<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/NCT02185755</url>
  </required_header>
  <id_info>
    <org_study_id>IBGMS standalone</org_study_id>
    <nct_id>NCT02185755</nct_id>
  </id_info>
  <brief_title>Internet Monitoring vs Medication to Control Blood Sugar in Type 2 Diabetes</brief_title>
  <official_title>Investigating if an Internet-Based Glucose Monitoring System is as Effective as Medication at Reducing HbA1c Levels in Type 2 Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Endocrine Research Society</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Endocrine Research Society</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Managing blood sugar levels is important for patients with type 2 diabetes (T2DM) to minimize&#xD;
      health problems and complications. One way for patients to notify doctors and receive&#xD;
      feedback about their blood sugar management is through an online system. As Internet-based&#xD;
      glucose monitoring systems (IBGMS) have already been shown to be effective, the investigators&#xD;
      hypothesize that IBGMS is effective as an intervention even when limiting feedback to&#xD;
      non-medicine related changes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Purpose:&#xD;
&#xD;
           To determine the effectiveness of an Internet-based glucose monitoring system (IBGMS) in&#xD;
           the absence of medication changes.&#xD;
&#xD;
        2. Hypothesis:&#xD;
&#xD;
           IBGMS without medication changes is comparable to conventional medication at reducing&#xD;
           HbA1c levels over 8% in patients with T2DM.&#xD;
&#xD;
        3. Justification:&#xD;
&#xD;
           Patients with T2DM having elevated HbA1c levels may be prescribed additional medications&#xD;
           to help manage their blood sugar levels, which include oral hypoglycemic agents and/or&#xD;
           insulin. As IBGMS has been shown to be effective in reducing HbA1c in T2DM, there is an&#xD;
           opportunity to determine whether if this system could be used as an alternative to&#xD;
           medication.&#xD;
&#xD;
           The benefits would include reduced side effects as a result of substituting for the&#xD;
           effects of medication, as well as reduced financial costs associated with acquiring&#xD;
           medication.&#xD;
&#xD;
           Considering that IBGMS increases the frequency at which patients receive feedback to&#xD;
           change medications as compared to typical treatment, the risk is as typical for a&#xD;
           patient opting for no medication changes for the same period of time.&#xD;
&#xD;
        4. Objectives: The primary end-point is to determine if patients using IBGMS have reduced&#xD;
           HbA1c values at followup, and to compare the reduction to the control group on typical&#xD;
           medications.&#xD;
&#xD;
        5. Research Method: 120 patients with T2DM satisfying the inclusion criteria will be&#xD;
           recruited and have baseline HbA1c established through regular lab blood tests. They will&#xD;
           be randomized into one of two groups, one that will be trained to use IBGMS and one&#xD;
           control group going on an appropriate additional medication.&#xD;
&#xD;
           The IBGMS group will be asked to report their blood sugars to their endocrinologist&#xD;
           biweekly and receive feedback for each report. No medication changes will be offered in&#xD;
           the feedback, but lifestyle or dietary recommendations may be included.&#xD;
&#xD;
           The control group will be asked to take their new medications as indicated by their&#xD;
           endocrinologist.&#xD;
&#xD;
           Both groups will have followup visits with their endocrinologist at 3 and 6 months, and&#xD;
           will also have blood tests done at those time points checking their HbA1c levels.&#xD;
&#xD;
           The effectiveness of both interventions will be evaluated individually and against each&#xD;
           other.&#xD;
&#xD;
           For the IBGMS group, a rescue secondary endpoint occurs if a subject maintains an HbA1c&#xD;
           level at or greater than 8% after 3 months; the subject will be withdrawn from the study&#xD;
           and put under standard care.&#xD;
&#xD;
        6. Statistical Analysis: The sample size was calculated to be 120 by estimating mean&#xD;
           differences and standard deviations using data from previous studies. For the&#xD;
           calculation the statistical power was 0.80 and alpha of 0.05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <primary_completion_date type="Actual">August 2016</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>HbA1c Levels before and after intervention</measure>
    <time_frame>6 months</time_frame>
    <description>Compare HbA1c Levels before and after intervention for both arms, as well as the difference in HbA1c Levels between arms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The secondary endpoint include severe hypoglycemia defined as requiring external aid (hospital or other).</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>A secondary endpoint includes adverse events such as unplanned hospitalizations for any cause that last more than 24 hours</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HbA1c levels remain at 8% or higher</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Type 2 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Internet-Based Glucose Monitoring System</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The subjects enrolled in the Internet Therapeutic Intervention arm receive standard care by testing their blood glucose at least 3 times daily and visit the endocrinologist every 3 months; however, they are also asked to upload their blood glucose readings online every 2 weeks for the health practitioner to view and provide feedback limited to non-medicine related comments and suggestions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal Medication Positive Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The subjects will be prescribed a new medication as appropriate for normal therapy. This group will receive no biweekly feedback nor require to report online, but will see the endocrinologist every 3 months up to 6 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Internet-Based Glucose Monitoring System</intervention_name>
    <arm_group_label>Internet-Based Glucose Monitoring System</arm_group_label>
    <other_name>Internet Blood Glucose Monitoring System</other_name>
    <other_name>Remote Blood Glucose Monitoring System</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal Medication Positive Control</intervention_name>
    <arm_group_label>Normal Medication Positive Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Type 2 diabetes patients being treated with oral hypoglycemic agents&#xD;
&#xD;
          -  HbA1c &gt; 8%&#xD;
&#xD;
          -  Willingness to test blood glucose levels a minimum of 3 times daily&#xD;
&#xD;
          -  Willingness to be trained on using the Internet-Based Glucose Monitoring System&#xD;
&#xD;
          -  Willingness to be randomized&#xD;
&#xD;
          -  Trained in self-blood glucose monitoring&#xD;
&#xD;
          -  Internet access on a computer&#xD;
&#xD;
          -  No prior use or training on IBGMS&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with medical conditions that may affect their study participation or results&#xD;
             will be excluded.&#xD;
&#xD;
          -  Patients using medications known to influence control of diabetes (eg steroids&#xD;
             systemic or inhaled)&#xD;
&#xD;
          -  Liver disease (AST (aspartate aminotransferase) or ALT (alanine aminotransferase)&#xD;
             levels &gt; 2.5 times the reference level)&#xD;
&#xD;
          -  Renal insufficient with a serum creatinine level &gt; 200 μmol/L&#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>Hugh D Tildesley, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Providence Health Care, University of British Columbia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dr. Hugh Tildesley Inc.</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V6E1M7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Nathan DM, Cleary PA, Backlund JY, Genuth SM, Lachin JM, Orchard TJ, Raskin P, Zinman B; Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study Research Group. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med. 2005 Dec 22;353(25):2643-53. doi: 10.1056/NEJMoa052187.</citation>
    <PMID>16371630</PMID>
  </reference>
  <reference>
    <citation>Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):837-53. Erratum In: Lancet 1999 Aug 14;354(9178):602.</citation>
    <PMID>9742976</PMID>
  </reference>
  <reference>
    <citation>Hirsch IB, Bode BW, Childs BP, Close KL, Fisher WA, Gavin JR, Ginsberg BH, Raine CH, Verderese CA. Self-Monitoring of Blood Glucose (SMBG) in insulin- and non-insulin-using adults with diabetes: consensus recommendations for improving SMBG accuracy, utilization, and research. Diabetes Technol Ther. 2008 Dec;10(6):419-39. doi: 10.1089/dia.2008.0104.</citation>
    <PMID>18937550</PMID>
  </reference>
  <reference>
    <citation>Austin MM, Haas L, Johnson T, Parkin CG, Parkin CL, Spollett G, Volpone MT. Self-monitoring of blood glucose: benefits and utilization. Diabetes Educ. 2006 Nov-Dec;32(6):835-6, 844-7. doi: 10.1177/0145721706295873. No abstract available.</citation>
    <PMID>17102152</PMID>
  </reference>
  <reference>
    <citation>Tildesley HD, Mazanderani AB, Ross SA. Effect of Internet therapeutic intervention on A1C levels in patients with type 2 diabetes treated with insulin. Diabetes Care. 2010 Aug;33(8):1738-40. doi: 10.2337/dc09-2256.</citation>
    <PMID>20668152</PMID>
  </reference>
  <reference>
    <citation>Cho JH, Chang SA, Kwon HS, Choi YH, Ko SH, Moon SD, Yoo SJ, Song KH, Son HS, Kim HS, Lee WC, Cha BY, Son HY, Yoon KH. Long-term effect of the Internet-based glucose monitoring system on HbA1c reduction and glucose stability: a 30-month follow-up study for diabetes management with a ubiquitous medical care system. Diabetes Care. 2006 Dec;29(12):2625-31. doi: 10.2337/dc05-2371.</citation>
    <PMID>17130195</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 7, 2014</study_first_submitted>
  <study_first_submitted_qc>July 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>August 17, 2017</last_update_submitted>
  <last_update_submitted_qc>August 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Endocrine Research Society</investigator_affiliation>
    <investigator_full_name>ERS Gap Student</investigator_full_name>
    <investigator_title>Medical Director</investigator_title>
  </responsible_party>
  <keyword>Internet-Based Glucose Monitoring System</keyword>
  <keyword>Type 2 Diabetes</keyword>
  <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>
  </condition_browse>
  <!-- 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/NCT02185755
org study id: IBGMS standalone
nct id: NCT02185755
lead sponsor: 
has dmc: No
Managing blood sugar levels is important for patients with type 2 diabetes (T2DM) to minimize
      health problems and complications. One way for patients to notify doctors and receive
      feedback about their blood sugar management is through an online system. As Internet-based
      glucose monitoring systems (IBGMS) have already been shown to be effective, the investigators
      hypothesize that IBGMS is effective as an intervention even when limiting feedback to
      non-medicine related changes.
1. Purpose:

           To determine the effectiveness of an Internet-based glucose monitoring system (IBGMS) in
           the absence of medication changes.

        2. Hypothesis:

           IBGMS without medication changes is comparable to conventional medication at reducing
           HbA1c levels over 8% in patients with T2DM.

        3. Justification:

           Patients with T2DM having elevated HbA1c levels may be prescribed additional medications
           to help manage their blood sugar levels, which include oral hypoglycemic agents and/or
           insulin. As IBGMS has been shown to be effective in reducing HbA1c in T2DM, there is an
           opportunity to determine whether if this system could be used as an alternative to
           medication.

           The benefits would include reduced side effects as a result of substituting for the
           effects of medication, as well as reduced financial costs associated with acquiring
           medication.

           Considering that IBGMS increases the frequency at which patients receive feedback to
           change medications as compared to typical treatment, the risk is as typical for a
           patient opting for no medication changes for the same period of time.

        4. Objectives: The primary end-point is to determine if patients using IBGMS have reduced
           HbA1c values at followup, and to compare the reduction to the control group on typical
           medications.

        5. Research Method: 120 patients with T2DM satisfying the inclusion criteria will be
           recruited and have baseline HbA1c established through regular lab blood tests. They will
           be randomized into one of two groups, one that will be trained to use IBGMS and one
           control group going on an appropriate additional medication.

           The IBGMS group will be asked to report their blood sugars to their endocrinologist
           biweekly and receive feedback for each report. No medication changes will be offered in
           the feedback, but lifestyle or dietary recommendations may be included.

           The control group will be asked to take their new medications as indicated by their
           endocrinologist.

           Both groups will have followup visits with their endocrinologist at 3 and 6 months, and
           will also have blood tests done at those time points checking their HbA1c levels.

           The effectiveness of both interventions will be evaluated individually and against each
           other.

           For the IBGMS group, a rescue secondary endpoint occurs if a subject maintains an HbA1c
           level at or greater than 8% after 3 months; the subject will be withdrawn from the study
           and put under standard care.

        6. Statistical Analysis: The sample size was calculated to be 120 by estimating mean
           differences and standard deviations using data from previous studies. For the
           calculation the statistical power was 0.80 and alpha of 0.05.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: HbA1c Levels before and after intervention
time frame: 6 months
description: Compare HbA1c Levels before and after intervention for both arms, as well as the difference in HbA1c Levels between arms.
measure: The secondary endpoint include severe hypoglycemia defined as requiring external aid (hospital or other).
time frame: 6 months
measure: A secondary endpoint includes adverse events such as unplanned hospitalizations for any cause that last more than 24 hours
time frame: 6 months
measure: HbA1c levels remain at 8% or higher
time frame: 3 months
arm group label: Internet-Based Glucose Monitoring System
arm group type: Active Comparator
description: The subjects enrolled in the Internet Therapeutic Intervention arm receive standard care by testing their blood glucose at least 3 times daily and visit the endocrinologist every 3 months; however, they are also asked to upload their blood glucose readings online every 2 weeks for the health practitioner to view and provide feedback limited to non-medicine related comments and suggestions.
arm group label: Normal Medication Positive Control
arm group type: Other
description: The subjects will be prescribed a new medication as appropriate for normal therapy. This group will receive no biweekly feedback nor require to report online, but will see the endocrinologist every 3 months up to 6 months.
intervention type: Other
intervention name: Internet-Based Glucose Monitoring System
arm group label: Internet-Based Glucose Monitoring System
other name: Internet Blood Glucose Monitoring System
other name: Remote Blood Glucose Monitoring System
intervention type: Drug
intervention name: Normal Medication Positive Control
arm group label: Normal Medication Positive Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Hugh D Tildesley, MD
role: Principal Investigator
affiliation: Providence Health Care, University of British Columbia
facility: 
country: Canada
citation: Nathan DM, Cleary PA, Backlund JY, Genuth SM, Lachin JM, Orchard TJ, Raskin P, Zinman B; Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study Research Group. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med. 2005 Dec 22;353(25):2643-53. doi: 10.1056/NEJMoa052187.
PMID: 16371630
citation: Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):837-53. Erratum In: Lancet 1999 Aug 14;354(9178):602.
PMID: 9742976
citation: Hirsch IB, Bode BW, Childs BP, Close KL, Fisher WA, Gavin JR, Ginsberg BH, Raine CH, Verderese CA. Self-Monitoring of Blood Glucose (SMBG) in insulin- and non-insulin-using adults with diabetes: consensus recommendations for improving SMBG accuracy, utilization, and research. Diabetes Technol Ther. 2008 Dec;10(6):419-39. doi: 10.1089/dia.2008.0104.
PMID: 18937550
citation: Austin MM, Haas L, Johnson T, Parkin CG, Parkin CL, Spollett G, Volpone MT. Self-monitoring of blood glucose: benefits and utilization. Diabetes Educ. 2006 Nov-Dec;32(6):835-6, 844-7. doi: 10.1177/0145721706295873. No abstract available.
PMID: 17102152
citation: Tildesley HD, Mazanderani AB, Ross SA. Effect of Internet therapeutic intervention on A1C levels in patients with type 2 diabetes treated with insulin. Diabetes Care. 2010 Aug;33(8):1738-40. doi: 10.2337/dc09-2256.
PMID: 20668152
citation: Cho JH, Chang SA, Kwon HS, Choi YH, Ko SH, Moon SD, Yoo SJ, Song KH, Son HS, Kim HS, Lee WC, Cha BY, Son HY, Yoon KH. Long-term effect of the Internet-based glucose monitoring system on HbA1c reduction and glucose stability: a 30-month follow-up study for diabetes management with a ubiquitous medical care system. Diabetes Care. 2006 Dec;29(12):2625-31. doi: 10.2337/dc05-2371.
PMID: 17130195
responsible party type: Principal Investigator
investigator affiliation: Endocrine Research Society
investigator full name: ERS Gap Student
investigator title: Medical Director
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2