Clinical trial NCT01932775: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2013-08-30
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
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
timeFrame: duration of hospital stay (maximum three weeks)
Secondary outcomes:
measure: Number of blood glucose measurements per day
timeFrame: duration of hospital stay (maximum three weeks)
measure: Adherence to the insulin dose suggestion of the GlucoTab system
timeFrame: duration of hospital stay (maximum three weeks)
measure: Mean daily blood glucose as calculated by premeal and bedtime blood glucose values: Overall and per treatment day
timeFrame: duration of hospital stay (maximum three weeks)
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
Study officials:
affiliation: Medical University of Graz, Department of Internal Medicine, Division of Endocrinology and Metabolism
name: Thomas R Pieber, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.