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

NCT01766752 | Completed Phase 3

• 1 other identifier: ClinDiab-03
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Type 2 Diabetes

Outcome Measures

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.

  duration of hospital stay (maximum three weeks)

Study Arms (2)

GlucoTab System

EXPERIMENTAL

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

Device: GlucoTab System

no intervention

NO INTERVENTION

standard care

Interventions

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

GlucoTab System

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University of Graz

Graz, 8036, Austria

Location

Related Publications (1)

• 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.

  PMID: 25927357 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 9, 2013
• First Posted: January 11, 2013
• Study Start: November 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: April 1, 2013
• Last Updated: April 10, 2013

Record last verified: 2013-01

Locations

AU (1)