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

Medical University of Graz

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes

Treatments: Device: GlucoTab System

Study type: Interventional

Funder types: Other

Identifiers

NCT01766752

ClinDiab-03

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

GlucoTab System

Experimental group

Description:

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

Treatment:

Device: GlucoTab System

no intervention

No Intervention group

Description:

standard care