<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/NCT04427189</url>
  </required_header>
  <id_info>
    <org_study_id>SWEET-10</org_study_id>
    <nct_id>NCT04427189</nct_id>
  </id_info>
  <brief_title>Better Control in Pediatric and Adolescent diabeteS: Working to crEate CEnTers of Reference (SWEET- Registry)</brief_title>
  <acronym>SWEET</acronym>
  <official_title>Better Control in Pediatric and Adolescent diabeteS: Working to crEate CEnTers of Reference</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kinderkrankenhaus auf der Bult</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>SWEET e.V</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Kinderkrankenhaus auf der Bult</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      SWEET-REGISTRY is a multi center, investigator initiated registry in patients with diabetes.&#xD;
      SWEET' is an acronym derived from 'Better control in Pediatric and Adolescent diabeteS:&#xD;
      Working to crEate CEnTers of Reference'. Having the vision of equal quality care for all&#xD;
      children with diabetes the mission of SWEET is to harmonize care to optimize outcomes of&#xD;
      children with diabetes worldwide. Initiated with support of the EU Public Health Program in&#xD;
      2008 the SWEET group has over 10 years of experience in creating and sustaining a high&#xD;
      quality professional network based on agreed standards of care, criteria for certification,&#xD;
      international guidelines and quality control. While originally focusing on the European&#xD;
      region, SWEET is currently expanding and has received increasingly global attention, with&#xD;
      centers across different continents including Asia, Africa, North and South-America. SWEET&#xD;
      extracts wherever possible the data from existing data collection sources and following&#xD;
      longitudinally unselected clinical populations of all pediatric diabetes patients as an&#xD;
      ongoing measure of benchmarking and a quality control cycle as well as a resource for&#xD;
      scientific studies and collaborative research. The SWEET registry was approved by the ethical&#xD;
      committee of Hannover Medical School and is associated with the AUF DER BULT Diabetes Centre&#xD;
      for Children and Adolescents, Hannover, Germany, which coordinates the SWEET collaboration.&#xD;
      Each center has to meet specific entry criteria showing diabetes expertise and compliance&#xD;
      with the International Society for Pediatric and Adolescent Diabetes (ISPAD) clinical&#xD;
      practice guidelines. The local institutional review boards of the participating centers&#xD;
      approved the pseudonymized data collection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The SWEET-Registry is a prospective evaluation of the effectiveness of multidisciplinary&#xD;
      treatment approaches of international pediatric diabetes centers.The hypothesis is that a&#xD;
      collaboration of pediatric diabetes centers will improve the situation for children with&#xD;
      diabetes ensuring that all children have the right to participate fully in all the&#xD;
      experiences of childhood and adolescence, regardless of whether they have diabetes and&#xD;
      wherever they live. Also it could reduce the effects of accelerated vascular ageing imposed&#xD;
      by the diabetic state and provide the basis for a long-term participation in professional and&#xD;
      family life without or with delayed debilitating long-term diabetes complications.&#xD;
&#xD;
      SWEET is a real-world study. Therefore the treatment decisions are made by the patient with&#xD;
      diabetes and the local treatment team.&#xD;
&#xD;
      The SWEET database combines data from distinct sources. Data is collected locally through&#xD;
      clinical databases, electronic health record systems, the standardized&#xD;
      SWEET-DPV-documentation software (https://sweet.zibmt.uni-ulm.de/software.php) or centers&#xD;
      download data from existing longitudinal registries. Twice yearly, data are transmitted to&#xD;
      the central database hosted by the Institute of Epidemiology and Medical Biometry, ZIBMT, Ulm&#xD;
      University, Ulm, Germany. The prospectively collected data is then combined into a common&#xD;
      database. Inconsistent/improbability or missing data is reported back to the centers for&#xD;
      correction. Data is then aggregated into an anonymized, cumulative database used for clinical&#xD;
      research, scientific analysis, and nationwide benchmarking.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 2008</start_date>
  <completion_date type="Anticipated">September 2028</completion_date>
  <primary_completion_date type="Anticipated">April 2028</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>20 Years</target_duration>
  <primary_outcome>
    <measure>Change of HbA1c level</measure>
    <time_frame>through study completion, an average of 1 year, up to 5 years</time_frame>
    <description>assessment of the metabolic situation based on the level of HbA1c</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>hypoglycemia rate</measure>
    <time_frame>through study completion, an average of 1 year, up to 5 years</time_frame>
    <description>number of events of severe hypoglycemia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time in Range</measure>
    <time_frame>through study completion, an average of 1 year, up to 5 years</time_frame>
    <description>percentage of CGM values between 70-180 mg/dl</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DKA rate</measure>
    <time_frame>through study completion, an average of 1 year, up to 5 years</time_frame>
    <description>number of hospitalizations due to DKA</description>
  </secondary_outcome>
  <enrollment type="Anticipated">100000</enrollment>
  <condition>Type 1 Diabetes</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients from Diabetes centres worldwide diagnosed with Diabetes mellitus&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diabetes mellitus (as diagnosed clinically)&#xD;
&#xD;
          2. Males and females of all Ages, but with a focus on pediatric care&#xD;
&#xD;
          3. Provision of informed consent from participant and all legal representatives prior to&#xD;
             any study specific procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. no diabetes&#xD;
&#xD;
          2. no consent,&#xD;
&#xD;
          3. Patient who, in the judgment of the Investigator, is found to be unlikely to comply&#xD;
             with the protocol, or has any severe concurrent medical or psychological condition&#xD;
             that may affect the interpretation of efficacy or safety data&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas Danne, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kinderkrankenhaus auf der Bult</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Thomas Prof. Danne, MD</last_name>
    <phone>+49 511 8115 3330</phone>
    <email>danne@hka.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Bärbel Dr. Aschemeier-Fuchs, PH</last_name>
    <phone>+49 511 8115 3342</phone>
    <email>aschemeier@hka.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Kinderkrankenhaus auf der Bult</name>
      <address>
        <city>Hanover</city>
        <state>Low Saxony</state>
        <zip>30173</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thomas Danne, MD</last_name>
      <phone>+49 511 8115 3330</phone>
      <email>danne@hka.de</email>
    </contact>
    <contact_backup>
      <last_name>Bärbel Aschemeier-Fuchs, PH</last_name>
      <phone>+49 511 81153342</phone>
      <email>aschemeier@hka.de</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>March 7, 2023</last_update_submitted>
  <last_update_submitted_qc>March 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kinderkrankenhaus auf der Bult</investigator_affiliation>
    <investigator_full_name>Thomas Danne</investigator_full_name>
    <investigator_title>Prof. Dr.</investigator_title>
  </responsible_party>
  <keyword>Pediatric</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</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/NCT04427189
org study id: SWEET-10
nct id: NCT04427189
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
SWEET-REGISTRY is a multi center, investigator initiated registry in patients with diabetes.
