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CompletedNCT01407289Updated Feb 5, 2013

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

A Phase 4 interventional study of Insulin Aspart, Insulin Glargine in Diabetes Mellitus, Type 2, sponsored by Medical University of Graz. Completed at 1 site in Austria. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2013-02-05.

Sponsored by Medical University of Graz · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
74
Allocation
Non-randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 74 is close to the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Medical University of Graz is the lead sponsor of 459 studies on the registry; 98 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Type 2 diabetes
  • Blood glucose in the range between 140 - 400 mg/dl
  • Expected stay ≥ 48 hours

Exclusion criteria

Exclusion Criteria:

  • Hyperglycemia without known history of type 2 diabetes mellitus
  • Impaired renal function (serum creatinine ≥3.0mg/dL)
  • Clinically relevant hepatic disease
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
74 participants (actual)

Study arms

  • 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

  • No intervention
    Standard care

    Patients in care of the Division of Cardiology will be treated using antihyperglycaemic therapy according to standard care.

Interventions

  • DrugInsulin Aspart, Insulin Glargine

    The Intervention is a paper based protocol, which provides suggestions for new insulin doses (basal-bolus regime).

06

What researchers measure

Primary outcomes

  1. Mean blood glucose

    Mean blood glucose over 24 hours

    Time frame: duration of hospital stay (48 hours - maximum three weeks)

Secondary outcomes

  1. Number of glucose measurements in hyperglycaemic ranges

    Time frame: duration of hospital stay (48 hours - maximum three weeks)

07

Study locations

1 site
  • Medical University of Graz, Division of Internal Medicine, Department of Endocrinology and Metabolism/ Cardiology
    Graz, 8036, Austria
08

References and documents

Publications

  • 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. PubMed 27103198 ↗
  • 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. PubMed 25927357 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01407289
Lead sponsor
Medical University of Graz
Responsible party
Pieber Thomas, MD (MD, Prof. of Medicine, Medical University of Graz) — Principal investigator
First posted
Aug 2, 2011
Start date
Jun 2011
Primary completion
Apr 2012
Completion
Apr 2012
Last update
Feb 5, 2013

Study contacts

Thomas Pieber, MD
principal investigator · Division of Endocrinology and Metabolism, Department of Internal Medicine Medical University of Graz
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

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