<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/NCT03240432</url>
  </required_header>
  <id_info>
    <org_study_id>WISDM</org_study_id>
    <nct_id>NCT03240432</nct_id>
  </id_info>
  <brief_title>Wireless Innovation for Seniors With Diabetes Mellitus</brief_title>
  <acronym>WISDM</acronym>
  <official_title>Wireless Innovation for Seniors With Diabetes Mellitus (WISDM)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jaeb Center for Health Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Leona M. and Harry B. Helmsley Charitable Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Juvenile Diabetes Research Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Jaeb Center for Health Research</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</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>
      The primary objective of the study is to determine if CGM can reduce hypoglycemia and improve&#xD;
      quality of life in older adults with T1D.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Reducing hypoglycemia is an important aspect of management of T1D in older adults, many of&#xD;
      whom have hypoglycemic unawareness, cognitive impairment, or both. CGM offers the opportunity&#xD;
      to reduce hypoglycemia and its related complications such as fractures from falls and&#xD;
      hospitalizations and improve quality of life including reducing hypoglycemic fear and&#xD;
      diabetes distress. Despite these potential benefits, CGM is used by only a small proportion&#xD;
      of older adults with T1D. Previous studies assessing CGM efficacy have included only a small&#xD;
      number of adults ≥ 60 years of age, excluded patients most prone to severe hypoglycemia,&#xD;
      focused on improving HbA1c rather than hypoglycemia, and used older generation CGM sensors.&#xD;
      These studies are not generalizable to the population of older adults with T1D. The potential&#xD;
      benefit of CGM in reducing hypoglycemia in the older adult population has not been well&#xD;
      studied. The goal of this study is to assess the potential benefits and risks of CGM in older&#xD;
      adults with T1D.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 26, 2017</start_date>
  <completion_date type="Actual">September 10, 2019</completion_date>
  <primary_completion_date type="Actual">June 6, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time spent with glucose level &lt;70 mg/dL</measure>
    <time_frame>6 months (26 weeks) from baseline</time_frame>
    <description>The primary outcome will be a treatment group comparison of the percentage of sensor values in the hypoglycemic range (&lt;70 mg/dL), adjusted for the baseline values and factors used to stratify randomization in a regression model. Residual values will be examined for an approximate normal distribution. If values are highly skewed, then a transformation or non-parametric methods will be used instead. The BGM Group will be wearing a blinded CGM for one week at 3 time points in the study (in addition to baseline). For analysis, sensor data from the CGM Group will be used from these same time periods to match up with the blinded CGM placed for the BGM Group. The CGM data will be pooled across each time point of CGM data collection for the primary analysis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in HbA1c</measure>
    <time_frame>6 months (26 weeks) from baseline</time_frame>
    <description>Mean ± SD values for the change in HbA1c from baseline to 26-weeks with 95% confidence intervals or percentiles appropriate to the distribution will be computed for each randomization group and compared in a regression model adjusted for baseline level and factors used to stratify randomization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in QOL: Preferring Hypoglycemia Scale</measure>
    <time_frame>6 months (26 weeks) from baseline</time_frame>
    <description>Mean ± SD values for the change in total score from baseline to 26-weeks with 95% confidence intervals or percentiles appropriate to the distribution will be reported for each randomization group, and compared in linear regression models adjusted for baseline level and factors used to stratify randomization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in QOL: Blood glucose Monitoring Satisfaction Questionnaire</measure>
    <time_frame>6 months (26 weeks) from baseline</time_frame>
    <description>Mean ± SD values for the change in total score from baseline to 26-weeks with 95% confidence intervals or percentiles appropriate to the distribution will be reported for each randomization group, and compared in linear regression models adjusted for baseline level and factors used to stratify randomization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in QOL: Hypoglycemia Fear Survey</measure>
    <time_frame>6 months (26 weeks) from baseline</time_frame>
