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

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Phase 3
Locations
Austria
Study Type
Interventional
Intervention
GlucoTab System
Sponsored by
Medical University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Medical University of Graz

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GlucoTab System

Arm Description

Outcomes

Primary Outcome Measures

Mean percentage of blood glucose measurements in the target range 70 to 140 mg/dl, as calculated by all premeal and bedtime glucose values measured ≥ 24 hours after start of therapy

Secondary Outcome Measures

Number of blood glucose measurements per day
Adherence to the insulin dose suggestion of the GlucoTab system
Mean daily blood glucose as calculated by premeal and bedtime blood glucose values: Overall and per treatment day

Full Information

First Posted
August 27, 2013
Last Updated
January 20, 2014
Sponsor
Medical University of Graz
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1. Study Identification

Unique Protocol Identification Number
NCT01932775
Brief Title
Efficacy, Usability Study of the GlucoTab System for Glycaemic Management in Type 2 Diabetic Patients at General Wards
Official Title
An Open, Single-centre, Non-controlled Study of Efficacy, Safety and Usability of the GlucoTab System for Glycaemic Management in Non-critically Ill Patients With Type 2 Diabetes at General Wards
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Graz

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 general wards.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GlucoTab System
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
GlucoTab System
Primary Outcome Measure Information:
Title
Mean percentage of blood glucose measurements in the target range 70 to 140 mg/dl, as calculated by all premeal and bedtime glucose values measured ≥ 24 hours after start of therapy
Time Frame
duration of hospital stay (maximum three weeks)
Secondary Outcome Measure Information:
Title
Number of blood glucose measurements per day
Time Frame
duration of hospital stay (maximum three weeks)
Title
Adherence to the insulin dose suggestion of the GlucoTab system
Time Frame
duration of hospital stay (maximum three weeks)
Title
Mean daily blood glucose as calculated by premeal and bedtime blood glucose values: Overall and per treatment day
Time Frame
duration of hospital stay (maximum three weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas R Pieber, MD
Organizational Affiliation
Medical University of Graz, Department of Internal Medicine, Division of Endocrinology and Metabolism
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria

12. IPD Sharing Statement

Citations:
PubMed Identifier
27103198
Citation
Donsa K, Beck P, Holl B, Mader JK, Schaupp L, Plank J, Neubauer KM, Baumgartner C, Pieber TR. Impact of errors in paper-based and computerized diabetes management with decision support for hospitalized patients with type 2 diabetes. A post-hoc analysis of a before and after study. Int J Med Inform. 2016 Jun;90:58-67. doi: 10.1016/j.ijmedinf.2016.03.007. Epub 2016 Mar 23.
Results Reference
derived
PubMed Identifier
25927357
Citation
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.
Results Reference
derived

Learn more about this trial

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

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