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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01932775
First received: August 27, 2013
Last updated: January 20, 2014
Last verified: January 2014
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of blood glucose measurements per day [ Time Frame: duration of hospital stay (maximum three weeks) ] [ Designated as safety issue: Yes ]
  • Adherence to the insulin dose suggestion of the GlucoTab system [ Time Frame: duration of hospital stay (maximum three weeks) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01932775

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

No publications provided

Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT01932775     History of Changes
Other Study ID Numbers: ClinDiab-04
Study First Received: August 27, 2013
Last Updated: January 20, 2014
Health Authority: Austria: 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 23, 2014