Back to resultsThe International Diabetes Closed Loop (iDCL) Trial: Clinical Acceptance of the Artificial Pancreas (DCLP3)
Primary Purpose
Type 1 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
t:slim X2 with Control-IQ Technology & Dexcom G6 CGM
Sensor-augmented pump (SAP)
Sponsored by
About this trial
This is an interventional other trial for Type 1 Diabetes Mellitus focused on measuring Artificial Pancreas (AP), Type 1 Diabetes Mellitus, Insulin Pump, Continuous Glucose Monitor (CGM), Closed Loop Control (CLC), Sensor-Augmented Pump (SAP)
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 1 year.
- Familiarity and use of a carbohydrate ratio for meal boluses.
- Age ≥14.0 years old.
- 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.
- 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.
- Willingness to suspend use of any personal CGM for the duration of the clinical trial once the study CGM is in use.
- 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
- Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol.
- 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.
- Total daily insulin dose (TDD) at least 10 U/day.
- Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial.
Exclusion Criteria
- Concurrent use of any non-insulin glucose-lowering agent other than metformin (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas).
- Hemophilia or any other bleeding disorder.
- A condition, which in the opinion of the investigator or designee, would put the participant or study at risk.
- Participation in another pharmaceutical or device trial at the time of enrollment or during the study.
- 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.
Sites / Locations
- Sansum Diabetes Research Institute
- Stanford University
- Barbara Davis Center, University of Colorado
- Harvard University (Joslin Diabetes Center)
- Mayo Clinic
- Icahn School of Medicine at Mount Sinai
- University of Virginia Center for Diabetes Technology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Closed Loop Control (CLC)
Sensor-Augmented Pump (SAP)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Time in Target Range
The primary outcome is time in target range 70-180 mg/dL measured by CGM in CLC group vs. SAP group.
Secondary Outcome Measures
CGM Time Above 180
CGM-measured % above 180 mg/dL
CGM Mean Glucose
CGM-measured mean glucose
HbA1c at 26 Weeks
Hemoglobin A1c measured at 26 weeks
CGM Time Below 70
CGM-measured % below 70 mg/dL
CGM Time Below 54
CGM-measured % below 54 mg/dL
CGM Time in Range 70-140 mg/dL
CGM-measured % in range 70-140 mg/dL
Coefficient of Variability
CGM measured glucose variability measured with the coefficient of variation (CV)
Standard Deviation of CGM
CGM measured glucose variability measured with the standard deviation (SD)
CGM Time Below 60
CGM-measured % below 60 mg/dL
LBGI
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)
CGM Hypoglycemia Events
CGM-measured events of at least 15 consecutive minutes <70mg/dL per week
CGM Time >250
CGM-measured % >250 mg/dL
CGM Time >300
CGM-measured % >300 mg/dL
HBGI
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)
Number of Participants With HbA1c <7.0% at 26 Weeks
Number of participants HbA1c <7.0% at 26 weeks
Number of Participants With HbA1c <7.5% at 26 Weeks
Number of Participants with HbA1c <7.5% at 26 weeks
Number of Participants With HbA1c Improvement From Baseline to 26 Weeks >0.5%
HbA1c improvement from baseline to 26 weeks >0.5%
Number of Participants With HbA1c Improvement From Baseline to 26 Weeks >1.0%
HbA1c improvement from baseline to 26 weeks >1.0%
HbA1c Relative Improvement From Baseline to 26 Weeks >10%
HbA1c relative improvement from baseline to 26 weeks >10%
Number of Participants With HbA1c Improvement From Baseline to 26 Weeks >1.0% or HbA1c <7.0% at 26 Weeks
HbA1c improvement from baseline to 26 weeks >1.0% or HbA1c <7.0% at 26 weeks
HFS-II
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.
Hyperglycemia Avoidance Scale
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.
Diabetes Distress Scale
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.
Hypoglycemia Confidence Scale
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.
Clarke Hypoglycemia Awareness Scores
Clarke Hypoglycemia Awareness Scores (0-7 score with higher scores associated with impaired awareness)
INSPIRE Survey Scores
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.
System Usability Scores (SUS)
System Usability Scores (SUS)-composite score from 0 to 100 with higher scores indicate better perceived usability
Technology Acceptance Questionnaire
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.
Total Daily Insulin
Total Daily Insulin (units)
Basal:Bolus Insulin Ratio
Basal:Bolus Insulin Ratio
Weight
Weight (kg)
BMI
Body Mass Index (BMI) kg/m^2
Full Information
NCT ID
NCT03563313
First Posted
June 7, 2018
Last Updated
April 17, 2020
Sponsor
University of Virginia
Collaborators
Jaeb Center for Health Research, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Tandem Diabetes Care, Inc., DexCom, Inc., Roche Diagnostics
1. Study Identification
Unique Protocol Identification Number
NCT03563313
Brief Title
The International Diabetes Closed Loop (iDCL) Trial: Clinical Acceptance of the Artificial Pancreas
Acronym
DCLP3
Official Title
A Pivotal Study of t:Slim X2 With Control-IQ Technology
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
June 28, 2018 (Actual)
Primary Completion Date
April 8, 2019 (Actual)
Study Completion Date
April 8, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
Collaborators
Jaeb Center for Health Research, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Tandem Diabetes Care, Inc., DexCom, Inc., Roche Diagnostics
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
Artificial Pancreas (AP), Type 1 Diabetes Mellitus, Insulin Pump, Continuous Glucose Monitor (CGM), Closed Loop Control (CLC), Sensor-Augmented Pump (SAP)
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized controlled trial of 6 month at home closed loop system vs. sensor-augmented pump.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
168 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Closed Loop Control (CLC)
Arm Type
Experimental
Arm Description
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.
Arm Title
Sensor-Augmented Pump (SAP)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
t:slim X2 with Control-IQ Technology & Dexcom G6 CGM
Intervention Description
Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home.
Intervention Type
Device
Intervention Name(s)
Sensor-augmented pump (SAP)
Intervention Description
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 Measure Information:
Title
Time in Target Range
Description
The primary outcome is time in target range 70-180 mg/dL measured by CGM in CLC group vs. SAP group.
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
CGM Time Above 180
Description
CGM-measured % above 180 mg/dL
Time Frame
26 weeks
Title
CGM Mean Glucose
Description
CGM-measured mean glucose
Time Frame
26 weeks
Title
HbA1c at 26 Weeks
Description
Hemoglobin A1c measured at 26 weeks
Time Frame
26 weeks
Title
CGM Time Below 70
Description
CGM-measured % below 70 mg/dL
Time Frame
26 weeks
Title
CGM Time Below 54
Description
CGM-measured % below 54 mg/dL
Time Frame
26 weeks
Title
CGM Time in Range 70-140 mg/dL
Description
CGM-measured % in range 70-140 mg/dL
Time Frame
26 weeks
Title
Coefficient of Variability
Description
CGM measured glucose variability measured with the coefficient of variation (CV)
Time Frame
26 weeks
Title
Standard Deviation of CGM
Description
CGM measured glucose variability measured with the standard deviation (SD)
Time Frame
26 weeks
Title
CGM Time Below 60
Description
CGM-measured % below 60 mg/dL
Time Frame
26 weeks
Title
LBGI
Description
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)
Time Frame
26 weeks
Title
CGM Hypoglycemia Events
Description
CGM-measured events of at least 15 consecutive minutes <70mg/dL per week
Time Frame
26 weeks
Title
CGM Time >250
Description
CGM-measured % >250 mg/dL
Time Frame
26 weeks
Title
CGM Time >300
Description
CGM-measured % >300 mg/dL
Time Frame
26 weeks
Title
HBGI
Description
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)
Time Frame
26 weeks
Title
Number of Participants With HbA1c <7.0% at 26 Weeks
Description
Number of participants HbA1c <7.0% at 26 weeks
Time Frame
26 weeks
Title
Number of Participants With HbA1c <7.5% at 26 Weeks
Description
Number of Participants with HbA1c <7.5% at 26 weeks
Time Frame
26 weeks
Title
Number of Participants With HbA1c Improvement From Baseline to 26 Weeks >0.5%
Description
HbA1c improvement from baseline to 26 weeks >0.5%
Time Frame
26 weeks
Title
Number of Participants With HbA1c Improvement From Baseline to 26 Weeks >1.0%
Description
HbA1c improvement from baseline to 26 weeks >1.0%
Time Frame
26 weeks
Title
HbA1c Relative Improvement From Baseline to 26 Weeks >10%
Description
HbA1c relative improvement from baseline to 26 weeks >10%
Time Frame
26 weeks
Title
Number of Participants With HbA1c Improvement From Baseline to 26 Weeks >1.0% or HbA1c <7.0% at 26 Weeks
Description
HbA1c improvement from baseline to 26 weeks >1.0% or HbA1c <7.0% at 26 weeks
Time Frame
26 weeks
Title
HFS-II
Description
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.
