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

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: NCT03563313
Recruitment Status : Completed
First Posted : June 20, 2018
Results First Posted : April 16, 2020
Last Update Posted : April 28, 2020
Sponsor:
Collaborators:
Jaeb Center for Health Research
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Tandem Diabetes Care, Inc.
DexCom, Inc.
Roche Diagnostics
Information provided by (Responsible Party):
Sue Brown, University of Virginia

Brief Summary:
The objective of the study is to assess efficacy and safety of a closed loop system (t:slim X2 with Control-IQ Technology) in a large randomized controlled trial.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Device: t:slim X2 with Control-IQ Technology & Dexcom G6 CGM Device: Sensor-augmented pump (SAP) 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 to 8 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 2:1 to the use of closed-loop control (CLC group) using t:slim X2 with Control-IQ Technology vs. SAP for 6 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized controlled trial of 6 month at home closed loop system vs. sensor-augmented pump.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Pivotal Study of t:Slim X2 With Control-IQ Technology
Actual Study Start Date : June 28, 2018
Actual Primary Completion Date : April 8, 2019
Actual Study Completion Date : April 8, 2019

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 6 months.
Device: t:slim X2 with Control-IQ Technology & Dexcom G6 CGM
Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home.

Active Comparator: Sensor-Augmented Pump (SAP)
Participants randomized to sensor-augmented pump (SAP) will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months.
Device: Sensor-augmented pump (SAP)
Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.




Primary Outcome Measures :
  1. Time in Target Range [ Time Frame: 26 weeks ]
    The primary outcome is time in target range 70-180 mg/dL measured by CGM in CLC group vs. SAP group.


Secondary Outcome Measures :
  1. CGM Time Above 180 [ Time Frame: 26 weeks ]
    CGM-measured % above 180 mg/dL

  2. CGM Mean Glucose [ Time Frame: 26 weeks ]
    CGM-measured mean glucose

  3. HbA1c at 26 Weeks [ Time Frame: 26 weeks ]
    Hemoglobin A1c measured at 26 weeks

  4. CGM Time Below 70 [ Time Frame: 26 weeks ]
    CGM-measured % below 70 mg/dL

  5. CGM Time Below 54 [ Time Frame: 26 weeks ]
    CGM-measured % below 54 mg/dL

  6. CGM Time in Range 70-140 mg/dL [ Time Frame: 26 weeks ]
    CGM-measured % in range 70-140 mg/dL

  7. Coefficient of Variability [ Time Frame: 26 weeks ]
    CGM measured glucose variability measured with the coefficient of variation (CV)

  8. Standard Deviation of CGM [ Time Frame: 26 weeks ]
    CGM measured glucose variability measured with the standard deviation (SD)

  9. CGM Time Below 60 [ Time Frame: 26 weeks ]
    CGM-measured % below 60 mg/dL

  10. LBGI [ Time Frame: 26 weeks ]
    Low blood glucose index by CGM with higher index indicating higher risk of hypoglycemia. Values <1 suggest minimal risk. Index of risk of low blood glucose excursion based on a standard formula for non-linear transformation of the blood glucose scale (Kovatchev BP, Cox DJ, Gonder-Frederick LA, Young-Hyman D, Schlundt D, Clarke WL: Assessment of risk for severe hypoglycemia among adults with IDDM: validation of the low blood glucose index. Diabetes Care 21:1870-1875, 1998)

  11. CGM Hypoglycemia Events [ Time Frame: 26 weeks ]
    CGM-measured events of at least 15 consecutive minutes <70mg/dL per week

  12. CGM Time >250 [ Time Frame: 26 weeks ]
    CGM-measured % >250 mg/dL

  13. CGM Time >300 [ Time Frame: 26 weeks ]
    CGM-measured % >300 mg/dL

  14. HBGI [ Time Frame: 26 weeks ]
    High blood glucose index by CGM with higher values indicating higher risk of hyperglycemia. Index of risk of high blood glucose excursion based on a standard formula for non-linear transformation of the blood glucose scale (Kovatchev BP, Cox DJ, Kumar A, Gonder-Frederick L, Clarke WL. Algorithmic evaluation of metabolic control and risk of severe hypoglycemia in type 1 and type 2 diabetes using self-monitoring blood glucose data. Diabetes Technol Ther 2003;5:817-828pmid:14633347)

  15. Number of Participants With HbA1c <7.0% at 26 Weeks [ Time Frame: 26 weeks ]
    Number of participants HbA1c <7.0% at 26 weeks

