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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pieber Thomas, MD, Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01766752
First received: January 9, 2013
Last updated: April 9, 2013
Last verified: January 2013

January 9, 2013
April 9, 2013
November 2012
March 2013   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01766752 on ClinicalTrials.gov Archive Site
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Performance of a Tablet Based Workflow and Decision Support System With Incorporated Software Algorithm Used for Glycaemic Management
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

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

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes
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
  • Experimental: GlucoTab System
    Investigational system: GlucoTab system supports the glycaemic management of non-critically ill patients with type two diabetes at the general ward.
    Intervention: Device: GlucoTab System
  • No Intervention: no intervention
    standard care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
April 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01766752
ClinDiab-03
Not Provided
Pieber Thomas, MD, Medical University of Graz
Medical University of Graz
Not Provided
Not Provided
Medical University of Graz
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP