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OpenTrials
Active, Not Recruiting

NCT Number: NCT01291719

Insulin Balanced Infusion System

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hyperglycemia Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

3113 Lawton Road

Orlando, Florida, 32803, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. glucose control in target range

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

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

Secondary outcomes

  1. hypoglycemia

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

    blood glucose <70 mg/dl

Sponsors and collaborators

Lead sponsor

Admetsys Corporation

Industry

Registry information

Official study title

Insulin Balanced Infusion System Control of Glucose

Important dates

Study start
2008
Primary completion
2026
Study completion
2026
First posted
Feb 8, 2011
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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