Back to resultsA Trial to Investigate Efficacy and Usability of Published Best Practice to Control Glycaemia
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Insulin Aspart, Insulin Glargine
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility 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
Sites / Locations
- Medical University of Graz, Division of Internal Medicine, Department of Endocrinology and Metabolism/ Cardiology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Insulin titration protocol
Standard care
Arm Description
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.
Patients in care of the Division of Cardiology will be treated using antihyperglycaemic therapy according to standard care.
Outcomes
Primary Outcome Measures
Mean blood glucose
Mean blood glucose over 24 hours
Secondary Outcome Measures
Number of glucose measurements in hyperglycaemic ranges
Full Information
NCT ID
NCT01407289
First Posted
July 19, 2011
Last Updated
February 4, 2013
Sponsor
Medical University of Graz
1. Study Identification
Unique Protocol Identification Number
NCT01407289
Brief Title
A Trial to Investigate Efficacy and Usability of Published Best Practice to Control Glycaemia
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 Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Graz
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Insulin titration protocol
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Patients in care of the Division of Cardiology will be treated using antihyperglycaemic therapy according to standard care.
Intervention Type
Drug
Intervention Name(s)
Insulin Aspart, Insulin Glargine
Intervention Description
The Intervention is a paper based protocol, which provides suggestions for new insulin doses (basal-bolus regime).
Primary Outcome Measure Information:
Title
Mean blood glucose
Description
Mean blood glucose over 24 hours
Time Frame
duration of hospital stay (48 hours - maximum three weeks)
Secondary Outcome Measure Information:
Title
Number of glucose measurements in hyperglycaemic ranges
Time Frame
duration of hospital stay (48 hours - maximum three weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Pieber, MD
Organizational Affiliation
Division of Endocrinology and Metabolism, Department of Internal Medicine Medical University of Graz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Graz, Division of Internal Medicine, Department of Endocrinology and Metabolism/ Cardiology
City
Graz
ZIP/Postal Code
8036
Country
Austria
12. IPD Sharing Statement
Citations:
PubMed Identifier
27103198
Citation
Donsa K, Beck P, Holl B, Mader JK, Schaupp L, Plank J, Neubauer KM, Baumgartner C, Pieber TR. Impact of errors in paper-based and computerized diabetes management with decision support for hospitalized patients with type 2 diabetes. A post-hoc analysis of a before and after study. Int J Med Inform. 2016 Jun;90:58-67. doi: 10.1016/j.ijmedinf.2016.03.007. Epub 2016 Mar 23.
Results Reference
derived
PubMed Identifier
25927357
Citation
Schaupp L, Donsa K, Neubauer KM, Mader JK, Aberer F, Holl B, Spat S, Augustin T, Beck P, Pieber TR, Plank J. Taking a Closer Look--Continuous Glucose Monitoring in Non-Critically Ill Hospitalized Patients with Type 2 Diabetes Mellitus Under Basal-Bolus Insulin Therapy. Diabetes Technol Ther. 2015 Sep;17(9):611-8. doi: 10.1089/dia.2014.0343. Epub 2015 Apr 30.
Results Reference
derived
Learn more about this trial
A Trial to Investigate Efficacy and Usability of Published Best Practice to Control Glycaemia
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