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

February 4, 2013 updated by: Pieber Thomas, MD, Medical University of Graz

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Medical University of Graz, Division of Internal Medicine, Department of Endocrinology and Metabolism/ Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean blood glucose
Time Frame: duration of hospital stay (48 hours - maximum three weeks)
Mean blood glucose over 24 hours
duration of hospital stay (48 hours - maximum three weeks)

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of glucose measurements in hyperglycaemic ranges
Time Frame: duration of hospital stay (48 hours - maximum three weeks)
duration of hospital stay (48 hours - maximum three weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Investigators

  • Principal Investigator: Thomas Pieber, MD, Division of Endocrinology and Metabolism, Department of Internal Medicine Medical University of Graz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

July 19, 2011

First Submitted That Met QC Criteria

July 29, 2011

First Posted (Estimate)

August 2, 2011

Study Record Updates

Last Update Posted (Estimate)

February 5, 2013

Last Update Submitted That Met QC Criteria

February 4, 2013

Last Verified

April 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ClinDiab-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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