  16. Number of Participants With HbA1c <7.5% at 26 Weeks [ Time Frame: 26 weeks ]
    Number of Participants with HbA1c <7.5% at 26 weeks

  17. Number of Participants With HbA1c Improvement From Baseline to 26 Weeks >0.5% [ Time Frame: 26 weeks ]
    HbA1c improvement from baseline to 26 weeks >0.5%

  18. Number of Participants With HbA1c Improvement From Baseline to 26 Weeks >1.0% [ Time Frame: 26 weeks ]
    HbA1c improvement from baseline to 26 weeks >1.0%

  19. HbA1c Relative Improvement From Baseline to 26 Weeks >10% [ Time Frame: 26 weeks ]
    HbA1c relative improvement from baseline to 26 weeks >10%

  20. Number of Participants With HbA1c Improvement From Baseline to 26 Weeks >1.0% or HbA1c <7.0% at 26 Weeks [ Time Frame: 26 weeks ]
    HbA1c improvement from baseline to 26 weeks >1.0% or HbA1c <7.0% at 26 weeks

  21. HFS-II [ Time Frame: 26 weeks ]
    For adults, teens and parents items on this survey are rated on a 5 point Likert scale from never (0) to almost always (4). The survey is scored by summing item responses. Fear of Hypoglycemia Survey (HFS-II) for adults has a total score that is summed from the two subscale scores (33 items) and ranges from 0 to 132 with higher scores indicating greater degrees of fear of hypoglycemia. The teen survey has a total of 25 items and the range of Total scores is 0 to 100. The parent version of the survey has a total of 26 items with Total scores that range from 0 to 108.

  22. Hyperglycemia Avoidance Scale [ Time Frame: 26 weeks ]
    Hyperglycemia Avoidance Scale total score is the sum of 21 items rated on a 4 point Likert scale from 0 (never) to 4 (almost always) and ranges from 0 to 84 with a higher score indicating greater degrees of avoiding hyperglycemia.

  23. Diabetes Distress Scale [ Time Frame: 26 weeks ]
    Diabetes Distress Scale for adults has 28 items rated on a 6 point Likert scale that ranges from 1 (not a problem) to 6 (a very serious problem). The total score is the mean of the sum of responses and ranges from 1 to 6 where a higher score indicates greater degrees of diabetes distress.

  24. Hypoglycemia Confidence Scale [ Time Frame: 26 weeks ]
    Hypoglycemia Confidence Scale has 20 items which are rated on a 4-point Likert Scale ranging from 1 (not confident at all) to 4 (very confident) with higher scores indicating higher confidence in dealing with hypoglycemia. A single score is computed by calculating the mean of the sum of all items and ranges from 1 to 4.

  25. Clarke Hypoglycemia Awareness Scores [ Time Frame: 26 weeks ]
    Clarke Hypoglycemia Awareness Scores (0-7 score with higher scores associated with impaired awareness)

  26. INSPIRE Survey Scores [ Time Frame: 26 weeks ]
    The INSPIRE questionnaire assesses user expectations and experiences with Insulin Delivery Systems: Perceptions, Ideas, Reflections, Expectations (INSPIRE). Survey total scores are computed by calculating the mean of the sum of all item ratings then multiplying the mean by 25 to scale the score to a range from 0 to 100. Higher scores indicate a more positive perception of insulin delivery systems. Items are rated on a 5 point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree). The Adult survey has 22 items, the Teens/Adolescents survey has 17 items and the Parent survey has 21 items.

  27. System Usability Scores (SUS) [ Time Frame: 26 weeks ]
    System Usability Scores (SUS)-composite score from 0 to 100 with higher scores indicate better perceived usability

  28. Technology Acceptance Questionnaire [ Time Frame: 26 weeks ]
    Technology Acceptance Survey measures the user's perceptions regarding the burdens and the barriers associated with a technology with a higher score indicates increased technology acceptance. There total score uses 37 items with items are rated on a 5 point scale ranging from 1 (strongly disagree) to 5 (strongly agree) for total score range of 37-185.

  29. Total Daily Insulin [ Time Frame: 26 weeks ]
    Total Daily Insulin (units)

  30. Basal:Bolus Insulin Ratio [ Time Frame: 26 weeks ]
    Basal:Bolus Insulin Ratio

  31. Weight [ Time Frame: 26 weeks ]
    Weight (kg)

  32. BMI [ Time Frame: 26 weeks ]
    Body Mass Index (BMI) kg/m^2


Other Outcome Measures:
  1. Number of Participants With Severe Hypoglycemia (Per Protocol) [ Time Frame: 26 weeks ]
    Severe hypoglycemia (per protocol)

  2. Number of Participants With Diabetic Ketoacidosis (Per Protocol) [ Time Frame: 26 weeks ]
    Diabetic ketoacidosis (per protocol)

  3. Ketone Events Defined as Day With Ketone Level >1.0 mmol/L [ Time Frame: 26 weeks ]
    Ketone events defined as day with ketone level >1.0 mmol/L

  4. CGM-measured Hypoglycemic Events (>15 Minutes With Glucose Concentration <54 mg/dL) [ Time Frame: 26 weeks ]
    CGM-measured hypoglycemic events (>15 minutes with glucose concentration <54 mg/dL)

  5. CGM-measured Hyperglycemic Events (>15 Minutes With Glucose Concentration >300 mg/dL) [ Time Frame: 26 weeks ]
    CGM-measured hyperglycemic events (>15 minutes with glucose concentration >300 mg/dL)

  6. BG-measured Hypoglycemic Events (One BG Record <54 mg/dL) [ Time Frame: 26 weeks ]
    BG-measured hypoglycemic events (one BG record <54 mg/dL)

  7. BG-measured Hyperglycemic Events (One BG Record >350 mg/dL) [ Time Frame: 26 weeks ]
    BG-measured hyperglycemic events (one BG record >350 mg/dL)

  8. Worsening of HbA1c From Baseline to 26 Weeks by >0.5% [ Time Frame: 26 weeks ]
    Worsening of HbA1c from baseline to 26 weeks by >0.5%

  9. Other Serious Adverse Events (SAE) and Serious Adverse Device Events (SADE) [ Time Frame: 26 weeks ]
    Other serious adverse events (SAE) and serious adverse device events (SADE)

  10. Adverse Device Effects (ADE) [ Time Frame: 26 weeks ]
    Adverse device effects (ADE)

  11. Unanticipated Adverse Device Effects (UADE) [ Time Frame: 26 weeks ]
    Unanticipated adverse device effects (UADE)

  12. Number of Participants With SH Events [ Time Frame: 26 weeks ]
    For this outcome, mean +/- SD or summary statistics appropriate to the distribution will be tabulated by treatment group

  13. SH Event Rate Per 100 Person-years [ Time Frame: 26 weeks ]
    For this outcome, severe hypoglycemia event rate per 100 person-years will be calculated as a rate.

  14. Number of Participants With DKA Events [ Time Frame: 26 weeks ]
    For this outcome, number of participants with diabetic ketoacidosis (DKA) will be tabulated.

  15. DKA Event Rate Per 100 Person-years [ Time Frame: 26 weeks ]
    For this outcome, the diabetic ketoacidosis event rate per 100 person-years will be calculated as a rate.

  16. Any Adverse Event Rate Per 100 Person-years [ Time Frame: 26 weeks ]
    For this outcome, the adverse event rate per 100 person-years calculated as a rate.



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:   14 Years and older   (Child, Adult, Older Adult)
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 1 year.
  2. Familiarity and use of a carbohydrate ratio for meal boluses.
  3. Age ≥14.0 years old.
  4. 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.
  5. 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.
  6. Willingness to suspend use of any personal CGM for the duration of the clinical trial once the study CGM is in use.
  7. Willingness to use a regular insulin pump during the study with no automatic insulin adjustment based on glucose level when assigned to participate in an SAP group
  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.
  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.

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. 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): NCT03563313


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, 55902
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
Jaeb Center for Health Research
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Tandem Diabetes Care, Inc.
DexCom, Inc.
Roche Diagnostics
Investigators
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Principal Investigator: Sue A. Brown, MD University of Virginia
  Study Documents (Full-Text)

Documents provided by Sue Brown, University of Virginia:
Study Protocol  [PDF] November 5, 2018
Statistical Analysis Plan  [PDF] October 12, 2018
Informed Consent Form  [PDF] August 31, 2018

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sue Brown, Principal Investigator, University of Virginia
ClinicalTrials.gov Identifier: NCT03563313    
Other Study ID Numbers: DCLP3
UC4DK108483 ( U.S. NIH Grant/Contract )
First Posted: June 20, 2018    Key Record Dates
Results First Posted: April 16, 2020
Last Update Posted: April 28, 2020
Last Verified: April 2020
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
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