<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/NCT03761615</url>
  </required_header>
  <id_info>
    <org_study_id>18-007081</org_study_id>
    <nct_id>NCT03761615</nct_id>
  </id_info>
  <brief_title>Longitudinal Observation of Insulin Requirements and Sensor Use in Pregnancy</brief_title>
  <acronym>LOIS-P</acronym>
  <official_title>Observational Study of Patient Important Outcomes in Pregnant Patients With Type 1 Diabetes Mellitus on Insulin Pump</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sansum Diabetes Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Harvard University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Icahn School of Medicine at Mount Sinai</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sansum Diabetes Research Institute</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall goal of this study is to enroll pregnant women with type 1 diabetes and follow&#xD;
      their glycemic outcomes prospectively throughout pregnancy and into the post-partum period.&#xD;
      The investigators anticipate that when compared to subjects using an Artificial pancreas&#xD;
      system (AP) as part of a future protocol, this comparator group of subjects undergoing usual&#xD;
      care will exhibit less time in target continuous glucose monitoring (CGM) glucose range&#xD;
      defined as 63-140 mg/dL and an increased duration of hypoglycemia with CGM glucose &lt;63 mg/dL.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an observational study. Data collected will include records of continuous glucose&#xD;
      monitoring (CGM) based glucose, insulin delivery, self-monitoring of blood glucose (SMBG),&#xD;
      and maternal and fetal outcomes from pregnant women with type 1 diabetes. These data will be&#xD;
      used to: (1) develop and refine algorithms for an AP system tailored to the needs of pregnant&#xD;
      women with type 1 diabetes, (2) to serve as a comparator group for concurrent AP protocols,&#xD;
      (3) describe Dexcom G6 CGM data throughout the pregnancy, and (4) describe insulin changes&#xD;
      which occur in pregnancy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 13, 2018</start_date>
  <completion_date type="Actual">June 9, 2021</completion_date>
  <primary_completion_date type="Actual">June 9, 2021</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Time in range glucose levels as determined by CGM</measure>
    <time_frame>Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum</time_frame>
    <description>Time in range defined as 63-140 mg/dL as determined by CGM analysis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time spent below target glucose range</measure>
    <time_frame>Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum</time_frame>
    <description>Time spent below target cgm glucose range defined as glucose &lt;63 mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of severe hypoglycemic events</measure>
    <time_frame>Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum</time_frame>
    <description>Frequency of severe hypoglycemic events, defined as requiring assistance from another, an emergency room visit or treatment with glucagon due to unconsciousness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time spent above target glucose range</measure>
    <time_frame>Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum</time_frame>
    <description>Time spent above target cgm glucose range defined as &gt;140 mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Episodes of clinically significant hyperglycemia</measure>
    <time_frame>Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum</time_frame>
    <description>Episodes of clinically significant hyperglycemia with CGM glucose &gt;180 mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Extent of glucose variability (GV)</measure>
    <time_frame>Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum</time_frame>
    <description>Glucose variability, defined using predetermined metrics of GV</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of time CGM active</measure>
    <time_frame>Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum</time_frame>
    <description>Percent of time CGM active per day (minutes of use/24 hours)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concordance of CGM data in relation to SMBG data</measure>
    <time_frame>Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum</time_frame>
    <description>Comparison of concordance of CGM data with measured SMBG glucose levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total daily insulin requirements</measure>
    <time_frame>Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum</time_frame>
    <description>Change in total daily insulin during pregnancy and the postpartum period (units/day)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Basal insulin requirements</measure>
    <time_frame>Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum</time_frame>
    <description>Change in basal insulin during pregnancy and the postpartum period (units/day)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin-to-carbohydrate ratio changes</measure>
    <time_frame>Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum</time_frame>
    <description>Change in insulin-to-carbohydrate ratio during pregnancy and the postpartum period (units/day)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insulin sensitivity changes</measure>
    <time_frame>Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum</time_frame>
    <description>Change in insulin sensitivity during pregnancy and the postpartum period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Carbohydrate consumption</measure>
    <time_frame>Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum</time_frame>
    <description>Change in carbohydrate consumption during pregnancy and the postpartum period (grams/day)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Ketoacidosis</measure>
    <time_frame>Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum</time_frame>
    <description>Episodes of ketoacidosis requiring emergency room or hospital admission</description>
  </other_outcome>
  <other_outcome>
    <measure>Maternal Complications</measure>
    <time_frame>Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum</time_frame>
    <description>Maternal complications including preeclampsia, pregnancy induced hypertension and polyhydramnios</description>
  </other_outcome>
  <other_outcome>
    <measure>Gestational weight gain</measure>
    <time_frame>Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum</time_frame>
    <description>Gestational weight gain</description>
  </other_outcome>
  <other_outcome>
    <measure>Gestational age at delivery</measure>
    <time_frame>Immediately at birth</time_frame>
    <description>Gestational age at delivery (Weeks)</description>
  </other_outcome>
  <other_outcome>
    <measure>Birth weight of baby</measure>
    <time_frame>Immediately at birth</time_frame>
    <description>Birth weight of baby (kg)</description>
  </other_outcome>
  <other_outcome>
    <measure>Fetal malformations</measure>
    <time_frame>Immediately at birth</time_frame>
    <description>Fetal malformations as recorded by obstetrics and noted at delivery</description>
  </other_outcome>
  <other_outcome>
    <measure>LGA</measure>
    <time_frame>Immediately at birth</time_frame>
    <description>Incidence of Large for Gestational Age based on WHO criteria at time of delivery</description>
  </other_outcome>
  <other_outcome>
    <measure>SGA</measure>
    <time_frame>Immediately at birth</time_frame>
    <description>Incidence of Small for Gestational Age based on WHO criteria at time of delivery</description>
  </other_outcome>
  <other_outcome>
    <measure>Preterm Birth</measure>
    <time_frame>Immediately at birth</time_frame>
    <description>Preterm birth (&lt;37 weeks and early preterm &lt; 34 weeks)</description>
  </other_outcome>
  <other_outcome>
    <measure>Neonatal hypoglycemia</measure>
    <time_frame>Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum</time_frame>
    <description>Neonatal hypoglycemia requiring IV dextrose</description>
  </other_outcome>
  <other_outcome>
    <measure>Neonatal NICU stay</measure>
    <time_frame>Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum</time_frame>
    <description>Neonatal NICU stay &gt; 24 hours and indication</description>
  </other_outcome>
  <other_outcome>
    <measure>Method of delivery</measure>
    <time_frame>Immediately at birth</time_frame>
    <description>Method of delivery and adverse events associated with delivery including shoulder dystocia</description>
  </other_outcome>
  <other_outcome>
    <measure>Mode of delivery</measure>
    <time_frame>Immediately at birth</time_frame>
    <description>Mode of delivery including induction rates and incidence of primary cesarean section (and indication noted)</description>
  </other_outcome>
  <other_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum</time_frame>
    <description>Length of hospital stay (Days)</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">30</enrollment>
  <condition>Type 1 Diabetes Mellitus</condition>
  <condition>Pregnancy in Diabetics</condition>
  <arm_group>
    <arm_group_label>type 1 diabetes and pregnancy</arm_group_label>
    <description>Pregnant women with T1D on insulin pumps (CSII/SAP/PLGS) will be offered enrollment in a prospective study that will capture: 1) Dexcom G6 CGM data, 2) self-monitoring of blood glucose (SMBG), 3) insulin pump settings, 4) insulin delivery records, and 5) maternal and fetal outcomes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Dexcom G6 CGM</intervention_name>
    <description>All women in the study will be given Dexcom G6 CGM and a study glucometer.</description>
    <arm_group_label>type 1 diabetes and pregnancy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women 18 years of age or older with T1D using an insulin pump&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis, based on investigator assessment, of T1D for at least one year and&#xD;
             using insulin for at least 1 year.&#xD;
&#xD;
          -  Criteria for documented hyperglycemia (at least 1 must be met):&#xD;
&#xD;
               -  Fasting glucose ≥126 mg/dL&#xD;
&#xD;
               -  Two-hour OGTT glucose ≥200 mg/dL&#xD;
&#xD;
               -  HbA1c ≥6.5% documented&#xD;
&#xD;
               -  Random glucose ≥200 mg/dL with symptoms&#xD;
&#xD;
               -  No data at diagnosis is available but the participant has a convincing history of&#xD;
                  hyperglycemia consistent with T1D&#xD;
&#xD;
          -  Criteria for requiring insulin at diagnosis (1 must be met):&#xD;
&#xD;
               -  Participant required insulin at diagnosis and continually thereafter.&#xD;
&#xD;
               -  Participant did not start insulin at diagnosis but upon investigator review&#xD;
                  likely needed insulin (significant hyperglycemia that did not respond to oral&#xD;
                  agents) and did require insulin eventually and used continually.&#xD;
&#xD;
               -  Participant did not start insulin at diagnosis but continued to be hyperglycemic,&#xD;
                  had positive islet cell antibodies - consistent with latent autoimmune diabetes&#xD;
                  in adults (LADA) and did require insulin eventually and used continually.&#xD;
&#xD;
          -  Currently using an insulin pump for diabetes management&#xD;
&#xD;
          -  Currently using or willing to use an insulin-to-carbohydrate ratio to calculate meal&#xD;
             bolus sizes&#xD;
&#xD;
          -  Willing to change insulin infusion site at least every 3 days.&#xD;
&#xD;
          -  Confirmed pregnancy&#xD;
&#xD;
          -  Current gestational age &lt;17 weeks&#xD;
&#xD;
          -  Age 18-40 years&#xD;
&#xD;
          -  HbA1c &lt;10.0%&#xD;
&#xD;
          -  Demonstration of proper mental status and cognition for the study&#xD;
&#xD;
          -  Ability to access the internet and upload CGM data remotely if needed&#xD;
&#xD;
          -  An understanding of and willingness to follow the protocol and sign the informed&#xD;
             consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  670 G users in Auto mode&#xD;
&#xD;
          -  Current gestational age ≥17 weeks&#xD;
&#xD;
          -  Cystic fibrosis&#xD;
&#xD;
          -  A known medical condition that in the judgment of the investigator might interfere&#xD;
             with the completion of the protocol such as the following examples:&#xD;
&#xD;
               -  Inpatient psychiatric treatment in the past 6 months&#xD;
&#xD;
               -  Abnormal renal function test results (calculated GFR &lt;60 mL/min/1.73m2); testing&#xD;
                  required for subjects with diabetes duration of greater than 5 years post onset&#xD;
                  of puberty&#xD;
&#xD;
               -  Active gastroparesis&#xD;
&#xD;
               -  Abuse of alcohol or recreational drugs&#xD;
&#xD;
               -  Infectious process not anticipated to resolve prior to study procedures (e.g.&#xD;
                  meningitis, pneumonia, osteomyelitis)&#xD;
&#xD;
               -  Uncontrolled arterial hypertension (Resting diastolic blood pressure &gt;95mmHg&#xD;
                  and/or systolic blood pressure &gt;160 mmHg) at the time of screening&#xD;
&#xD;
               -  Chronic oral steroid use&#xD;
&#xD;
          -  A recent injury to body or limb, muscular disorder, use of any medication, any&#xD;
             carcinogenic disease, or other significant medical disorder if that injury, medication&#xD;
             or disease in the judgment of the investigator will affect the completion of the&#xD;
             protocol&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eyal Dassau, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Harvard University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Carol Levy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yogish C Kudva, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jordan E Pinsker, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sansum Diabetes Research Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Barak Rosenn, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kristin Castorino, DO</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sansum Diabetes Research Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Grenye O'Malley, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sansum Diabetes Research Institute</name>
      <address>
        <city>Santa Barbara</city>
        <state>California</state>
        <zip>93105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>November 24, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>December 2, 2022</last_update_submitted>
  <last_update_submitted_qc>December 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>type 1 diabetes</keyword>
  <keyword>pregnancy</keyword>
  <keyword>continues glucose monitoring</keyword>
  <keyword>artificial pancreas</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pregnancy in Diabetics</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Plan to create a public database of study results per NIH open data policy.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>1 year after study data analysis is complete and results are published.</ipd_time_frame>
  </patient_data>
  <pending_results>
    <submitted>December 10, 2022</submitted>
  </pending_results>
  <!-- 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/NCT03761615
org study id: 18-007081
nct id: NCT03761615
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The overall goal of this study is to enroll pregnant women with type 1 diabetes and follow
      their glycemic outcomes prospectively throughout pregnancy and into the post-partum period.
      The investigators anticipate that when compared to subjects using an Artificial pancreas
      system (AP) as part of a future protocol, this comparator group of subjects undergoing usual
      care will exhibit less time in target continuous glucose monitoring (CGM) glucose range
      defined as 63-140 mg/dL and an increased duration of hypoglycemia with CGM glucose <63 mg/dL.
This is an observational study. Data collected will include records of continuous glucose
      monitoring (CGM) based glucose, insulin delivery, self-monitoring of blood glucose (SMBG),
      and maternal and fetal outcomes from pregnant women with type 1 diabetes. These data will be
      used to: (1) develop and refine algorithms for an AP system tailored to the needs of pregnant
      women with type 1 diabetes, (2) to serve as a comparator group for concurrent AP protocols,
      (3) describe Dexcom G6 CGM data throughout the pregnancy, and (4) describe insulin changes
      which occur in pregnancy.
observational model: Cohort
time perspective: Prospective
measure: Time in range glucose levels as determined by CGM
time frame: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum
description: Time in range defined as 63-140 mg/dL as determined by CGM analysis
measure: Time spent below target glucose range
time frame: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum
description: Time spent below target cgm glucose range defined as glucose <63 mg/dL
measure: Frequency of severe hypoglycemic events
time frame: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum
description: Frequency of severe hypoglycemic events, defined as requiring assistance from another, an emergency room visit or treatment with glucagon due to unconsciousness
measure: Time spent above target glucose range
time frame: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum
description: Time spent above target cgm glucose range defined as >140 mg/dL
measure: Episodes of clinically significant hyperglycemia
time frame: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum
description: Episodes of clinically significant hyperglycemia with CGM glucose >180 mg/dL
measure: Extent of glucose variability (GV)
time frame: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum
description: Glucose variability, defined using predetermined metrics of GV
measure: Percent of time CGM active
time frame: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum
description: Percent of time CGM active per day (minutes of use/24 hours)
measure: Concordance of CGM data in relation to SMBG data
time frame: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum
description: Comparison of concordance of CGM data with measured SMBG glucose levels
measure: Total daily insulin requirements
time frame: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum
description: Change in total daily insulin during pregnancy and the postpartum period (units/day)
measure: Basal insulin requirements
time frame: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum
description: Change in basal insulin during pregnancy and the postpartum period (units/day)
measure: Insulin-to-carbohydrate ratio changes
time frame: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum
description: Change in insulin-to-carbohydrate ratio during pregnancy and the postpartum period (units/day)
measure: Insulin sensitivity changes
time frame: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum
description: Change in insulin sensitivity during pregnancy and the postpartum period
measure: Carbohydrate consumption
time frame: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum
description: Change in carbohydrate consumption during pregnancy and the postpartum period (grams/day)
measure: Ketoacidosis
time frame: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum
description: Episodes of ketoacidosis requiring emergency room or hospital admission
measure: Maternal Complications
time frame: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum
description: Maternal complications including preeclampsia, pregnancy induced hypertension and polyhydramnios
measure: Gestational weight gain
time frame: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum
description: Gestational weight gain
measure: Gestational age at delivery
time frame: Immediately at birth
description: Gestational age at delivery (Weeks)
measure: Birth weight of baby
time frame: Immediately at birth
description: Birth weight of baby (kg)
measure: Fetal malformations
time frame: Immediately at birth
description: Fetal malformations as recorded by obstetrics and noted at delivery
measure: LGA
time frame: Immediately at birth
description: Incidence of Large for Gestational Age based on WHO criteria at time of delivery
measure: SGA
time frame: Immediately at birth
description: Incidence of Small for Gestational Age based on WHO criteria at time of delivery
measure: Preterm Birth
time frame: Immediately at birth
description: Preterm birth (<37 weeks and early preterm < 34 weeks)
measure: Neonatal hypoglycemia
time frame: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum
description: Neonatal hypoglycemia requiring IV dextrose
measure: Neonatal NICU stay
time frame: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum
description: Neonatal NICU stay > 24 hours and indication
measure: Method of delivery
time frame: Immediately at birth
description: Method of delivery and adverse events associated with delivery including shoulder dystocia
measure: Mode of delivery
time frame: Immediately at birth
description: Mode of delivery including induction rates and incidence of primary cesarean section (and indication noted)
measure: Length of hospital stay
time frame: Prior to 17 weeks gestation (enrollment) through up to 6 weeks postpartum
description: Length of hospital stay (Days)
arm group label: type 1 diabetes and pregnancy
description: Pregnant women with T1D on insulin pumps (CSII/SAP/PLGS) will be offered enrollment in a prospective study that will capture: 1) Dexcom G6 CGM data, 2) self-monitoring of blood glucose (SMBG), 3) insulin pump settings, 4) insulin delivery records, and 5) maternal and fetal outcomes.
intervention type: Device
intervention name: Dexcom G6 CGM
description: All women in the study will be given Dexcom G6 CGM and a study glucometer.
arm group label: type 1 diabetes and pregnancy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Eyal Dassau, PhD
role: Principal Investigator
affiliation: Harvard University
last name: Carol Levy, MD
role: Principal Investigator
affiliation: Icahn School of Medicine at Mount Sinai
last name: Yogish C Kudva, MD
role: Principal Investigator
affiliation: Mayo Clinic
last name: Jordan E Pinsker, MD
role: Principal Investigator
affiliation: Sansum Diabetes Research Institute
last name: Barak Rosenn, MD
role: Principal Investigator
affiliation: Icahn School of Medicine at Mount Sinai
last name: Kristin Castorino, DO
role: Principal Investigator
affiliation: Sansum Diabetes Research Institute
last name: Grenye O'Malley, MD
role: Principal Investigator
affiliation: Icahn School of Medicine at Mount Sinai
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pregnancy in Diabetics
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
sharing ipd: Yes
ipd description: Plan to create a public database of study results per NIH open data policy.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: 1 year after study data analysis is complete and results are published.
submitted: December 10, 2022