Performance of a Tablet Based Workflow and Decision Support System With Incorporated Software Algorithm Used for Glycaemic Management

Phase 3

Completed

• Conditions: Type 2 Diabetes
• Interventions: Device: GlucoTab System

• Registration Number: NCT01766752
• Lead Sponsor: Medical University of Graz

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Status Verified: 2013-01
• Study First Submitted: 2013-01-09
• Study First Submitted QC: 2013-01-09
• Study First Posted: 2013-01-11
• Primary Completion: 2013-03
• Study Completion: 2013-04
• Last Update Submitted: 2013-04-09
• Last Update Posted: 2013-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GlucoTab System	GlucoTab System	Investigational system: GlucoTab system supports the glycaemic management of non-critically ill patients with type two diabetes at the general ward.

Primary Outcome Measures

Name	Time	Method
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.	duration of hospital stay (maximum three weeks)

Trial Locations

Locations (1)

Medical University of Graz; 🇦🇹 Graz, Austria