Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 48 of 447 for:    subcutaneous | "Diabetes Mellitus, Insulin-Dependent"

Flexible Insulin Therapy Untethered Insulin Regimen in Avidly Exercising Patients With Type 1 Diabetes: FIT Untethered (FIT Untethered)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03838783
Recruitment Status : Recruiting
First Posted : February 12, 2019
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Ronnie Aronson, MD, LMC Diabetes & Endocrinology Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Drug: Insulin Degludec Phase 4

Detailed Description:
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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 15, 2018
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
No Intervention: Usual CSII
Continue to use the established CSII insulin therapy
Experimental: Untethered CSII
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
Drug: Insulin Degludec
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
Other Name: Tresiba




Primary Outcome Measures :
  1. Time in range within 6 hours [ Time Frame: 6 hours ]
    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


Secondary Outcome Measures :
  1. Change in glucose within 60 mins after high-intensity exercise starts [ Time Frame: 60 mins ]
    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)

  2. Change in glucose within 120 mins after moderate-intensity exercise starts [ Time Frame: 120 mins ]
    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)

  3. Time spent in hypoglycemia 24 hours after exercise [ Time Frame: 24 hours ]
    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

  4. Time in range 24 hours after exercise [ Time Frame: 24 hours ]
    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

  5. Time spent in hyperglycemia 24 hours after exercise [ Time Frame: 24 hours ]
    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

  6. Time in range in the last 4 weeks of each study phase [ Time Frame: 4 weeks ]
    Percentage of time with CGM glucose between 4.0 - 10.0 mmol/L in the last 4 weeks of each study phase

  7. Frequency of hypoglycemia 24 hours after exercise [ Time Frame: 24 hours ]
    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

  8. Frequency of hypoglycemia in the last 4 weeks of each study phase [ Time Frame: 4 weeks ]
    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

  9. Change in Diabetes Medication Satisfaction (DiabMedSat) Score [ Time Frame: 11 weeks ]

    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


  10. Change in Hypoglycemia Fear Score [ Time Frame: 11 weeks ]

    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


  11. Change in TRIM-D Score [ Time Frame: 11 weeks ]

    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




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults with clinical diagnosis of T1D
  • Age 18-55 years, inclusive
  • Diagnosis of T1D ≥ 6 months
  • A1c ≤ 8.5% at screening visit
  • Using stable CSII therapy for ≥ 6 months
  • Exercise regularly (≥ 3 times per week of moderate or vigorous exercise)
  • VO2peak ≥ 30 ml/kg/min for females and ≥ 32 ml/kg/min for males
  • Willing to adhere to the protocol requirements for the duration of the study
  • Written informed consent
  • Fasting C-peptide value of < 0.7 ng/mL (0.23 nmol/L) at screening visit

Exclusion Criteria:

  • Pregnant or lactating
  • Already using a split regimen of combination CSII and basal insulin injection
  • Active diabetic retinopathy (proliferated diabetic retinopathy, or vitreous hemorrhage in past 6 months) that could potentially be worsened by the exercise protocol
  • Any evidence of unstable cardiovascular disease, disorders or abnormalities as per physician's discretion
  • Currently following a very low calorie or other weight-loss diet which may impact glucose control and mask the primary and secondary outcome measures
  • More than one episode of severe hypoglycemia with seizure, coma or requiring assistance of another person during the past 6 months
  • Known hypoglycemia unawareness
  • Use of acetaminophen (Tylenol) during the study period
  • Medications other than insulin that might impact outcome measures:

    • Beta blockers
    • Any agents that affect hepatic glucose production, including all beta adrenergic agonists or antagonists, all xanthine derivatives
    • Pramlintide
    • Any non-insulin diabetes therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03838783


Contacts
Layout table for location contacts
Contact: Ronnie Aronson, MD 416-645-2929 aronsonresearch@lmc.ca

Locations
Layout table for location information
Canada, Ontario
LMC Diabetes & Endocrinology Ltd. Recruiting
Toronto, Ontario, Canada, M4G 3E8
Contact: Nichole Mckay, MSc         
Sponsors and Collaborators
LMC Diabetes & Endocrinology Ltd.

Publications:

Layout table for additonal information
Responsible Party: Ronnie Aronson, MD, Chief Medical Officer, LMC Diabetes & Endocrinology Ltd.
ClinicalTrials.gov Identifier: NCT03838783     History of Changes
Other Study ID Numbers: FIT Untethered
First Posted: February 12, 2019    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Ronnie Aronson, MD, LMC Diabetes & Endocrinology Ltd.:
Exercise
Insulin Degludec
Continuous glucose monitoring (CGM)
Continuous Subcutaneous Insulin Infusion (CSII)

Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs