Back to resultsThe International Diabetes Closed Loop (iDCL) Trial: Clinical Acceptance of the Artificial Pancreas (DCLP3 Extension)
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
t:slim X2 with Basal-IQ & Dexcom G6 CGM
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:
- Successful completion of the original 6-month RCT within the prior 14 days
- 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.
- 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 not use a personal CGM for the duration of the study
- Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol
- Willingness to use only lispro (Humalog) or aspart (Novolog), and to use no other insulin during the study.
- 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., 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
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)
Predictive-Low Glucose Suspend (PLGS)
Arm Description
Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology & Dexcom G6 Continuous Glucose Monitor (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 sensor-augmented pump (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.
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.
Outcomes
Primary Outcome Measures
Time in Target Range
The primary exploratory outcome is time in target range 70-180 mg/dL measured by CGM comparing the randomized groups CLC vs PLGS. Results from SAP to CLC group is also included here without the primary intention of comparing to CLC vs PLGS groups.
Secondary Outcome Measures
CGM Time Above 180
CGM-measured % above 180 mg/dL
CGM Mean Glucose
CGM-measured mean glucose
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 Variation
CGM measured glucose variability measured with the coefficient of variation (CV)
Standard Deviation
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 <70 mg/dL
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)
HbA1c at 13 Weeks
HbA1c at 13 weeks.
HbA1c <7.0% at 13 Weeks
HbA1c <7.0% at 13 weeks.
HbA1c <7.5% at 13 Weeks
HbA1c <7.5% at 13 weeks.
HbA1c Change From Baseline to 13 Weeks >0.5%
HbA1c change from baseline to 13 weeks >0.5%.
HbA1c Change From Baseline to 13 Weeks >1.0%
HbA1c change from baseline to 13 weeks >1.0%.
HbA1c Relative Change From Baseline to 13 Weeks >10%
HbA1c relative change from baseline to 13 weeks >10%.
HbA1c Change From Baseline to 13 Weeks >1.0% or HbA1C <7.0% at 13 Weeks
HbA1c change from baseline to 13 weeks >1.0% or HbA1c <7.0% at 13 weeks.
HFS-II Adult
Fear of Hypoglycemia Survey (HFS-II) total score and 3 sub scales (5 point scale with never to almost always)
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.
HFS-II Teen
Fear of Hypoglycemia Survey (HFS-II) total score and 3 sub scales (5 point scale with never to almost always)
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.The teen survey has a total of 25 items and the range of Total scores is 0 to 100.
HFS-II Parents
Fear of Hypoglycemia Survey (HFS-II) total score and 3 sub scales (5 point scale with never to almost always)
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 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 9 items which are self-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- Adults
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.
INSPIRE Survey Scores- Teens
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 Teens/Adolescents survey has 17 items.
INSPIRE Survey Scores- Parents
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 Parent survey has 21 items.
System Usability Scores (SUS)
System Usability Scores (SUS)-composite score from 0 to 100 with higher scores indicating 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/kg)
Basal:Bolus Insulin Ratio
Basal:Bolus Insulin Ratio.
Weight
Weight (kg)
BMI
Body Mass Index (BMI) kg/m2
Full Information
NCT ID
NCT03591354
First Posted
June 19, 2018
Last Updated
August 29, 2022
Sponsor
University of Virginia
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Jaeb Center for Health Research, Tandem Diabetes Care, Inc., DexCom, Inc., Roche Diagnostics
1. Study Identification
Unique Protocol Identification Number
NCT03591354
Brief Title
The International Diabetes Closed Loop (iDCL) Trial: Clinical Acceptance of the Artificial Pancreas (DCLP3 Extension)
Official Title
An Extension Study of t:Slim X2 With Control-IQ Technology
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
January 17, 2019 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
March 9, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Jaeb Center for Health Research, 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
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.
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 randomized controlled trial (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
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 3 months at home closed loop system vs. predictive-low glucose suspend.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
164 (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 Continuous Glucose Monitor (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 sensor-augmented pump (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.
Arm Title
Predictive-Low Glucose Suspend (PLGS)
Arm Type
Active Comparator
Arm Description
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.
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 insulin pump with Control-IQ Technology & Dexcom G6 CGM for 3 months.
Intervention Type
Device
Intervention Name(s)
t:slim X2 with Basal-IQ & Dexcom G6 CGM
Intervention Description
Participants will use a Tandem t:slim X2 insulin pump with Basal-IQ and a study CGM (Dexcom G6) for 3 months.
Primary Outcome Measure Information:
Title
Time in Target Range
Description
The primary exploratory outcome is time in target range 70-180 mg/dL measured by CGM comparing the randomized groups CLC vs PLGS. Results from SAP to CLC group is also included here without the primary intention of comparing to CLC vs PLGS groups.
Time Frame
13 weeks
Secondary Outcome Measure Information:
Title
CGM Time Above 180
Description
CGM-measured % above 180 mg/dL
Time Frame
13 weeks
Title
CGM Mean Glucose
Description
CGM-measured mean glucose
Time Frame
13 weeks
Title
CGM Time Below 70
Description
CGM-measured % below 70 mg/dL
Time Frame
13 weeks
Title
CGM Time Below 54
Description
CGM-measured % below 54 mg/dL
Time Frame
13 weeks
Title
CGM Time in Range 70-140 mg/dL
Description
CGM-measured % in range 70-140 mg/dL
Time Frame
13 weeks
Title
Coefficient of Variation
Description
CGM measured glucose variability measured with the coefficient of variation (CV)
Time Frame
13 weeks
Title
Standard Deviation
Description
CGM measured glucose variability measured with the standard deviation (SD)
Time Frame
13 weeks
Title
CGM Time Below 60
Description
CGM-measured % below 60 mg/dL
Time Frame
13 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
13 weeks
Title
CGM Hypoglycemia Events
Description
CGM-measured events of at least 15 consecutive minutes <70 mg/dL
Time Frame
13 weeks
Title
CGM Time >250
Description
CGM-measured % >250 mg/dL
Time Frame
13 weeks
Title
CGM Time >300
Description
CGM-measured % >300 mg/dL
Time Frame
13 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
13 weeks
Title
HbA1c at 13 Weeks
Description
HbA1c at 13 weeks.
Time Frame
13 weeks
Title
HbA1c <7.0% at 13 Weeks
Description
HbA1c <7.0% at 13 weeks.
Time Frame
13 weeks
Title
HbA1c <7.5% at 13 Weeks
Description
HbA1c <7.5% at 13 weeks.
Time Frame
13 weeks
Title
HbA1c Change From Baseline to 13 Weeks >0.5%
Description
HbA1c change from baseline to 13 weeks >0.5%.
Time Frame
13 weeks
Title
HbA1c Change From Baseline to 13 Weeks >1.0%
Description
HbA1c change from baseline to 13 weeks >1.0%.
Time Frame
13 weeks
Title
HbA1c Relative Change From Baseline to 13 Weeks >10%
Description
HbA1c relative change from baseline to 13 weeks >10%.
Time Frame
13 weeks
Title
HbA1c Change From Baseline to 13 Weeks >1.0% or HbA1C <7.0% at 13 Weeks
Description
HbA1c change from baseline to 13 weeks >1.0% or HbA1c <7.0% at 13 weeks.
Time Frame
13 weeks
Title
HFS-II Adult
Description
Fear of Hypoglycemia Survey (HFS-II) total score and 3 sub scales (5 point scale with never to almost always)
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.
Time Frame
13 weeks
Title
HFS-II Teen
Description
Fear of Hypoglycemia Survey (HFS-II) total score and 3 sub scales (5 point scale with never to almost always)
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.The teen survey has a total of 25 items and the range of Total scores is 0 to 100.
Time Frame
13 weeks
Title
HFS-II Parents
Description
Fear of Hypoglycemia Survey (HFS-II) total score and 3 sub scales (5 point scale with never to almost always)
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 parent version of the survey has a total of 26 items with Total scores that range from 0 to 108.
Time Frame
13 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
13 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
13 weeks
Title
Hypoglycemia Confidence Scale
Description
Hypoglycemia Confidence Scale has 9 items which are self-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
13 weeks
Title
Clarke Hypoglycemia Awareness Scores
Description
Clarke Hypoglycemia Awareness Scores (0-7 score with higher scores associated with impaired awareness)
Time Frame
13 weeks
Title
INSPIRE Survey Scores- Adults
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.
Time Frame
13 weeks
Title
INSPIRE Survey Scores- Teens
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 Teens/Adolescents survey has 17 items.
Time Frame
13 weeks
Title
INSPIRE Survey Scores- Parents
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 Parent survey has 21 items.
Time Frame
13 weeks
Title
System Usability Scores (SUS)
Description
System Usability Scores (SUS)-composite score from 0 to 100 with higher scores indicating better perceived usability
Time Frame
13 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
13 weeks
Title
Total Daily Insulin
Description
Total Daily Insulin (units/kg)
Time Frame
13 weeks
Title
Basal:Bolus Insulin Ratio
Description
Basal:Bolus Insulin Ratio.
Time Frame
13 weeks
Title
Weight
Description
Weight (kg)
Time Frame
13 weeks
Title
BMI
Description
Body Mass Index (BMI) kg/m2
Time Frame
13 weeks
Other Pre-specified Outcome Measures:
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
13 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
13 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
13 weeks
Title
Worsening of HbA1c From Randomization to 13 Weeks by >0.5%
Description
Worsening of HbA1c from randomization to 13 weeks by >0.5%.
Time Frame
13 weeks
Title
Serious Adverse Events With a Possible or Greater Relationship to a Study Device (Including Anticipated and Unanticipated Adverse Device Effects)
Description
Serious adverse events with a possible or greater relationship to a study device (including anticipated and unanticipated adverse device effects).
Time Frame
13 weeks
Title
Adverse Device Effects (ADE) That do Not Meet Criteria for SAE
Description
Adverse device effects (ADE) that do not meet criteria for SAE.
Time Frame
13 weeks
Title
Other Serious Adverse Events Not Related to a Study Device
Description
Other serious adverse events not related to a study device.
Time Frame
13 weeks
Title
Severe Hypoglycemic Events
Description
Number of Severe Hypoglycemic events over initial 13 weeks of trial
Time Frame
13 weeks
Title
Severe Hypoglycemic Event Rate Per 100 Person-years
Description
Number of severe hypoglycemic events per 100 person-years over initial 13 weeks of trial
Time Frame
13 weeks
Title
Diabetic Ketoacidosis (DKA) Events
Description
Number of DKA events over initial 13 weeks of trial
Time Frame
13 weeks
Title
Diabetic Ketoacidosis (DKA) Event Rate Per 100 Person-years
Description
Number of DKA events per 100 person-years over initial 13 weeks
Time Frame
13 weeks
Title
Any Adverse Event Rate Per 100 Person-years
Description
Number of adverse events per 100 person-years over initial 13 weeks
Time Frame
13 weeks
Title
Time in Target Range From Months 4-12
Description
CGM time in target range 70-180mg/dL for all participants using CLC from Months 4-12.
Time Frame
Months 4-12
Title
CGM Time Above 180 From Months 4-12
Description
CGM-measured % above 180mg/dL from Months 4-12
Time Frame
Months 4-12
Title
CGM Mean Glucose From Months 4-12
Description
CGM-measured mean glucose from Months 4-12
Time Frame
Months 4-12
Title
CGM Time Below 70 From Months 4-12
Description
CGM-measured % below 70 mg/dL from Months 4-12
Time Frame
Months 4-12
Title
CGM Time Below 54 From Months 4-12
Description
CGM-measured % time below 54mg/dL from Months 4-12
Time Frame
Months 4-12
Title
CGM Time in Range 70-140 mg/dL From Months 4-12
Description
CGM-measured % time in range 70-140mg/dL from Months 4-12
Time Frame
Months 4-12
Title
Coefficient of Variation From Months 4-12
Description
CGM measured glucose variability measured with the coefficient of variation from Months 4-12
Time Frame
Months 4-12
Title
Standard Deviation From Months 4-12
Description
CGM measured glucose variability measured with the standard deviation (SD) from Months 4-12
Time Frame
Months 4-12
Title
CGM Time Below 60 From Months 4-12
Description
CGM-measured % below 60mg/dL from Months 4-12
Time Frame
Months 4-12
Title
LBGI From Months 4-12
Description
LBGI from Months 4-12. 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
Months 4-12
Title
HBGI From Months 4-12
Description
HBGI from Months 4-12. 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
Months 4-12
Title
CGM Hypoglycemia Events From Months 4-12
Description
CGM-measured events of at least 15 consecutive minutes <70mg/dL from Months 4-12
Time Frame
Months 4-12
Title
CGM Time >250 From Months 4-12
Description
CGM-measured % time >250 mg/dL from Months 4-12
Time Frame
Months 4-12
Title
CGM Time >300 From Months 4-12
Description
CGM-measured % time >300 mg/dL from Months 4-12
Time Frame
Months 4-12
Title
HbA1c at Month 6
Description
HbA1c measured at Month 6 of this extension study
Time Frame
Month 6 of study
Title
HbA1c at Month 9
Description
HbA1c measured at month 9 of this extension study
Time Frame
Month 9 of study
Title
HbA1c at Month 12
Description
HbA1c measured at Month 12 of this extension study
Time Frame
Month 12 of study
Title
Ketone Events Defined as Days With Ketone Level >1.0 mmol/L From Months 4-12
Description
Ketone Events Defined as Number of Days with at least one Ketone Level >1.0 mmol/L from Months 4-12
Time Frame
Months 4-12
Title
CGM-measured Hypoglycemia Events (>15 Minutes With Glucose Concentration <54mg/dL) From Months 4-12
Description
CGM-measured Hypoglycemia Events (>15 minutes with glucose concentration <54mg/dL) from Months 4-12 measured as a rate per week.
Time Frame
Months 4-12
Title
CGM-measured Hyperglycemic Events From Months 4-12
Description
CGM-measured Hyperglycemic Events (>15 consecutive minutes with CGM glucose >300mg/dL) from Months 4-12
Time Frame
Months 4-12
Title
Number of Severe Hypoglycemic Events From Months 4-12
Description
Number of Severe Hypoglycemic Events from Months 4-12.
Time Frame
Months 4-12
Title
Number of Diabetic Ketoacidosis (DKA) Events From Months 4-12
Description
Number of Diabetic Ketoacidosis (DKA) events from Months 4-12.
Time Frame
Months 4-12
Title
Other Serious Adverse Events Not Related to a Study Device From Months 4-12
Description
Other Serious Adverse Events Not Related to a Study Device from Months 4-12.
Time Frame
Months 4-12
Title
Any Adverse Event Rate Per 100 Person-years From Months 4-12
Description
Any Adverse Event Rate per 100 person-years from Months 4-12.
Time Frame
Months 4-12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Successful completion of the original 6-month RCT within the prior 14 days
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.
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 not use a personal CGM for the duration of the study
Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol
Willingness to use only lispro (Humalog) or aspart (Novolog), and to use no other insulin during the study.
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., 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sue 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
55905
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
35099294
Citation
Levy CJ, O'Malley G, Raghinaru D, Kudva YC, Laffel LM, Pinsker JE, Lum JW, Brown SA; iDCL Trial Research Group. Insulin Delivery and Glucose Variability Throughout the Menstrual Cycle on Closed Loop Control for Women with Type 1 Diabetes. Diabetes Technol Ther. 2022 May;24(5):357-361. doi: 10.1089/dia.2021.0431. Epub 2022 Feb 21.
Results Reference
derived
Learn more about this trial
The International Diabetes Closed Loop (iDCL) Trial: Clinical Acceptance of the Artificial Pancreas (DCLP3 Extension)
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