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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 29, 2014