Insulin Balanced Infusion System

NCT01291719 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: IBIS-1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hyperglycemia; Diabetes

Keywords

closed loop glucose control; intensive care glucose control

Outcome Measures

Primary Outcomes (1)

• glucose control in target range

  blood glucose measurements in target range (80-125 mg/dl)

  data will be evaluated within 6 months after completion of all 40 studies

Secondary Outcomes (1)

• hypoglycemia

  data will be evaluated within 6 months after all 40 studies are completed

Study Arms (1)

insulin and glucose infusion

EXPERIMENTAL

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

Interventions

glucose and insulin infusions DEVICE

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

insulin and glucose infusion

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• pregnancy
• renal or hepatic disease
• corticosteroids
• poor intravenous access
• anemia
• electrolyte abnormality

Sponsors & Collaborators

• Admetsys Corporation: lead

Study Sites (1)

3113 Lawton Road

Orlando, Florida, 32803, United States

Location

Related Publications (2)

• Hashemi N, Valk T, Houlind K, Ejskjaer N. Insulin-Based Infusion System: Preliminary Study. J Diabetes Sci Technol. 2019 Sep;13(5):935-940. doi: 10.1177/1932296818821349. Epub 2019 Jan 24.

  PMID: 30678470 RESULT

• Hashemi N, Valk T, Houlind K, Ejskjaer N. Insulin-Based Infusion System: Advancing the Development. J Diabetes Sci Technol. 2019 Sep;13(5):941-948. doi: 10.1177/1932296819832876. Epub 2019 Mar 10.

  PMID: 30854885 RESULT

MeSH Terms

Conditions

Hyperglycemia; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Timothy W Valk, MD

  Admetsys Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Scientist

Model Details: Insulin and glucose infusion in closed loop control; intervention is glucose control with insulin and glucose infusion

Study Record Dates

• First Submitted: February 5, 2011
• First Posted: February 8, 2011
• Study Start: November 1, 2008
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)