Closed Loop Insulin Pump Therapy After Islet Auto-Transplantation

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01945138
• Other study ID #: CLTPIAT2013
• Secondary ID: 21856
• Status: Completed
• Phase: N/A
• First received: August 19, 2013
• Last updated: December 9, 2015
• Start date: February 2014
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 64 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pancreatitis
• Diabetes Mellitus
• Pancreatitis
• Pancreatitis, Chronic

Intervention

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).

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	Medtronic Diabetes, University of Minnesota, MN

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	No
Secondary	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	Yes
Secondary	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	No
Secondary	Study Period: Percent Time BG in Range 70-140 mg/dL	Additional measure of glycemic variability	continuous over the 72 hour investigation period	No
Secondary	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	No
Secondary	Study Period: % of Time CGM BG <70 mg/dL		continuous over the 72 hour investigation period	No
Secondary	Study Period: CGM AUC With Glucose> 140 mg/dL		continuous over the 72 hour investigation period	No
Secondary	Study Period: % of Time CGM BG > 140 mg/dL		continuous over the 72 hour investigation period	No
Secondary	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	No
Secondary	Study Period: Daily Insulin Needs	Calculated as total daily dose of insulin.	Average of 3 day study period	No
Secondary	Day 14 Follow-Up: Average Serum BG		Day 14 Follow-Up	No
Secondary	Day 14 Follow-Up: C-Peptide		Day 14 Follow-Up:	No
Secondary	Day 28 Follow-Up: Average Serum BG		Day 28 Follow-Up	No
Secondary	Day 28 Follow-Up: C-Peptide		Day 28 Follow-Up	No
Secondary	6 Month Follow-Up: A1c		6 Month Follow-Up:	No
Secondary	6 Month Follow-Up: Total Daily Insulin Dose		6 Month Follow-Up:	No
Secondary	6 Month Follow-Up: Fasting BG		6 Month Follow-Up:	No
Secondary	6 Month Follow-Up: Peak C-Peptide		6 Month Follow-Up:	No