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NCT02053077 Clinical Trial

Risk Identification of the GlucoTab System in Routine Use

Diabetes Mellitus Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02053077
Other study ID # ClinDiab-05
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2014
Est. completion date June 26, 2016

Study information
Verified date May 2023
Source Medical University of Graz
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Identification of risks of the GlucoTab system in routine use.

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.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date June 26, 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Austria Medical University of Graz Graz Styria

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy: Blood Glucose During 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 Efficacy: Blood Glucose During Hospital Stay 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
Secondary Usability: Coverage of the GlucoTab 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
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