Clinical trial NCT01945138: Closed Loop Insulin Pump Therapy After Islet Auto-Transplantation
Official title: Efficacy and Feasibility of Fully Automated Closed Loop Insulin Pump Therapy After Islet Auto-Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pancreatitis
Diabetes Mellitus
Keywords: Total Pancreatectomy
Islet Auto-Transplantation
Closed Loop Insulin Pump
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Medtronic Diabetes
First posted: 2013-09-18
Enrollment: 14
Sex: ALL
Minimum age (years): 21
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Study Period: Average Serum BG
timeFrame: 3 days of investigation period
measure: Study Period: Serum BG Standard Deviation
timeFrame: 3 days of investigation period
Secondary outcomes:
measure: Study Period: Continuous Glucose Monitor (CGM) BG Average
timeFrame: continuously over the 72 hour investigational period
measure: Study Period: Continuous Glucose Monitor Standard Deviation of BG
timeFrame: continuous over the 72 hour investigation period
measure: Study Period: Percent Time BG in Range 70-140 mg/dL
timeFrame: continuous over the 72 hour investigation period
measure: Study Period: CGM Area Under the Curve (AUC) With Glucose < 70 mg/dL
timeFrame: continuous over the 72 hour investigation period
measure: Study Period: % of Time CGM BG <70 mg/dL
timeFrame: continuous over the 72 hour investigation period
measure: Study Period: CGM AUC With Glucose> 140 mg/dL
timeFrame: continuous over the 72 hour investigation period
measure: Study Period: % of Time CGM BG > 140 mg/dL
timeFrame: continuous over the 72 hour investigation period
measure: Study Period: Morning C-peptide
timeFrame: Average of 3 day study period
measure: Study Period: Daily Insulin Needs
timeFrame: Average of 3 day study period
measure: Day 14 Follow-Up: Average Serum BG
timeFrame: Day 14 Follow-Up
measure: Day 14 Follow-Up: C-Peptide
timeFrame: Day 14 Follow-Up:
measure: Day 28 Follow-Up: Average Serum BG
timeFrame: Day 28 Follow-Up
measure: Day 28 Follow-Up: C-Peptide
timeFrame: Day 28 Follow-Up
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Melena Bellin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Forlenza GP, Nathan BM, Moran AM, Dunn TB, Beilman GJ, Pruett TL, Bellin MD. Successful Application of Closed-Loop Artificial Pancreas Therapy After Islet Autotransplantation. Am J Transplant. 2016 Feb;16(2):527-34. doi: 10.1111/ajt.13539. Epub 2015 Nov 20.