NCT01766752CompletedPhase 3
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
Medical University of Graz2 sites in 1 country30 target enrollmentStarted: November 1, 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- 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.
Study Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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)
Secondary Outcomes
No secondary outcomes reported
Investigators
Pieber Thomas, MD
MD
Medical University of Graz
Study Sites (2)
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