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

NCT ID: NCT01407289

Last Updated: 2013-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Insulin Aspart, Insulin Glargine

Intervention Type DRUG

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

Standard care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Insulin Aspart, Insulin Glargine

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

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Pieber Thomas, MD

MD, Prof. of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas Pieber, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Graz, , Austria

Site Status

Countries

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Austria

References

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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.

Reference Type DERIVED
PMID: 27103198 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25927357 (View on PubMed)

Other Identifiers

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ClinDiab-02

Identifier Type: -

Identifier Source: org_study_id

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