Skip to main content
OpenTrials
Completed

NCT Number: NCT01932775

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medical University of Graz

Graz, 8036, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GlucoTab System

Device

Primary outcomes

  1. 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

  1. Number of blood glucose measurements per day

    Time frame: duration of hospital stay (maximum three weeks)

  2. Adherence to the insulin dose suggestion of the GlucoTab system

    Time frame: duration of hospital stay (maximum three weeks)

  3. Mean daily blood glucose as calculated by premeal and bedtime blood glucose values: Overall and per treatment day

    Time frame: duration of hospital stay (maximum three weeks)

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Aug 30, 2013
Registry last updated
Jan 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.