<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/NCT03306810</url>
  </required_header>
  <id_info>
    <org_study_id>Q321dnro 47/17</org_study_id>
    <nct_id>NCT03306810</nct_id>
  </id_info>
  <brief_title>Recognition and Treatment of Dysglycemia. AGS - Acute Glucose Service</brief_title>
  <acronym>AGS</acronym>
  <official_title>Recognition and Treatment of Dysglycemia in Elective Knee and Hip Arthroplasties. AGS - Acute Glucose Service</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Joint Authority for Päijät-Häme Social and Health Care</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Joint Authority for Päijät-Häme Social and Health Care</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      AGS (Acute Glucose Service ) is an inpatient glucose management service consisting of Nurse&#xD;
      Practitioner and physician. Team manages not - consulted- based preoperative assessment,&#xD;
      perioperative glucose control, patient education and supervision, but also transition of care&#xD;
      postoperatively. The goal is to detect and treat dysglycemias , but also provide an active&#xD;
      and constantly ongoing education to other hospital teams.&#xD;
&#xD;
      AGS improves better overall- survival of arthroplastic patients and is an effective way to&#xD;
      recognize and treat dysglycemias and to organize constantly ongoing education.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      600 elective knee and hip arthroplastic patients are collected. 200 patients before AG-&#xD;
      service will be compared to 400 patients after AGS. The latter group is divided to two 200&#xD;
      patients groups: 1) with AGS 2) with AGS extended to first control in 3 months (AG- nurse may&#xD;
      be contacted by phone). Patients are followed up up to 5 years. Controls will be held after 3&#xD;
      months, 1 year and 5 years after operation including B-Hba1c, 15 D Quality of life assessment&#xD;
      and patient interview.&#xD;
&#xD;
      There are several aims of the team and study: to detect, diagnose and optimize treatment&#xD;
      (including medication) of diabetic/ dysglycemic patients from preoperative assessment 1 week&#xD;
      before operation to postoperative care. With blood glucose target 42 - 86 mmol/mol results&#xD;
      better overall survival, lesser complications (i.e. infections, cardiovascular or renal&#xD;
      complications) and shorter length of hospital stay. Other aim is to find undiagnosed&#xD;
      diabetics or those at risk of developing diabetes. One aim is to find risk factors, which&#xD;
      lead to stress hyperglycemia during perioperative period or diabetes in 5 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 26, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Survival</measure>
    <time_frame>1-5 years</time_frame>
    <description>Improved survival</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>1-5 years</time_frame>
    <description>Less complications after AG-service</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Dysglycemia</condition>
  <condition>Arthroplasty Complications</condition>
  <arm_group>
    <arm_group_label>AG service</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In the &quot;Active Comparator Arm&quot;: Screening, follow-up and treatment of dysglycemias in the elective orthopedic prosthetic surgery (knee / hip) patients in the Päijät-Häme Central hospital will be optimized and individualized in the patients in personal manner.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Without AG service</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>In the &quot;No intervention Arm&quot;: Screening, follow-up and treatment of dysglycemias in the elective orthopedic prosthetic surgery (knee / hip) patients follows the current protocol of Päijät-Häme Central hospital.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>AG service</intervention_name>
    <description>The AG service group is divided to two 200 patients groups: 1) with AGS 2) with AGS extended to first control in 3 months (AG- nurse may be contacted by phone). Patients are followed up up to 5 years.</description>
    <arm_group_label>AG service</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged &gt; 18 years&#xD;
&#xD;
          -  Elective knee and hip arthroplasty patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are incompetent to give informed consent&#xD;
&#xD;
          -  Patients who are incompetent to assess their Quality-of-Life personally&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marianne Ylikoski, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Päijät Häme Central Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marianne Ylikoski, MD</last_name>
    <phone>+358447195268</phone>
    <email>marianne.ylikoski@phhyky.fi</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Raine Tiihonen, MD, PhD</last_name>
