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OpenTrials
Completed

NCT Number: NCT01766752

Performance of a Tablet Based Workflow and Decision Support System With Incorporated Software Algorithm Used for Glycaemic Management

Objective: To investigate the performance (safety) of the GlucoTab system for glycaemic management in non-critically ill patients with type 2 diabetes at the general ward

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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–90 year

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 - 90 years (both inclusive)
  • Type 2 diabetes treated with diet, oral agents, non-insulin injected anti-diabetic medicine, insulin therapy or any combination of the four

Exclusion criteria

  • Impaired renal function (serum creatinine ≥3.0mg/dL)
  • 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
  • Terminally ill patients
  • Participation in a trial within 3 months prior to this trial
  • Known or suspected allergy to insulin

Treatment and study plan

GlucoTab System

Device

Tablet based workflow and decision support system with incorporated software algorithm (GlucoTab) used for glycaemic management in non-critically ill patients with type 2 diabetes at the general ward

Primary outcomes

  1. The primary endpoint is the percentage of actions the system supports either to capture BG values or provide insulin dose suggestions according to the REACTION algorithm.

    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 Feasibility Study of the Performance of a Tablet Based Workflow and Decision Support System With Incorporated Software Algorithm Used for Glycaemic Management in Non-critically Ill Patients With Type 2 Diabetes at the General Ward

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 11, 2013
Registry last updated
Apr 10, 2013

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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