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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01932775
Recruitment Status : Completed
First Posted : August 30, 2013
Last Update Posted : January 22, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Type 2 Diabetes Device: GlucoTab System Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
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
Study Start Date : May 2013
Primary Completion Date : December 2013
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: GlucoTab System Device: GlucoTab System


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. Number of blood glucose measurements per day [ Time Frame: duration of hospital stay (maximum three weeks) ]
  2. Adherence to the insulin dose suggestion of the GlucoTab system [ Time Frame: duration of hospital stay (maximum three weeks) ]
  3. 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) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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