Closed Loop Insulin Pump Therapy After Islet Auto-Transplantation

NCT ID: NCT01945138

Last Updated: 2017-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2015-12-31

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.

Conditions

Chronic Pancreatitis; Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Closed Loop Insulin

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

Group Type: EXPERIMENTAL

Closed Loop Insulin

Intervention Type: DEVICE

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).

Interventions

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).

Intervention Type: DEVICE

Other Intervention 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)

Eligibility 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Diabetes

INDUSTRY

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Melena Bellin, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 26588810 (View on PubMed)

Other Identifiers

21856

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CLTPIAT2013

Identifier Type: -

Identifier Source: org_study_id