Risk Identification of the GlucoTab System in Routine Use

May 11, 2023 updated by: Pieber Thomas, MD, Medical University of Graz

A Study to Identify Risks in Routine Use of the GlucoTab System for Glycaemic Management in Non-critically Ill Patients With Type 2 Diabetes at General Wards

Identification of risks of the GlucoTab system in routine use.

Study Overview

Status

Completed

Conditions

Detailed Description

A study to identify risks in routine use of the GlucoTab system for glycaemic management in non-critically ill patients with type 2 diabetes at general wards.

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Styria
      • Graz, Styria, Austria, 8010
        • Medical University of Graz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

non-critically ill patients with type 2 diabetes at general wards

Description

Inclusion Criteria:

  • informed consent obtained after being advised of the nature of the study
  • type 2 diabetes or new-onset hyperglycaemia which require s.c. insulin therapy during hospital stay
  • diabetes therapy supported by GlucoTab system

Exclusion Criteria:

  • type 1 diabetes mellitus
  • intravenous insulin therapy
  • hyperglycaemic episodes (ketoacidosis, hyperosmolar state) if they require intravenous insulin therapy
  • gestational diabetes or pregnancy
  • known or suspected allergy to certain insulin types, named in the user manual
  • total parenteral nutrition (TPN)
  • any mental condition rendering the patient incapable of giving his consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy: Blood Glucose During Hospital Stay, an Expected Average of 1 Week
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 1 week
efficacy: mean daily blood glucose during hospital stay, an expected average of 1 week
participants will be followed for the duration of hospital stay, an expected average of 1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy: Blood Glucose During Hospital Stay
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 1 week
Efficacy: mean pre-breakfast blood glucose during hospital stay
participants will be followed for the duration of hospital stay, an expected average of 1 week
Usability: Coverage of the GlucoTab
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Usability: coverage of the GlucoTab treatment during hospital stay
Participants will be followed for the duration of hospital stay, an expected average of 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Investigators

  • Principal Investigator: Thomas R. Pieber, Univ.Prof.Dr, Medical University of Graz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 26, 2016

Study Registration Dates

First Submitted

January 29, 2014

First Submitted That Met QC Criteria

January 31, 2014

First Posted (Estimate)

February 3, 2014

Study Record Updates

Last Update Posted (Actual)

May 12, 2023

Last Update Submitted That Met QC Criteria

May 11, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • ClinDiab-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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