<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/NCT03838783</url>
  </required_header>
  <id_info>
    <org_study_id>FIT Untethered</org_study_id>
    <nct_id>NCT03838783</nct_id>
  </id_info>
  <brief_title>Flexible Insulin Therapy Untethered Insulin Regimen in Avidly Exercising Patients With Type 1 Diabetes: FIT Untethered</brief_title>
  <acronym>FIT Untethered</acronym>
  <official_title>Flexible Insulin Therapy Untethered Insulin Regimen Using Insulin Degludec and Continuous Subcutaneous Insulin Infusion in Avidly Exercising Patients With Type 1 Diabetes: FIT Untethered</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>LMC Diabetes &amp; Endocrinology Ltd.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>LMC Diabetes &amp; Endocrinology Ltd.</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall objective of this study is to evaluate glycemic control and patient-reported&#xD;
      outcomes in patients with Type 1 diabetes (T1D) who use insulin degludec and continuous&#xD;
      subcutaneous insulin infusion in a combination untethered regimen during moderate or&#xD;
      high-intensity exercise.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      FIT untethered is an open-label, randomized, repeated measures cross-over design study,&#xD;
      testing glycemic control in &quot;untethered&quot; continuous subcutaneous insulin infusion (CSII)&#xD;
      therapy compared to usual CSII therapy, in physically active patients with T1D (N=30). During&#xD;
      2-week screening visits, participants are randomized into either the usual CSII arm or the&#xD;
      untethered CSII arm. Patients in the usual group continue with their established CSII&#xD;
      therapy. Patients in the untethered group are to administer 50% of their basal dose through&#xD;
      an insulin degludec injection every morning, with the other 50% achieved through their&#xD;
      established CSII therapy. Bolus insulin remains at the established dose in both groups. After&#xD;
      randomization, patients begin Phase I and transition into a 2-week insulin optimization&#xD;
      period. Then, participants will complete 2 in-clinic, supervised exercise visits (1 moderate&#xD;
      and 1 high intensity exercises) in the following week. After, participants must complete 2&#xD;
      unsupervised at-home exercises per week for 3 weeks (cumulative total of 2 moderate and 4&#xD;
      high intensity exercises). After the home exercise period, participants cross-over to the&#xD;
      other study arm and begin Phase II. Phase II is similar to Phase I: 2 weeks of insulin dose&#xD;
      optimization, 1 week of supervised clinic exercise, and 3 weeks of unsupervised home&#xD;
      exercise. For both in-clinic and home-based exercise, the participant's insulin pump will be&#xD;
      disconnected and suspended 60 minutes prior to beginning the workout, and will be reconnected&#xD;
      immediately following each workout. A continuous glucose monitoring (CGM) device will be worn&#xD;
      by each participant for the entire duration of the study. The co-primary outcomes of the&#xD;
      study include time in range (4.0 - 10.0 mmol/L) in the 6 hours after the start of moderate-&#xD;
      and high-intensity exercise. The key secondary outcomes include the glucose variability&#xD;
      during the 24 hour period after the start of both moderate and high intensity exercise, and&#xD;
      patient reported outcomes before and after exercise.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 15, 2018</start_date>
  <completion_date type="Anticipated">June 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2019</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>Randomization for the sequence of Interventions (A and B) will be done by an interactive system that will randomly assign patients to an intervention sequence.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time in range within 6 hours</measure>
    <time_frame>6 hours</time_frame>
    <description>Percentage of time with CGM glucose between 4.0 - 10.0 mmol/L within 6 hours after the start of high-intensity or moderate-intensity, in-clinic exercise</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in glucose within 60 mins after high-intensity exercise starts</measure>
    <time_frame>60 mins</time_frame>
    <description>Plasma glucose at 30 mins after after the end of a 30-min high-intensity, in-clinic exercise minus plasma glucose at baseline (right before exercise)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in glucose within 120 mins after moderate-intensity exercise starts</measure>
    <time_frame>120 mins</time_frame>
    <description>Plasma glucose at 30 mins after the end of a 90-min moderate-intensity, in-clinic exercise minus plasma glucose at baseline (right before exercise)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time spent in hypoglycemia 24 hours after exercise</measure>
    <time_frame>24 hours</time_frame>
    <description>Percentage of time with CGM glucose &lt;4.0 mmol/L within 24 hour after the start of high intensity exercise or moderate intensity in-clinic exercise</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time in range 24 hours after exercise</measure>
    <time_frame>24 hours</time_frame>
    <description>Percentage of time with CGM glucose between 4.0 - 10.0 mmol/L within 24 hour after the start of high intensity exercise or moderate intensity in-clinic exercise</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time spent in hyperglycemia 24 hours after exercise</measure>
    <time_frame>24 hours</time_frame>
    <description>Percentage of time with CGM glucose &gt; 10.0 mmol/L within 24 hour after the start of high intensity exercise or moderate intensity in-clinic exercise</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time in range in the last 4 weeks of each study phase</measure>
    <time_frame>4 weeks</time_frame>
    <description>Percentage of time with CGM glucose between 4.0 - 10.0 mmol/L in the last 4 weeks of each study phase</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of hypoglycemia 24 hours after exercise</measure>
    <time_frame>24 hours</time_frame>
    <description>Number of hypoglycemic episodes, which are defined as CGM glucose &lt;4.0 mmol/L lasting ≥15 minutes within 24 hours following high intensity exercise or moderate intensity in-clinic exercise</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of hypoglycemia in the last 4 weeks of each study phase</measure>
    <time_frame>4 weeks</time_frame>
    <description>Number of hypoglycemic episodes, which are defined as CGM glucose &lt;4.0 mmol/L lasting ≥15 minutes in the last 4 weeks of each study phase</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Diabetes Medication Satisfaction (DiabMedSat) Score</measure>
    <time_frame>11 weeks</time_frame>
    <description>Diabetes Medication Satisfaction questionnaire is to measure the level of patients' satisfaction with their diabetes medication(s) in the past 2 weeks. The score range will be 0 to 100. The higher the score, the less the satisfaction.&#xD;
The change of scores is the score difference between Visit 24 and Visit 2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Hypoglycemia Fear Score</measure>
    <time_frame>11 weeks</time_frame>
    <description>Hypoglycemia Fear will be measured by the Hypoglycemia Fear Survey which assesses the subject's behaviors to avoid hypoglycemia and to measure the subjects' worries about hypoglycemia and its consequences in the past 3 months. The range of the score will be 0 to 132. The higher the score, the greater the fear.&#xD;
The changes of scores are the score difference between Visit 24 and Visit 2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in TRIM-D Score</measure>
    <time_frame>11 weeks</time_frame>
    <description>Treatment Related Impact Measure - Diabetes Device (TRIM-D Device) questionnaire will be used to generate TRIM-D-Score. It measures the level of the subject's satisfaction with the device used to take the diabetes medication. The range of this score will be 3-15. The higher the score, The greater satisfaction.&#xD;
The changes of scores are the score difference between Visit 24 and Visit 2</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Type 1 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Usual CSII</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Continue to use the established CSII insulin therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Untethered CSII</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Basal dosing - total CSII basal dose will be delivered by 50% through continuing CSII therapy used prior to study enrollment and 50% through the addition of once daily insulin degludec injected in the morning; Bolus dosing - continue the established bolus insulin dose</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Insulin Degludec</intervention_name>
    <description>50% of the patient's daily basal insulin dose delivered through once daily insulin degludec injected in the morning; 50% of the basal insulin to be delivered through previously established CSII</description>
    <arm_group_label>Untethered CSII</arm_group_label>
    <other_name>Tresiba</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults with clinical diagnosis of T1D&#xD;
&#xD;
          -  Age 18-55 years, inclusive&#xD;
&#xD;
          -  Diagnosis of T1D ≥ 6 months&#xD;
&#xD;
          -  A1c ≤ 8.5% at screening visit&#xD;
&#xD;
          -  Using stable CSII therapy for ≥ 6 months&#xD;
&#xD;
          -  Exercise regularly (≥ 3 times per week of moderate or vigorous exercise)&#xD;
&#xD;
          -  VO2peak ≥ 30 ml/kg/min for females and ≥ 32 ml/kg/min for males&#xD;
&#xD;
          -  Willing to adhere to the protocol requirements for the duration of the study&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
          -  Fasting C-peptide value of &lt; 0.7 ng/mL (0.23 nmol/L) at screening visit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or lactating&#xD;
&#xD;
          -  Already using a split regimen of combination CSII and basal insulin injection&#xD;
&#xD;
          -  Active diabetic retinopathy (proliferated diabetic retinopathy, or vitreous hemorrhage&#xD;
             in past 6 months) that could potentially be worsened by the exercise protocol&#xD;
&#xD;
          -  Any evidence of unstable cardiovascular disease, disorders or abnormalities as per&#xD;
             physician's discretion&#xD;
&#xD;
          -  Currently following a very low calorie or other weight-loss diet which may impact&#xD;
             glucose control and mask the primary and secondary outcome measures&#xD;
&#xD;
          -  More than one episode of severe hypoglycemia with seizure, coma or requiring&#xD;
             assistance of another person during the past 6 months&#xD;
&#xD;
          -  Known hypoglycemia unawareness&#xD;
&#xD;
          -  Use of acetaminophen (Tylenol) during the study period&#xD;
&#xD;
          -  Medications other than insulin that might impact outcome measures:&#xD;
&#xD;
               -  Beta blockers&#xD;
&#xD;
               -  Any agents that affect hepatic glucose production, including all beta adrenergic&#xD;
                  agonists or antagonists, all xanthine derivatives&#xD;
&#xD;
               -  Pramlintide&#xD;
&#xD;
               -  Any non-insulin diabetes therapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ronnie Aronson, MD</last_name>
    <phone>416-645-2929</phone>
    <email>aronsonresearch@lmc.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>LMC Diabetes &amp; Endocrinology Ltd.</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4G 3E8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nichole Mckay, MSc</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Doyle EA, Weinzimer SA, Steffen AT, Ahern JA, Vincent M, Tamborlane WV. A randomized, prospective trial comparing the efficacy of continuous subcutaneous insulin infusion with multiple daily injections using insulin glargine. Diabetes Care. 2004 Jul;27(7):1554-8. doi: 10.2337/diacare.27.7.1554.</citation>
    <PMID>15220227</PMID>
  </reference>
  <reference>
    <citation>Binek A, Rembierz-Knoll A, Polanska J, Jarosz-Chobot P. Reasons for the discontinuation of therapy of personal insulin pump in children with type 1 diabetes. Pediatr Endocrinol Diabetes Metab. 2016 Feb 18;21(2):65-9. doi: 10.18544/PEDM-21.02.0026.</citation>
    <PMID>26901138</PMID>
  </reference>
  <reference>
    <citation>Wong JC, Boyle C, DiMeglio LA, Mastrandrea LD, Abel KL, Cengiz E, Cemeroglu PA, Aleppo G, Largay JF, Foster NC, Beck RW, Adi S; T1D Exchange Clinic Network. Evaluation of Pump Discontinuation and Associated Factors in the T1D Exchange Clinic Registry. J Diabetes Sci Technol. 2017 Mar;11(2):224-232. doi: 10.1177/1932296816663963. Epub 2016 Sep 25.</citation>
    <PMID>27595711</PMID>
  </reference>
  <reference>
    <citation>Benbenek-Klupa T, Matejko B, Klupa T. Metabolic control in type 1 diabetes patients practicing combat sports: at least two-year follow-up study. Springerplus. 2015 Mar 17;4:133. doi: 10.1186/s40064-015-0919-5. eCollection 2015.</citation>
    <PMID>25825689</PMID>
  </reference>
  <reference>
    <citation>Delvecchio M, Zecchino C, Salzano G, Faienza MF, Cavallo L, De Luca F, Lombardo F. Effects of moderate-severe exercise on blood glucose in Type 1 diabetic adolescents treated with insulin pump or glargine insulin. J Endocrinol Invest. 2009 Jun;32(6):519-24. doi: 10.1007/BF03346499.</citation>
