Back to results

Closed Loop Insulin Pump Therapy After Islet Auto-Transplantation

Primary Purpose

Chronic Pancreatitis, Diabetes Mellitus

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Closed Loop Insulin

About this trial

This is an interventional treatment trial for Chronic Pancreatitis focused on measuring Total Pancreatectomy, Islet Auto-Transplantation, Closed Loop Insulin Pump

Eligibility Criteria

21 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Closed Loop Insulin

Arm Description

Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.

Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.

Outcomes

Primary Outcome Measures

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.

Study Period: Serum BG Standard Deviation

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

Secondary Outcome Measures

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

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.

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

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.

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

Study Period: CGM AUC With Glucose> 140 mg/dL

Study Period: % of Time CGM BG > 140 mg/dL

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.

Study Period: Daily Insulin Needs

Calculated as total daily dose of insulin.

Day 14 Follow-Up: Average Serum BG

Day 14 Follow-Up: C-Peptide

Day 28 Follow-Up: Average Serum BG

Day 28 Follow-Up: C-Peptide

Full Information

NCT ID

NCT01945138

First Posted

August 19, 2013

Last Updated

June 30, 2017

Sponsor

University of Minnesota

Collaborators

Medtronic Diabetes

1. Study Identification

Unique Protocol Identification Number

NCT01945138

Brief Title

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

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

February 2014 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Minnesota

Collaborators

Medtronic Diabetes

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Pancreatitis, Diabetes Mellitus

Keywords

Total Pancreatectomy, Islet Auto-Transplantation, Closed Loop Insulin Pump

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

No Intervention

Arm Description

Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.

Arm Title

Closed Loop Insulin

Arm Type

Experimental

Arm Description

Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.

Intervention Type

Device

Intervention Name(s)

Closed Loop Insulin

Other Intervention Name(s)

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)

Intervention Description

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).

Primary Outcome Measure Information:

Title

Study Period: Average Serum BG

Description

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

Title

Study Period: Serum BG Standard Deviation

Description

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 Outcome Measure Information:

Title

Study Period: Continuous Glucose Monitor (CGM) BG Average

Description

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

Title

Study Period: Continuous Glucose Monitor Standard Deviation of BG

Description

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

Time Frame