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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pieber Thomas, MD, Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01407289
First received: July 19, 2011
Last updated: February 4, 2013
Last verified: April 2012
History of Changes

July 19, 2011
February 4, 2013
June 2011
April 2012   (final data collection date for primary outcome measure)
Mean blood glucose [ Time Frame: duration of hospital stay (48 hours - maximum three weeks) ] [ Designated as safety issue: No ]
Mean blood glucose over 24 hours
Mean blood glucose [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 12 days ] [ Designated as safety issue: No ]
Mean blood glucose over 24 hours
Complete list of historical versions of study NCT01407289 on ClinicalTrials.gov Archive Site
Number of glucose measurements in hyperglycaemic ranges [ Time Frame: duration of hospital stay (48 hours - maximum three weeks) ] [ Designated as safety issue: Yes ]
Number of glucose measurements in hyperglycaemic ranges [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 12 days ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Trial to Investigate Efficacy and Usability of Published Best Practice to Control Glycaemia
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

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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
Drug: Insulin Aspart, Insulin Glargine
The Intervention is a paper based protocol, which provides suggestions for new insulin doses (basal-bolus regime).
  • Experimental: Insulin titration protocol
    Patients in care at the Division of Endocrinology will be treated by enhanced version of published best paper based practice insulin titration protocol to control glycaemia in hospitalised patients with type 2 diabetes.
    Intervention: Drug: Insulin Aspart, Insulin Glargine
  • No Intervention: Standard care
    Patients in care of the Division of Cardiology will be treated using antihyperglycaemic therapy according to standard care.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
74
April 2012
April 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01407289
ClinDiab-02
Not Provided
Pieber Thomas, MD, Medical University of Graz
Medical University of Graz
Not Provided
Principal Investigator: Thomas Pieber, MD Division of Endocrinology and Metabolism, Department of Internal Medicine Medical University of Graz
Medical University of Graz
April 2012

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