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NCT01407289 Clinical Trial

A Trial to Investigate Efficacy and Usability of Published Best Practice to Control Glycaemia

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
An Open, Single-centre, Controlled Trial to Investigate the Efficacy and Usability of Published Best Practice to Control Glycaemia in Hospitalised Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01407289
Other study ID # ClinDiab-02
Secondary ID
Status Completed
Phase Phase 4
First received July 19, 2011
Last updated February 4, 2013
Start date June 2011
Est. completion date April 2012

Study information
Verified date April 2012
Source Medical University of Graz
Contact n/a
Is FDA regulated No
Health authority Austria: Agency for Health and Food Safety
Study type Interventional

Clinical Trial Summary

The purpose of the study is to compare the efficacy of enhanced published best practice paper-based insulin titration protocol for glycaemic control in hospitalised patients with type 2 diabetes for the length of hospital stay.

Recruitment information / eligibility
Status Completed
Enrollment 74
Est. completion date April 2012
Est. primary completion date April 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- Type 2 diabetes

- Blood glucose in the range between 140 - 400 mg/dl

- Expected stay = 48 hours

Exclusion Criteria:

- Hyperglycemia without known history of type 2 diabetes mellitus

- Impaired renal function (serum creatinine =3.0mg/dL)

- Clinically relevant hepatic disease

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Insulin Aspart, Insulin Glargine
The Intervention is a paper based protocol, which provides suggestions for new insulin doses (basal-bolus regime).

Locations
Country Name City State
Austria Medical University of Graz, Division of Internal Medicine, Department of Endocrinology and Metabolism/ Cardiology Graz

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean blood glucose Mean blood glucose over 24 hours duration of hospital stay (48 hours - maximum three weeks) No
Secondary Number of glucose measurements in hyperglycaemic ranges duration of hospital stay (48 hours - maximum three weeks) Yes
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