Closed Loop Insulin Pump Therapy After Islet Auto-Transplantation

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).

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Chronic Pancreatitis
• Intervention / Treatment: Device: Closed Loop Insulin

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.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55454
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
Experimental: Closed Loop Insulin; Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.	Device: Closed Loop Insulin; 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).; Other Names: Medtronic ePID 2.0 system; Medtronic Paradigm REAL-Time Insulin Pump (MMT-722); Enlite Glucose Sensor (MMT-7008X); MiniLink REAL-Time Transmitter (MMT-7703XNA); ComLink Device (MMT-7304)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	3 days of investigation period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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	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.	continuous over the 72 hour investigation period
Study Period: % of Time CGM BG <70 mg/dL		continuous over the 72 hour investigation period
Study Period: CGM AUC With Glucose> 140 mg/dL		continuous over the 72 hour investigation period
Study Period: % of Time CGM BG > 140 mg/dL		continuous over the 72 hour investigation period
Study Period: Morning C-peptide	A single C-peptide measurement collected daily x 3 days, collected at random (meaning not in a fasting state) each morning. Expressed as average for each patient.	Average of 3 day study period
Study Period: Daily Insulin Needs	Calculated as total daily dose of insulin.	Average of 3 day study period
Day 14 Follow-Up: Average Serum BG		Day 14 Follow-Up
Day 14 Follow-Up: C-Peptide		Day 14 Follow-Up:
Day 28 Follow-Up: Average Serum BG		Day 28 Follow-Up
Day 28 Follow-Up: C-Peptide		Day 28 Follow-Up

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: Medtronic Diabetes
• Investigators: Principal Investigator: Melena Bellin, MD, University of Minnesota

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: August 19, 2013
• First Submitted That Met QC Criteria: September 13, 2013
• First Posted (Estimate): September 18, 2013

Study Record Updates

• Last Update Posted (Actual): July 31, 2017
• Last Update Submitted That Met QC Criteria: June 30, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Total Pancreatectomy; Islet Auto-Transplantation; Closed Loop Insulin Pump
• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis; Pancreatitis, Chronic; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc
• Other Study ID Numbers: CLTPIAT2013; 21856 (Other Grant/Funding Number: University of Minnesota - CTSI)