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

Medical University of Graz1 site in 1 country99 target enrollmentMay 2013

ConditionsType 2 Diabetes

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Type 2 Diabetes
Sponsor: Medical University of Graz
Enrollment: 99
Locations: 1
Primary Endpoint: 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
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2013

End Date

December 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Medical University of Graz

Responsible Party

Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

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))