    <PMID>19474521</PMID>
  </reference>
  <reference>
    <citation>Yardley JE, Zaharieva DP, Jarvis C, Riddell MC. The &quot;ups&quot; and &quot;downs&quot; of a bike race in people with type 1 diabetes: dramatic differences in strategies and blood glucose responses in the Paris-to-Ancaster Spring Classic. Can J Diabetes. 2015 Apr;39(2):105-10. doi: 10.1016/j.jcjd.2014.09.003. Epub 2014 Dec 6.</citation>
    <PMID>25492557</PMID>
  </reference>
  <reference>
    <citation>Riddell MC, Gallen IW, Smart CE, Taplin CE, Adolfsson P, Lumb AN, Kowalski A, Rabasa-Lhoret R, McCrimmon RJ, Hume C, Annan F, Fournier PA, Graham C, Bode B, Galassetti P, Jones TW, Millan IS, Heise T, Peters AL, Petz A, Laffel LM. Exercise management in type 1 diabetes: a consensus statement. Lancet Diabetes Endocrinol. 2017 May;5(5):377-390. doi: 10.1016/S2213-8587(17)30014-1. Epub 2017 Jan 24. Erratum In: Lancet Diabetes Endocrinol. 2017 May;5(5):e3.</citation>
    <PMID>28126459</PMID>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>July 26, 2018</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>February 11, 2019</last_update_submitted>
  <last_update_submitted_qc>February 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>LMC Diabetes &amp; Endocrinology Ltd.</investigator_affiliation>
    <investigator_full_name>Ronnie Aronson, MD</investigator_full_name>
    <investigator_title>Chief Medical Officer</investigator_title>
  </responsible_party>
  <keyword>Exercise</keyword>
  <keyword>Insulin Degludec</keyword>
  <keyword>Continuous glucose monitoring (CGM)</keyword>
  <keyword>Continuous Subcutaneous Insulin Infusion (CSII)</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 1</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03838783
org study id: FIT Untethered
nct id: NCT03838783
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The overall objective of this study is to evaluate glycemic control and patient-reported
      outcomes in patients with Type 1 diabetes (T1D) who use insulin degludec and continuous
      subcutaneous insulin infusion in a combination untethered regimen during moderate or
      high-intensity exercise.
FIT untethered is an open-label, randomized, repeated measures cross-over design study,
      testing glycemic control in "untethered" continuous subcutaneous insulin infusion (CSII)
      therapy compared to usual CSII therapy, in physically active patients with T1D (N=30). During
      2-week screening visits, participants are randomized into either the usual CSII arm or the
      untethered CSII arm. Patients in the usual group continue with their established CSII
      therapy. Patients in the untethered group are to administer 50% of their basal dose through
      an insulin degludec injection every morning, with the other 50% achieved through their
      established CSII therapy. Bolus insulin remains at the established dose in both groups. After
      randomization, patients begin Phase I and transition into a 2-week insulin optimization
      period. Then, participants will complete 2 in-clinic, supervised exercise visits (1 moderate
      and 1 high intensity exercises) in the following week. After, participants must complete 2
      unsupervised at-home exercises per week for 3 weeks (cumulative total of 2 moderate and 4
      high intensity exercises). After the home exercise period, participants cross-over to the
      other study arm and begin Phase II. Phase II is similar to Phase I: 2 weeks of insulin dose
      optimization, 1 week of supervised clinic exercise, and 3 weeks of unsupervised home
      exercise. For both in-clinic and home-based exercise, the participant's insulin pump will be
      disconnected and suspended 60 minutes prior to beginning the workout, and will be reconnected
      immediately following each workout. A continuous glucose monitoring (CGM) device will be worn
      by each participant for the entire duration of the study. The co-primary outcomes of the
      study include time in range (4.0 - 10.0 mmol/L) in the 6 hours after the start of moderate-
      and high-intensity exercise. The key secondary outcomes include the glucose variability
      during the 24 hour period after the start of both moderate and high intensity exercise, and
      patient reported outcomes before and after exercise.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Randomization for the sequence of Interventions (A and B) will be done by an interactive system that will randomly assign patients to an intervention sequence.
primary purpose: Treatment
masking: None (Open Label)
measure: Time in range within 6 hours
time frame: 6 hours
description: Percentage of time with CGM glucose between 4.0 - 10.0 mmol/L within 6 hours after the start of high-intensity or moderate-intensity, in-clinic exercise
measure: Change in glucose within 60 mins after high-intensity exercise starts
time frame: 60 mins
description: Plasma glucose at 30 mins after after the end of a 30-min high-intensity, in-clinic exercise minus plasma glucose at baseline (right before exercise)
measure: Change in glucose within 120 mins after moderate-intensity exercise starts
time frame: 120 mins
description: Plasma glucose at 30 mins after the end of a 90-min moderate-intensity, in-clinic exercise minus plasma glucose at baseline (right before exercise)
measure: Time spent in hypoglycemia 24 hours after exercise
time frame: 24 hours
description: Percentage of time with CGM glucose <4.0 mmol/L within 24 hour after the start of high intensity exercise or moderate intensity in-clinic exercise
measure: Time in range 24 hours after exercise
time frame: 24 hours
description: Percentage of time with CGM glucose between 4.0 - 10.0 mmol/L within 24 hour after the start of high intensity exercise or moderate intensity in-clinic exercise
measure: Time spent in hyperglycemia 24 hours after exercise
time frame: 24 hours
description: Percentage of time with CGM glucose > 10.0 mmol/L within 24 hour after the start of high intensity exercise or moderate intensity in-clinic exercise
measure: Time in range in the last 4 weeks of each study phase
time frame: 4 weeks
description: Percentage of time with CGM glucose between 4.0 - 10.0 mmol/L in the last 4 weeks of each study phase
measure: Frequency of hypoglycemia 24 hours after exercise
time frame: 24 hours
description: Number of hypoglycemic episodes, which are defined as CGM glucose <4.0 mmol/L lasting ≥15 minutes within 24 hours following high intensity exercise or moderate intensity in-clinic exercise
measure: Frequency of hypoglycemia in the last 4 weeks of each study phase
time frame: 4 weeks
description: Number of hypoglycemic episodes, which are defined as CGM glucose <4.0 mmol/L lasting ≥15 minutes in the last 4 weeks of each study phase
measure: Change in Diabetes Medication Satisfaction (DiabMedSat) Score
time frame: 11 weeks
description: Diabetes Medication Satisfaction questionnaire is to measure the level of patients' satisfaction with their diabetes medication(s) in the past 2 weeks. The score range will be 0 to 100. The higher the score, the less the satisfaction.
The change of scores is the score difference between Visit 24 and Visit 2
measure: Change in Hypoglycemia Fear Score
time frame: 11 weeks
description: Hypoglycemia Fear will be measured by the Hypoglycemia Fear Survey which assesses the subject's behaviors to avoid hypoglycemia and to measure the subjects' worries about hypoglycemia and its consequences in the past 3 months. The range of the score will be 0 to 132. The higher the score, the greater the fear.
The changes of scores are the score difference between Visit 24 and Visit 2
measure: Change in TRIM-D Score
time frame: 11 weeks
description: Treatment Related Impact Measure - Diabetes Device (TRIM-D Device) questionnaire will be used to generate TRIM-D-Score. It measures the level of the subject's satisfaction with the device used to take the diabetes medication. The range of this score will be 3-15. The higher the score, The greater satisfaction.
The changes of scores are the score difference between Visit 24 and Visit 2
arm group label: Usual CSII
arm group type: No Intervention
description: Continue to use the established CSII insulin therapy
arm group label: Untethered CSII
arm group type: Experimental
description: Basal dosing - total CSII basal dose will be delivered by 50% through continuing CSII therapy used prior to study enrollment and 50% through the addition of once daily insulin degludec injected in the morning; Bolus dosing - continue the established bolus insulin dose
intervention type: Drug
intervention name: Insulin Degludec
description: 50% of the patient's daily basal insulin dose delivered through once daily insulin degludec injected in the morning; 50% of the basal insulin to be delivered through previously established CSII
arm group label: Untethered CSII
other name: Tresiba
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Ronnie Aronson, MD
phone: 416-645-2929
email: aronsonresearch@lmc.ca
facility: 
status: Recruiting
contact: 
country: Canada
citation: Doyle EA, Weinzimer SA, Steffen AT, Ahern JA, Vincent M, Tamborlane WV. A randomized, prospective trial comparing the efficacy of continuous subcutaneous insulin infusion with multiple daily injections using insulin glargine. Diabetes Care. 2004 Jul;27(7):1554-8. doi: 10.2337/diacare.27.7.1554.
PMID: 15220227
citation: Binek A, Rembierz-Knoll A, Polanska J, Jarosz-Chobot P. Reasons for the discontinuation of therapy of personal insulin pump in children with type 1 diabetes. Pediatr Endocrinol Diabetes Metab. 2016 Feb 18;21(2):65-9. doi: 10.18544/PEDM-21.02.0026.
PMID: 26901138
citation: Wong JC, Boyle C, DiMeglio LA, Mastrandrea LD, Abel KL, Cengiz E, Cemeroglu PA, Aleppo G, Largay JF, Foster NC, Beck RW, Adi S; T1D Exchange Clinic Network. Evaluation of Pump Discontinuation and Associated Factors in the T1D Exchange Clinic Registry. J Diabetes Sci Technol. 2017 Mar;11(2):224-232. doi: 10.1177/1932296816663963. Epub 2016 Sep 25.
PMID: 27595711
citation: Benbenek-Klupa T, Matejko B, Klupa T. Metabolic control in type 1 diabetes patients practicing combat sports: at least two-year follow-up study. Springerplus. 2015 Mar 17;4:133. doi: 10.1186/s40064-015-0919-5. eCollection 2015.
PMID: 25825689
citation: Delvecchio M, Zecchino C, Salzano G, Faienza MF, Cavallo L, De Luca F, Lombardo F. Effects of moderate-severe exercise on blood glucose in Type 1 diabetic adolescents treated with insulin pump or glargine insulin. J Endocrinol Invest. 2009 Jun;32(6):519-24. doi: 10.1007/BF03346499.
PMID: 19474521
citation: Yardley JE, Zaharieva DP, Jarvis C, Riddell MC. The "ups" and "downs" of a bike race in people with type 1 diabetes: dramatic differences in strategies and blood glucose responses in the Paris-to-Ancaster Spring Classic. Can J Diabetes. 2015 Apr;39(2):105-10. doi: 10.1016/j.jcjd.2014.09.003. Epub 2014 Dec 6.
PMID: 25492557
citation: Riddell MC, Gallen IW, Smart CE, Taplin CE, Adolfsson P, Lumb AN, Kowalski A, Rabasa-Lhoret R, McCrimmon RJ, Hume C, Annan F, Fournier PA, Graham C, Bode B, Galassetti P, Jones TW, Millan IS, Heise T, Peters AL, Petz A, Laffel LM. Exercise management in type 1 diabetes: a consensus statement. Lancet Diabetes Endocrinol. 2017 May;5(5):377-390. doi: 10.1016/S2213-8587(17)30014-1. Epub 2017 Jan 24. Erratum In: Lancet Diabetes Endocrinol. 2017 May;5(5):e3.
PMID: 28126459
responsible party type: Principal Investigator
investigator affiliation: LMC Diabetes & Endocrinology Ltd.
investigator full name: Ronnie Aronson, MD
investigator title: Chief Medical Officer
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
mesh term: Insulin
sharing ipd: No