NCT01945138|CompletedResultsDMC
Closed Loop Insulin Pump Therapy After Islet Auto-Transplantation
Efficacy and Feasibility of Fully Automated Closed Loop Insulin Pump Therapy After Islet Auto-Transplantation
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Sponsor study identifier
Secondary identifiers
OTHER_GRANT · University of Minnesota - CTSI
interventional
14
1 country
1
Study Start
February 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2015
Actual (reported)Study Completion
December 2015
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 19, 2013
Actual (reported)September 18, 2013
Actual (reported)February 2014
Date type not reportedThis date has not been verified as actual or estimated.
June 2015
Actual (reported)December 2015
Actual (reported)January 13, 2016
Actual (reported)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
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
Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.
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).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Minnesota
Minneapolis, Minnesota, 55454, United States
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.
Melena Bellin, MD
University of Minnesota
14 participants (actual enrollment reported by the registry).
First Submitted
August 19, 2013
First Posted
September 18, 2013
Study Start
February 2014
Date type not reportedThis date has not been verified as actual or estimated.
Efficacy Study of Interactive Web Application for Problem Solving in Diabetes Management
Contact the study team to confirm eligibility.
Primary Completion
June 2015
Actual (reported)Study Completion
December 2015
Actual (reported)Last Updated
July 31, 2017
Results First Posted
January 13, 2016
Record last verified: 2017-06
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Source: ClinicalTrials.gov.
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