<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/NCT02248454</url>
  </required_header>
  <id_info>
    <org_study_id>High fat bolus</org_study_id>
    <nct_id>NCT02248454</nct_id>
  </id_info>
  <brief_title>Insulin Bolus Required for High Fat Foods in Type 1 Diabetes</brief_title>
  <official_title>Evaluation of Insulin Bolus for High Fat Meals</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Joslin Diabetes Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Boston Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Joslin Diabetes Center</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>
      The purpose of this study is to evaluate an insulin bolus for use to cover higher fat meals.&#xD;
&#xD;
      Subjects will have several admissions during which the investigators will apply an iterative&#xD;
      dose escalation protocol to derive an optimized insulin bolus dose (carbohydrate-to-insulin&#xD;
      ratio for fat to minimize postprandial hyperglycemia following higher fat meals. The&#xD;
      investigators hypothesize that the incremental insulin dose required to cover dietary fat in&#xD;
      patients with type 1 diabetes will be related to total daily insulin dose (U/kg).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects for this study will be adults with type 1 diabetes who use an insulin pump for&#xD;
      diabetes self-management.&#xD;
&#xD;
      Subjects will be admitted to the clinical research center in the morning in the fasting&#xD;
      state. Subjects will have several admissions. During the initial two admissions, subjects&#xD;
      will receive either pizza-low fat or pizza-high fat, covered with insulin doses calculated&#xD;
      from their usual insulin-to-carbohydrate ratio. Study subjects in whom the bolus did not&#xD;
      provide adequate insulin coverage for pizza-high fat will then undergo an additional 1-5&#xD;
      admissions during which they will receive the pizza-high fat meal with progressively&#xD;
      increasing insulin doses until ≥ 90% of all postprandial glucose values are within the target&#xD;
      range 80-180 mg/dL.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Predictors of fat &quot;sensitivity&quot;</measure>
    <time_frame>0-360 minutes</time_frame>
    <description>To test the hypothesis that incremental dose increase required to cover dietary fat in patients with type 1 diabetes will be related to total daily insulin dose (TDD; U/kg) we will perform regression analysis with TDD as independent variable and the increase in insulin requirements (calculated as percent change for high fat vs low fat meal) as the dependent variable.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Type 1 Diabetes</condition>
  <arm_group>
    <arm_group_label>Insulin bolus dose/type</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lispro insulin, dose calculated by modeling analysis</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lispro</intervention_name>
    <description>Increasing insulin doses</description>
    <arm_group_label>Insulin bolus dose/type</arm_group_label>
    <other_name>Humalog</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients (aged 18-75 years) with type 1 diabetes &gt; 3 years, on insulin pump&#xD;
             therapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History or symptoms suggestive of gastroparesis or gastric dysmotility; History of&#xD;
             celiac disease, pancreatic exocrine dysfunction or other conditions that cause&#xD;
             malabsorption or maldigestion; Eating disorder; Diet allergies; Special diet&#xD;
             restrictions, such as vegan; Medications know to affect insulin sensitivity (such as&#xD;
             glucocorticoids) or affect gastrointestinal motility (such as reglan); High-titre&#xD;
             insulin autoantibodies with delayed insulin kinetics; Women who are breast feeding,&#xD;
             pregnant, or wanting to become pregnant.&#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>Howard Wolpert, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Joslin Diabetes Center</affiliation>
  </overall_official>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>September 22, 2014</study_first_submitted>
  <study_first_submitted_qc>September 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>April 25, 2017</last_update_submitted>
  <last_update_submitted_qc>April 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin Lispro</mesh_term>
  </intervention_browse>
  <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/NCT02248454
org study id: High fat bolus
nct id: NCT02248454
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate an insulin bolus for use to cover higher fat meals.

      Subjects will have several admissions during which the investigators will apply an iterative
      dose escalation protocol to derive an optimized insulin bolus dose (carbohydrate-to-insulin
      ratio for fat to minimize postprandial hyperglycemia following higher fat meals. The
      investigators hypothesize that the incremental insulin dose required to cover dietary fat in
      patients with type 1 diabetes will be related to total daily insulin dose (U/kg).
Subjects for this study will be adults with type 1 diabetes who use an insulin pump for
      diabetes self-management.

      Subjects will be admitted to the clinical research center in the morning in the fasting
      state. Subjects will have several admissions. During the initial two admissions, subjects
      will receive either pizza-low fat or pizza-high fat, covered with insulin doses calculated
      from their usual insulin-to-carbohydrate ratio. Study subjects in whom the bolus did not
      provide adequate insulin coverage for pizza-high fat will then undergo an additional 1-5
      admissions during which they will receive the pizza-high fat meal with progressively
      increasing insulin doses until ≥ 90% of all postprandial glucose values are within the target
      range 80-180 mg/dL.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Predictors of fat "sensitivity"
time frame: 0-360 minutes
description: To test the hypothesis that incremental dose increase required to cover dietary fat in patients with type 1 diabetes will be related to total daily insulin dose (TDD; U/kg) we will perform regression analysis with TDD as independent variable and the increase in insulin requirements (calculated as percent change for high fat vs low fat meal) as the dependent variable.
arm group label: Insulin bolus dose/type
arm group type: Experimental
description: Lispro insulin, dose calculated by modeling analysis
intervention type: Drug
intervention name: Lispro
description: Increasing insulin doses
arm group label: Insulin bolus dose/type
other name: Humalog
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Howard Wolpert, MD
role: Principal Investigator
affiliation: Joslin Diabetes Center
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 1
mesh term: Insulin Lispro
sharing ipd: No