<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/NCT04422821</url>
  </required_header>
  <id_info>
    <org_study_id>931156</org_study_id>
    <nct_id>NCT04422821</nct_id>
  </id_info>
  <brief_title>Flash Glucose Monitoring in Gestational Diabetes Mellitus: Study Protocol for a Randomized Controlled Trial</brief_title>
  <acronym>FLAMINGO</acronym>
  <official_title>Flash Glucose Monitoring in Gestational Diabetes Mellitus: Study Protocol for a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Warsaw</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Warsaw</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>
      Gestational diabetes mellitus (GDM) is glucose intolerance diagnosed for the first time in&#xD;
      pregnancy. According to literature GDM affects 3-10% of pregnant women and is a risk factor&#xD;
      for multiple maternal and fetal complications. During pregnancy GDM significantly increases&#xD;
      the risk of fetal macrosomia, shoulder dystocia, birth trauma and Cesarean section.&#xD;
      Furthermore, the long-term complications of GDM include increased risk of development of&#xD;
      diabetes mellitus type 2 in the mother, as well as increased risk of obesity, diabetes and&#xD;
      metabolic syndrome occurrence in their children. It has been well-documented that the risk of&#xD;
      above-mentioned complications increases with the level of maternal hyperglycemia.&#xD;
&#xD;
      Proper glycemia control is one of the key elements in the effective treatment of GDM. Until&#xD;
      recently, glucose monitoring was solely performed using glucose meters, which required&#xD;
      multiple fingerpricks. Nowadays, due to the glycemia monitoring systems development, such as&#xD;
      flash glucose monitoring (FGM), glucose levels may be measured less invasively through&#xD;
      subcutaneous sensor application. As shown in one of the studies, FGM due to the ease of use,&#xD;
      was 3 times more often applied as a method of glycemia control than SMBG. As a result,&#xD;
      patients from FGM group had significantly better blood glucose control.&#xD;
&#xD;
      The main purpose of our study is to evaluate the impact of new method of glycemia control&#xD;
      (FGM) on the efficacy of treatment of GDM. By analyzing results of this study, such as mean&#xD;
      glycemia levels, number of women requiring insulin therapy and maternal-fetal perinatal&#xD;
      outcomes the investigators will provide a scientific basis for more common use of FGM in the&#xD;
      population of pregnant women affected by GDM.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized controlled trial performed at the 1st Department of Obstetrics and&#xD;
      Gynecology of Medical University of Warsaw. The study will recruit 100 women at 24-28 weeks&#xD;
      of gestation . Women diagnosed with GDM, who will meet the inclusion criteria, will be&#xD;
      individually randomized to Flash Glucose Monitoring (n=50) or Self-Monitoring of Blood&#xD;
      Glucose (n=50) group.&#xD;
&#xD;
      The study group will obtain instruction for using Freestyle Libre app to measure and collect&#xD;
      glycemia results using a mobile phone.&#xD;
&#xD;
      The control group will be informed about proper use of glucose meters.&#xD;
&#xD;
      All participants will be obliged to measure fasting and 1-h postprandial glucose&#xD;
      concentrations in a daily manner, together with once per week midnight measurement.&#xD;
&#xD;
      All participants will obtain dietary recommendations for gestational diabetes mellitus and&#xD;
      recommendations about daily physical activity in pregnancy.&#xD;
&#xD;
      In order to assess daily physical activity all participants will obtain a wristband allowing&#xD;
      for footsteps measurement.&#xD;
&#xD;
      An evaluation of patient's dietary habits will be based on Eating Assessment Test prepared by&#xD;
      the Polish National Institute of Public Health - National Institute of Hygiene.&#xD;
&#xD;
      Clinical and laboratory results of the mother and their newborns will be collected for&#xD;
      analysis during the course of pregnancy.&#xD;
&#xD;
      After delivery, at the follow-up visit research staff will retrieve maternal and neonatal&#xD;
      outcomes from patients medical history.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Actual">November 10, 2022</completion_date>
  <primary_completion_date type="Actual">October 31, 2022</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>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean glycemia results (fasting and 1-h postprandial glucose concentrations)</measure>
    <time_frame>28 days after the recruitment visit</time_frame>
    <description>Glycemia results analysis according to Polish Society of Obstetricians and Gynecologists (PSOG) recommendations for gestational diabetes mellitus.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients requiring insulin therapy</measure>
    <time_frame>2, 4 and 8 weeks after the recruitment visit</time_frame>
    <description>Number of patients in each group requiring insulin therapy will by analyzed at the second, third and fourth follow-up visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Long-term glycemic control using blood HbA1c serum concentration</measure>
    <time_frame>4 and 8 weeks after the recruitment visit</time_frame>
    <description>Difference in HbA1c serum concentration in each group will by analyzed at the third and fourth follow-up visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of hypoglycemia episodes (glucose concentration &lt;70 mg/dl) during one month analysis</measure>
    <time_frame>0-4 weeks after the recruitment visit</time_frame>
    <description>Number of hypoglycemia episodes in each group will by analyzed at third visit, to check whether there is a difference between the groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity during one month analysis</measure>
    <time_frame>0-4 weeks after the recruitment visit</time_frame>
    <description>Number of footsteps walk per day in each group will by analyzed at the third follow-up visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compliance with diet recommendations</measure>
    <time_frame>2, 4 and 8 weeks after the recruitment visit</time_frame>
    <description>Diet assessment in each group will be performed at the second, third and fourth follow-up visit to check compliance with diet recommendations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gestational weight gain</measure>
    <time_frame>2, 4 and 8 weeks after the recruitment visit</time_frame>
    <description>Gestational weight gain in each group will by analyzed at the second, third and fourth follow-up visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mode of delivery (rate of vaginal delivery/ Cesarean section)</measure>
    <time_frame>24-72 hours after the delivery</time_frame>
    <description>Rate of vaginal delivery versus cesarean section in each group will by analyzed at the fifth follow-up visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fetal birth-weight</measure>
    <time_frame>24-72 hours after the delivery</time_frame>
    <description>Fetal birth-weight in each group will by analyzed at the fifth follow-up visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neonatal glycemia</measure>
    <time_frame>24-72 hours after the delivery</time_frame>
    <description>Neonatal glycemia in each group will by analyzed at the fifth follow-up visit, to check the rate of neonatal hypoglycemia.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Gestational Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>FreeStyle Libre™</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>FreeStyle Libre™ will comprise 50 pregnant women between 24-28 weeks of gestation, diagnosed with gestational diabetes mellitus, who will receive subcutaneous sensor for glucose monitoring (FreeStyle Libre™; Abbott Diabetes Care, Alameda, CA) for 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>iXell®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>iXell® will comprise 50 pregnant women between 24-28 weeks of gestation, diagnosed with gestational diabetes mellitus, who will monitor glycemia through use of standard glucose meter (iXell®; Genexo sp; Warsaw, Poland) for 4 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Flash Glucose Monitoring</intervention_name>
    <description>Flash Glucose Monitoring FreeStyle Libre™ (Abbott Diabetes Care, Alameda, CA) sensor placed subcutaneously that will be applied for 14 days, then removed and changed for the second sensor for the next 14 days.</description>
    <arm_group_label>FreeStyle Libre™</arm_group_label>
    <other_name>FreeStyle Libre™ (Abbott Diabetes Care, Alameda, CA)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Self-Monitoring of Blood Glucose</intervention_name>
    <description>Self-Monitoring of Blood Glucose with a standard glucose meter (iXell®; Genexo sp; Warsaw, Poland) performed through a skin-puncturing 4 times a day for 28 days.</description>
    <arm_group_label>iXell®</arm_group_label>
    <other_name>iXell®; Genexo sp; Warsaw, Poland</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age ≥ 18 years&#xD;
&#xD;
          -  singleton pregnancy between 24-28 weeks of gestation&#xD;
&#xD;
          -  gestational diabetes mellitus diagnosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  multiple pregnancy&#xD;
&#xD;
          -  fetal malformations&#xD;
&#xD;
          -  pre-gestational diabetes mellitus&#xD;
&#xD;
          -  chronic or pregnancy-induced hypertension&#xD;
&#xD;
          -  chronic renal or hepatic disease, in-vitro fertilization&#xD;
&#xD;
          -  delivery &lt;37 weeks of gestation&#xD;
&#xD;
          -  pre-mature rupture of membranes&#xD;
&#xD;
          -  placenta previa&#xD;
&#xD;
          -  stillbirth&#xD;
&#xD;
          -  smoking in pregnancy&#xD;
&#xD;
          -  intake of medications including: methyldopa, tetracyclin, acetylosalicylic acid,&#xD;
             acetaminofen, ibuprofen, L-dopa, tolazamide, tolbutamide&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mirosław Wielgoś, MD PhD, Prof.</last_name>
    <role>Study Director</role>
    <affiliation>Medical University of Warsaw</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>1st Department of Obstetrics and Gynecology, Medical University of Warsaw</name>
      <address>
        <city>Warsaw</city>
        <state>Starynkiewicza Sq. 1/3</state>
        <zip>02-015</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <reference>
    <citation>Scott EM, Bilous RW, Kautzky-Willer A. Accuracy, User Acceptability, and Safety Evaluation for the FreeStyle Libre Flash Glucose Monitoring System When Used by Pregnant Women with Diabetes. Diabetes Technol Ther. 2018 Mar;20(3):180-188. doi: 10.1089/dia.2017.0386. Epub 2018 Feb 22.</citation>
    <PMID>29470094</PMID>
  </reference>
  <reference>
    <citation>Bolinder J, Antuna R, Geelhoed-Duijvestijn P, Kroger J, Weitgasser R. Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial. Lancet. 2016 Nov 5;388(10057):2254-2263. doi: 10.1016/S0140-6736(16)31535-5. Epub 2016 Sep 12.</citation>
    <PMID>27634581</PMID>
  </reference>
  <reference>
    <citation>Mancini G, Berioli MG, Santi E, Rogari F, Toni G, Tascini G, Crispoldi R, Ceccarini G, Esposito S. Flash Glucose Monitoring: A Review of the Literature with a Special Focus on Type 1 Diabetes. Nutrients. 2018 Jul 29;10(8):992. doi: 10.3390/nu10080992.</citation>
    <PMID>30060632</PMID>
  </reference>
  <reference>
    <citation>Dunn TC, Xu Y, Hayter G, Ajjan RA. Real-world flash glucose monitoring patterns and associations between self-monitoring frequency and glycaemic measures: A European analysis of over 60 million glucose tests. Diabetes Res Clin Pract. 2018 Mar;137:37-46. doi: 10.1016/j.diabres.2017.12.015. Epub 2017 Dec 24.</citation>
    <PMID>29278709</PMID>
  </reference>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>May 31, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>December 19, 2022</last_update_submitted>
  <last_update_submitted_qc>December 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Warsaw</investigator_affiliation>
    <investigator_full_name>AGATA MAJEWSKA</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>gestational diabetes mellitus</keyword>
  <keyword>flash glucose monitoring</keyword>
  <keyword>glycemia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes, Gestational</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data will be available on reasonable request.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>The deidentified participant data will become available upon publishing the protocol and results of the study. Study protocol will be available immediately following publication.</ipd_time_frame>
    <ipd_access_criteria>The data will be provided on reasonable request for anyone after methodologically sound proposal (contact details: amajewska2@wum.edu.pl).</ipd_access_criteria>
  </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/NCT04422821
org study id: 931156
nct id: NCT04422821
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Gestational diabetes mellitus (GDM) is glucose intolerance diagnosed for the first time in
      pregnancy. According to literature GDM affects 3-10% of pregnant women and is a risk factor
      for multiple maternal and fetal complications. During pregnancy GDM significantly increases
      the risk of fetal macrosomia, shoulder dystocia, birth trauma and Cesarean section.
      Furthermore, the long-term complications of GDM include increased risk of development of
      diabetes mellitus type 2 in the mother, as well as increased risk of obesity, diabetes and
      metabolic syndrome occurrence in their children. It has been well-documented that the risk of
      above-mentioned complications increases with the level of maternal hyperglycemia.

      Proper glycemia control is one of the key elements in the effective treatment of GDM. Until
      recently, glucose monitoring was solely performed using glucose meters, which required
      multiple fingerpricks. Nowadays, due to the glycemia monitoring systems development, such as
      flash glucose monitoring (FGM), glucose levels may be measured less invasively through
      subcutaneous sensor application. As shown in one of the studies, FGM due to the ease of use,
      was 3 times more often applied as a method of glycemia control than SMBG. As a result,
      patients from FGM group had significantly better blood glucose control.

      The main purpose of our study is to evaluate the impact of new method of glycemia control
      (FGM) on the efficacy of treatment of GDM. By analyzing results of this study, such as mean
      glycemia levels, number of women requiring insulin therapy and maternal-fetal perinatal
      outcomes the investigators will provide a scientific basis for more common use of FGM in the
      population of pregnant women affected by GDM.
This is a randomized controlled trial performed at the 1st Department of Obstetrics and
      Gynecology of Medical University of Warsaw. The study will recruit 100 women at 24-28 weeks
      of gestation . Women diagnosed with GDM, who will meet the inclusion criteria, will be
      individually randomized to Flash Glucose Monitoring (n=50) or Self-Monitoring of Blood
      Glucose (n=50) group.

      The study group will obtain instruction for using Freestyle Libre app to measure and collect
      glycemia results using a mobile phone.

      The control group will be informed about proper use of glucose meters.

      All participants will be obliged to measure fasting and 1-h postprandial glucose
      concentrations in a daily manner, together with once per week midnight measurement.

      All participants will obtain dietary recommendations for gestational diabetes mellitus and
      recommendations about daily physical activity in pregnancy.

      In order to assess daily physical activity all participants will obtain a wristband allowing
      for footsteps measurement.

      An evaluation of patient's dietary habits will be based on Eating Assessment Test prepared by
      the Polish National Institute of Public Health - National Institute of Hygiene.

      Clinical and laboratory results of the mother and their newborns will be collected for
      analysis during the course of pregnancy.

      After delivery, at the follow-up visit research staff will retrieve maternal and neonatal
      outcomes from patients medical history.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Mean glycemia results (fasting and 1-h postprandial glucose concentrations)
time frame: 28 days after the recruitment visit
description: Glycemia results analysis according to Polish Society of Obstetricians and Gynecologists (PSOG) recommendations for gestational diabetes mellitus.
measure: Number of patients requiring insulin therapy
time frame: 2, 4 and 8 weeks after the recruitment visit
description: Number of patients in each group requiring insulin therapy will by analyzed at the second, third and fourth follow-up visit.
measure: Long-term glycemic control using blood HbA1c serum concentration
time frame: 4 and 8 weeks after the recruitment visit
description: Difference in HbA1c serum concentration in each group will by analyzed at the third and fourth follow-up visit.
measure: Number of hypoglycemia episodes (glucose concentration <70 mg/dl) during one month analysis
time frame: 0-4 weeks after the recruitment visit
description: Number of hypoglycemia episodes in each group will by analyzed at third visit, to check whether there is a difference between the groups.
measure: Physical activity during one month analysis
time frame: 0-4 weeks after the recruitment visit
description: Number of footsteps walk per day in each group will by analyzed at the third follow-up visit.
measure: Compliance with diet recommendations
time frame: 2, 4 and 8 weeks after the recruitment visit
description: Diet assessment in each group will be performed at the second, third and fourth follow-up visit to check compliance with diet recommendations.
measure: Gestational weight gain
time frame: 2, 4 and 8 weeks after the recruitment visit
description: Gestational weight gain in each group will by analyzed at the second, third and fourth follow-up visit.
measure: Mode of delivery (rate of vaginal delivery/ Cesarean section)
time frame: 24-72 hours after the delivery
description: Rate of vaginal delivery versus cesarean section in each group will by analyzed at the fifth follow-up visit.
measure: Fetal birth-weight
time frame: 24-72 hours after the delivery
description: Fetal birth-weight in each group will by analyzed at the fifth follow-up visit.
measure: Neonatal glycemia
time frame: 24-72 hours after the delivery
description: Neonatal glycemia in each group will by analyzed at the fifth follow-up visit, to check the rate of neonatal hypoglycemia.
arm group label: FreeStyle Libre™
arm group type: Experimental
description: FreeStyle Libre™ will comprise 50 pregnant women between 24-28 weeks of gestation, diagnosed with gestational diabetes mellitus, who will receive subcutaneous sensor for glucose monitoring (FreeStyle Libre™; Abbott Diabetes Care, Alameda, CA) for 4 weeks.
arm group label: iXell®
arm group type: Active Comparator
description: iXell® will comprise 50 pregnant women between 24-28 weeks of gestation, diagnosed with gestational diabetes mellitus, who will monitor glycemia through use of standard glucose meter (iXell®; Genexo sp; Warsaw, Poland) for 4 weeks.
intervention type: Device
intervention name: Flash Glucose Monitoring
description: Flash Glucose Monitoring FreeStyle Libre™ (Abbott Diabetes Care, Alameda, CA) sensor placed subcutaneously that will be applied for 14 days, then removed and changed for the second sensor for the next 14 days.
arm group label: FreeStyle Libre™
other name: FreeStyle Libre™ (Abbott Diabetes Care, Alameda, CA)
intervention type: Device
intervention name: Self-Monitoring of Blood Glucose
description: Self-Monitoring of Blood Glucose with a standard glucose meter (iXell®; Genexo sp; Warsaw, Poland) performed through a skin-puncturing 4 times a day for 28 days.
arm group label: iXell®
other name: iXell®; Genexo sp; Warsaw, Poland
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mirosław Wielgoś, MD PhD, Prof.
role: Study Director
affiliation: Medical University of Warsaw
facility: 
country: Poland
citation: Scott EM, Bilous RW, Kautzky-Willer A. Accuracy, User Acceptability, and Safety Evaluation for the FreeStyle Libre Flash Glucose Monitoring System When Used by Pregnant Women with Diabetes. Diabetes Technol Ther. 2018 Mar;20(3):180-188. doi: 10.1089/dia.2017.0386. Epub 2018 Feb 22.
PMID: 29470094
citation: Bolinder J, Antuna R, Geelhoed-Duijvestijn P, Kroger J, Weitgasser R. Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial. Lancet. 2016 Nov 5;388(10057):2254-2263. doi: 10.1016/S0140-6736(16)31535-5. Epub 2016 Sep 12.
PMID: 27634581
citation: Mancini G, Berioli MG, Santi E, Rogari F, Toni G, Tascini G, Crispoldi R, Ceccarini G, Esposito S. Flash Glucose Monitoring: A Review of the Literature with a Special Focus on Type 1 Diabetes. Nutrients. 2018 Jul 29;10(8):992. doi: 10.3390/nu10080992.
PMID: 30060632
citation: Dunn TC, Xu Y, Hayter G, Ajjan RA. Real-world flash glucose monitoring patterns and associations between self-monitoring frequency and glycaemic measures: A European analysis of over 60 million glucose tests. Diabetes Res Clin Pract. 2018 Mar;137:37-46. doi: 10.1016/j.diabres.2017.12.015. Epub 2017 Dec 24.
PMID: 29278709
responsible party type: Principal Investigator
investigator affiliation: Medical University of Warsaw
investigator full name: AGATA MAJEWSKA
investigator title: Principal Investigator
mesh term: Diabetes, Gestational
mesh term: Diabetes Mellitus
sharing ipd: Yes
ipd description: Data will be available on reasonable request.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: The deidentified participant data will become available upon publishing the protocol and results of the study. Study protocol will be available immediately following publication.
ipd access criteria: The data will be provided on reasonable request for anyone after methodologically sound proposal (contact details: amajewska2@wum.edu.pl).