Insulin Balanced Infusion System

Phase 1

Active, not recruiting

• Conditions: Hyperglycemia; Diabetes
• Interventions: Device: glucose and insulin infusions

• Registration Number: NCT01291719
• Lead Sponsor: Admetsys Corporation

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

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2011-02-05
• Study First Submitted QC: 2011-02-07
• Study First Posted: 2011-02-08
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-30
• Primary Completion: 2026-11
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
insulin and glucose infusion	glucose and insulin infusions	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

Primary Outcome Measures

Name	Time	Method
glucose control in target range	data will be evaluated within 6 months after completion of all 40 studies	blood glucose measurements in target range (80-125 mg/dl)

Secondary Outcome Measures

Name	Time	Method
hypoglycemia	data will be evaluated within 6 months after all 40 studies are completed	blood glucose \<70 mg/dl

Trial Locations

Locations (1)

3113 Lawton Road; 🇺🇸 Orlando, Florida, United States