Risk Identification of the GlucoTab System in Routine Use

NCT ID: NCT02053077

Last Updated: 2023-05-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-28

Study Completion Date

2016-06-26

Brief Summary

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Identification of risks of the GlucoTab system in routine use.

Detailed Description

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A study to identify risks in routine use of the GlucoTab system for glycaemic management in non-critically ill patients with type 2 diabetes at general wards.

Conditions

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Diabetes Mellitus

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* informed consent obtained after being advised of the nature of the study
* type 2 diabetes or new-onset hyperglycaemia which require s.c. insulin therapy during hospital stay
* diabetes therapy supported by GlucoTab system

Exclusion Criteria

* type 1 diabetes mellitus
* intravenous insulin therapy
* hyperglycaemic episodes (ketoacidosis, hyperosmolar state) if they require intravenous insulin therapy
* gestational diabetes or pregnancy
* known or suspected allergy to certain insulin types, named in the user manual
* total parenteral nutrition (TPN)
* any mental condition rendering the patient incapable of giving his consent
Minimum Eligible Age

18 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

Univ. Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas R. Pieber, Univ.Prof.Dr

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz

Locations

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Medical University of Graz

Graz, Styria, Austria

Site Status

Countries

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Austria

Other Identifiers

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ClinDiab-05

Identifier Type: -

Identifier Source: org_study_id

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