Overview

This trial is active, not recruiting.

Conditions hyperglycemia, diabetes
Treatment glucose and insulin infusions
Phase phase 1/phase 2
Sponsor Admetsys Corporation
Start date November 2008
End date November 2018
Trial size 40 participants
Trial identifier NCT01291719, IBIS-1

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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
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

Primary Outcomes

Measure
glucose control in target range
time frame: data will be evaluated within 6 months after completion of all 40 studies

Secondary Outcomes

Measure
hypoglycemia
time frame: data will be evaluated within 6 months after all 40 studies are completed

Eligibility Criteria

Male or female participants from 21 years up to 85 years old.

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

Additional Information

Official title Insulin Balanced Infusion System Control of Glucose
Principal investigator Timothy W Valk, MD
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
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Admetsys Corporation.