<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02241317</url>
  </required_header>
  <id_info>
    <org_study_id>2014-831R-MA</org_study_id>
    <nct_id>NCT02241317</nct_id>
  </id_info>
  <brief_title>Diabetes Mellitus at the University Medical Center of Mannheim</brief_title>
  <acronym>DmUMM</acronym>
  <official_title>Effects of Training of Medical Staff on the Outcome of In-Patients With Diabetes Mellitus on Regular Wards</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitätsmedizin Mannheim</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitätsmedizin Mannheim</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Development of a training concept for health care professionals (nursing and medical staff),&#xD;
      according to the current guidelines on treatment of in-patients with Diabetes. Primary&#xD;
      endpoint is the change in hypoglycaemia rates comparing data before and after the training.&#xD;
      Hereby we can derive the effects of staff training on the quality of health care in this&#xD;
      patient population.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The prevalence of Diabetes in in-patients is about 32% and therefore exceeds significantly&#xD;
      the prevalence in general population.&#xD;
&#xD;
      In most cases Diabetes is only a secondary diagnosis the medical staff has to deal with&#xD;
      daily. The diagnosis which leads to hospital admission and the often multiple comorbidities&#xD;
      complicate the metabolic control. Blood sugar imbalances present an additional risk for these&#xD;
      patients and increase in-hospital mortality, length of hospital stay and general&#xD;
      complications as nosocomial infections.&#xD;
&#xD;
      To improve hospital care for diabetics the Endocrine Society and the American College of&#xD;
      Physicians published new guidelines on blood glucose management for non-ICU wards. Primarily&#xD;
      they contain recommendations for blood glucose target range and standards to improve&#xD;
      inpatient hospital care like standard operating procedures for blood glucose monitoring as&#xD;
      well as hyper- and hypoglycaemic disturbances through to discharge management.&#xD;
&#xD;
      We developed a training concept for health care professionals (nursing and medical staff),&#xD;
      according to the current guidelines on treatment of in-patients with Diabetes. Primary&#xD;
      endpoint is the change in hypoglycaemia rates comparing data before and after the training.&#xD;
      Hereby we can derive the effects of staff training on the quality of health care in this&#xD;
      patient population.&#xD;
&#xD;
      So far there was only one comparable study published which showed a significant improvement&#xD;
      of treatment quality by reducing hypoglycaemia rates considerably . The results of this study&#xD;
      cannot be transferred due to substantial structural differences. More over there are no&#xD;
      national diabetes management guidelines for inpatient treatment in Germany.&#xD;
&#xD;
      The following data will be collected:&#xD;
&#xD;
        -  Anthropometric data (Age, Sex, Bodyweight, Height)&#xD;
&#xD;
        -  Diagnosis&#xD;
&#xD;
        -  POCT blood glucose values&#xD;
&#xD;
        -  Other laboratory values&#xD;
&#xD;
        -  Length of hospital stay&#xD;
&#xD;
      This study conforms to the requirements of the Declaration of Helsinki, Revision of 1996.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>June 2014</start_date>
  <completion_date type="Anticipated">April 2015</completion_date>
  <primary_completion_date type="Anticipated">March 2015</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Hypoglycaemia</measure>
    <time_frame>2013-2015 (two years)</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">5000</enrollment>
  <condition>Diabetes Mellitus</condition>
  <condition>Hypoglycaemia</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        In-Patients with Diabetes mellitus&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diabetes mellitus&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;18 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alexander Lammert, Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitätsmedizin Mannheim</affiliation>
  </overall_official>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 11, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>September 15, 2014</last_update_submitted>
  <last_update_submitted_qc>September 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 16, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universitätsmedizin Mannheim</investigator_affiliation>
    <investigator_full_name>Alexander Lammert</investigator_full_name>
    <investigator_title>Dr. med. Alexander Lammert</investigator_title>
  </responsible_party>
  <keyword>Diabetes mellitus</keyword>
  <keyword>Hypoglycaemia</keyword>
  <keyword>staff training</keyword>
  <keyword>Education</keyword>
  <keyword>blood glucose</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Hypoglycemia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02241317
org study id: 2014-831R-MA
nct id: NCT02241317
lead sponsor: 
has dmc: No
Development of a training concept for health care professionals (nursing and medical staff),
      according to the current guidelines on treatment of in-patients with Diabetes. Primary
      endpoint is the change in hypoglycaemia rates comparing data before and after the training.
      Hereby we can derive the effects of staff training on the quality of health care in this
      patient population.
The prevalence of Diabetes in in-patients is about 32% and therefore exceeds significantly
      the prevalence in general population.

      In most cases Diabetes is only a secondary diagnosis the medical staff has to deal with
      daily. The diagnosis which leads to hospital admission and the often multiple comorbidities
      complicate the metabolic control. Blood sugar imbalances present an additional risk for these
      patients and increase in-hospital mortality, length of hospital stay and general
      complications as nosocomial infections.

      To improve hospital care for diabetics the Endocrine Society and the American College of
      Physicians published new guidelines on blood glucose management for non-ICU wards. Primarily
      they contain recommendations for blood glucose target range and standards to improve
      inpatient hospital care like standard operating procedures for blood glucose monitoring as
      well as hyper- and hypoglycaemic disturbances through to discharge management.

      We developed a training concept for health care professionals (nursing and medical staff),
      according to the current guidelines on treatment of in-patients with Diabetes. Primary
      endpoint is the change in hypoglycaemia rates comparing data before and after the training.
      Hereby we can derive the effects of staff training on the quality of health care in this
      patient population.

      So far there was only one comparable study published which showed a significant improvement
      of treatment quality by reducing hypoglycaemia rates considerably . The results of this study
      cannot be transferred due to substantial structural differences. More over there are no
      national diabetes management guidelines for inpatient treatment in Germany.

      The following data will be collected:

        -  Anthropometric data (Age, Sex, Bodyweight, Height)

        -  Diagnosis

        -  POCT blood glucose values

        -  Other laboratory values

        -  Length of hospital stay

      This study conforms to the requirements of the Declaration of Helsinki, Revision of 1996.
observational model: Cohort
time perspective: Prospective
measure: Hypoglycaemia
time frame: 2013-2015 (two years)
blood samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alexander Lammert, Dr. med.
role: Principal Investigator
affiliation: Universitätsmedizin Mannheim
responsible party type: Principal Investigator
investigator affiliation: Universitätsmedizin Mannheim
investigator full name: Alexander Lammert
investigator title: Dr. med. Alexander Lammert
mesh term: Diabetes Mellitus
mesh term: Hypoglycemia