NCT01945138

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 18, 2013

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
1 month until next milestone

Results Posted

Study results publicly available

January 13, 2016

Completed
Last Updated

July 31, 2017

Status Verified

June 1, 2017

Enrollment Period

1.3 years

First QC Date

August 19, 2013

Results QC Date

June 15, 2015

Last Update Submit

June 30, 2017

Conditions

Chronic PancreatitisDiabetes Mellitus

Keywords

Total PancreatectomyIslet Auto-TransplantationClosed Loop Insulin Pump

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (13)

  • Study Period: Continuous Glucose Monitor (CGM) BG Average

    continuously over the 72 hour investigational period

  • Study Period: Continuous Glucose Monitor Standard Deviation of BG

    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

  • Study Period: CGM Area Under the Curve (AUC) With Glucose < 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

  • +8 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

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

Closed Loop Insulin

EXPERIMENTAL

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

Interventions

Closed Loop InsulinDEVICE

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).

Also known as: 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)
Closed Loop Insulin

Eligibility Criteria

Age21 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55454, United States

Location

Related Publications (1)

  • 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.

    PMID: 26588810DERIVED

MeSH Terms

Conditions

Pancreatitis, ChronicDiabetes Mellitus

Condition Hierarchy (Ancestors)

PancreatitisPancreatic DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Dr. Melena Bellin
Organization
University of Minnesota
bell0130@umn.edu
612-624-5409

Study Officials

  • Melena Bellin, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2013

First Posted

September 18, 2013

Study Start

February 1, 2014

Primary Completion

June 1, 2015

Study Completion

December 1, 2015

Last Updated

July 31, 2017

Results First Posted

January 13, 2016

Record last verified: 2017-06

Locations

US(1)