Trial document




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  DRKS00009837

Trial Description

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Title

diabetes mellitus screening for ambulant an in hospital patients - feasibility study

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

With this study we want to recognize, inform and treat at an early stage patients with diabetes mellitus risk or illness

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Brief Summary in Scientific Language

Feasability study for diabetes screening with an POC HbA1c testing for patients without known diabetes mellitus or at risk of diabetes mellitus illness. By positive testing the patients are informed and treatment is iniciated

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Organizational Data

  •   DRKS00009837
  •   2016/02/25
  •   [---]*
  •   yes
  •   Approved
  •   AS 148(bB)12015, Ethik-Kommission der Landesärztekammer Brandenburg
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Secondary IDs

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Health Condition or Problem studied

  •   diabetes mellitus
  •   E10-E14 -  Diabetes mellitus
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Interventions/Observational Groups

  •   screening with HbA1c for diabetes mellitus
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Identification of the number of patients with unknown diabetes mellitus risk or illness out of all patients coming for treatment to the hospital with HbA1c screening

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Secondary Outcome

none

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2016/03/08
  •   500
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

all people with unknown Diabetes mellitus in medical history

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Exclusion Criteria

under 18 years, diabetes mellitus, no o.k.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinikum Ernst von Bergmann gGmbH
    • Ms.  Privatdozentin Dr. med.  Ortrud  Vargas Hein 
    • Charlottenstraße 72
    • 14467  Potsdam
    • Germany
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    • Klinikum Ernst von Bergmann gGmbH
    • Ms.  Privatdozentin Dr. med.  Ortrud  Vargas Hein 
    • Charlottenstraße 72
    • 14467  Potsdam
    • Germany
    end of 1:1-Block address scientific-contact
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    end of 1:1-Block address contact scientific-contact
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    • Klinikum Ernst von Bergmann gGmbH
    • Ms.  Privatdozentin Dr. med.  Ortrud  Vargas Hein 
    • Charlottenstraße 72
    • 14467  Potsdam
    • Germany
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Sources of Monetary or Material Support

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    • Klinikum Ernst von Bergmann gGmbH
    • Ms.  Privatdozentin Dr. med.  Ortrud  Vargas Hein 
    • Charlottenstraße 72
    • 14467  Potsdam
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/12/31
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.