      SWEET' is an acronym derived from 'Better control in Pediatric and Adolescent diabeteS:
      Working to crEate CEnTers of Reference'. Having the vision of equal quality care for all
      children with diabetes the mission of SWEET is to harmonize care to optimize outcomes of
      children with diabetes worldwide. Initiated with support of the EU Public Health Program in
      2008 the SWEET group has over 10 years of experience in creating and sustaining a high
      quality professional network based on agreed standards of care, criteria for certification,
      international guidelines and quality control. While originally focusing on the European
      region, SWEET is currently expanding and has received increasingly global attention, with
      centers across different continents including Asia, Africa, North and South-America. SWEET
      extracts wherever possible the data from existing data collection sources and following
      longitudinally unselected clinical populations of all pediatric diabetes patients as an
      ongoing measure of benchmarking and a quality control cycle as well as a resource for
      scientific studies and collaborative research. The SWEET registry was approved by the ethical
      committee of Hannover Medical School and is associated with the AUF DER BULT Diabetes Centre
      for Children and Adolescents, Hannover, Germany, which coordinates the SWEET collaboration.
      Each center has to meet specific entry criteria showing diabetes expertise and compliance
      with the International Society for Pediatric and Adolescent Diabetes (ISPAD) clinical
      practice guidelines. The local institutional review boards of the participating centers
      approved the pseudonymized data collection.
The SWEET-Registry is a prospective evaluation of the effectiveness of multidisciplinary
      treatment approaches of international pediatric diabetes centers.The hypothesis is that a
      collaboration of pediatric diabetes centers will improve the situation for children with
      diabetes ensuring that all children have the right to participate fully in all the
      experiences of childhood and adolescence, regardless of whether they have diabetes and
      wherever they live. Also it could reduce the effects of accelerated vascular ageing imposed
      by the diabetic state and provide the basis for a long-term participation in professional and
      family life without or with delayed debilitating long-term diabetes complications.

      SWEET is a real-world study. Therefore the treatment decisions are made by the patient with
      diabetes and the local treatment team.

      The SWEET database combines data from distinct sources. Data is collected locally through
      clinical databases, electronic health record systems, the standardized
      SWEET-DPV-documentation software (https://sweet.zibmt.uni-ulm.de/software.php) or centers
      download data from existing longitudinal registries. Twice yearly, data are transmitted to
      the central database hosted by the Institute of Epidemiology and Medical Biometry, ZIBMT, Ulm
      University, Ulm, Germany. The prospectively collected data is then combined into a common
      database. Inconsistent/improbability or missing data is reported back to the centers for
      correction. Data is then aggregated into an anonymized, cumulative database used for clinical
      research, scientific analysis, and nationwide benchmarking.
observational model: Cohort
time perspective: Prospective
measure: Change of HbA1c level
time frame: through study completion, an average of 1 year, up to 5 years
description: assessment of the metabolic situation based on the level of HbA1c
measure: hypoglycemia rate
time frame: through study completion, an average of 1 year, up to 5 years
description: number of events of severe hypoglycemia
measure: Time in Range
time frame: through study completion, an average of 1 year, up to 5 years
description: percentage of CGM values between 70-180 mg/dl
measure: DKA rate
time frame: through study completion, an average of 1 year, up to 5 years
description: number of hospitalizations due to DKA
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Thomas Danne, MD
role: Principal Investigator
affiliation: Kinderkrankenhaus auf der Bult
last name: Thomas Prof. Danne, MD
phone: +49 511 8115 3330
email: danne@hka.de
last name: Bärbel Dr. Aschemeier-Fuchs, PH
phone: +49 511 8115 3342
email: aschemeier@hka.de
facility: 
status: Recruiting
contact: 
contact backup: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Kinderkrankenhaus auf der Bult
investigator full name: Thomas Danne
investigator title: Prof. Dr.
mesh term: Diabetes Mellitus