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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 18, 2014