An Open, Single-centre, Non-controlled Feasibility Study of the Performance of a Tablet Based Workflow and Decision Support System With Incorporated Software Algorithm Used for Glycaemic Management in Non-critically Ill Patients With Type 2 Diabetes at the General Ward

Medical University of Graz1 site in 1 country30 target enrollmentNovember 2012

ConditionsType 2 Diabetes

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Type 2 Diabetes
Sponsor: Medical University of Graz
Enrollment: 30
Locations: 1
Primary Endpoint: The primary endpoint is the percentage of actions the system supports either to capture BG values or provide insulin dose suggestions according to the REACTION algorithm.
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Objective: To investigate the performance (safety) of the GlucoTab system for glycaemic management in non-critically ill patients with type 2 diabetes at the general ward

Registry

clinicaltrials.gov

Start Date

November 2012

End Date

April 2013

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Medical University of Graz

Responsible Party

Principal Investigator

Pieber Thomas, MD

Medical University of Graz

Eligibility Criteria

Inclusion Criteria

•Informed consent obtained after being advised of the nature of the study
•Male or female aged 18 - 90 years (both inclusive)
•Type 2 diabetes treated with diet, oral agents, non-insulin injected anti-diabetic medicine, insulin therapy or any combination of the four

Exclusion Criteria

•Impaired renal function (serum creatinine ≥3.0mg/dL)
•Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient
•Pregnancy
•Any mental condition rendering the patient incapable of giving his consent
•Terminally ill patients
•Participation in a trial within 3 months prior to this trial
•Known or suspected allergy to insulin

Outcomes

Primary Outcomes

The primary endpoint is the percentage of actions the system supports either to capture BG values or provide insulin dose suggestions according to the REACTION algorithm.

Time Frame: duration of hospital stay (maximum three weeks)