xml: <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/NCT05977218</url>
    </required_header>
    <id_info>
      <org_study_id>diatest2024</org_study_id>
      <nct_id>NCT05977218</nct_id>
    </id_info>
    <brief_title>DIATEST - mHealth and Type 2 Diabetes Mellitus</brief_title>
    <acronym>DIATEST</acronym>
    <official_title>DIATEST - a mHealth Intervention to Improve Clinical Management of Type 2 Diabetes Mellitus</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Linkoeping University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Linkoeping University</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>
        Dietary modification is effective in the prevention and treatment of type 2 diabetes mellitus&#xD;
        (T2DM). However, the access to dieticians in primary care is limited. While mHealth tools&#xD;
        have been shown to improve diet and clinical management of patients with T2DM, there are&#xD;
        currently no mobile health (mHealth) tools that are effective in improving diet and clinical&#xD;
        management of T2DM in Sweden. The aim of this project is to study the effect of the&#xD;
        FoodSwitch app, an mHealth intervention for patients with T2DM.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This randomized controlled trial will determine the effect of the FoodSwitch app for&#xD;
        healthier food choices on HbA1c, blood lipids, renal function and low-grade inflammation in&#xD;
        individuals with T2DM. The effect of the mHealth tool on HbA1c and cardiovascular risk&#xD;
        factors, will be compared to standard dietary advice for patients with T2DM. Randomization&#xD;
        will be performed in a 1:1 ratio to receive the FoodSwitch app intervention or control and&#xD;
        stratified by age (&lt;50 years/≥50 years), sex, and baseline insulin use (Yes/No). The&#xD;
        intervention group will scan all their purchased packaged food with the FoodSwitch app for&#xD;
        one week at 6 and 12, 18 and 26 weeks. The control group will photograph and upload images of&#xD;
        their receipts or share digital shopping receipts for one week at 6 and 12, 18 and 26 weeks.&#xD;
        All participants in both the intervention and control group will report symptoms, functions,&#xD;
        and quality of life, as often as they like as well as at 6 and 12, 18 and 26 weeks. All&#xD;
        participants will be mailed a blood and urine collection kit and instructed to use it and to&#xD;
        self-measure waist circumference at the start of the study and at 26 weeks. The primary&#xD;
        outcome (HbA1c) and secondary outcomes (blood measurements of total cholesterol, LDL and HDL&#xD;
        cholesterol, eGFR, TNF-α, IL-1β, IL-6, CRP, proteomics, and metabolomics; microalbuminuria;&#xD;
        self-measured waist circumference; self-reported quality of life, 24-hour dietary recall, as&#xD;
        well as other present symptoms; smartphone-obtained physical activity levels and patterns)&#xD;
        will be evaluated at 26 weeks. National registry-obtained data on medication use,&#xD;
        hospitalizations and deaths will also be evaluated.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 1, 2024</start_date>
    <completion_date type="Anticipated">December 31, 2029</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2029</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>HbA1c (mmol/mol)</measure>
      <time_frame>Change from baseline at week 26</time_frame>
      <description>Hemoglobin A1C (mmol/mol)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Total cholesterol (mmol/l)</measure>
      <time_frame>Change from baseline at week 26</time_frame>
      <description>Total cholesterol (mmol/l)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>LDL (mmol/l)</measure>
      <time_frame>Change from baseline at week 26</time_frame>
      <description>Low-density lipoprotein (mmol/l)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>HDL (mmol/l)</measure>
      <time_frame>Change from baseline at week 26</time_frame>
      <description>High-density lipoprotein (mmol/l)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>eGFR (ml/min)</measure>
      <time_frame>Change from baseline at week 26</time_frame>
      <description>Estimated glomerular filtration rate (ml/min)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>TNF-α (ng/L)</measure>
      <time_frame>Change from baseline at week 26</time_frame>
      <description>Tumor necrosis factor - alpha (ng/L)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>IL-1β (ng/L)</measure>
      <time_frame>Change from baseline at week 26</time_frame>
      <description>Interleukin 1β (ng/L)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>IL-6 (ng/L)</measure>
      <time_frame>Change from baseline at week 26</time_frame>
      <description>Interleukin 6 (ng/L)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>hsCRP (mg/L)</measure>
      <time_frame>Change from baseline at week 26</time_frame>
      <description>High sensitive c-reactive protein (mg/L)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proteomics, and metabolomics</measure>
      <time_frame>Change from baseline at week 26</time_frame>
      <description>The analysis of proteomics and metabolomics is explorative, and therefore the selection of proteins and metabolites is not pre-determined but will rather include those that are available and deemed appropriate at the time of analysis</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Albuminuria (mg/l)</measure>
      <time_frame>Change from baseline at week 26</time_frame>
      <description>Albuminuria (mg/l)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self-measured waist circumference (cm)</measure>
      <time_frame>Change from baseline at week 26</time_frame>
      <description>Self-measured waist circumference (cm)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self-reported quality of life</measure>
      <time_frame>Change from baseline at week 26</time_frame>
      <description>Self-reported quality of life - questionnaire</description>
    </secondary_outcome>
    <other_outcome>
      <measure>24-hour dietary recall</measure>
      <time_frame>Change from baseline at week 26</time_frame>
      <description>24-hour dietary recall</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">900</enrollment>
    <condition>Diabetes Mellitus, Type 2</condition>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Access to the 'DiabetesSwitch' filter of the FoodSwitch app when food shopping during 26 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Access to written dietary advice during 26 weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>FoodSwitch</intervention_name>
      <description>Access to the 'DiabetesSwitch' filter of the FoodSwitch app when food shopping. When a packaged food item bar code is scanned, the FoodSwitch app will show an interpretive nutritional information score for the scanned product and recommend alternate healthier food options in the same category.</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  age 18-75 years&#xD;
  &#xD;
            -  regularly participate in grocery shopping&#xD;
  &#xD;
            -  self-report of having T2DM, with or without diabetes medication&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  no access to BankID (a digital identification system commonly used in Sweden), thus&#xD;
               unable to consent to the study&#xD;
  &#xD;
            -  fail to complete the run-in procedures&#xD;
  &#xD;
            -  HbA1c &lt;48 mmol/mol in combination with no ongoing diabetes treatment&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Karin Rådholm, MD, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Linkoeping University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lana Hebib, MD</last_name>
      <phone>013-28 10 00</phone>
      <email>lana.hebib@liu.se</email>
    </overall_contact>
    <reference>
      <citation>Dunford E, Trevena H, Goodsell C, Ng KH, Webster J, Millis A, Goldstein S, Hugueniot O, Neal B. FoodSwitch: A Mobile Phone App to Enable Consumers to Make Healthier Food Choices and Crowdsourcing of National Food Composition Data. JMIR Mhealth Uhealth. 2014 Aug 21;2(3):e37. doi: 10.2196/mhealth.3230.</citation>
      <PMID>25147135</PMID>
    </reference>
    <reference>
      <citation>Coughlin SS, Whitehead M, Sheats JQ, Mastromonico J, Hardy D, Smith SA. Smartphone Applications for Promoting Healthy Diet and Nutrition: A Literature Review. Jacobs J Food Nutr. 2015;2(3):021.</citation>
      <PMID>26819969</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 6, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Linkoeping University</investigator_affiliation>
      <investigator_full_name>Lana Hebib</investigator_full_name>
      <investigator_title>Principal investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Diabetes Mellitus</mesh_term>
      <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>After publication in a peer-reviewed journal and for the period of time for which local archive regulations stipulate.</ipd_time_frame>
      <ipd_access_criteria>To be determined on a case by case basis.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05977218
  org study id: diatest2024
  nct id: NCT05977218
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Dietary modification is effective in the prevention and treatment of type 2 diabetes mellitus
        (T2DM). However, the access to dieticians in primary care is limited. While mHealth tools
        have been shown to improve diet and clinical management of patients with T2DM, there are
        currently no mobile health (mHealth) tools that are effective in improving diet and clinical
        management of T2DM in Sweden. The aim of this project is to study the effect of the
        FoodSwitch app, an mHealth intervention for patients with T2DM.
  This randomized controlled trial will determine the effect of the FoodSwitch app for
        healthier food choices on HbA1c, blood lipids, renal function and low-grade inflammation in
        individuals with T2DM. The effect of the mHealth tool on HbA1c and cardiovascular risk
        factors, will be compared to standard dietary advice for patients with T2DM. Randomization
        will be performed in a 1:1 ratio to receive the FoodSwitch app intervention or control and
        stratified by age (<50 years/≥50 years), sex, and baseline insulin use (Yes/No). The
        intervention group will scan all their purchased packaged food with the FoodSwitch app for
        one week at 6 and 12, 18 and 26 weeks. The control group will photograph and upload images of
        their receipts or share digital shopping receipts for one week at 6 and 12, 18 and 26 weeks.
        All participants in both the intervention and control group will report symptoms, functions,
        and quality of life, as often as they like as well as at 6 and 12, 18 and 26 weeks. All
        participants will be mailed a blood and urine collection kit and instructed to use it and to
        self-measure waist circumference at the start of the study and at 26 weeks. The primary
        outcome (HbA1c) and secondary outcomes (blood measurements of total cholesterol, LDL and HDL
        cholesterol, eGFR, TNF-α, IL-1β, IL-6, CRP, proteomics, and metabolomics; microalbuminuria;
        self-measured waist circumference; self-reported quality of life, 24-hour dietary recall, as
        well as other present symptoms; smartphone-obtained physical activity levels and patterns)
        will be evaluated at 26 weeks. National registry-obtained data on medication use,
        hospitalizations and deaths will also be evaluated.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Single (Outcomes Assessor)
  measure: HbA1c (mmol/mol)
  time frame: Change from baseline at week 26
  description: Hemoglobin A1C (mmol/mol)
  measure: Total cholesterol (mmol/l)
  time frame: Change from baseline at week 26
  description: Total cholesterol (mmol/l)
  measure: LDL (mmol/l)
  time frame: Change from baseline at week 26
  description: Low-density lipoprotein (mmol/l)
  measure: HDL (mmol/l)
  time frame: Change from baseline at week 26
  description: High-density lipoprotein (mmol/l)
  measure: eGFR (ml/min)
  time frame: Change from baseline at week 26
  description: Estimated glomerular filtration rate (ml/min)
  measure: TNF-α (ng/L)
  time frame: Change from baseline at week 26
  description: Tumor necrosis factor - alpha (ng/L)
  measure: IL-1β (ng/L)
  time frame: Change from baseline at week 26
  description: Interleukin 1β (ng/L)
  measure: IL-6 (ng/L)
  time frame: Change from baseline at week 26
  description: Interleukin 6 (ng/L)
  measure: hsCRP (mg/L)
  time frame: Change from baseline at week 26
  description: High sensitive c-reactive protein (mg/L)
  measure: Proteomics, and metabolomics
  time frame: Change from baseline at week 26
  description: The analysis of proteomics and metabolomics is explorative, and therefore the selection of proteins and metabolites is not pre-determined but will rather include those that are available and deemed appropriate at the time of analysis
  measure: Albuminuria (mg/l)
  time frame: Change from baseline at week 26
  description: Albuminuria (mg/l)
  measure: Self-measured waist circumference (cm)
  time frame: Change from baseline at week 26
  description: Self-measured waist circumference (cm)
  measure: Self-reported quality of life
  time frame: Change from baseline at week 26
  description: Self-reported quality of life - questionnaire
  measure: 24-hour dietary recall
  time frame: Change from baseline at week 26
  description: 24-hour dietary recall
  arm group label: Intervention
  arm group type: Experimental
  description: Access to the 'DiabetesSwitch' filter of the FoodSwitch app when food shopping during 26 weeks.
  arm group label: Control
  arm group type: No Intervention
  description: Access to written dietary advice during 26 weeks.
  intervention type: Other
  intervention name: FoodSwitch
  description: Access to the 'DiabetesSwitch' filter of the FoodSwitch app when food shopping. When a packaged food item bar code is scanned, the FoodSwitch app will show an interpretive nutritional information score for the scanned product and recommend alternate healthier food options in the same category.
  arm group label: Intervention
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Karin Rådholm, MD, PhD
  role: Study Director
  affiliation: Linkoeping University
  last name: Lana Hebib, MD
  phone: 013-28 10 00
  email: lana.hebib@liu.se
  citation: Dunford E, Trevena H, Goodsell C, Ng KH, Webster J, Millis A, Goldstein S, Hugueniot O, Neal B. FoodSwitch: A Mobile Phone App to Enable Consumers to Make Healthier Food Choices and Crowdsourcing of National Food Composition Data. JMIR Mhealth Uhealth. 2014 Aug 21;2(3):e37. doi: 10.2196/mhealth.3230.
  PMID: 25147135
  citation: Coughlin SS, Whitehead M, Sheats JQ, Mastromonico J, Hardy D, Smith SA. Smartphone Applications for Promoting Healthy Diet and Nutrition: A Literature Review. Jacobs J Food Nutr. 2015;2(3):021.
  PMID: 26819969
  responsible party type: Principal Investigator
  investigator affiliation: Linkoeping University
  investigator full name: Lana Hebib
  investigator title: Principal investigator
  mesh term: Diabetes Mellitus
  mesh term: Diabetes Mellitus, Type 2
  sharing ipd: Yes
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Analytic Code
  ipd time frame: After publication in a peer-reviewed journal and for the period of time for which local archive regulations stipulate.
  ipd access criteria: To be determined on a case by case basis.