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
  Purpose

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 Intervention Phase
Diabetes Mellitus, Type 2
Drug: Insulin Aspart, Insulin Glargine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Number of glucose measurements in hyperglycaemic ranges [ Time Frame: duration of hospital stay (48 hours - maximum three weeks) ] [ Designated as safety issue: Yes ]

Enrollment: 74
Study Start Date: June 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: July 19, 2011
Last Updated: February 4, 2013
Health Authority: Austria: Agency for Health and Food Safety

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

ClinicalTrials.gov processed this record on July 22, 2014