    <phone>+358444406151</phone>
    <email>raine.tiihonen@phhyky.fi</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Päijät-Häme Central Hospital</name>
      <address>
        <city>Lahti</city>
        <zip>15850</zip>
        <country>Finland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marianne Ylikoski, MD</last_name>
      <phone>+358447195268</phone>
      <email>marianne.ylikoski@phhyky.fi</email>
    </contact>
    <contact_backup>
      <last_name>Raine Tiihonen, MD, PhD</last_name>
      <phone>+3584406151</phone>
      <email>raine.tiihonen@phhyky.fi</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>October 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>October 10, 2017</last_update_submitted>
  <last_update_submitted_qc>October 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Joint Authority for Päijät-Häme Social and Health Care</investigator_affiliation>
    <investigator_full_name>Marjo Soini</investigator_full_name>
    <investigator_title>CRA</investigator_title>
  </responsible_party>
  <keyword>Perioperative complications</keyword>
  <keyword>Dysglycemia management team</keyword>
  <keyword>Nurse Practitioner</keyword>
  <keyword>Hospital</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03306810
org study id: Q321dnro 47/17
nct id: NCT03306810
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
AGS (Acute Glucose Service ) is an inpatient glucose management service consisting of Nurse
      Practitioner and physician. Team manages not - consulted- based preoperative assessment,
      perioperative glucose control, patient education and supervision, but also transition of care
      postoperatively. The goal is to detect and treat dysglycemias , but also provide an active
      and constantly ongoing education to other hospital teams.

      AGS improves better overall- survival of arthroplastic patients and is an effective way to
      recognize and treat dysglycemias and to organize constantly ongoing education.
600 elective knee and hip arthroplastic patients are collected. 200 patients before AG-
      service will be compared to 400 patients after AGS. The latter group is divided to two 200
      patients groups: 1) with AGS 2) with AGS extended to first control in 3 months (AG- nurse may
      be contacted by phone). Patients are followed up up to 5 years. Controls will be held after 3
      months, 1 year and 5 years after operation including B-Hba1c, 15 D Quality of life assessment
      and patient interview.

      There are several aims of the team and study: to detect, diagnose and optimize treatment
      (including medication) of diabetic/ dysglycemic patients from preoperative assessment 1 week
      before operation to postoperative care. With blood glucose target 42 - 86 mmol/mol results
      better overall survival, lesser complications (i.e. infections, cardiovascular or renal
      complications) and shorter length of hospital stay. Other aim is to find undiagnosed
      diabetics or those at risk of developing diabetes. One aim is to find risk factors, which
      lead to stress hyperglycemia during perioperative period or diabetes in 5 years.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Survival
time frame: 1-5 years
description: Improved survival
measure: Complications
time frame: 1-5 years
description: Less complications after AG-service
arm group label: AG service
arm group type: Active Comparator
description: In the "Active Comparator Arm": Screening, follow-up and treatment of dysglycemias in the elective orthopedic prosthetic surgery (knee / hip) patients in the Päijät-Häme Central hospital will be optimized and individualized in the patients in personal manner.
arm group label: Without AG service
arm group type: No Intervention
description: In the "No intervention Arm": Screening, follow-up and treatment of dysglycemias in the elective orthopedic prosthetic surgery (knee / hip) patients follows the current protocol of Päijät-Häme Central hospital.
intervention type: Other
intervention name: AG service
description: The AG service group is divided to two 200 patients groups: 1) with AGS 2) with AGS extended to first control in 3 months (AG- nurse may be contacted by phone). Patients are followed up up to 5 years.
arm group label: AG service
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Marianne Ylikoski, MD
role: Principal Investigator
affiliation: Päijät Häme Central Hospital
last name: Marianne Ylikoski, MD
phone: +358447195268
email: marianne.ylikoski@phhyky.fi
last name: Raine Tiihonen, MD, PhD
phone: +358444406151
email: raine.tiihonen@phhyky.fi
facility: 
status: Recruiting
contact: 
contact backup: 
country: Finland
responsible party type: Principal Investigator
investigator affiliation: Joint Authority for Päijät-Häme Social and Health Care
investigator full name: Marjo Soini
investigator title: CRA
sharing ipd: No