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A Study of t:Slim X2 With Control-IQ Technology (DCLP5)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03844789
Recruitment Status : Active, not recruiting
First Posted : February 18, 2019
Last Update Posted : October 3, 2019
Sponsor:
Collaborators:
Tandem Diabetes Care, Inc.
DexCom, Inc.
Jaeb Center for Health Research
Information provided by (Responsible Party):
University of Virginia

Brief Summary:
The purpose of this study is to learn whether an investigational automated insulin delivery system ("study system") for children with type 1 diabetes can safely improve blood glucose (sometimes called blood sugar) control. The system uses continuous glucose monitoring (CGM), an insulin pump, and a software algorithm to automatically give insulin and control blood glucose. This is called a "closed-loop control" system.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Device: t:slim X2 with Control-IQ Technology & Dexcom G6 CGM Device: Standard of Care Not Applicable

Detailed Description:
After consent is signed, eligibility will be assessed. Eligible participants not currently using an insulin pump and Dexcom CGM with minimum data requirements will initiate a run-in phase of 2-4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) using t:slim X2 with Control-IQ Technology vs. Standard of Care (SC) for 16 weeks. The Standard of Care (SC) group will be offered to transition to use CLC and the experimental arm will extend their use of CLC for 12 weeks.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The International Diabetes Closed Loop (iDCL) Trial: Clinical Acceptance of the Artificial Pancreas in Pediatrics: A Study of t:Slim X2 With Control-IQ Technology
Actual Study Start Date : June 6, 2019
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Closed Loop Control (CLC)
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology & Dexcom G6 CGM vs Standard of Care (SC) for 4 months. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 4 months. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Device: t:slim X2 with Control-IQ Technology & Dexcom G6 CGM
Eligible participants will be use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology & Dexcom G6 CGM
Other Name: Experimental

Active Comparator: Standard of Care (SC)
Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 weeks that will be customized based on whether the participant is already a pump or CGM user. Participants who skip or successfully complete the run-in will be randomly assigned 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Standard of Care (SC) for 4 months. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Device: Standard of Care
Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Other Name: Control




Primary Outcome Measures :
  1. Target in range in main study [ Time Frame: 4 months ]
    The primary outcome for the first phase is time in target range 70-180 mg/dL measured by CGM in CLC group vs. SC group

  2. Target in range in extension study [ Time Frame: 3 months ]
    The primary outcome for the extension phase is improving time in range 70-180 mg/dL by CGM when SC (control group) transitions to t:slim X2 with Control-IQ compared with the same group during the Main Phase.


Secondary Outcome Measures :
  1. CGM-measured % above 180 mg/dL [ Time Frame: 7 months ]
    Percent

  2. GM-measured mean glucose [ Time Frame: 7 months ]
    mg/dL

  3. HbA1c at 16 weeks [ Time Frame: 7 months ]
    Percent

  4. CGM-measured % below 70 mg/dL [ Time Frame: 7 months ]
    Percent

  5. CGM-measured % below 54 mg/dL [ Time Frame: 7 months ]
    Percent


Other Outcome Measures:
  1. % in range 70-140 mg/dL [ Time Frame: 7 months ]
    Percent - CGM measured

  2. glucose variability measured with the coefficient of variation (CV) [ Time Frame: 7 months ]
    Coefficient of variation- CGM measured

  3. glucose variability measured with the standard deviation (DV) [ Time Frame: 7 months ]
    Standard Deviation- CGM measured

  4. % <60 mg/dL [ Time Frame: 7 months ]
    Percent- CGM measured

  5. low blood glucose index [ Time Frame: 7 months ]
    index- CGM measured

  6. hypoglycemia events (defined as at least 15 consecutive minutes <70 mg\dL) [ Time Frame: 7 months ]
    mg/dL- CGM measured

  7. %>250 mg/dL [ Time Frame: 7 Months ]
    Percent- CGM measured

  8. % >300 mg/dL [ Time Frame: 7 months ]
    Percent- CGM measured

  9. high blood glucose index [ Time Frame: 7 months ]
    index- CGM measured

  10. HbA1c < 7.0% at 16 weeks [ Time Frame: 16 weeks ]
    Percent - HbA1c

  11. HbA1c <7.5% at 16 weeks [ Time Frame: 16 weeks ]
    Percent - HbA1c

  12. HbA1c improvement from baseline to 16 weeks >0.5% [ Time Frame: 16 weeks ]
    Percent - HbA1c

  13. HbA1c improvement from baseline to 16 weeks >1.0% [ Time Frame: 16 weeks ]
    Percent - HbA1c

  14. HbA1c relative improvement from baseline to 16 weeks >10% [ Time Frame: 16 weeks ]
    Percent - HbA1c

  15. Percent - HbA1c improvement from baseline to 16 weeks >1.0% or HbA1c <7.0% at 16 weeks [ Time Frame: 16 weeks ]
    Percent - HbA1c