    <description>Mean ± SD values for the change in total score from baseline to 26-weeks with 95% confidence intervals or percentiles appropriate to the distribution will be reported for each randomization group, and compared in linear regression models adjusted for baseline level and factors used to stratify randomization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in QOL: Diabetes Distress Questionnaire</measure>
    <time_frame>6 months (26 weeks) from baseline</time_frame>
    <description>Mean ± SD values for the change in total score from baseline to 26-weeks with 95% confidence intervals or percentiles appropriate to the distribution will be reported for each randomization group, and compared in linear regression models adjusted for baseline level and factors used to stratify randomization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in QOL: PROMIS Measures for QOL</measure>
    <time_frame>6 months (26 weeks) from baseline</time_frame>
    <description>Mean ± SD values for the change in total score from baseline to 26-weeks with 95% confidence intervals or percentiles appropriate to the distribution will be reported for each randomization group, and compared in linear regression models adjusted for baseline level and factors used to stratify randomization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in QOL: NIH Cognitive Toolbox</measure>
    <time_frame>6 months (26 weeks) from baseline</time_frame>
    <description>Mean ± SD values for the change in total score from baseline to 26-weeks with 95% confidence intervals or percentiles appropriate to the distribution will be reported for each randomization group, and compared in linear regression models adjusted for baseline level and factors used to stratify randomization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in QOL: NIH Emotions Toolbox</measure>
    <time_frame>6 months (26 weeks) from baseline</time_frame>
    <description>Mean ± SD values for the change in total and composite score from baseline to 26-weeks with 95% confidence intervals or percentiles appropriate to the distribution will be reported for each randomization group, and compared in linear regression models adjusted for baseline level and factors used to stratify randomization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time spent with glucose level &lt;60 mg/dL</measure>
    <time_frame>6 months (26 weeks) from baseline</time_frame>
    <description>Analyses will be similar to the primary objective.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time spent with glucose level &lt;54 mg/dL</measure>
    <time_frame>6 months (26 weeks) from baseline</time_frame>
    <description>Analyses will be similar to the primary objective.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Rate of episodes of severe hypoglycemia</measure>
    <time_frame>baseline to 6 months (26 weeks)</time_frame>
    <description>A hypoglycemic event will be defined as severe low blood sugar requiring assistance of another person due to altered or loss of consciousness. The rate of episodes will be tabulated and assessed using a regression model adjusted for baseline number of events.</description>
  </other_outcome>
  <other_outcome>
    <measure>Rate of episodes of diabetic ketoacidosis events</measure>
    <time_frame>baseline to 6 months (26 weeks)</time_frame>
    <description>A diabetic ketoacidosis event will be defined as hyperglycemia meeting all of the following criteria:&#xD;
Symptoms such as polyuria, polydipsia, nausea, or vomiting;&#xD;
Serum ketones &gt;1.5 mmol/L or large/moderate urine ketones;&#xD;
Either arterial blood pH &lt;7.30 or venous pH &lt;7.24 or serum bicarbonate &lt;15; and&#xD;
Treatment provided in a health care facility&#xD;
The rate of episodes of diabetic ketoacidosis will be tabulated and assessed using a regression model adjusted for baseline number of events.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of falls</measure>
    <time_frame>baseline to 6 months (26 weeks)</time_frame>
    <description>The number of falls and any resulting injuries will be tabulated and compared between treatment groups using a Fisher's exact test.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of ER visits</measure>
    <time_frame>baseline to 6 months (26 weeks)</time_frame>
    <description>The number of ER visits will be tabulated and compared between treatment groups using a Fisher's exact test.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of hospitalizations</measure>
    <time_frame>baseline to 6 months (26 weeks)</time_frame>
    <description>The number of hospitalizations will be tabulated and compared between treatment groups using a Fishers's exact test.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of device-related adverse events</measure>
    <time_frame>baseline to 6 months (26 weeks)</time_frame>
    <description>The study investigator will determine if an adverse event (severe hypoglycemic events, diabetic ketoacidosis events, falls, hospitalizations, ER visits, etc.) may have been caused by the study intervention (CGM) by any of the following:&#xD;
