Insulin Balanced Infusion System

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Timothy Valk MD, Admetsys Corporation Identifier:
First received: February 5, 2011
Last updated: January 26, 2015
Last verified: January 2015

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; study to develop a closed loop for use in intensive care units and surgery

Condition Intervention Phase
Device: glucose and insulin infusions
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: November 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: insulin and glucose infusion
trial of experimental technique in outpatient setting; the group under study will be comprised of type 1 and type 2 diabetic individuals ; they will have automated treatment using algorithm which regulates balancing infusions of glucose and/or insulin intravenously without manual intervention; blood glucose target of 80-180 mg/dl will be guide for the automated system
Device: glucose and insulin infusions
combined algorithm directed glucose and insulin infusion with 5 minute blood glucose measurements to direct glucose control; regular insulin and glucose are infused intravenously as adjusted by the algorithm without manual intervention in the group of diabetic individuals under study to adjust the glucose level to a target range of 80-180 mg/dl

Detailed Description:

The study is using an experimental design outpatient with individuals having treatment using an automated closed loop glucose control unit; glucoses are measured every 5 minutes using a intravenous glucose sensor and infusion of glucose and insulin are altered without manual intervention as directed by algorithm


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

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
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Please refer to this study by its identifier: NCT01291719

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

No publications provided

Responsible Party: Timothy Valk MD, Chief Scientist, Admetsys Corporation Identifier: NCT01291719     History of Changes
Other Study ID Numbers: IBIS-1
Study First Received: February 5, 2011
Last Updated: January 26, 2015
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:
Glucose Metabolism Disorders
Metabolic Diseases
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs processed this record on October 08, 2015