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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01766752
• Other study ID #: ClinDiab-03
• Status: Completed
• Phase: Phase 3
• First received: January 9, 2013
• Last updated: April 9, 2013
• Start date: November 2012
• Est. completion date: April 2013

Study information

• Verified date: January 2013
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: The Austrian Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Device:
• GlucoTab System
Tablet based workflow and decision support system with incorporated software algorithm (GlucoTab) used for glycaemic management in non-critically ill patients with type 2 diabetes at the general ward

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes