Insulin Balanced Infusion System

Admetsys

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Diabetes; Hyperglycemia

Treatments: Device: glucose and insulin infusions

Study type: Interventional

Funder types: Industry

Identifiers

NCT01291719

IBIS-1

Details and patient eligibility

About

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

Full 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

Enrollment: 40 estimated patients

Sex: All

Ages: 21 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

insulin and glucose infusion

Experimental group

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

Treatment:

Device: glucose and insulin infusions