Type 1 Diabetes MellitusDCLP3NCT03563313
The International Diabetes Closed Loop (iDCL) Trial: Clinical Acceptance of the Artificial Pancreas
A study testing Sensor-augmented pump (SAP) in people with Type 1 Diabetes Mellitus, run by University of Virginia at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Sensor-augmented pump (SAP)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 7 sitesUnited States
- Study dates
- 28 Jun 2018to 8 Apr 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Barbara Davis Center, University of Colorado
Aurora, Colorado, 80045
Harvard University (Joslin Diabetes Center)
Boston, Massachusetts, 02215
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, 22903
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Mayo Clinic
Rochester, Minnesota, 55902
Sansum Diabetes Research Institute
Santa Barbara, California, 93105
Stanford University
Stanford, California, 94304
About this study
Official title: A Pivotal Study of t:Slim X2 With Control-IQ Technology
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.
Read the 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.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- t:slim X2 with Control-IQ Technology & Dexcom G6 CGM, Sensor-augmented pump (SAP)
- Keywords
- Artificial Pancreas (AP), Type 1 Diabetes Mellitus, Insulin Pump, Continuous Glucose Monitor (CGM), Closed Loop Control (CLC), Sensor-Augmented Pump (SAP)
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
t:slim X2 with Control-IQ Technology & Dexcom G6 CGMDevice
Participants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home.
Sensor-augmented pump (SAP)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Closed Loop Control (CLC) | Experimental | 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. Receives: Device: t:slim X2 with Control-IQ Technology & Dexcom G6 CGM |
| Sensor-Augmented Pump (SAP) | Active comparator | 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. Receives: Device: Sensor-augmented pump (SAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 26 weeks
Secondary outcomes (32)
CGM Time Above 180
CGM-measured % above 180 mg/dL
Measured: 26 weeks
CGM Mean Glucose
CGM-measured mean glucose
Measured: 26 weeks
HbA1c at 26 Weeks
Hemoglobin A1c measured at 26 weeks
Measured: 26 weeks
CGM Time Below 70
CGM-measured % below 70 mg/dL
Measured: 26 weeks
CGM Time Below 54
CGM-measured % below 54 mg/dL
Measured: 26 weeks
CGM Time in Range 70-140 mg/dL
CGM-measured % in range 70-140 mg/dL
Measured: 26 weeks
Coefficient of Variability
CGM measured glucose variability measured with the coefficient of variation (CV)
Measured: 26 weeks
Standard Deviation of CGM
CGM measured glucose variability measured with the standard deviation (SD)
Measured: 26 weeks
CGM Time Below 60
CGM-measured % below 60 mg/dL
Measured: 26 weeks
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)
Measured: 26 weeks
CGM Hypoglycemia Events
CGM-measured events of at least 15 consecutive minutes <70mg/dL per week
Measured: 26 weeks
CGM Time >250
CGM-measured % >250 mg/dL
Measured: 26 weeks
CGM Time >300
CGM-measured % >300 mg/dL
Measured: 26 weeks
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)
Measured: 26 weeks
Number of Participants With HbA1c <7.0% at 26 Weeks
Number of participants HbA1c <7.0% at 26 weeks
Measured: 26 weeks
Number of Participants With HbA1c <7.5% at 26 Weeks
Number of Participants with HbA1c <7.5% at 26 weeks
Measured: 26 weeks
Number of Participants With HbA1c Improvement From Baseline to 26 Weeks >0.5%
HbA1c improvement from baseline to 26 weeks >0.5%
Measured: 26 weeks
Number of Participants With HbA1c Improvement From Baseline to 26 Weeks >1.0%
HbA1c improvement from baseline to 26 weeks >1.0%
Measured: 26 weeks
HbA1c Relative Improvement From Baseline to 26 Weeks >10%
HbA1c relative improvement from baseline to 26 weeks >10%
Measured: 26 weeks
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
Measured: 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.
Measured: 26 weeks
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.
Measured: 26 weeks
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.
Measured: 26 weeks
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.
Measured: 26 weeks
Clarke Hypoglycemia Awareness Scores
Clarke Hypoglycemia Awareness Scores (0-7 score with higher scores associated with impaired awareness)
Measured: 26 weeks
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.
Measured: 26 weeks
System Usability Scores (SUS)
System Usability Scores (SUS)-composite score from 0 to 100 with higher scores indicate better perceived usability
Measured: 26 weeks
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.
Measured: 26 weeks
Total Daily Insulin
Total Daily Insulin (units)
Measured: 26 weeks
Basal:Bolus Insulin Ratio
Basal:Bolus Insulin Ratio
Measured: 26 weeks
Weight
Weight (kg)
Measured: 26 weeks
BMI
Body Mass Index (BMI) kg/m^2
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2018
- Study start28 Jun 2018
- Primary completion8 Apr 2019
- Study completion8 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled trial of 6 month at home closed loop system vs. sensor-augmented pump.
