Closed Loop Insulin Pump Therapy After Islet Auto-Transplantation

N/ACompletedNCT01945138

University of Minnesota14 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Pancreatitis Diabetes Mellitus

Interventions

Closed Loop InsulinDEVICE

The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms).

Eligibility

Sex: ALLMin age: 21 YearsMax age: 64 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Minnesota

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

Study Period: Average Serum BG

Mean blood glucose value: a single report of the average of the analytical blood glucose values will be computed and compared between the pump and control groups.

Time frame: 3 days of investigation period

Study Period: Serum BG Standard Deviation

Measure of glycemic variability. This is the standard deviation in all serum BG values for each individual patient.

Time frame: 3 days of investigation period

Secondary Outcomes

Study Period: Continuous Glucose Monitor (CGM) BG Average

Continuous glucose monitoring sensor data: The CGM's in the pump and control groups will collect glucose readings continuously over a 72 hour period

Time frame: continuously over the 72 hour investigational period

Study Period: Continuous Glucose Monitor Standard Deviation of BG

measure of glycemic variability by CGM. This is the standard deviation within each patient for all CGM glucose readings.

Time frame: continuous over the 72 hour investigation period

Study Period: Percent Time BG in Range 70-140 mg/dL

Additional measure of glycemic variability, as reflected by CGM measures, % time in the range of 70-140 on CGM

Time frame: continuous over the 72 hour investigation period

Study Period: CGM Area Under the Curve (AUC) With Glucose < 70 mg/dL

Calculated as the area under the curve on the CGM tracing that the glucose is under 70 mg/dL.

Time frame: continuous over the 72 hour investigation period

Study Period: % of Time CGM BG <70 mg/dL

Data from ClinicalTrials.gov

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