Component disconnections&#xD;
CGM sensors lasting fewer than 7 days&#xD;
CGM tape adherence issues&#xD;
Battery lifespan deficiency due to inadequate charging or extensive wireless communication&#xD;
Intermittent device component disconnections/communication failures not leading to system replacement&#xD;
Device issues clearly addressed in the user guide manual that do not require additional troubleshooting&#xD;
Skin reactions from CGM sensor placement that don't meet criteria for AE reporting&#xD;
The number of device-related adverse events will be tabulated and compared between treatment groups using a Fisher's exact test.</description>
  </other_outcome>
  <other_outcome>
    <measure>Hyperglycemia: time &gt;180 mg/dL</measure>
    <time_frame>6 months (26 weeks) from baseline</time_frame>
    <description>Time spent &gt;180 mg/dL will be compared between groups using the methods described above for the primary objective.</description>
  </other_outcome>
  <other_outcome>
    <measure>Hyperglycemia: time &gt;250 mg/dL</measure>
    <time_frame>6 months (26 weeks) from baseline</time_frame>
    <description>Time spent &gt;250 mg/dL will be compared between groups using the methods described above for the primary objective.</description>
  </other_outcome>
  <other_outcome>
    <measure>Hyperglycemia: time &gt;300mg/dL</measure>
    <time_frame>6 months (26 weeks) from baseline</time_frame>
    <description>Time spent &gt;300mg/dL will be compared between groups using the methods described above for the primary objective.</description>
  </other_outcome>
  <other_outcome>
    <measure>Hyperglycemia: area under the curve 180 mg/dL</measure>
    <time_frame>6 months (26 weeks) from baseline</time_frame>
    <description>The area under the curve for 180 mg/dL will be compared between groups using the methods described above for the primary objective.</description>
  </other_outcome>
  <other_outcome>
    <measure>Hyperglycemia: high blood glucose index</measure>
    <time_frame>6 months (26 weeks) from baseline</time_frame>
    <description>High blood glucose index will be compared between groups using the methods described above for the primary objective.</description>
  </other_outcome>
  <other_outcome>
    <measure>Time in range 70-180 mg/dL</measure>
    <time_frame>6 months (26 weeks) from baseline</time_frame>
    <description>The time in range (70-180 mg/dL) will be compared between groups using the methods described above for the primary objective.</description>
  </other_outcome>
  <other_outcome>
    <measure>Mean glucose</measure>
    <time_frame>6 months (26 weeks) from baseline</time_frame>
    <description>Mean glucose will be compared between groups using the methods described above for the primary objective.</description>
  </other_outcome>
  <other_outcome>
    <measure>Glycemic variability (coefficient of variation)</measure>
    <time_frame>6 months (26 weeks) from baseline</time_frame>
    <description>Glycemic variability will be compared between groups using the methods described above for the primary objective.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Type 1 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Continuous Glucose Monitor group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>CGM group participants will be asked to use a Dexcom CGM sensor on a daily basis, inserting a new sensor as needed. Participants will be instructed to use the sensor according to FDA labeling. In addition, participants will be advised to check the blood glucose when symptoms or expectations do not match the CGM reading. Participants will have clinic visits at 10 days, 4 weeks, 8 weeks, 16 weeks, and 26 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Blood Glucose Meter group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>BGM group participants will be asked to use a study blood glucose meter with test strips for a fingerstick blood glucose check with a recommendation of 4 times a day. Participants will be permitted to check a fingerstick glucose as many times a day as they choose. Participants will have a phone visits at 10 days and clinic visits at 4 weeks, 8 weeks, 16 weeks, and 26 weeks. In addition to the in-clinic study visits, the BGM group will have blinded sensor placement visits one week prior to each of the 8, 16, and 26 week visits.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Dexcom CGM</intervention_name>
    <description>CGM group will be instructed on how to utilize the CGM data for diabetes management. Participants will be encouraged to use CGM values for making diabetes management decisions and will be provided guidelines for when to confirm with a study BGM fingerstick.</description>
    <arm_group_label>Continuous Glucose Monitor group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        To be eligible for the study, all participants must meet the following criteria:&#xD;
