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

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01932775
• Other study ID #: ClinDiab-04
• Status: Completed
• Phase: Phase 3
• First received: August 27, 2013
• Last updated: January 20, 2014
• Start date: May 2013
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Device:
• GlucoTab System

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz

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	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		duration of hospital stay (maximum three weeks)	Yes
Secondary	Number of blood glucose measurements per day		duration of hospital stay (maximum three weeks)	Yes
Secondary	Adherence to the insulin dose suggestion of the GlucoTab system		duration of hospital stay (maximum three weeks)	No
Secondary	Mean daily blood glucose as calculated by premeal and bedtime blood glucose values: Overall and per treatment day		duration of hospital stay (maximum three weeks)	No