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Completed

NCT Number: NCT02053077

Risk Identification of the GlucoTab System in Routine Use

Identification of risks of the GlucoTab system in routine use.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Graz

Graz, Styria, 8010, Austria

About this study

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.

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
  • 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

Treatment and study plan

Primary outcomes

  1. Efficacy: Blood Glucose During Hospital Stay, an Expected Average of 1 Week

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 1 week

    efficacy: mean daily blood glucose during hospital stay, an expected average of 1 week

Secondary outcomes

  1. Efficacy: Blood Glucose During Hospital Stay

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 1 week

    Efficacy: mean pre-breakfast blood glucose during hospital stay

  2. Usability: Coverage of the GlucoTab

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week

    Usability: coverage of the GlucoTab treatment during hospital stay

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 3, 2014
Registry last updated
May 12, 2023

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.

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