Closed Loop Insulin Pump Therapy After Islet Auto-Transplantation

• ClinicalTrials.gov Identifier: NCT01945138
• Recruitment Status: Completed
• First Posted: September 18, 2013
• Results First Posted: January 13, 2016
• Last Update Posted: July 31, 2017
• Sponsor: University of Minnesota
• Collaborator: Medtronic Diabetes
• Information provided by (Responsible Party): University of Minnesota

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).

Condition or disease	Intervention/treatment	Phase
Chronic Pancreatitis; Diabetes Mellitus	Device: Closed Loop Insulin	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy and Feasibility of Fully Automated Closed Loop Insulin Pump Therapy After Islet Auto-Transplantation
• Study Start Date: February 2014
• Actual Primary Completion Date: June 2015
• Actual Study Completion Date: December 2015

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures :

1. Study Period: Average Serum BG [ Time Frame: 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.
2. Study Period: Serum BG Standard Deviation [ Time Frame: 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 :

1. Study Period: Continuous Glucose Monitor (CGM) BG Average [ Time Frame: 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
2. Study Period: Continuous Glucose Monitor Standard Deviation of BG [ Time Frame: 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.
3. Study Period: Percent Time BG in Range 70-140 mg/dL [ Time Frame: 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
4. Study Period: CGM Area Under the Curve (AUC) With Glucose < 70 mg/dL [ Time Frame: 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.
5. Study Period: % of Time CGM BG <70 mg/dL [ Time Frame: continuous over the 72 hour investigation period ]
6. Study Period: CGM AUC With Glucose> 140 mg/dL [ Time Frame: continuous over the 72 hour investigation period ]
7. Study Period: % of Time CGM BG > 140 mg/dL [ Time Frame: continuous over the 72 hour investigation period ]
8. Study Period: Morning C-peptide [ Time Frame: 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.
9. Study Period: Daily Insulin Needs [ Time Frame: Average of 3 day study period ]
   Calculated as total daily dose of insulin.
10. Day 14 Follow-Up: Average Serum BG [ Time Frame: Day 14 Follow-Up ]
11. Day 14 Follow-Up: C-Peptide [ Time Frame: Day 14 Follow-Up: ]
12. Day 28 Follow-Up: Average Serum BG [ Time Frame: Day 28 Follow-Up ]
13. Day 28 Follow-Up: C-Peptide [ Time Frame: Day 28 Follow-Up ]

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Minnesota

University of Minnesota

Minneapolis, Minnesota, United States, 55454

Sponsors and Collaborators

University of Minnesota

Medtronic Diabetes

Investigators

• Principal Investigator: Melena Bellin, MD; University of Minnesota

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT01945138
• Other Study ID Numbers: CLTPIAT2013; 21856 ( Other Grant/Funding Number: University of Minnesota - CTSI )
• First Posted: September 18, 2013
• Results First Posted: January 13, 2016
• Last Update Posted: July 31, 2017
• Last Verified: June 2017

Keywords provided by University of Minnesota:

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

Additional relevant MeSH terms:

Pancreatitis; Pancreatitis, Chronic; Pancreatic Diseases; Digestive System Diseases; Insulin; Insulin, Globin Zinc; Hypoglycemic Agents; Physiological Effects of Drugs