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Completed

NCT Number: NCT01407289

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Graz, 8036, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Insulin Aspart, Insulin Glargine

Drug

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

Primary outcomes

  1. Mean blood glucose

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

    Mean blood glucose over 24 hours

Secondary outcomes

  1. Number of glucose measurements in hyperglycaemic ranges

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

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 2, 2011
Registry last updated
Feb 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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