Insulin Balanced Infusion System

Diabetes Clinical Trial

Official title:

Insulin Balanced Infusion System Control of Glucose

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01291719
• Other study ID #: IBIS-1
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: November 2008
• Est. completion date: November 2025

Study information

• Verified date: July 2023
• Source: Admetsys Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Hyperglycemia

Intervention

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

Locations

Country	Name	City	State
United States	3113 Lawton Road	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Admetsys Corporation

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	hypoglycemia	blood glucose <70 mg/dl	data will be evaluated within 6 months after all 40 studies are completed