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The International Diabetes Closed Loop (iDCL) Trial: Clinical Acceptance of the Artificial Pancreas (DCLP3 Extension)

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: NCT03591354
Recruitment Status : Enrolling by invitation
First Posted : July 19, 2018
Last Update Posted : July 25, 2019
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Jaeb Center for Health Research
Tandem Diabetes Care, Inc.
DexCom, Inc.
Roche Diagnostics
Information provided by (Responsible Party):
Sue Brown, University of Virginia

Brief Summary:
This is a 3-month extension study (DCLP3 Extension) following a primary trial (DCLP3 or NCT03563313) to assess efficacy and safety of a closed loop system (t:slim X2 with Control-IQ Technology) in a large randomized controlled trial. Upon completion of the NIH 3-month extension study, subjects will be invited to participate in a continued use phase with Control-IQ Technology, funded by Tandem Diabetes Care, until the equipment has received FDA approval for commercial use.

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

Detailed Description:

Participants in the 6 month primary trial (DCLP3) will be invited to continue in this 3-month extension study (DCLP3 Extension) following completion of the primary trial. The closed-loop control (CLC) Intervention Group participants from the primary trial will be randomly assigned to continue CLC or to switch to Predictive Low-Glucose Suspend (PLGS) therapy with t:slim X2 with Basal-IQ and Dexcom G6 for 3 months. The Sensor-Augmented Pump (SAP) Control Group participants from the primary trial will be assigned to CLC using t:slim X2 with Control-IQ Technology and Dexcom G6 (CGM) for 3 months. Upon completion of the extension study, subjects will be invited to participate in continued use of the Control-IQ Technology until the equipment has received FDA approval for commercial use.

This extension phase has two separate objectives:

Objective 1: Among participants who used CLC in the primary trial: the primary efficacy outcome for the RCT is time in target range 70-180 mg/dL measured by CGM in CLC group vs. PLGS group over 3 months. Safety outcomes also will be assessed Objective 2: Among participants who used SAP in the primary trial: the primary outcome is to obtain additional safety data. Efficacy also will be assessed as a pre-post within participant analysis

Note: Primary Trial (DCLP3) is NCT03563313


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized controlled trial of 3 months at home closed loop system vs. predictive-low glucose suspend.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: An Extension Study of t:Slim X2 With Control-IQ Technology
Actual Study Start Date : January 17, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Closed Loop Control (CLC)

Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 3 months.

Objective 1: This arm is participants who had 6 months of CLC in the primary trial (DCLP3 Pivotal Trial)

Objective 2: This arm is participants who had 6 months of SAP in the primary trial (DCLP3 Pivotal Trial)

Objective 3: This arm is participants who had 3 months of CLC in the extension trial (DCLP3 Extension) will continue use of the Control-IQ Technology & Dexcom G6 CGM until the product is commercially available.

Device: t:slim X2 with Control-IQ Technology & Dexcom G6 CGM
Participants will use the Tandem t:slim X2 insulin pump with Control-IQ Technology & Dexcom G6 CGM for 3 months.

Active Comparator: Predictive-Low Glucose Suspend (PLGS)

Participants randomized to Predictive-Low Glucose Suspend (PLGS) will use the t:slim X2 with Basal-IQ & Dexcom G6 CGM for 3 months.

Objective 1: This arm is participants who had 6 months of PLGS in the primary trial (DCLP3 Pivotal Trial)

Objective 2: This arm is not applicable to objective 2

Objective 3: This arm is participants who had 3 months of PLGS in the extension trial (DCLP3 Extension) will continue use of the Control-IQ Technology & Dexcom G6 CGM until the product is commercially available.

Device: t:slim X2 with Basal-IQ & Dexcom G6 CGM
Participants will use a Tandem t:slim X2 insulin pump with Basal-IQ and a study CGM (Dexcom G6) for 3 months.




