<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/NCT02227303</url>
  </required_header>
  <id_info>
    <org_study_id>MOVE-2014</org_study_id>
    <nct_id>NCT02227303</nct_id>
  </id_info>
  <brief_title>A Pilot Open Label Clinical Trial to Evaluate the Combined Impact of Two Mobile Health Products on Health Outcomes in Overweight Adults With Type 2 Diabetes</brief_title>
  <official_title>A Pilot Open Label Clinical Trial to Evaluate the Combined Impact of Two Mobile Health Products on Health Outcomes in Overweight Adults With Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medidata Solutions</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Miami Research Associates</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Medidata Solutions</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to explore the effect of 8-weeks use of the Medidata Patient&#xD;
      Cloud (a mobile application for capturing data directly from subjects, enabling entry of&#xD;
      diary and quality of life data into internet-enabled devices) in combination with an activity&#xD;
      tracker (Fitbit Flex) on health outcomes in overweight people with Type 2 Diabetes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 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>Changes from baseline to 8 weeks in glucose, insulin, fructosamine and HgbA1c</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes from baseline to 4 and 8 weeks in body weight.</measure>
    <time_frame>4 to 8 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes from baseline to 4 and 8 weeks in compliance with nutrition goals as measured via dichotomous questionnaire.</measure>
    <time_frame>4 to 8 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes from baseline to 4 and 8 weeks in compliance with exercise goals as measured by steps per day (provided by the Fitbit Flex).</measure>
    <time_frame>4 to 8 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Weekly changes over 8 weeks as compared to baseline in quality of life as measured by the PROMIS® Global Health questionnaire (global physical health and global mental health subscale scores and social and overall health scores).</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <other_outcome>
    <measure>Changes from baseline to 4 and 8 weeks on quality of sleep as measured via the sleep efficiency score (provided by the Fitbit Flex).</measure>
    <time_frame>4 to 8 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Changes from baseline to 4 and 8 weeks in compliance with exercise goals as measured by active minutes (provided by the Fitbit Flex; requires subject input of data).</measure>
    <time_frame>4 to 8 weeks</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Lifestyle counseling</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>lifestyle modification instructional and motivational sessions</intervention_name>
    <arm_group_label>Lifestyle counseling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male and female subjects, aged 18 to 60 years, who are English or Spanish speakers.&#xD;
&#xD;
          2. BMI 25 to 34.9 kg/m2&#xD;
&#xD;
          3. Subject has type 2 diabetes with HgbA1c &lt; 8.0%&#xD;
&#xD;
          4. Subject's glucose is controlled with either diet alone or oral agents that do not&#xD;
             cause hypoglycemia (e.g. Metformin, DPP-4 inhibitors, Thiazolidinediones,&#xD;
             Alpha-Glucosidase Inhibitors and GLP-1 agonists).&#xD;
&#xD;
          5. Subject is motivated to increase their activity and make other lifestyle changes.&#xD;
&#xD;
          6. Subject has:&#xD;
&#xD;
               -  A compatible Apple mobile device with the iOS 7 operating system installed:&#xD;
&#xD;
                    -  iPhone 4 or newer&#xD;
&#xD;
                    -  iPad 2 or newer&#xD;
&#xD;
                    -  iPad Mini&#xD;
&#xD;
                    -  iPod touch 5th gen (2012 model) or newer&#xD;
&#xD;
               -  500MB of free space on the iPhone, iPad, or iPod touch&#xD;
&#xD;
               -  A valid mobile phone number to receive daily updates via SMS text messaging&#xD;
&#xD;
               -  An active iTunes account/password to install study-related software (&quot;apps&quot;)&#xD;
&#xD;
               -  Access to Wi-Fi or a mobile data plan to send study data&#xD;
&#xD;
          7. Female subject is surgically sterile, post-menopausal or agrees to use an acceptable&#xD;
             method of birth control as defined in section 2.7.&#xD;
&#xD;
          8. Subject agrees to not use any new vitamin and/or mineral supplement until after study&#xD;
             completion.&#xD;
&#xD;
          9. Subject agrees to not take any dietary or herbal supplements or products until after&#xD;
             study completion. Seven-day washout period prior to study inclusion allowed.&#xD;
&#xD;
         10. Subject is willing and able to comply with the protocol including:&#xD;
&#xD;
               1. Attending 3 visits, approximately 2 hours each&#xD;
&#xD;
               2. Wearing and inputting required information into the Fitbit Flex activity tracker&#xD;
&#xD;
               3. Receiving alerts from the Medidata Patient Cloud&#xD;
&#xD;
               4. Working on making nutrition and exercise changes over the 8-week study period&#xD;
&#xD;
               5. Using and updating his/her iPhone, iPad, iPad Mini or iTouch as per study&#xD;
                  requirements (e.g. downloading the iOS7 operating system, downloading the&#xD;
                  Medidata Patient Cloud and Fitbit Flex apps, and receiving daily text messages).&#xD;
&#xD;
         11. Subject is able to understand and sign the informed consent to participate in the&#xD;
             study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject has any of the following medical conditions:&#xD;
&#xD;
               1. active heart disease&#xD;
&#xD;
               2. uncontrolled high blood pressure (≥ 140/90 mmHg)&#xD;
&#xD;
               3. renal or hepatic impairment/disease&#xD;
&#xD;
               4. Type I diabetes&#xD;
&#xD;
               5. bipolar disorder&#xD;
&#xD;
               6. active psychiatric disease&#xD;
&#xD;
               7. Parkinson's disease&#xD;
&#xD;
               8. unstable thyroid disease&#xD;
&#xD;
               9. immune disorder (such as HIV/AIDS)&#xD;
&#xD;
              10. any medical condition deemed exclusionary by the Principal Investigator (PI)&#xD;
&#xD;
          2. Subject has a history of cancer (except localized skin cancer without metastases or in&#xD;
             situ cervical cancer) within five years prior to screening.&#xD;
&#xD;
          3. Subject is taking oral agents that can cause hypoglycemia (e.g. sulfonylureas,&#xD;
             meglitinides and insulin).&#xD;
&#xD;
          4. Subject is taking or has taken in the past 28 days any supplement or medication&#xD;
             (prescription or over the counter) for weight loss (see section 2.6.2); 28-day washout&#xD;
             required for study inclusion.&#xD;
&#xD;
          5. Subject is on an unstable dose of medication (defined as fewer than 90 days at the&#xD;
             same dose).&#xD;
&#xD;
          6. Subject is currently taking any medication deemed exclusionary by PI.&#xD;
&#xD;
          7. Subject exhibits evidence of hepatic or renal dysfunction as evidenced by ALT, AST, AP&#xD;
             being ≥ 2 times the upper limit of normal or serum creatinine value ≥ 2.0 mg/dl or&#xD;
             other clinically significant abnormal clinical laboratory value per PI discretion.&#xD;
&#xD;
          8. Subject has a clinically relevant abnormality as defined by the PI or interpreting&#xD;
             physician with respect to the electrocardiogram (ECG).&#xD;
&#xD;
          9. Subject has a QTc interval &gt; 450 msec for males and &gt; 470 msec for females.&#xD;
&#xD;
         10. Subject has a history of drug or alcohol abuse in the past 12 months.&#xD;
&#xD;
         11. Subject has begun/stopped smoking ≤ 6 months ago OR has plans to begin/quit smoking.&#xD;
&#xD;
         12. Subject has experienced a weight loss or gain greater than 4.5 kg (approximately 10&#xD;
             lbs) in the past 3 months.&#xD;
&#xD;
         13. Subject is pregnant, lactating, or planning to become pregnant during the study&#xD;
             period.&#xD;
&#xD;
         14. Subject has any condition or abnormality that, in the opinion of the investigator,&#xD;
             would compromise the safety of the subject or the quality of the study data.&#xD;
&#xD;
         15. Subject has taken an investigational product within 30 days of study enrollment (visit&#xD;
             2).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Diane R. Krieger, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Miami Research Associates. Miami, FL.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Miami Research Associates (MRA)</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Evert AB, Boucher JL, Cypress M, Dunbar SA, Franz MJ, Mayer-Davis EJ, Neumiller JJ, Nwankwo R, Verdi CL, Urbanski P, Yancy WS Jr. Nutrition therapy recommendations for the management of adults with diabetes. Diabetes Care. 2014 Jan;37 Suppl 1:S120-43. doi: 10.2337/dc14-S120. No abstract available.</citation>
    <PMID>24357208</PMID>
  </reference>
  <reference>
    <citation>Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.</citation>
    <PMID>8628042</PMID>
  </reference>
  <reference>
    <citation>Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.</citation>
    <PMID>17695343</PMID>
  </reference>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>August 25, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2014</study_first_posted>
  <last_update_submitted>March 19, 2015</last_update_submitted>
  <last_update_submitted_qc>March 19, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 24, 2015</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 2</mesh_term>
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>September 12, 2016</submitted>
    <returned>October 31, 2016</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/NCT02227303
org study id: MOVE-2014
nct id: NCT02227303
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to explore the effect of 8-weeks use of the Medidata Patient
      Cloud (a mobile application for capturing data directly from subjects, enabling entry of
      diary and quality of life data into internet-enabled devices) in combination with an activity
      tracker (Fitbit Flex) on health outcomes in overweight people with Type 2 Diabetes.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Changes from baseline to 8 weeks in glucose, insulin, fructosamine and HgbA1c
time frame: 8 weeks
measure: Changes from baseline to 4 and 8 weeks in body weight.
time frame: 4 to 8 weeks
measure: Changes from baseline to 4 and 8 weeks in compliance with nutrition goals as measured via dichotomous questionnaire.
time frame: 4 to 8 weeks
measure: Changes from baseline to 4 and 8 weeks in compliance with exercise goals as measured by steps per day (provided by the Fitbit Flex).
time frame: 4 to 8 weeks
measure: Weekly changes over 8 weeks as compared to baseline in quality of life as measured by the PROMIS® Global Health questionnaire (global physical health and global mental health subscale scores and social and overall health scores).
time frame: 8 weeks
measure: Changes from baseline to 4 and 8 weeks on quality of sleep as measured via the sleep efficiency score (provided by the Fitbit Flex).
time frame: 4 to 8 weeks
measure: Changes from baseline to 4 and 8 weeks in compliance with exercise goals as measured by active minutes (provided by the Fitbit Flex; requires subject input of data).
time frame: 4 to 8 weeks
arm group label: Lifestyle counseling
arm group type: Other
intervention type: Behavioral
intervention name: lifestyle modification instructional and motivational sessions
arm group label: Lifestyle counseling
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Diane R. Krieger, MD
role: Principal Investigator
affiliation: Miami Research Associates. Miami, FL.
facility: 
country: United States
citation: Evert AB, Boucher JL, Cypress M, Dunbar SA, Franz MJ, Mayer-Davis EJ, Neumiller JJ, Nwankwo R, Verdi CL, Urbanski P, Yancy WS Jr. Nutrition therapy recommendations for the management of adults with diabetes. Diabetes Care. 2014 Jan;37 Suppl 1:S120-43. doi: 10.2337/dc14-S120. No abstract available.
PMID: 24357208
citation: Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.
PMID: 8628042
citation: Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
PMID: 17695343
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Overweight
submitted: September 12, 2016
returned: October 31, 2016