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

Phase 3

Completed

• Conditions: Type 2 Diabetes
• Interventions: Device: GlucoTab System

• Registration Number: NCT01932775
• Lead Sponsor: Medical University of Graz

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-08-27
• Study First Submitted QC: 2013-08-27
• Study First Posted: 2013-08-30
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-20
• Last Update Posted: 2014-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GlucoTab System	GlucoTab System	-

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures

Name	Time	Method
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)
Number of blood glucose measurements per day	duration of hospital stay (maximum three weeks)
Adherence to the insulin dose suggestion of the GlucoTab system	duration of hospital stay (maximum three weeks)

Trial Locations

Locations (1)

Medical University of Graz; 🇦🇹 Graz, Austria