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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Hyperglycemia
Diabetes
 Device: glucose and insulin infusion
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Insulin Balanced Infusion System Control of Glucose

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Admetsys Corporation:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 40
Study Start Date: November 2008
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: insulin and glucose infusion Device: glucose and insulin infusion
combined algorithm directed glucose and insulin infusion with 10-20 minute blood glucose measurements to direct glucose control

  Eligibility

Ages Eligible for Study:   21 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01291719

Locations
United States, Florida
3113 Lawton Road
Orlando, Florida, United States, 32803
Sponsors and Collaborators
Admetsys Corporation
Investigators
Principal Investigator: Timothy W Valk, MD Admetsys Corporation
  More Information

No publications provided

Responsible Party: Timothy Valk MD, Chief Scientist, Admetsys Corporation
ClinicalTrials.gov Identifier: NCT01291719     History of Changes
Other Study ID Numbers: IBIS-1
Study First Received: February 5, 2011
Last Updated: January 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Admetsys Corporation:
closed loop glucose control
intensive care glucose control

Additional relevant MeSH terms:
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
 Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013