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Efficacy, Usability Study of the GlucoTab System for Glycaemic Management in Type 2 Diabetic Patients at General Wards

This study has been completed.
Information provided by (Responsible Party):
Medical University of Graz Identifier:
First received: August 27, 2013
Last updated: January 20, 2014
Last verified: January 2014
Objective: To investigate the performance (safety) of the GlucoTab system for glycaemic management in non-critically ill patients with type 2 diabetes at general wards.

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open, Single-centre, Non-controlled Study of Efficacy, Safety and Usability of the GlucoTab System for Glycaemic Management in Non-critically Ill Patients With Type 2 Diabetes at General Wards

Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • Mean percentage of blood glucose measurements in the target range 70 to 140 mg/dl, as calculated by all premeal and bedtime glucose values measured ≥ 24 hours after start of therapy [ Time Frame: duration of hospital stay (maximum three weeks) ]

Secondary Outcome Measures:
  • Number of blood glucose measurements per day [ Time Frame: duration of hospital stay (maximum three weeks) ]
  • Adherence to the insulin dose suggestion of the GlucoTab system [ Time Frame: duration of hospital stay (maximum three weeks) ]
  • Mean daily blood glucose as calculated by premeal and bedtime blood glucose values: Overall and per treatment day [ Time Frame: duration of hospital stay (maximum three weeks) ]

Enrollment: 99
Study Start Date: May 2013
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GlucoTab System Device: GlucoTab System


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Informed consent obtained after being advised of the nature of the study
  • Male or female aged ≥18 years
  • Type 2 diabetes (treated with diet, oral agents, non-insulin injected anti-diabetic medicine, insulin therapy or any combination of the four) or newly diagnosed hyperglycaemia which requires s.c. insulin therapy

Exclusion Criteria:

  • Type 1 diabetes, gestational diabetes
  • 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
  • Known or suspected allergy to insulin glargine or insulin aspart
  • Continuous parenteral nutrition
  • Participation in another trial which can influence the software algorithm
  Contacts and Locations
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Please refer to this study by its identifier: NCT01932775

Medical University of Graz
Graz, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
Principal Investigator: Thomas R Pieber, MD Medical University of Graz, Department of Internal Medicine, Division of Endocrinology and Metabolism
  More Information