Primary Outcome Measures :
  1. Time in target range [ Time Frame: 13 weeks ]
    The primary exploratory outcome is time in target range 70-180 mg/dL measured by CGM


Secondary Outcome Measures :
  1. CGM Time above 180 [ Time Frame: 13 weeks ]
    CGM-measured % above 180 mg/dL

  2. CGM mean glucose [ Time Frame: 13 weeks ]
    CGM-measured mean glucose

  3. CGM Time below 70 [ Time Frame: 13 weeks ]
    CGM-measured % below 70 mg/dL

  4. CGM Time below 54 [ Time Frame: 13 weeks ]
    CGM-measured % below 54 mg/dL

  5. CGM Time in range 70-140 mg/dL [ Time Frame: 13 weeks ]
    CGM-measured % in range 70-140 mg/dL

  6. Coefficient of Variability [ Time Frame: 13 weeks ]
    CGM measured glucose variability measured with the coefficient of variation (CV)

  7. Standard Deviation [ Time Frame: 13 weeks ]
    CGM measured glucose variability measured with the standard deviation (SD)

  8. CGM Time below 60 [ Time Frame: 13 weeks ]
    CGM-measured % below 60 mg/dL

  9. LBGI [ Time Frame: 13 weeks ]
    Low Blood Glucose Index by CGM

  10. CGM Hypoglycemia Events [ Time Frame: 13 weeks ]
    CGM-measured of at least 15 consecutive minutes <54 mg/dL

  11. CGM Time >250 [ Time Frame: 13 weeks ]
    CGM-measured % >250 mg/dL

  12. CGM Time >300 [ Time Frame: 13 weeks ]
    CGM-measured % >300 mg/dL

  13. HBGI [ Time Frame: 13 weeks ]
    High Blood Glucose Index by CGM

  14. HbA1c at 13 weeks [ Time Frame: 13 weeks ]
    HbA1c at 13 weeks

  15. HbA1c <7.0% at 13 weeks [ Time Frame: 13 weeks ]
    HbA1c <7.0% at 13 weeks

  16. HbA1c <7.5% at 13 weeks [ Time Frame: 13 weeks ]
    HbA1c <7.5% at 13 weeks

  17. HbA1c change from baseline to 13 weeks >0.5% [ Time Frame: 13 weeks ]
    HbA1c change from baseline to 13 weeks >0.5%

  18. HbA1c change from baseline to 13 weeks >1.0% [ Time Frame: 13 weeks ]
    HbA1c change from baseline to 13 weeks >1.0%

  19. HbA1c relative change from baseline to 13 weeks >10% [ Time Frame: 13 weeks ]
    HbA1c relative change from baseline to 13 weeks >10%

  20. HbA1c change from baseline to 13 weeks >1.0% or HbA1C <7.0% at 13 weeks [ Time Frame: 13 weeks ]
    HbA1c change from baseline to 13 weeks >1.0% or HbA1c <7.0% at 13 weeks

  21. HFS-II [ Time Frame: 13 weeks ]
    Fear of Hypoglycemia Survey (HFS-II) total score and 3 sub scales (5 point scale with never to almost always)

  22. Hyperglycemia Avoidance Scale [ Time Frame: 13 weeks ]
    Hyperglycemia Avoidance Scale total score and 4 sub scales (5 point scale from never to always)

  23. Diabetes Distress Scale [ Time Frame: 13 weeks ]
    Diabetes Distress Scale total score and 4 sub scales [6 point Likert Scale from 1 (no problem) to 6 (serious problem)]

  24. Hypoglycemia Confidence Scale [ Time Frame: 13 weeks ]
    Hypoglycemia Confidence Scale total score (4 point scale from not confident at all to very confident)

  25. Clarke Hypoglycemia Awareness Scores [ Time Frame: 13 weeks ]
    Clarke Hypoglycemia Awareness Scores (0-7 score with higher scores associated with impaired awareness)

  26. INSPIRE Survey Scores [ Time Frame: 13 weeks ]
    INSPIRE Survey Scores (5 point Likert scale from strongly agree to strongly disagree)

  27. System Usability Scores (SUS) [ Time Frame: 13 weeks ]
    System Usability Scores (SUS)-composite score from 0 to 100 with higher scores indicating better perceived usability

  28. Technology Acceptance Questionnaire [ Time Frame: 13 weeks ]
    Technology Acceptance Questionnaire- 5 point Likert scale from strongly agree to strongly disagree

  29. Total Daily Insulin [ Time Frame: 13 weeks ]
    Total Daily Insulin (units/kg)

  30. Basal:Bolus Insulin Ratio [ Time Frame: 13 weeks ]
    Basal:Bolus Insulin Ratio

  31. Weight [ Time Frame: 13 weeks ]
    Weight (kg)

  32. BMI [ Time Frame: 13 weeks ]
    Body Mass Index (BMI) kg/m2


Other Outcome Measures:
  1. Ketone events defined as day with ketone level >1.0 mmol/L [ Time Frame: 13 weeks ]
    Ketone events defined as day with ketone level > 1.0 mmol/L

  2. CGM-measured hypoglycemic events (>15 minutes with glucose concentration <54 mg/dL) [ Time Frame: 13 weeks ]
    CGM-measured hypoglycemic events (>15 minutes with glucose concentration <54)

  3. CGM-measured hyperglycemic events (>120 minutes with glucose concentration >300 mg/dL) [ Time Frame: 13 weeks ]
    CGM-measured hyperglycemic events (>120 minutes with glucose concentration >300 mg/dL)

  4. Worsening of HbA1c from randomization to 13 weeks by >0.5% [ Time Frame: 13 weeks ]
    Worsening of HbA1c from randomization to 13 weeks by >0.5%

  5. Serious adverse events with a possible or greater relationship to a study device (including anticipated and unanticipated adverse device effects) [ Time Frame: 13 weeks ]
    Serious adverse events with a possible or greater relationship to a study device (including anticipated and unanticipated adverse device effects)

  6. Adverse device effects (ADE) that do not meet criteria for SAE [ Time Frame: 13 weeks ]
    Adverse device effects (ADE) that do not meet criteria for SAE

  7. Other serious adverse events not related to a study device [ Time Frame: 13 weeks ]
    Other serious adverse events not related to a study device

  8. Number of SH events [ Time Frame: 13 weeks ]
    Mean +/- SD or summary statistics appropriate to the distribution will be tabulated by treatment group

  9. SH event rate per 100 person-years [ Time Frame: 13 weeks ]
    Mean +/- SD or summary statistics appropriate to the distribution will be tabulated by treatment group

  10. Number of DKA events [ Time Frame: 13 weeks ]
    Mean +/- SD or summary statistics appropriate to the distribution will be tabulated by treatment group

  11. DKA event rate per 100 person-years [ Time Frame: 13 weeks ]
    Mean +/- SD or summary statistics appropriate to the distribution will be tabulated by treatment group

  12. Any adverse event rate per 100 person-years [ Time Frame: 13 weeks ]
    Mean +/- SD or summary statistics appropriate to the distribution will be tabulated by treatment group



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Successful completion of the original 6-month RCT within the prior 14 days
  2. 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 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.
  3. For participants <18 years old, living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact the participant in case of an emergency.
  4. Willingness to not use a personal CGM for the duration of the study
  5. Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol
  6. Willingness to use only lispro (Humalog) or aspart (Novolog), and to use no other insulin during the study.
  7. Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial

Exclusion Criteria

  1. Concurrent use of any non-insulin glucose-lowering agent other than metformin (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 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
  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., Dexcom, Inc., or TypeZero Technologies, LLC, 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): NCT03591354


Locations
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United States, California
Sansum Diabetes Research Institute
Santa Barbara, California, United States, 93105
Stanford University
Stanford, California, United States, 94304
United States, Colorado
Barbara Davis Center, University of Colorado
Aurora, Colorado, United States, 80045
United States, Massachusetts
Harvard University (Joslin Diabetes Center)
Boston, Massachusetts, United States, 02215
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
United States, Virginia
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, United States, 22903
Sponsors and Collaborators
University of Virginia
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Jaeb Center for Health Research
Tandem Diabetes Care, Inc.
DexCom, Inc.
Roche Diagnostics
Investigators
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Principal Investigator: Sue Brown, MD University of Virginia

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Responsible Party: Sue Brown, Principal Investigator, University of Virginia
ClinicalTrials.gov Identifier: NCT03591354     History of Changes
Other Study ID Numbers: DCLP3 Extension
UC4DK108483 ( U.S. NIH Grant/Contract )
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 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.
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 Sue Brown, University of Virginia:
Artificial Pancreas (AP)
Type 1 Diabetes Mellitus
Insulin Pump
Continuous Glucose Monitor (CGM)
Closed Loop Control (CLC)
Sensor-Augmented Pump (SAP)
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs