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Insulin Balanced Infusion System

Primary Purpose

Hyperglycemia, Diabetes

Status

Active

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

glucose and insulin infusions

About this trial

This is an interventional treatment trial for Hyperglycemia focused on measuring closed loop glucose control, intensive care glucose control

Eligibility Criteria

21 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

3113 Lawton Road

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

insulin and glucose infusion

Arm Description

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

Outcomes

Primary Outcome Measures

glucose control in target range

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

Secondary Outcome Measures

hypoglycemia

blood glucose <70 mg/dl

Full Information

NCT ID

NCT01291719

First Posted

February 5, 2011

Last Updated

July 18, 2023

Sponsor

Admetsys Corporation

1. Study Identification

Unique Protocol Identification Number

NCT01291719

Brief Title

Insulin Balanced Infusion System

Official Title

Insulin Balanced Infusion System Control of Glucose

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

November 2008 (undefined)

Primary Completion Date

November 2025 (Anticipated)

Study Completion Date

November 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Admetsys Corporation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperglycemia, Diabetes

Keywords

closed loop glucose control, intensive care glucose control

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Model Description

Insulin and glucose infusion in closed loop control

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

insulin and glucose infusion

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

glucose and insulin infusions

Intervention Description

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

Primary Outcome Measure Information:

Title

glucose control in target range

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

hypoglycemia

Description

blood glucose <70 mg/dl

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Timothy W Valk, MD

Organizational Affiliation

Admetsys Corporation

Official's Role

Principal Investigator

Facility Information:

Facility Name

3113 Lawton Road

City

Orlando

State/Province

Florida

ZIP/Postal Code

32803

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

with publication the data will be shared

Citations:

PubMed Identifier

30678470

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.

Results Reference

result

PubMed Identifier

30854885

Citation

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.

Results Reference

result

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Insulin Balanced Infusion System

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