&#xD;
          1. Clinical diagnosis of insulin dependent presumed autoimmune type 1 diabetes by the&#xD;
             investigator and meeting at least one of the following criteria:&#xD;
&#xD;
             i. Age &gt; 6 months and &lt; 10 years old at diagnosis OR ii. Positive pancreatic&#xD;
             autoantibodies at any time (GAD-65, IA-2, ICA or ZnT8) or positive anti-insulin&#xD;
             autoantibody at diagnosis only (within 10 days of starting insulin) OR iii. Presence&#xD;
             of 2 or more of the following clinical indicators suggestive of type 1 diabetes:&#xD;
&#xD;
               1. Age at diagnosis &lt; 40 years&#xD;
&#xD;
               2. Non-obese at diagnosis according to BMI (&lt; 95th percentile pediatric and &lt; 30&#xD;
                  kg/m2 adult)&#xD;
&#xD;
               3. Diabetic ketoacidosis (DKA) at any time,&#xD;
&#xD;
               4. Plasma C-peptide level &lt; 0.8 ng/ml (with blood glucose &gt; 80 mg/dL if available)&#xD;
                  at any time&#xD;
&#xD;
               5. Family history of type 1 diabetes in a first degree relative (parent, sibling, or&#xD;
                  child).&#xD;
&#xD;
          2. Age ≥60 years&#xD;
&#xD;
          3. HbA1c &lt;10.0% at screening or within 30 days prior to screening visit (the upper limit&#xD;
             was selected as a surrogate measure of likelihood of adherence to the protocol with&#xD;
             the belief that those with higher HbA1c levels are generally noncompliant with&#xD;
             diabetes management and thus not good candidates for the trial)&#xD;
&#xD;
          4. Insulin regimen involves either use of an insulin pump (a minimum of 40% of study&#xD;
             population) or multiple daily injections of insulin (minimum of 40% of study&#xD;
             population).&#xD;
&#xD;
          5. Participant is able to manage his/her diabetes with respect to insulin administration&#xD;
             and glucose monitoring (which may include assistance from spouse or other caregiver)&#xD;
&#xD;
          6. Participant understands the study protocol and agrees to comply with it&#xD;
&#xD;
          7. Participant comprehends written and spoken English&#xD;
&#xD;
          8. At least 240 hours (10 out of 14 days) of sensor glucose data with appropriate number&#xD;
             of calibrations from the blinded CGM pre-randomization phase&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Individuals meeting any of the following exclusion criteria at baseline will be excluded&#xD;
        from study participation.&#xD;
&#xD;
          1. Use of unblinded CGM, outside of a research study, as part of real-time diabetes&#xD;
             management in the last 3 months&#xD;
&#xD;
          2. At least 10% of time spent with sensor glucose levels &lt; 54 mg/dl during the blinded&#xD;
             CGM screening period AND a severe hypoglycemic event in the past 6 months (a severe&#xD;
             hypoglycemic event that required assistance of another person due to altered&#xD;
             consciousness, and required another person to actively administer carbohydrate,&#xD;
             glucagon, or other resuscitative actions (see section 8.1).&#xD;
&#xD;
          3. Extreme visual or hearing impairment that would impair ability to use real-time CGM&#xD;
             assessed at screening visit&#xD;
&#xD;
          4. Known adhesive allergy or skin reaction during the blinded CGM pre-randomization phase&#xD;
             that would preclude participation in the randomized trial&#xD;
&#xD;
          5. Plans to begin non-insulin medication for blood glucose lowering during the course of&#xD;
             the study&#xD;
&#xD;
          6. Stage 4 or 5 renal disease or most recent GFR &lt; 30 ml/min/m2 from local lab within the&#xD;
             past 6 months&#xD;
&#xD;
          7. The presence of a significant medical or psychiatric condition or use of a medication&#xD;
             that in the judgment of the investigator may affect completion of any aspect of the&#xD;
             protocol, or is likely to be associated with life expectancy of &lt;1 year.&#xD;
&#xD;
          8. Clinical diagnosis of dementia (cognitive impairment that is mild and not considered&#xD;
             sufficient for diagnosis of dementia is acceptable)&#xD;
&#xD;
          9. Need for use of acetaminophen or acetaminophen-containing products on a regular basis&#xD;
             during the 6 months of the trial (unless stipulation no longer required with use of&#xD;
             newer generation sensors)&#xD;
&#xD;
         10. Inpatient psychiatric treatment in the past 6 months&#xD;
&#xD;
         11. Participation in an intervention study (including psychological studies) in past 6&#xD;
             weeks.&#xD;
&#xD;
         12. Expectation that participant will be moving out of the area of the clinical center&#xD;
             during the next 6 months, unless the move will be to an area served by another study&#xD;