Time Frame
26 weeks
Title
Hyperglycemia Avoidance Scale
Description
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.
Time Frame
26 weeks
Title
Diabetes Distress Scale
Description
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.
Time Frame
26 weeks
Title
Hypoglycemia Confidence Scale
Description
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.
Time Frame
26 weeks
Title
Clarke Hypoglycemia Awareness Scores
Description
Clarke Hypoglycemia Awareness Scores (0-7 score with higher scores associated with impaired awareness)
Time Frame
26 weeks
Title
INSPIRE Survey Scores
Description
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.
Time Frame
26 weeks
Title
System Usability Scores (SUS)
Description
System Usability Scores (SUS)-composite score from 0 to 100 with higher scores indicate better perceived usability
Time Frame
26 weeks
Title
Technology Acceptance Questionnaire
Description
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.
Time Frame
26 weeks
Title
Total Daily Insulin
Description
Total Daily Insulin (units)
Time Frame
26 weeks
Title
Basal:Bolus Insulin Ratio
Description
Basal:Bolus Insulin Ratio
Time Frame
26 weeks
Title
Weight
Description
Weight (kg)
Time Frame
26 weeks
Title
BMI
Description
Body Mass Index (BMI) kg/m^2
Time Frame
26 weeks
Other Pre-specified Outcome Measures:
Title
Number of Participants With Severe Hypoglycemia (Per Protocol)
Description
Severe hypoglycemia (per protocol)
Time Frame
26 weeks
Title
Number of Participants With Diabetic Ketoacidosis (Per Protocol)
Description
Diabetic ketoacidosis (per protocol)
Time Frame
26 weeks
Title
Ketone Events Defined as Day With Ketone Level >1.0 mmol/L
Description
Ketone events defined as day with ketone level >1.0 mmol/L
Time Frame
26 weeks
Title
CGM-measured Hypoglycemic Events (>15 Minutes With Glucose Concentration <54 mg/dL)
Description
CGM-measured hypoglycemic events (>15 minutes with glucose concentration <54 mg/dL)
Time Frame
26 weeks
Title
CGM-measured Hyperglycemic Events (>15 Minutes With Glucose Concentration >300 mg/dL)
Description
CGM-measured hyperglycemic events (>15 minutes with glucose concentration >300 mg/dL)
Time Frame
26 weeks
Title
BG-measured Hypoglycemic Events (One BG Record <54 mg/dL)
Description
BG-measured hypoglycemic events (one BG record <54 mg/dL)
Time Frame
26 weeks
Title
BG-measured Hyperglycemic Events (One BG Record >350 mg/dL)
Description
BG-measured hyperglycemic events (one BG record >350 mg/dL)
Time Frame
26 weeks
Title
Worsening of HbA1c From Baseline to 26 Weeks by >0.5%
Description
Worsening of HbA1c from baseline to 26 weeks by >0.5%
Time Frame
26 weeks
Title
Other Serious Adverse Events (SAE) and Serious Adverse Device Events (SADE)
Description
Other serious adverse events (SAE) and serious adverse device events (SADE)
Time Frame
26 weeks
Title
Adverse Device Effects (ADE)
Description
Adverse device effects (ADE)
Time Frame
26 weeks
Title
Unanticipated Adverse Device Effects (UADE)
Description
Unanticipated adverse device effects (UADE)
Time Frame
26 weeks
Title
Number of Participants With SH Events
Description
For this outcome, mean +/- SD or summary statistics appropriate to the distribution will be tabulated by treatment group
Time Frame
26 weeks
Title
SH Event Rate Per 100 Person-years
Description
For this outcome, severe hypoglycemia event rate per 100 person-years will be calculated as a rate.
Time Frame
26 weeks
Title
Number of Participants With DKA Events
Description
For this outcome, number of participants with diabetic ketoacidosis (DKA) will be tabulated.
Time Frame
26 weeks
Title
DKA Event Rate Per 100 Person-years
Description
For this outcome, the diabetic ketoacidosis event rate per 100 person-years will be calculated as a rate.
Time Frame
26 weeks
Title
Any Adverse Event Rate Per 100 Person-years
Description
For this outcome, the adverse event rate per 100 person-years calculated as a rate.
Time Frame
26 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 1 year.
Familiarity and use of a carbohydrate ratio for meal boluses.
Age ≥14.0 years old.
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.
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.
Willingness to suspend use of any personal CGM for the duration of the clinical trial once the study CGM is in use.
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
Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol.
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.
Total daily insulin dose (TDD) at least 10 U/day.
Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial.
Exclusion Criteria
Concurrent use of any non-insulin glucose-lowering agent other than metformin (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas).
Hemophilia or any other bleeding disorder.
A condition, which in the opinion of the investigator or designee, would put the participant or study at risk.
Participation in another pharmaceutical or device trial at the time of enrollment or during the study.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sue A. Brown, MD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sansum Diabetes Research Institute
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Barbara Davis Center, University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Harvard University (Joslin Diabetes Center)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
University of Virginia Center for Diabetes Technology
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
Generally, data will be made available after the primary publications of each study.
IPD Sharing 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.
Citations:
PubMed Identifier
35104166
Citation
Kanapka LG, Lum JW, Beck RW. Insulin Pump Infusion Set Failures Associated with Prolonged Hyperglycemia: Frequency and Relationship to Age and Type of Infusion Set During 22,741 Infusion Set Wears. Diabetes Technol Ther. 2022 Jun;24(6):396-402. doi: 10.1089/dia.2021.0548. Epub 2022 Feb 23.
Results Reference
derived
PubMed Identifier
35020488
Citation
Ekhlaspour L, Town M, Raghinaru D, Lum JW, Brown SA, Buckingham BA. Glycemic Outcomes in Baseline Hemoglobin A1C Subgroups in the International Diabetes Closed-Loop Trial. Diabetes Technol Ther. 2022 Aug;24(8):588-591. doi: 10.1089/dia.2021.0524. Epub 2022 Feb 8.
Results Reference
derived
PubMed Identifier
34115959
Citation
Kudva YC, Laffel LM, Brown SA, Raghinaru D, Pinsker JE, Ekhlaspour L, Levy CJ, Messer LH, Kovatchev BP, Lum JW, Beck RW, Gonder-Frederick L; iDCL Trial Research Group. Patient-Reported Outcomes in a Randomized Trial of Closed-Loop Control: The Pivotal International Diabetes Closed-Loop Trial. Diabetes Technol Ther. 2021 Oct;23(10):673-683. doi: 10.1089/dia.2021.0089.
Results Reference
derived
PubMed Identifier
33216667
Citation
Isganaitis E, Raghinaru D, Ambler-Osborn L, Pinsker JE, Buckingham BA, Wadwa RP, Ekhlaspour L, Kudva YC, Levy CJ, Forlenza GP, Beck RW, Kollman C, Lum JW, Brown SA, Laffel LM; iDCL Trial Research Group. Closed-Loop Insulin Therapy Improves Glycemic Control in Adolescents and Young Adults: Outcomes from the International Diabetes Closed-Loop Trial. Diabetes Technol Ther. 2021 May;23(5):342-349. doi: 10.1089/dia.2020.0572. Epub 2021 Jan 21.
Results Reference
derived
PubMed Identifier
33155824
Citation
O'Malley G, Messer LH, Levy CJ, Pinsker JE, Forlenza GP, Isganaitis E, Kudva YC, Ekhlaspour L, Raghinaru D, Lum J, Brown SA; iDCL Trial Research Group. Clinical Management and Pump Parameter Adjustment of the Control-IQ Closed-Loop Control System: Results from a 6-Month, Multicenter, Randomized Clinical Trial. Diabetes Technol Ther. 2021 Apr;23(4):245-252. doi: 10.1089/dia.2020.0472.
Results Reference
derived
PubMed Identifier
31618560
Citation
Brown SA, Kovatchev BP, Raghinaru D, Lum JW, Buckingham BA, Kudva YC, Laffel LM, Levy CJ, Pinsker JE, Wadwa RP, Dassau E, Doyle FJ 3rd, Anderson SM, Church MM, Dadlani V, Ekhlaspour L, Forlenza GP, Isganaitis E, Lam DW, Kollman C, Beck RW; iDCL Trial Research Group. Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes. N Engl J Med. 2019 Oct 31;381(18):1707-1717. doi: 10.1056/NEJMoa1907863. Epub 2019 Oct 16.
Results Reference
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Learn more about this trial
The International Diabetes Closed Loop (iDCL) Trial: Clinical Acceptance of the Artificial Pancreas
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