  16. Questionnaire - Fear of Hypoglycemia Survey (HFS-II) - total score, 2 subscales and 4 factor scores: 1- Behavior (avoidance and maintain high BG), 2- Worry (helplessness and social consequences) [ Time Frame: 7 months ]
    Questionnaire

  17. Questionnaire - Clarke Hypoglycemia Awareness Scores [ Time Frame: 7 Months ]
    Questionnaire

  18. Questionnaire - Problem Areas in Diabetes Survey (PAID) [ Time Frame: 7 Months ]
    Questionnaire

  19. Questionnaire - INSPIRE survey scores [ Time Frame: 7 months ]
    Questionnaire

  20. Questionnaire - PedsQL Diabetes Module - total score and 5 subscales: 1- Diabetes, 2 - Treatment I, 3 - Treament II, 4 - Worry, 5 - Communication [ Time Frame: 7 months ]
    Questionnaire

  21. Questionnaire - Pittsburgh Sleep Quality Index (Parent only) [ Time Frame: 7 months ]
    Questionnaire

  22. Questionnaire - System Usability Scale (SUS) [ Time Frame: 7 months ]
    Questionnaire

  23. Insulin - Total daily insulin (units/kg) [ Time Frame: 7 months ]
    units/kg

  24. Insulin - Basal: bolus insulin ratio [ Time Frame: 7 months ]
    bolus insulin ratio

  25. Weight and Body Mass Index (BMI) [ Time Frame: 7 months ]
    Weight and BMI



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.


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Ages Eligible for Study:   6 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 6 months
  2. Familiarity and use of a carbohydrate ratio for meal boluses.
  3. Age ≥ 6 and ≤ 13 years old
  4. Weight ≥25 kg and ≤140 kg
  5. For females, not currently known to be pregnant If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all females of child-bearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
  6. Living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff.
  7. Willingness to suspend use of any personal closed loop system that they use at home for the duration of the clinical trial once the study CGM is in use
  8. Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol
  9. Willingness to switch to lispro (Humalog) or aspart (Novolog) if not using already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study for participants using to t:slim X2. This includes:

    • Participants randomized to Control IQ
    • Participants on the SC group on MDI treatment that will be provided a Tandem pump to switch to CSII
    • Participates that are already in Continuous Subcutaneous Insulin Infusion (CSII) randomized to SC during the extension phase when transition to Control IQ
  10. Total daily insulin dose (TDD) at least 10 U/day
  11. Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial
  12. Participant and parent(s)/guardian(s) willingness to participate in all training sessions as directed by study staff.

Exclusion Criteria:

  1. Concurrent use of any non-insulin glucose-lowering agent other than metformin (including glucagon-like peptide [GLP-1] agonists, Symlin, dipeptidyl peptidase 4 [DPP-4] inhibitors, sodium-glucose cotransporter-2 (SGLT2) inhibitors, sulfonylureas).
  2. Hemophilia or any other bleeding disorder
  3. A condition, which in the opinion of the investigator or designee, would put the participant or study at risk (specified on the study procedure manual)
  4. Participation in another pharmaceutical or device trial at the time of enrollment or during the study
  5. Employed by, or having immediate family members employed by Tandem Diabetes Care, Inc., or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial

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): NCT03844789


Locations
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United States, California
Stanford University
Stanford, California, United States, 94304
United States, Colorado
Barbara Davis Center, University of Colorado
Aurora, Colorado, United States, 80045
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06511
United States, Virginia
UVA Center for Diabetes Technology
Charlottesville, Virginia, United States, 22903
Sponsors and Collaborators
University of Virginia
Tandem Diabetes Care, Inc.
DexCom, Inc.
Jaeb Center for Health Research
Investigators
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Principal Investigator: Melissa J Schoelwer, MD University of Virginia

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Responsible Party: University of Virginia
ClinicalTrials.gov Identifier: NCT03844789     History of Changes
Other Study ID Numbers: DCLP5
First Posted: February 18, 2019    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Will follow the NIH Data Sharing Policy and Implementation Guidance on sharing research resources for research purposes to qualified individuals within the scientific community.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Generally, data will be made available after the primary publications of each study.
Access Criteria:

The Data Sharing Agreements will be formulated by the Steering Committee in collaboration with the NIH Project Scientist Program Official.

In addition, under special arrangements, complete data sets will be provided to industry partners who would use the data for regulatory clearance (PMA - pre-market approval) of the tested artificial pancreas system. This will be done in response to the specific requirements of RFA-DK-14-024 for this project to "…generate data able to satisfy safety and efficacy requirements by regulatory agencies regarding the clinical testing of artificial pancreas device systems" in the target population of people with type 1 diabetes.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by University of Virginia:
Artificial Pancreas (AP)
Control-IQ System
Insulin Pump
Closed Loop Control (CLC)
Continuous Glucose Monitor (CGM)
Standard of Care (SC)
Multiple Daily Injections (MDI)
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs