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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01407289
Recruitment Status : Completed
First Posted : August 2, 2011
Last Update Posted : February 5, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Insulin Aspart, Insulin Glargine Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : June 2011
Primary Completion Date : April 2012
Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.
Drug: Insulin Aspart, Insulin Glargine
The Intervention is a paper based protocol, which provides suggestions for new insulin doses (basal-bolus regime).
No Intervention: Standard care
Patients in care of the Division of Cardiology will be treated using antihyperglycaemic therapy according to standard care.


Outcome Measures

Primary Outcome Measures :
  1. Mean blood glucose [ Time Frame: duration of hospital stay (48 hours - maximum three weeks) ]
    Mean blood glucose over 24 hours


Secondary Outcome Measures :
  1. Number of glucose measurements in hyperglycaemic ranges [ Time Frame: duration of hospital stay (48 hours - maximum three weeks) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01407289


Locations
Austria
Medical University of Graz, Division of Internal Medicine, Department of Endocrinology and Metabolism/ Cardiology
Graz, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
Investigators
Principal Investigator: Thomas Pieber, MD Division of Endocrinology and Metabolism, Department of Internal Medicine Medical University of Graz
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pieber Thomas, MD, MD, Prof. of Medicine, Medical University of Graz
ClinicalTrials.gov Identifier: NCT01407289     History of Changes
Other Study ID Numbers: ClinDiab-02
First Posted: August 2, 2011    Key Record Dates
Last Update Posted: February 5, 2013
Last Verified: April 2012

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Insulin Glargine
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs