<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/NCT04416269</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00117027</org_study_id>
    <secondary_id>1K23DK124647-01</secondary_id>
    <nct_id>NCT04416269</nct_id>
  </id_info>
  <brief_title>Oral Anti Diabetic Agents in the Hospital</brief_title>
  <official_title>Use of Oral Antidiabetic Agents in Hospitalized Patients With Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Emory University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized controlled clinical trial will assess whether continuation of home oral&#xD;
      antidiabetic agents during hospitalization can be used as a safe and effective alternative to&#xD;
      insulin therapy in the management of diabetes in the hospital. The primary outcome of the&#xD;
      study is to determine differences in glycemic control as measured by mean daily blood glucose&#xD;
      concentration between oral antidiabetic medications and basal bolus therapy in hospitalized&#xD;
      patients with type 2 diabetes (T2D).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hyperglycemia in the hospital is common and has been associated with increased hospital&#xD;
      complications, length of stay, and mortality. Improving glycemic control has been shown to&#xD;
      improve length of stay, multi-organ failure, systemic infections, as well as short- and&#xD;
      long-term mortality. Clinical guidelines from professional organizations recommend the use of&#xD;
      subcutaneous (SQ) insulin as the preferred therapy for glycemic control in general medical&#xD;
      and surgical patients with T2D. This approach, however, is labor intensive requiring multiple&#xD;
      daily insulin injections, costly, and associated with significant risk of iatrogenic&#xD;
      hypoglycemia&#xD;
&#xD;
      Over 75% of patients with T2D are treated with oral antidiabetic drugs (OADs) but due to the&#xD;
      lack of safety and efficacy data from randomized controlled trials, clinical guidelines&#xD;
      recommend stopping OADs during hospitalization. The current clinical guidelines have raised&#xD;
      concerns with the use of OADs including risk of hypoglycemia with sulfonylureas, fluid&#xD;
      retention and worsening of heart failure with thiazolidinediones, and risk of&#xD;
      metformin-associated lactic acidosis in patients with severe renal impairment. However,&#xD;
      several observational studies have reported that the use of OADs results in similar glycemic&#xD;
      control without increased risk of complications compared to insulin regimens. A recent&#xD;
      observational study that included 17,325 hospitalized patients with T2D, found that patients&#xD;
      treated with OADs had similar glycemic control without differences in complications and no&#xD;
      increase in rates of hypoglycemia compared to those treated with insulin.&#xD;
&#xD;
      This study will assess whether continuation of home oral antidiabetic agents during&#xD;
      hospitalization can be used as a safe and effective alternative to insulin therapy in the&#xD;
      management of diabetes in hospital patients with T2D. For a subset of participants (50&#xD;
      patients per group), a CGM devise will be placed for the duration of the study to assess&#xD;
      parameters of glycemic control and hypoglycemia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 7, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2024</primary_completion_date>
  <phase>Phase 4</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean daily BG concentration</measure>
    <time_frame>During hospital stay (up to 10 days)</time_frame>
    <description>Mean daily BG concentration will be compared between OADs and basal bolus therapy in hospitalized patients with T2D.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of mild hypoglycemic events</measure>
    <time_frame>During hospital stay (up to 10 days)</time_frame>
    <description>Mild hypoglycemic events are defined as BG &lt;70 mg/dl. Hypoglycemic events are assessed by point of care (POC) testing and continues glucose monitoring (CGM).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of clinically significant hypoglycemic events</measure>
    <time_frame>During hospital stay (up to 10 days)</time_frame>
    <description>Clinically significant hypoglycemic events are defined as BG &lt;54 mg/dl. Hypoglycemic events are assessed by POC testing and CGM.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of severe hypoglycemic severe (&lt;40 mg/dl) events</measure>
    <time_frame>During hospital stay (up to 10 days)</time_frame>
    <description>Severe hypoglycemic events are defined as BG &lt;40 mg/dl. Hypoglycemic events are assessed by POC testing and CGM.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of BG within target range without hypoglycemia</measure>
    <time_frame>During hospital stay (up to 10 days)</time_frame>
    <description>The percentage of BG values within the target range of 70-180 mg/dl and without hypoglycemia will be compared between study arms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of episodes of hyperglycemia after the first day of treatment</measure>
    <time_frame>During hospital stay (up to 10 days)</time_frame>
    <description>The number of episodes of hyperglycemia (BG &gt; 280 mg/dl) after the first day of treatment will be compared between study arms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daily dose of insulin</measure>
    <time_frame>During hospital stay (up to 10 days)</time_frame>
    <description>The total daily dose of insulin will be compared between study arms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients using oral antidiabetic drugs (OADs) during hospitalization</measure>
    <time_frame>During hospital stay (up to 10 days)</time_frame>
    <description>The number of participants using OADs during hospitalization use will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OAD dose used during hospitalization</measure>
    <time_frame>During hospital stay (up to 10 days)</time_frame>
    <description>Dosage of OADs used during hospitalization will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients on OADs requiring insulin rescue therapy</measure>
    <time_frame>During hospital stay (up to 10 days)</time_frame>
    <description>The number of patients on OADs requiring insulin rescue therapy will be recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of episodes of treatment failure</measure>
    <time_frame>During hospital stay (up to 10 days)</time_frame>
    <description>Treatment failure is defined as mean daily BG &gt; 240 mg/dl or 3 consecutive BG &gt; 240 mg/dl.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycemic variability in participants receiving CGM monitoring</measure>
    <time_frame>During hospital stay (up to 10 days)</time_frame>
    <description>Glycemic variability will be measured using the coefficient of variation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time above BG target range (&gt;180 mg/dl) in participants receiving CGM monitoring</measure>
    <time_frame>During hospital stay (up to 10 days)</time_frame>
    <description>The percentage of time above BG target range (&gt;180 mg/dl) will be assessed in participants receiving CGM monitoring.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time in BG target range (70-180 mg/dl) in participants receiving CGM monitoring</measure>
    <time_frame>During hospital stay (up to 10 days)</time_frame>
    <description>The percentage of time in the BG target range (70-180 mg/dl) will be assessed in participants receiving CGM monitoring.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time below BG target range (BG &lt;70 mg/dl) in participants receiving CGM monitoring</measure>
    <time_frame>During hospital stay (up to 10 days)</time_frame>
    <description>The percentage of time below BG target range (BG &lt;70 mg/dl) will be assessed in participants receiving CGM monitoring.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of hospital complications</measure>
    <time_frame>During hospital stay (up to 10 days)</time_frame>
    <description>Hospital complications is assessed as a composite variable including infectious, renal, pulmonary, neurologic, cardiovascular complications, and mortality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In-hospital mortality</measure>
    <time_frame>During hospital stay (up to 10 days)</time_frame>
    <description>In-hospital mortality will be recorded will be compared between study arms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of individual hospital complications</measure>
    <time_frame>Up to 40 days (hospital stay plus 30 days after discharge)</time_frame>
    <description>Number of individual hospital complications will be compared between study arms. The specific complications assessed for this outcome include acute respiratory failure, acute renal failure (incremental rise in creatinine by 0.5 mg/dL from baseline), infection during hospitalization not felt to be present on admission (including wound infection, urinary tract infection, bacteremia), myocardial infarction, cardiac arrhythmia, congestive heart failure, and cardiac arrest.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital costs</measure>
    <time_frame>During hospital stay (up to 10 days)</time_frame>
    <description>Total hospital costs will be compared between study arms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>During hospital stay (up to 10 days)</time_frame>
    <description>Length of hospital stay, in days, will be compared between study arms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Costs for diabetes specific therapies</measure>
    <time_frame>During hospital stay (up to 10 days)</time_frame>
    <description>Costs for diabetes specific therapies (including insulin, oral agents, and cost of injection administration) will be compared between study arms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of hospital re-admissions</measure>
    <time_frame>within 30 days of hospital discharge</time_frame>
    <description>Number of hospital re-admissions within 30 days of hospital discharge will be compared between study arms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of emergency room visits</measure>
    <time_frame>within 30 days of hospital discharge</time_frame>
    <description>Number of emergency room visits within 30 days of hospital discharge will be compared between study arms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants requiring ICU care</measure>
    <time_frame>During hospital stay (up to 10 days)</time_frame>
    <description>The number of participants transferred to the ICU will be compared between study arms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nursing antihyperglycemic drug preference survey</measure>
    <time_frame>Day of hospital discharge (up to 10 days)</time_frame>
    <description>The nurse who provided the most care for the participant during hospitalization completed a 7-item survey assessing antihyperglycemic drug preference. Nurses indicate if they agree or disagree with statements related to patient outcomes, workload requirements of insulin therapy, and perceived usefulness and safety of OADs. A summary score is not calculated for this qualitative survey.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient antihyperglycemic drug preference survey</measure>
    <time_frame>Day of hospital discharge (up to 10 days)</time_frame>
    <description>Participants will complete a 2 to 5-item survey assessing preferences of antihyperglycemic medications while hospitalized. Participants indicate if they agree or disagree with statements about OAD and insulin use during hospital stays, timely administration of insulin, and concerns about low blood sugar. A summary score is not calculated for this qualitative survey.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">260</enrollment>
  <condition>Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Oral Anti-diabetes Drugs (OADs) alone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>OADs will be continued at same outpatient dosage unless contraindicated</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Basal bolus insulin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Basal insulin with glargine or detemir and rapid-acting insulin (lispro/aspart) will be used as per the hospital formulary. OADs and non-insulin injectable antidiabetic medication will be discontinued on admission.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oral Anti-diabetes Drugs alone</intervention_name>
    <description>OADs will be continued at same outpatient dosage unless contraindicated. Participants will be switched to the preferred drug within the category of medication they take at home. Dose adjustment for OADs will be based on clinical/laboratory status. The OAD will be held if the participant is placed on strict nil per os (NPO) and is unable to take oral medications after enrollment.</description>
    <arm_group_label>Oral Anti-diabetes Drugs (OADs) alone</arm_group_label>
    <other_name>metformin</other_name>
    <other_name>sulfonylureas</other_name>
    <other_name>pioglitazone</other_name>
    <other_name>dipeptidyl peptidase-4 (DPP-4) inhibitors</other_name>
    <other_name>sodium-glucose co-transporter 2 (SGLT2) inhibitors</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Basal bolus insulin</intervention_name>
    <description>Basal insulin with glargine or detemir will be used as per the hospital formulary.</description>
    <arm_group_label>Basal bolus insulin</arm_group_label>
    <other_name>glargine</other_name>
    <other_name>detemir</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Supplemental insulin</intervention_name>
    <description>Supplemental (correction) lispro or aspart insulin following the supplemental/sliding scale standard of care protocol for BG &gt;140 mg/dl.</description>
    <arm_group_label>Basal bolus insulin</arm_group_label>
    <arm_group_label>Oral Anti-diabetes Drugs (OADs) alone</arm_group_label>
    <other_name>Humalog</other_name>
    <other_name>Novolog</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Continuous glucose monitoring (CGM)</intervention_name>
    <description>A subset of participants (50 per study arm) will be randomized to take part in an optional study where a CGM device will be placed for the duration of the study. CGM reports will be reviewed at the end of the study to assess parameters of glycemic control and hypoglycemia, and not used for insulin dose adjustment.&#xD;
The Dexcom CGM is a small sensor that inserts just under the skin to continuously monitor glucose levels. Results are transmitted to the wearer's smartphone every five minutes.</description>
    <arm_group_label>Basal bolus insulin</arm_group_label>
    <arm_group_label>Oral Anti-diabetes Drugs (OADs) alone</arm_group_label>
    <other_name>Dexcom</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males or females, age 18-80 years admitted to a general medicine and surgery services&#xD;
&#xD;
          -  Known history of T2D receiving OADs either as monotherapy or in combination therapy&#xD;
&#xD;
          -  Admission BG &lt; 250 mg/dl or randomization BG &lt;250 mg/dl and not receiving basal&#xD;
             insulin&#xD;
&#xD;
          -  Patients receiving OADs in combination with GLP-1 receptor agonists (GLP-1RA) who have&#xD;
             HbA1c &lt;7.5% within the past three months&#xD;
&#xD;
          -  HbA1c &lt;10%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No known history of diabetes&#xD;
&#xD;
          -  Laboratory evidence of diabetic ketoacidosis&#xD;
&#xD;
          -  Subjects with a history of type 1 diabetes (suggested by BMI &lt; 25 requiring insulin&#xD;
             therapy or with a history of diabetic ketoacidosis, or ketonuria)&#xD;
&#xD;
          -  Meeting any exclusion criteria based on specific contraindications to their home oral&#xD;
             therapy&#xD;
&#xD;
          -  Acute critical illness or cardiac surgery expected to require admission to a critical&#xD;
             care unit&#xD;
&#xD;
          -  Gastrointestinal obstruction, adynamic ileus, or expected to require gastrointestinal&#xD;
             suction&#xD;
&#xD;
          -  Medical or surgical patients expected to be kept NPO for &gt;24-48 hours after admission&#xD;
             or after completion of surgical procedure&#xD;
&#xD;
          -  Impaired renal function (eGFR &lt;30 ml/min)&#xD;
&#xD;
          -  Current treatment with oral or injectable corticosteroid&#xD;
&#xD;
          -  Mental condition rendering the subject unable to understand the nature and scope of&#xD;
             the study&#xD;
&#xD;
          -  Female subjects who are pregnant or breastfeeding at time of enrollment in the study&#xD;
&#xD;
          -  New or recent onset (within two weeks) of coronavirus disease 2019 (COVID-19)&#xD;
             infection at the time of admission&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maya Fayfman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Maya Fayfman, MD</last_name>
    <phone>404-778-1664</phone>
    <email>maya.fayfman@emory.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Emory University Hospital Midtown</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maya Fayfman, MD</last_name>
      <phone>404-778-1664</phone>
      <email>maya.fayfman@emory.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Emory University Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maya Fayfman, MD</last_name>
      <phone>404-778-1664</phone>
      <email>maya.fayfman@emory.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Grady Memorial Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maya Fayfman, MD</last_name>
      <phone>404-778-1664</phone>
      <email>maya.fayfman@emory.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 2, 2023</last_update_submitted>
  <last_update_submitted_qc>June 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Emory University</investigator_affiliation>
    <investigator_full_name>Maya Fayfman</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Hyperglycemia</keyword>
  <keyword>Insulin therapy</keyword>
  <keyword>Oral therapy</keyword>
  <keyword>Basal bolus therapy</keyword>
  <keyword>Mean daily blood glucose</keyword>
  <keyword>Hospitalization</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin</mesh_term>
    <mesh_term>Insulin, Globin Zinc</mesh_term>
    <mesh_term>Metformin</mesh_term>
    <mesh_term>Pioglitazone</mesh_term>
    <mesh_term>Dipeptidyl-Peptidase IV Inhibitors</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be available for sharing.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Individual participant data will be made available for sharing beginning 3 months and ending 5 years following article publication.</ipd_time_frame>
    <ipd_access_criteria>Individual participant data will be made available for sharing to researchers who provide a methodologically sound proposal. The proposal should be directed to maya.fayfman@emory.edu. To gain access, data requestors will need to sign a data access agreement.</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/NCT04416269
org study id: IRB00117027
secondary id: 1K23DK124647-01
nct id: NCT04416269
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: Yes
is us export: No
This randomized controlled clinical trial will assess whether continuation of home oral
      antidiabetic agents during hospitalization can be used as a safe and effective alternative to
      insulin therapy in the management of diabetes in the hospital. The primary outcome of the
      study is to determine differences in glycemic control as measured by mean daily blood glucose
      concentration between oral antidiabetic medications and basal bolus therapy in hospitalized
      patients with type 2 diabetes (T2D).
Hyperglycemia in the hospital is common and has been associated with increased hospital
      complications, length of stay, and mortality. Improving glycemic control has been shown to
      improve length of stay, multi-organ failure, systemic infections, as well as short- and
      long-term mortality. Clinical guidelines from professional organizations recommend the use of
      subcutaneous (SQ) insulin as the preferred therapy for glycemic control in general medical
      and surgical patients with T2D. This approach, however, is labor intensive requiring multiple
      daily insulin injections, costly, and associated with significant risk of iatrogenic
      hypoglycemia

      Over 75% of patients with T2D are treated with oral antidiabetic drugs (OADs) but due to the
      lack of safety and efficacy data from randomized controlled trials, clinical guidelines
      recommend stopping OADs during hospitalization. The current clinical guidelines have raised
      concerns with the use of OADs including risk of hypoglycemia with sulfonylureas, fluid
      retention and worsening of heart failure with thiazolidinediones, and risk of
      metformin-associated lactic acidosis in patients with severe renal impairment. However,
      several observational studies have reported that the use of OADs results in similar glycemic
      control without increased risk of complications compared to insulin regimens. A recent
      observational study that included 17,325 hospitalized patients with T2D, found that patients
      treated with OADs had similar glycemic control without differences in complications and no
      increase in rates of hypoglycemia compared to those treated with insulin.

      This study will assess whether continuation of home oral antidiabetic agents during
      hospitalization can be used as a safe and effective alternative to insulin therapy in the
      management of diabetes in hospital patients with T2D. For a subset of participants (50
      patients per group), a CGM devise will be placed for the duration of the study to assess
      parameters of glycemic control and hypoglycemia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mean daily BG concentration
time frame: During hospital stay (up to 10 days)
description: Mean daily BG concentration will be compared between OADs and basal bolus therapy in hospitalized patients with T2D.
measure: Number of mild hypoglycemic events
time frame: During hospital stay (up to 10 days)
description: Mild hypoglycemic events are defined as BG <70 mg/dl. Hypoglycemic events are assessed by point of care (POC) testing and continues glucose monitoring (CGM).
measure: Number of clinically significant hypoglycemic events
time frame: During hospital stay (up to 10 days)
description: Clinically significant hypoglycemic events are defined as BG <54 mg/dl. Hypoglycemic events are assessed by POC testing and CGM.
measure: Number of severe hypoglycemic severe (<40 mg/dl) events
time frame: During hospital stay (up to 10 days)
description: Severe hypoglycemic events are defined as BG <40 mg/dl. Hypoglycemic events are assessed by POC testing and CGM.
measure: Percent of BG within target range without hypoglycemia
time frame: During hospital stay (up to 10 days)
description: The percentage of BG values within the target range of 70-180 mg/dl and without hypoglycemia will be compared between study arms.
measure: Number of episodes of hyperglycemia after the first day of treatment
time frame: During hospital stay (up to 10 days)
description: The number of episodes of hyperglycemia (BG > 280 mg/dl) after the first day of treatment will be compared between study arms.
measure: Daily dose of insulin
time frame: During hospital stay (up to 10 days)
description: The total daily dose of insulin will be compared between study arms.
measure: Number of patients using oral antidiabetic drugs (OADs) during hospitalization
time frame: During hospital stay (up to 10 days)
description: The number of participants using OADs during hospitalization use will be recorded.
measure: OAD dose used during hospitalization
time frame: During hospital stay (up to 10 days)
description: Dosage of OADs used during hospitalization will be recorded.
measure: Number of patients on OADs requiring insulin rescue therapy
time frame: During hospital stay (up to 10 days)
description: The number of patients on OADs requiring insulin rescue therapy will be recorded
measure: Number of episodes of treatment failure
time frame: During hospital stay (up to 10 days)
description: Treatment failure is defined as mean daily BG > 240 mg/dl or 3 consecutive BG > 240 mg/dl.
measure: Glycemic variability in participants receiving CGM monitoring
time frame: During hospital stay (up to 10 days)
description: Glycemic variability will be measured using the coefficient of variation
measure: Time above BG target range (>180 mg/dl) in participants receiving CGM monitoring
time frame: During hospital stay (up to 10 days)
description: The percentage of time above BG target range (>180 mg/dl) will be assessed in participants receiving CGM monitoring.
measure: Time in BG target range (70-180 mg/dl) in participants receiving CGM monitoring
time frame: During hospital stay (up to 10 days)
description: The percentage of time in the BG target range (70-180 mg/dl) will be assessed in participants receiving CGM monitoring.
measure: Time below BG target range (BG <70 mg/dl) in participants receiving CGM monitoring
time frame: During hospital stay (up to 10 days)
description: The percentage of time below BG target range (BG <70 mg/dl) will be assessed in participants receiving CGM monitoring.
measure: Number of hospital complications
time frame: During hospital stay (up to 10 days)
description: Hospital complications is assessed as a composite variable including infectious, renal, pulmonary, neurologic, cardiovascular complications, and mortality.
measure: In-hospital mortality
time frame: During hospital stay (up to 10 days)
description: In-hospital mortality will be recorded will be compared between study arms.
measure: Number of individual hospital complications
time frame: Up to 40 days (hospital stay plus 30 days after discharge)
description: Number of individual hospital complications will be compared between study arms. The specific complications assessed for this outcome include acute respiratory failure, acute renal failure (incremental rise in creatinine by 0.5 mg/dL from baseline), infection during hospitalization not felt to be present on admission (including wound infection, urinary tract infection, bacteremia), myocardial infarction, cardiac arrhythmia, congestive heart failure, and cardiac arrest.
measure: Hospital costs
time frame: During hospital stay (up to 10 days)
description: Total hospital costs will be compared between study arms.
measure: Length of hospital stay
time frame: During hospital stay (up to 10 days)
description: Length of hospital stay, in days, will be compared between study arms.
measure: Costs for diabetes specific therapies
time frame: During hospital stay (up to 10 days)
description: Costs for diabetes specific therapies (including insulin, oral agents, and cost of injection administration) will be compared between study arms.
measure: Number of hospital re-admissions
time frame: within 30 days of hospital discharge
description: Number of hospital re-admissions within 30 days of hospital discharge will be compared between study arms.
measure: Number of emergency room visits
time frame: within 30 days of hospital discharge
description: Number of emergency room visits within 30 days of hospital discharge will be compared between study arms.
measure: Number of participants requiring ICU care
time frame: During hospital stay (up to 10 days)
description: The number of participants transferred to the ICU will be compared between study arms.
measure: Nursing antihyperglycemic drug preference survey
time frame: Day of hospital discharge (up to 10 days)
description: The nurse who provided the most care for the participant during hospitalization completed a 7-item survey assessing antihyperglycemic drug preference. Nurses indicate if they agree or disagree with statements related to patient outcomes, workload requirements of insulin therapy, and perceived usefulness and safety of OADs. A summary score is not calculated for this qualitative survey.
measure: Patient antihyperglycemic drug preference survey
time frame: Day of hospital discharge (up to 10 days)
description: Participants will complete a 2 to 5-item survey assessing preferences of antihyperglycemic medications while hospitalized. Participants indicate if they agree or disagree with statements about OAD and insulin use during hospital stays, timely administration of insulin, and concerns about low blood sugar. A summary score is not calculated for this qualitative survey.
arm group label: Oral Anti-diabetes Drugs (OADs) alone
arm group type: Experimental
description: OADs will be continued at same outpatient dosage unless contraindicated
arm group label: Basal bolus insulin
arm group type: Active Comparator
description: Basal insulin with glargine or detemir and rapid-acting insulin (lispro/aspart) will be used as per the hospital formulary. OADs and non-insulin injectable antidiabetic medication will be discontinued on admission.
intervention type: Drug
intervention name: Oral Anti-diabetes Drugs alone
description: OADs will be continued at same outpatient dosage unless contraindicated. Participants will be switched to the preferred drug within the category of medication they take at home. Dose adjustment for OADs will be based on clinical/laboratory status. The OAD will be held if the participant is placed on strict nil per os (NPO) and is unable to take oral medications after enrollment.
arm group label: Oral Anti-diabetes Drugs (OADs) alone
other name: metformin
other name: sulfonylureas
other name: pioglitazone
other name: dipeptidyl peptidase-4 (DPP-4) inhibitors
other name: sodium-glucose co-transporter 2 (SGLT2) inhibitors
intervention type: Drug
intervention name: Basal bolus insulin
description: Basal insulin with glargine or detemir will be used as per the hospital formulary.
arm group label: Basal bolus insulin
other name: glargine
other name: detemir
intervention type: Drug
intervention name: Supplemental insulin
description: Supplemental (correction) lispro or aspart insulin following the supplemental/sliding scale standard of care protocol for BG >140 mg/dl.
arm group label: Basal bolus insulin
arm group label: Oral Anti-diabetes Drugs (OADs) alone
other name: Humalog
other name: Novolog
intervention type: Device
intervention name: Continuous glucose monitoring (CGM)
description: A subset of participants (50 per study arm) will be randomized to take part in an optional study where a CGM device will be placed for the duration of the study. CGM reports will be reviewed at the end of the study to assess parameters of glycemic control and hypoglycemia, and not used for insulin dose adjustment.
The Dexcom CGM is a small sensor that inserts just under the skin to continuously monitor glucose levels. Results are transmitted to the wearer's smartphone every five minutes.
arm group label: Basal bolus insulin
arm group label: Oral Anti-diabetes Drugs (OADs) alone
other name: Dexcom
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Maya Fayfman, MD
role: Principal Investigator
affiliation: Emory University
last name: Maya Fayfman, MD
phone: 404-778-1664
email: maya.fayfman@emory.edu
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Emory University
investigator full name: Maya Fayfman
investigator title: Associate Professor
mesh term: Insulin
mesh term: Insulin, Globin Zinc
mesh term: Metformin
mesh term: Pioglitazone
mesh term: Dipeptidyl-Peptidase IV Inhibitors
sharing ipd: Yes
ipd description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be available for sharing.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Analytic Code
ipd time frame: Individual participant data will be made available for sharing beginning 3 months and ending 5 years following article publication.
ipd access criteria: Individual participant data will be made available for sharing to researchers who provide a methodologically sound proposal. The proposal should be directed to maya.fayfman@emory.edu. To gain access, data requestors will need to sign a data access agreement.