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Insulin Balanced Infusion System

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01291719
First Posted: February 8, 2011
Last Update Posted: July 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Timothy Valk MD, Admetsys Corporation
  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; study to develop a closed loop for use in intensive care units and surgery

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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 Timothy Valk MD, 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 ]
    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 ]
    blood glucose <70 mg/dl


Estimated Enrollment: 40
Study Start Date: November 2008
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2018 (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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Timothy Valk MD, Chief Scientist, Admetsys Corporation
ClinicalTrials.gov Identifier: NCT01291719     History of Changes
Other Study ID Numbers: IBIS-1
First Submitted: February 5, 2011
First Posted: February 8, 2011
Last Update Posted: July 12, 2016
Last Verified: January 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Timothy Valk MD, Admetsys Corporation:
closed loop glucose control
intensive care glucose control

Additional relevant MeSH terms:
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs