Closed Loop Insulin Pump Therapy After Islet Auto-Transplantation

Not Applicable

Completed

• Conditions: Diabetes Mellitus; Chronic Pancreatitis
• Interventions: Device: Closed Loop Insulin

• Registration Number: NCT01945138
• Lead Sponsor: University of Minnesota

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-08-19
• Study First Submitted QC: 2013-09-13
• Study First Posted: 2013-09-18
• Study Start: 2014-02
• Primary Completion: 2015-06
• Results First Submitted: 2015-06-15
• Study Completion: 2015-12
• Results First Submitted QC: 2015-12-09
• Results First Posted: 2016-01-13
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-30
• Last Update Posted: 2017-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• Patients undergoing total pancreatectomy and islet auto-transplantation.
• Patients ages 21 to 64 years old

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Study Period: Average Serum BG	3 days of investigation period	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	3 days of investigation period	Measure of glycemic variability. This is the standard deviation in all serum BG values for each individual patient.

Secondary Outcome Measures

Name	Time	Method
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
Study Period: Continuous Glucose Monitor Standard Deviation of BG	continuous over the 72 hour investigation period	measure of glycemic variability by CGM. This is the standard deviation within each patient for all CGM glucose readings.
Study Period: Continuous Glucose Monitor (CGM) BG Average	continuously over the 72 hour investigational period	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: % of Time CGM BG <70 mg/dL	continuous over the 72 hour investigation period
Study Period: Percent Time BG in Range 70-140 mg/dL	continuous over the 72 hour investigation period	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	continuous over the 72 hour investigation period	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 > 140 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: Morning C-peptide	Average of 3 day study period	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	Average of 3 day study period	Calculated as total daily dose of insulin.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States