Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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 26, 2015
Last verified: January 2015

February 5, 2011
January 26, 2015
November 2008
November 2016   (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; study to develop a closed loop for use in intensive care units and surgery

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

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 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
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
Intervention: Device: glucose and insulin infusions
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
November 2016
November 2016   (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 2015

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