Insulin Balanced Infusion System

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Timothy Valk MD, Admetsys Corporation
ClinicalTrials.gov Identifier:
NCT01291719
First received: February 5, 2011
Last updated: January 22, 2013
Last verified: January 2013

February 5, 2011
January 22, 2013
November 2008
January 2014   (final data collection date for primary outcome measure)
glucose control in target range [ Time Frame: data will be evaluated within 6 months after completion of all 40 studies ] [ Designated as safety issue: Yes ]
blood glucose measurements in target range (80-125 mg/dl)
Same as current
Complete list of historical versions of study NCT01291719 on ClinicalTrials.gov Archive Site
hypoglycemia [ Time Frame: data will be evaluated within 6 months after all 40 studies are completed ] [ Designated as safety issue: Yes ]
blood glucose <70 mg/dl
Same as current
Not Provided
Not Provided
 
Insulin Balanced Infusion System
Insulin Balanced Infusion System Control of Glucose

The purpose of this study is to study the use of a counterbalancing system of glucose and insulin infusion with frequent blood glucose monitoring and combined adaptive algorithm can produce tight glycemic control without hypoglycemia; closed loop for use in intensive care units and surgery.

Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hyperglycemia
  • Diabetes
Device: glucose and insulin infusion
combined algorithm directed glucose and insulin infusion with 10-20 minute blood glucose measurements to direct glucose control
Experimental: insulin and glucose infusion
Intervention: Device: glucose and insulin infusion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
July 2014
January 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • type 1 or type 2 diabetic individuals on insulin ages 21-85 with A1c 7-9.9%
  • glucose at time of study > 150 mg/dl

Exclusion Criteria:

  • pregnancy
  • renal or hepatic disease
  • corticosteroids
  • poor intravenous access
  • anemia
  • electrolyte abnormality
Both
21 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01291719
IBIS-1
Yes
Timothy Valk MD, Admetsys Corporation
Admetsys Corporation
Not Provided
Principal Investigator: Timothy W Valk, MD Admetsys Corporation
Admetsys Corporation
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP