requirements will be lower and the C-peptide levels higher in
the closed loop group than in the control group.

Inclusion Criteria:

- Patients undergoing total pancreatectomy and islet auto-transplantation.

- Patients ages 21 to 64 years old

Exclusion Criteria:

- Preexisting diabetes

- Use of acetaminophen during study period, which interferes with CGM sensor function

- Any medical condition requiring corticosteroids

- Severe Psychiatric disease or developmental delays, that might interfere with the
ability to provide informed consent

- Any other medical condition which in the opinion of the investigators impairs the
person's ability to safely participate in the trial
We found this trial at
1
site
Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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from
Minneapolis, MN
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