Closed Loop Insulin Pump Therapy After Islet Auto-Transplantation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy and Feasibility of Fully Automated Closed Loop Insulin Pump Therapy After Islet Auto-Transplantation

Conditions
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Chronic Pancreatitis, Diabetes Mellitus

Intervention / Treatment
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* Device: Closed Loop Insulin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>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<br>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<br>* 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).<br>* Other names: ComLink Device (MMT-7304);|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Pancreatectomy, Islet Auto-Transplantation, Closed Loop Insulin Pump