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
  Purpose

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


Condition Intervention Phase
Type 2 Diabetes
Device: GlucoTab System
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • 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 ]

Enrollment: 30
Study Start Date: November 2012
Study Completion Date: April 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GlucoTab System
Investigational system: GlucoTab system supports the glycaemic management of non-critically ill patients with type two diabetes at the general ward.
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
No Intervention: no intervention
standard care

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01766752

Locations
Austria
Medical University of Graz
Graz, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
  More Information

No publications provided

Responsible Party: Pieber Thomas, MD, MD, Medical University of Graz
ClinicalTrials.gov Identifier: NCT01766752     History of Changes
Other Study ID Numbers: ClinDiab-03
Study First Received: January 9, 2013
Last Updated: April 9, 2013
Health Authority: Austria: The Austrian Agency for Health and Food Safety

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 15, 2014