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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01932775
First received: August 27, 2013
Last updated: January 20, 2014
Last verified: January 2014

August 27, 2013
January 20, 2014
May 2013
December 2013   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01932775 on ClinicalTrials.gov Archive Site
  • Number of blood glucose measurements per day [ Time Frame: duration of hospital stay (maximum three weeks) ] [ Designated as safety issue: Yes ]
  • Adherence to the insulin dose suggestion of the GlucoTab system [ Time Frame: duration of hospital stay (maximum three weeks) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: duration of hospital stay (maximum three weeks) ] [ Designated as safety issue: Yes ]
    • Number of hypoglycaemic episodes requiring third party help
    • Number of blood glucose measurements per day
    • Number of missed blood glucose measurements per day
    • Number of additionally required blood glucose measurements
    • Insulin dose - basal, bolus and corrective insulin dose per day
    • Number of insulin injections per day
    • Number and reasons for non-performance of insulin injections per day
    • Relevant concomitant medication (corticosteroids, parenteral bolus nutrition)
  • Usability [ Time Frame: duration of hospital stay (maximum three weeks) ] [ Designated as safety issue: No ]
    • Adherence to the insulin dose suggestion of the GlucoTab system
    • User satisfaction with the GlucoTab system regarding the user interface and the provided functionality
    • Malfunctions of the GlucoTab system
    • Other usability parameters like user workload and support of treatment workflow
  • Efficacy [ Time Frame: duration of hospital stay (maximum three weeks) ] [ Designated as safety issue: No ]
    • Mean daily blood glucose as calculated by premeal and bedtime blood glucose values: Overall and per treatment day
    • Mean pre-breakfast blood glucose, mean pre-lunch blood glucose, mean pre-dinner blood glucose, mean bedtime blood glucose
    • Mean pre-enrolment blood glucose
    • Number and percentage of the following ranges: 0-<40 mg/dl, 40-<70 mg/dl, 70-<100 mg/dl, 100-140 mg/dl, >140-<180 mg/dl, 180-<300 mg/dl, ≥ 300 mg/dl.
    • Time of glucose measurements in the following ranges: 0-<40 mg/dl, 40-<70 mg/dl, 70-<100 mg/dl, 100-140 mg/dl, >140-<180 mg/dl, 180-<300 mg/dl, ≥ 300 mg/dl
Not Provided
Not Provided
 
Efficacy, Usability Study of the GlucoTab System for Glycaemic Management in Type 2 Diabetic Patients at General Wards
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

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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes
Device: GlucoTab System
Experimental: GlucoTab System
Intervention: Device: GlucoTab System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
99
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01932775
ClinDiab-04
No
Medical University of Graz
Medical University of Graz
Not Provided
Principal Investigator: Thomas R Pieber, MD Medical University of Graz, Department of Internal Medicine, Division of Endocrinology and Metabolism
Medical University of Graz
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP