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

NCT ID: NCT01766752

Last Updated: 2013-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-04-30

Brief Summary

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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

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GlucoTab System

Investigational system: GlucoTab system supports the glycaemic management of non-critically ill patients with type two diabetes at the general ward.

Group Type EXPERIMENTAL

GlucoTab System

Intervention Type 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

no intervention

standard care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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GlucoTab System

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

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Pieber Thomas, MD

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Medical University of Graz

Graz, , Austria

Site Status

Countries

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Austria

References

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Schaupp L, Donsa K, Neubauer KM, Mader JK, Aberer F, Holl B, Spat S, Augustin T, Beck P, Pieber TR, Plank J. Taking a Closer Look--Continuous Glucose Monitoring in Non-Critically Ill Hospitalized Patients with Type 2 Diabetes Mellitus Under Basal-Bolus Insulin Therapy. Diabetes Technol Ther. 2015 Sep;17(9):611-8. doi: 10.1089/dia.2014.0343. Epub 2015 Apr 30.

Reference Type DERIVED
PMID: 25927357 (View on PubMed)

Other Identifiers

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ClinDiab-03

Identifier Type: -

Identifier Source: org_study_id

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