<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/NCT03792399</url>
  </required_header>
  <id_info>
    <org_study_id>NCKUH-10508011</org_study_id>
    <nct_id>NCT03792399</nct_id>
  </id_info>
  <brief_title>Continuous Glucose Monitoring With Immediate or Delayed Counseling Feedback</brief_title>
  <official_title>Impact of Innovative Technology on Geriatric Diabetic Patients: Evaluation of Quality of Life, Self Efficacy and Glycemic Control Among Patients With Experience of Continuous Glucose Monitoring</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cheng-Kung University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Cheng-Kung University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to explore the effect of feedback counseling using professional&#xD;
      continuous glucose monitoring on glycemic control, self-efficacy, and self-management&#xD;
      behaviors among middle aged and older adults with poor controlled type 2 diabetes mellitus.&#xD;
      This study also explores the difference on timing of feedback after continuous glucose&#xD;
      monitoring exam.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After scheduled routine professional continuous glucose monitoring (CGM) exam, participants&#xD;
      in both the intervention and control group receive ordinary education and regimen adjustment&#xD;
      as indicated based on CGM results. For participants in the intervention group, they will also&#xD;
      receive CGM counseling immediately on the day of CGM sensor removal. For participants in the&#xD;
      control group, they will receive CGM counseling on the day of routine 3 months outpatient&#xD;
      visit.&#xD;
&#xD;
      Qualitative data are collected through in-depth interview: User expectation, acceptability&#xD;
      and satisfaction of CGM are also explored during in-depth interview with a semi-structured&#xD;
      questionnaire.&#xD;
&#xD;
      Quantitative data were collected through validated questionnaires, including evaluation of&#xD;
      depression by a short form of the Center for Epidemiologic Studies Depression Scale Revised&#xD;
      (CES-D-R), emotional stress by Problem Areas in Diabetes Scale (PAID), self efficacy by&#xD;
      Stanford Self-Efficacy for Diabetes (SES), at pretest and 3 months after CGM counseling.&#xD;
&#xD;
      Anthropometric Measurements. Body height, body weight, body mass index, and blood pressure&#xD;
      were recorded at pre-test and post-test interview.&#xD;
&#xD;
      Blood Tests. Routine biochemistry, fasting plasma glucose, hemoglobin A1c (HbA1c) are&#xD;
      collected within 2 weeks of pretest and posttest day.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 7, 2016</start_date>
  <completion_date type="Actual">October 12, 2017</completion_date>
  <primary_completion_date type="Actual">October 12, 2017</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of HbA1c</measure>
    <time_frame>Baseline and 3 months after CGM counseling</time_frame>
    <description>Change of HbA1c in 3 months after CGM counseling.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of score for self efficacy</measure>
    <time_frame>Baseline and 3 months after CGM counseling</time_frame>
    <description>Change of Stanford Self-Efficacy for Diabetes Scale (SES) in 3 months after CGM counseling. The score for each item ranged from 1-10. The score of the scale is the mean of the eight items. Higher number indicated higher self-efficacy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of score for diabetes associated stress</measure>
    <time_frame>Baseline and 3 months after CGM counseling</time_frame>
    <description>Change of score for Problem Areas in Diabetes Scale (PAID) in 3 months after CGM counseling. PAID is a 20-item self-reported questionnaire with scale 0-4 for each question, generating a total score of 0-100. A score of ≥ 40 is defined as emotional burnout.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of score for depression</measure>
    <time_frame>Baseline and 3 months after CGM counseling</time_frame>
    <description>Change of score for Center for Epidemiologic Studies Depression Scale Revised (CESD-R) in 3 months after CGM counseling. With 10-ietm CESD-R scale scoring 10 or more defined as having depression (range 0 to 30).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in diet composition</measure>
    <time_frame>Baseline and 3 months after CGM counseling</time_frame>
    <description>Change of carbohydrate amounts, fruits amount in 3 months after CGM counseling.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in exercise amount, time spent in light activity</measure>
    <time_frame>Baseline and 3 months after CGM counseling</time_frame>
    <description>Exercise amount recorded by acelerometers, built in sports bracelet (Fitbit Charge HRTM Wireless Heart Rate + Activity Wristband). Time spent in light activity per day in 3 months after CGM counseling feedback is compared with baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in exercise amount, time spent in moderate activity</measure>
    <time_frame>Baseline and 3 months after CGM counseling</time_frame>
    <description>Exercise amount recorded by acelerometers, built in sports bracelet (Fitbit Charge HRTM Wireless Heart Rate + Activity Wristband). Time spent in moderate activity per day in 3 months after CGM counseling feedback is compared with baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in exercise amount, time spent in intense activity</measure>
    <time_frame>Baseline and 3 months after CGM counseling</time_frame>
    <description>Exercise amount recorded by acelerometers, built in sports bracelet (Fitbit Charge HRTM Wireless Heart Rate + Activity Wristband). Time spent in intense activity per day in 3 months after CGM counseling feedback is compared with baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in exercise amount (time spent in sedentary behavior)</measure>
    <time_frame>Baseline and 3 months after CGM counseling</time_frame>
    <description>Exercise amount recorded by acelerometers, built in sports bracelet (Fitbit Charge HRTM Wireless Heart Rate + Activity Wristband). Time spent in sedentary behavior in 3 months after CGM counseling feedback is compared with baseline.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Type2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Immediate feedback counseling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Professional CGM calibrate blood glucose via a glucsoe-oxidase-impregnated membrane during a 5 day period. The patient wearing professional CGM is randomized to immediate feedback after data downloaded into computer.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Delayed feedback counseling</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Professional CGM calibrate blood glucose via a glucsoe-oxidase-impregnated membrane during a 5 day period. The patient wearing professional CGM is randomized to delayed feedback (standard care, i.e., CGM graphs interpretation at scheduled 3 months outpatient visit).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>feedback counseling</intervention_name>
    <description>Professoinal CGM in combination with diet and exercise record is used as teaching material to help patient realize their blood glucose pattern and to modify their behavior after counseling feedback.</description>
    <arm_group_label>Delayed feedback counseling</arm_group_label>
    <arm_group_label>Immediate feedback counseling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 45 years old or more at recent outpatient visits;&#xD;
&#xD;
          -  Type 2 diabetic patients followed up at National Cheng Kung University Hospital;&#xD;
&#xD;
          -  Patients planned to receive CGM suggested by primary care physician due to inadequate&#xD;
             controlled blood glucose.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with diagnosis of generalized inflammation, advanced malignancy, end-stage&#xD;
             renal disease on regular dialysis, status post renal transplantation, end-stage liver,&#xD;
             heart or pulmonary disease;&#xD;
&#xD;
          -  Patients who are taking systemic glucocorticoids;&#xD;
&#xD;
          -  Any acute or chronic inflammatory disease as determined by a leukocyte count over&#xD;
             10,000/mm3 or clinical signs of infection;&#xD;
&#xD;
          -  Patients who could not complete the questionnaires or who could not follow order due&#xD;
             to cognitive impairment or in bed-ridden status;&#xD;
&#xD;
          -  Patients diagnosed as thalassemia, glucose-6-phosphate dehydrogenase deficiency, and&#xD;
             any other hemoglobinopathies that may influence the accuracy of hemoglobulin A1c&#xD;
             measurement were also excluded. Patients who received blood transfusion in recent 3&#xD;
             months were also excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ching-Ju Chiu, Ph.D.</last_name>
    <role>Study Director</role>
    <affiliation>Institute of Gerontology, NCKU</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ye-Fong Du, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>NCKUH</affiliation>
  </overall_official>
  <reference>
    <citation>Allen NA, Fain JA, Braun B, Chipkin SR. Continuous glucose monitoring counseling improves physical activity behaviors of individuals with type 2 diabetes: A randomized clinical trial. Diabetes Res Clin Pract. 2008 Jun;80(3):371-9. doi: 10.1016/j.diabres.2008.01.006. Epub 2008 Mar 4.</citation>
    <PMID>18304674</PMID>
  </reference>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 8, 2018</study_first_submitted>
  <study_first_submitted_qc>January 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>January 1, 2019</last_update_submitted>
  <last_update_submitted_qc>January 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>continuous glucose monitoring</keyword>
  <keyword>immediate feedback counseling</keyword>
  <keyword>delayed feedback counseling</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>The study protocol will be shared after study publication.</ipd_description>
  </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/NCT03792399
org study id: NCKUH-10508011
nct id: NCT03792399
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is designed to explore the effect of feedback counseling using professional
      continuous glucose monitoring on glycemic control, self-efficacy, and self-management
      behaviors among middle aged and older adults with poor controlled type 2 diabetes mellitus.
      This study also explores the difference on timing of feedback after continuous glucose
      monitoring exam.
After scheduled routine professional continuous glucose monitoring (CGM) exam, participants
      in both the intervention and control group receive ordinary education and regimen adjustment
      as indicated based on CGM results. For participants in the intervention group, they will also
      receive CGM counseling immediately on the day of CGM sensor removal. For participants in the
      control group, they will receive CGM counseling on the day of routine 3 months outpatient
      visit.

      Qualitative data are collected through in-depth interview: User expectation, acceptability
      and satisfaction of CGM are also explored during in-depth interview with a semi-structured
      questionnaire.

      Quantitative data were collected through validated questionnaires, including evaluation of
      depression by a short form of the Center for Epidemiologic Studies Depression Scale Revised
      (CES-D-R), emotional stress by Problem Areas in Diabetes Scale (PAID), self efficacy by
      Stanford Self-Efficacy for Diabetes (SES), at pretest and 3 months after CGM counseling.

      Anthropometric Measurements. Body height, body weight, body mass index, and blood pressure
      were recorded at pre-test and post-test interview.

      Blood Tests. Routine biochemistry, fasting plasma glucose, hemoglobin A1c (HbA1c) are
      collected within 2 weeks of pretest and posttest day.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change of HbA1c
time frame: Baseline and 3 months after CGM counseling
description: Change of HbA1c in 3 months after CGM counseling.
measure: Change of score for self efficacy
time frame: Baseline and 3 months after CGM counseling
description: Change of Stanford Self-Efficacy for Diabetes Scale (SES) in 3 months after CGM counseling. The score for each item ranged from 1-10. The score of the scale is the mean of the eight items. Higher number indicated higher self-efficacy.
measure: Change of score for diabetes associated stress
time frame: Baseline and 3 months after CGM counseling
description: Change of score for Problem Areas in Diabetes Scale (PAID) in 3 months after CGM counseling. PAID is a 20-item self-reported questionnaire with scale 0-4 for each question, generating a total score of 0-100. A score of ≥ 40 is defined as emotional burnout.
measure: Change of score for depression
time frame: Baseline and 3 months after CGM counseling
description: Change of score for Center for Epidemiologic Studies Depression Scale Revised (CESD-R) in 3 months after CGM counseling. With 10-ietm CESD-R scale scoring 10 or more defined as having depression (range 0 to 30).
measure: Change in diet composition
time frame: Baseline and 3 months after CGM counseling
description: Change of carbohydrate amounts, fruits amount in 3 months after CGM counseling.
measure: Change in exercise amount, time spent in light activity
time frame: Baseline and 3 months after CGM counseling
description: Exercise amount recorded by acelerometers, built in sports bracelet (Fitbit Charge HRTM Wireless Heart Rate + Activity Wristband). Time spent in light activity per day in 3 months after CGM counseling feedback is compared with baseline.
measure: Change in exercise amount, time spent in moderate activity
time frame: Baseline and 3 months after CGM counseling
description: Exercise amount recorded by acelerometers, built in sports bracelet (Fitbit Charge HRTM Wireless Heart Rate + Activity Wristband). Time spent in moderate activity per day in 3 months after CGM counseling feedback is compared with baseline.
measure: Change in exercise amount, time spent in intense activity
time frame: Baseline and 3 months after CGM counseling
description: Exercise amount recorded by acelerometers, built in sports bracelet (Fitbit Charge HRTM Wireless Heart Rate + Activity Wristband). Time spent in intense activity per day in 3 months after CGM counseling feedback is compared with baseline.
measure: Change in exercise amount (time spent in sedentary behavior)
time frame: Baseline and 3 months after CGM counseling
description: Exercise amount recorded by acelerometers, built in sports bracelet (Fitbit Charge HRTM Wireless Heart Rate + Activity Wristband). Time spent in sedentary behavior in 3 months after CGM counseling feedback is compared with baseline.
arm group label: Immediate feedback counseling
arm group type: Experimental
description: Professional CGM calibrate blood glucose via a glucsoe-oxidase-impregnated membrane during a 5 day period. The patient wearing professional CGM is randomized to immediate feedback after data downloaded into computer.
arm group label: Delayed feedback counseling
arm group type: Other
description: Professional CGM calibrate blood glucose via a glucsoe-oxidase-impregnated membrane during a 5 day period. The patient wearing professional CGM is randomized to delayed feedback (standard care, i.e., CGM graphs interpretation at scheduled 3 months outpatient visit).
intervention type: Behavioral
intervention name: feedback counseling
description: Professoinal CGM in combination with diet and exercise record is used as teaching material to help patient realize their blood glucose pattern and to modify their behavior after counseling feedback.
arm group label: Delayed feedback counseling
arm group label: Immediate feedback counseling
criteria: 
gender: All
minimum age: 45 Years
maximum age: N/A
healthy volunteers: No
last name: Ching-Ju Chiu, Ph.D.
role: Study Director
affiliation: Institute of Gerontology, NCKU
last name: Ye-Fong Du, M.D.
role: Principal Investigator
affiliation: NCKUH
citation: Allen NA, Fain JA, Braun B, Chipkin SR. Continuous glucose monitoring counseling improves physical activity behaviors of individuals with type 2 diabetes: A randomized clinical trial. Diabetes Res Clin Pract. 2008 Jun;80(3):371-9. doi: 10.1016/j.diabres.2008.01.006. Epub 2008 Mar 4.
PMID: 18304674
responsible party type: Sponsor
sharing ipd: Undecided
ipd description: The study protocol will be shared after study publication.