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

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

NCT01932775

ClinDiab-04

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 general wards.

Enrollment: 99 patients

Sex: All

Ages: 18+ 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 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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99 participants in 1 patient group

GlucoTab System

Experimental group

Treatment:

Device: GlucoTab System