Investigation of an insulin-dosing advice system to control blood glucose in hospitalised patients with type 2 diabetes

Conditions: Type 2 Diabetes
MedDRA version: 13.1Level: LLTClassification code 10049746Term: Insulin-requiring type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2011-001918-34-AT

Lead Sponsor: Medizinische Universität Graz

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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 (diagnosed at least 3 months prior to study start) treated with diet, oral agents, non-insulin injected anti-diabetic medicine, insulin therapy or any combination of the four
•Blood glucose in the range between 140 – 400 mg/dl (both inclusive)
•Expected stay = 48 hours

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 34

Exclusion Criteria

•Hyperglycemia without known history of type 2 diabetes mellitus
•Impaired renal function (serum creatinine =3.0mg/dL)
•Clinically relevant hepatic disease
•Presence or history of diabetic ketoacidosis
•Pregnancy
•Any mental condition rendering the patient incapable of giving his consent
•Terminally ill patients
•Participation in a trail within 3 months prior to this trail
•Known or suspected allergy to insulin

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the efficacy of enhanced published best practice paper-based insulin titration protocol (ePBP) for glycaemic control in hospitalised patients with type 2 diabetes for the length of hospital stay, with a maximum of 21 days.;Secondary Objective: To evaluate safety and usability of ePBP for glycaemic control in hospitalised patients with type 2 diabetes, with a maximum of 21 days.<br>To compare the efficacy of ePBP vs. standard care (SC) for glycaemic control in hospitalised patients with type 2 diabetes for the length of hospital stay, with a maximum of 21 days. <br>;Primary end point(s): Mean blood glucose as calculated by premeal and bedtime glucose values per treatment day ;Timepoint(s) of evaluation of this end point: At hospital discharge / transfer to other ward/department / if study period exceeds 21 days

Secondary Outcome Measures