             center.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kellee Miller</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jaeb Center for Health Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Southern California</name>
      <address>
        <city>Beverly Hills</city>
        <state>California</state>
        <zip>90211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Scripps Whittier Diabetes Institute</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado - Barbara Davis Center</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Hospital Diabetes Institute</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanta Diabetes Associates</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30318</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iowa Diabetes and Endocrinology Research Center</name>
      <address>
        <city>West Des Moines</city>
        <state>Iowa</state>
        <zip>50265</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Massachusetts</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01655</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Health System</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>International Diabetes Center</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55416</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>Washington University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</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>
    <facility>
      <name>Columbia University - Naomi Berrie Diabetes Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SUNY Upstate Medical University</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of North Carolina</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27517</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health &amp; Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington Diabetes Care Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>September 11, 2019</last_update_submitted>
  <last_update_submitted_qc>September 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 12, 2019</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</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>August 14, 2020</submitted>
    <returned>August 31, 2020</returned>
  </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/NCT03240432
org study id: WISDM
nct id: NCT03240432
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The primary objective of the study is to determine if CGM can reduce hypoglycemia and improve
      quality of life in older adults with T1D.
Reducing hypoglycemia is an important aspect of management of T1D in older adults, many of
      whom have hypoglycemic unawareness, cognitive impairment, or both. CGM offers the opportunity
      to reduce hypoglycemia and its related complications such as fractures from falls and
      hospitalizations and improve quality of life including reducing hypoglycemic fear and
      diabetes distress. Despite these potential benefits, CGM is used by only a small proportion
      of older adults with T1D. Previous studies assessing CGM efficacy have included only a small
      number of adults ≥ 60 years of age, excluded patients most prone to severe hypoglycemia,
      focused on improving HbA1c rather than hypoglycemia, and used older generation CGM sensors.
      These studies are not generalizable to the population of older adults with T1D. The potential
      benefit of CGM in reducing hypoglycemia in the older adult population has not been well
      studied. The goal of this study is to assess the potential benefits and risks of CGM in older
      adults with T1D.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Time spent with glucose level <70 mg/dL
time frame: 6 months (26 weeks) from baseline
description: The primary outcome will be a treatment group comparison of the percentage of sensor values in the hypoglycemic range (<70 mg/dL), adjusted for the baseline values and factors used to stratify randomization in a regression model. Residual values will be examined for an approximate normal distribution. If values are highly skewed, then a transformation or non-parametric methods will be used instead. The BGM Group will be wearing a blinded CGM for one week at 3 time points in the study (in addition to baseline). For analysis, sensor data from the CGM Group will be used from these same time periods to match up with the blinded CGM placed for the BGM Group. The CGM data will be pooled across each time point of CGM data collection for the primary analysis.
measure: Change in HbA1c
time frame: 6 months (26 weeks) from baseline
description: Mean ± SD values for the change in HbA1c from baseline to 26-weeks with 95% confidence intervals or percentiles appropriate to the distribution will be computed for each randomization group and compared in a regression model adjusted for baseline level and factors used to stratify randomization.
measure: Change in QOL: Preferring Hypoglycemia Scale
time frame: 6 months (26 weeks) from baseline
description: Mean ± SD values for the change in total score from baseline to 26-weeks with 95% confidence intervals or percentiles appropriate to the distribution will be reported for each randomization group, and compared in linear regression models adjusted for baseline level and factors used to stratify randomization.
measure: Change in QOL: Blood glucose Monitoring Satisfaction Questionnaire
time frame: 6 months (26 weeks) from baseline
description: Mean ± SD values for the change in total score from baseline to 26-weeks with 95% confidence intervals or percentiles appropriate to the distribution will be reported for each randomization group, and compared in linear regression models adjusted for baseline level and factors used to stratify randomization.
measure: Change in QOL: Hypoglycemia Fear Survey
time frame: 6 months (26 weeks) from baseline
description: Mean ± SD values for the change in total score from baseline to 26-weeks with 95% confidence intervals or percentiles appropriate to the distribution will be reported for each randomization group, and compared in linear regression models adjusted for baseline level and factors used to stratify randomization.
measure: Change in QOL: Diabetes Distress Questionnaire
time frame: 6 months (26 weeks) from baseline
description: Mean ± SD values for the change in total score from baseline to 26-weeks with 95% confidence intervals or percentiles appropriate to the distribution will be reported for each randomization group, and compared in linear regression models adjusted for baseline level and factors used to stratify randomization.
measure: Change in QOL: PROMIS Measures for QOL
time frame: 6 months (26 weeks) from baseline
description: Mean ± SD values for the change in total score from baseline to 26-weeks with 95% confidence intervals or percentiles appropriate to the distribution will be reported for each randomization group, and compared in linear regression models adjusted for baseline level and factors used to stratify randomization.
measure: Change in QOL: NIH Cognitive Toolbox
time frame: 6 months (26 weeks) from baseline
description: Mean ± SD values for the change in total score from baseline to 26-weeks with 95% confidence intervals or percentiles appropriate to the distribution will be reported for each randomization group, and compared in linear regression models adjusted for baseline level and factors used to stratify randomization.
measure: Change in QOL: NIH Emotions Toolbox
time frame: 6 months (26 weeks) from baseline
description: Mean ± SD values for the change in total and composite score from baseline to 26-weeks with 95% confidence intervals or percentiles appropriate to the distribution will be reported for each randomization group, and compared in linear regression models adjusted for baseline level and factors used to stratify randomization.
measure: Time spent with glucose level <60 mg/dL
time frame: 6 months (26 weeks) from baseline
description: Analyses will be similar to the primary objective.
measure: Time spent with glucose level <54 mg/dL
time frame: 6 months (26 weeks) from baseline
description: Analyses will be similar to the primary objective.
measure: Rate of episodes of severe hypoglycemia
time frame: baseline to 6 months (26 weeks)
description: A hypoglycemic event will be defined as severe low blood sugar requiring assistance of another person due to altered or loss of consciousness. The rate of episodes will be tabulated and assessed using a regression model adjusted for baseline number of events.
measure: Rate of episodes of diabetic ketoacidosis events
time frame: baseline to 6 months (26 weeks)
description: A diabetic ketoacidosis event will be defined as hyperglycemia meeting all of the following criteria:
Symptoms such as polyuria, polydipsia, nausea, or vomiting;
Serum ketones >1.5 mmol/L or large/moderate urine ketones;
Either arterial blood pH <7.30 or venous pH <7.24 or serum bicarbonate <15; and
Treatment provided in a health care facility
The rate of episodes of diabetic ketoacidosis will be tabulated and assessed using a regression model adjusted for baseline number of events.
measure: Number of falls
time frame: baseline to 6 months (26 weeks)
description: The number of falls and any resulting injuries will be tabulated and compared between treatment groups using a Fisher's exact test.
measure: Number of ER visits
time frame: baseline to 6 months (26 weeks)
description: The number of ER visits will be tabulated and compared between treatment groups using a Fisher's exact test.
measure: Number of hospitalizations
time frame: baseline to 6 months (26 weeks)
description: The number of hospitalizations will be tabulated and compared between treatment groups using a Fishers's exact test.
measure: Number of device-related adverse events
time frame: baseline to 6 months (26 weeks)
description: The study investigator will determine if an adverse event (severe hypoglycemic events, diabetic ketoacidosis events, falls, hospitalizations, ER visits, etc.) may have been caused by the study intervention (CGM) by any of the following:
Component disconnections
CGM sensors lasting fewer than 7 days
CGM tape adherence issues
Battery lifespan deficiency due to inadequate charging or extensive wireless communication
Intermittent device component disconnections/communication failures not leading to system replacement
Device issues clearly addressed in the user guide manual that do not require additional troubleshooting
Skin reactions from CGM sensor placement that don't meet criteria for AE reporting
The number of device-related adverse events will be tabulated and compared between treatment groups using a Fisher's exact test.
measure: Hyperglycemia: time >180 mg/dL
time frame: 6 months (26 weeks) from baseline
description: Time spent >180 mg/dL will be compared between groups using the methods described above for the primary objective.
measure: Hyperglycemia: time >250 mg/dL
time frame: 6 months (26 weeks) from baseline
description: Time spent >250 mg/dL will be compared between groups using the methods described above for the primary objective.
measure: Hyperglycemia: time >300mg/dL
time frame: 6 months (26 weeks) from baseline
description: Time spent >300mg/dL will be compared between groups using the methods described above for the primary objective.
measure: Hyperglycemia: area under the curve 180 mg/dL
time frame: 6 months (26 weeks) from baseline
description: The area under the curve for 180 mg/dL will be compared between groups using the methods described above for the primary objective.
measure: Hyperglycemia: high blood glucose index
time frame: 6 months (26 weeks) from baseline
description: High blood glucose index will be compared between groups using the methods described above for the primary objective.
measure: Time in range 70-180 mg/dL
time frame: 6 months (26 weeks) from baseline
description: The time in range (70-180 mg/dL) will be compared between groups using the methods described above for the primary objective.
measure: Mean glucose
time frame: 6 months (26 weeks) from baseline
description: Mean glucose will be compared between groups using the methods described above for the primary objective.
measure: Glycemic variability (coefficient of variation)
time frame: 6 months (26 weeks) from baseline
description: Glycemic variability will be compared between groups using the methods described above for the primary objective.
arm group label: Continuous Glucose Monitor group
arm group type: Active Comparator
description: CGM group participants will be asked to use a Dexcom CGM sensor on a daily basis, inserting a new sensor as needed. Participants will be instructed to use the sensor according to FDA labeling. In addition, participants will be advised to check the blood glucose when symptoms or expectations do not match the CGM reading. Participants will have clinic visits at 10 days, 4 weeks, 8 weeks, 16 weeks, and 26 weeks.
arm group label: Blood Glucose Meter group
arm group type: No Intervention
description: BGM group participants will be asked to use a study blood glucose meter with test strips for a fingerstick blood glucose check with a recommendation of 4 times a day. Participants will be permitted to check a fingerstick glucose as many times a day as they choose. Participants will have a phone visits at 10 days and clinic visits at 4 weeks, 8 weeks, 16 weeks, and 26 weeks. In addition to the in-clinic study visits, the BGM group will have blinded sensor placement visits one week prior to each of the 8, 16, and 26 week visits.
intervention type: Device
intervention name: Dexcom CGM
description: CGM group will be instructed on how to utilize the CGM data for diabetes management. Participants will be encouraged to use CGM values for making diabetes management decisions and will be provided guidelines for when to confirm with a study BGM fingerstick.
arm group label: Continuous Glucose Monitor group
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kellee Miller
role: Principal Investigator
affiliation: Jaeb Center for Health Research
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country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
submitted: August 14, 2020
returned: August 31, 2020