- Masking
- None (open label)
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Jaeb Center for Health Research, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Tandem Diabetes Care, Inc., DexCom, Inc., Roche Diagnostics GmbH
- Responsible party
- Principal investigator, Sue Brown, University of Virginia
- Investigators
- Sue A. Brown, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03563313
- Sponsor's protocol ID
- DCLP3
- Other IDs
- UC4DK108483
- Acronym
- DCLP3
- Status last verified
- Apr 2020
- First submitted
- 7 Jun 2018
- Last updated
- 28 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Will follow the NIH Data Sharing Policy and Implementation Guidance on sharing research resources for research purposes to qualified individuals within the scientific community.
Publications
Beck RW, Kanapka LG, Breton MD, Brown SA, Wadwa RP, Buckingham BA, Kollman C, Kovatchev B. A Meta-Analysis of Randomized Trial Outcomes for the t:slim X2 Insulin Pump with Control-IQ Technology in Youth and Adults from Age 2 to 72. Diabetes Technol Ther. 2023 May;25(5):329-342. doi: 10.1089/dia.2022.0558. Epub 2023 Apr 12.
PubMed 37067353Kanapka 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.
PubMed 35104166Ekhlaspour 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.
PubMed 35020488Kudva 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.
PubMed 34115959Isganaitis 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.
PubMed 33216667O'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.
PubMed 33155824Brown 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.
PubMed 31618560
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pivotal Study of t:Slim X2 With Control-IQ Technology
- ClinicalTrials.gov ID
- NCT03563313
- Acronym / sponsor ID
- DCLP3 / DCLP3
- Conditions
- 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)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Jaeb Center for Health Research, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Tandem Diabetes Care, Inc., DexCom, Inc., Roche Diagnostics GmbH
- Study start
- 28 Jun 2018 (actual)
- Primary completion
- 8 Apr 2019 (actual)
- Study completion
- 8 Apr 2019 (actual)
- First posted
- 20 Jun 2018 (actual)
- Results
- Posted 28 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized controlled trial of 6 month at home closed loop system vs. sensor-augmented pump.
| Arm | Type | Receives |
|---|---|---|
| Closed Loop Control (CLC) | Experimental | Device: t:slim X2 with Control-IQ Technology & Dexcom G6 CGMParticipants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months. |
| Sensor-Augmented Pump (SAP) | Active comparator | Device: 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. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| t:slim X2 with Control-IQ Technology & Dexcom G6 CGMParticipants will use the Tandem t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 6 months at home. | Device | Closed Loop Control (CLC) |
| 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. | Device | Sensor-Augmented Pump (SAP) |
Primary outcome
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.
32 secondary outcomes
CGM Time Above 180
Time frame: 26 weeks
CGM Mean Glucose
Time frame: 26 weeks
HbA1c at 26 Weeks
Time frame: 26 weeks
CGM Time Below 70
Time frame: 26 weeks
CGM Time Below 54
Time frame: 26 weeks
CGM Time in Range 70-140 mg/dL
Time frame: 26 weeks
Coefficient of Variability
Time frame: 26 weeks
Standard Deviation of CGM
Time frame: 26 weeks
CGM Time Below 60
Time frame: 26 weeks
LBGI
Time frame: 26 weeks
CGM Hypoglycemia Events
Time frame: 26 weeks
CGM Time >250
Time frame: 26 weeks
CGM Time >300
Time frame: 26 weeks
HBGI
Time frame: 26 weeks
Number of Participants With HbA1c <7.0% at 26 Weeks
Time frame: 26 weeks
Number of Participants With HbA1c <7.5% at 26 Weeks
Time frame: 26 weeks
Number of Participants With HbA1c Improvement From Baseline to 26 Weeks >0.5%
Time frame: 26 weeks
Number of Participants With HbA1c Improvement From Baseline to 26 Weeks >1.0%
Time frame: 26 weeks
HbA1c Relative Improvement From Baseline to 26 Weeks >10%
Time frame: 26 weeks
Number of Participants With HbA1c Improvement From Baseline to 26 Weeks >1.0% or HbA1c <7.0% at 26 Weeks
Time frame: 26 weeks
HFS-II
Time frame: 26 weeks
Hyperglycemia Avoidance Scale
Time frame: 26 weeks
Diabetes Distress Scale
Time frame: 26 weeks
Hypoglycemia Confidence Scale
Time frame: 26 weeks
Clarke Hypoglycemia Awareness Scores
Time frame: 26 weeks
INSPIRE Survey Scores
Time frame: 26 weeks
System Usability Scores (SUS)
Time frame: 26 weeks
Technology Acceptance Questionnaire
Time frame: 26 weeks
Total Daily Insulin
Time frame: 26 weeks
Basal:Bolus Insulin Ratio
Time frame: 26 weeks
Weight
Time frame: 26 weeks
BMI
Time frame: 26 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37067353Beck RW, Kanapka LG, Breton MD, Brown SA, Wadwa RP, Buckingham BA, Kollman C, Kovatchev B. A Meta-Analysis of Randomized Trial Outcomes for the t:slim X2 Insulin Pump with Control-IQ Technology in Youth and Adults from Age 2 to 72. Diabetes Technol Ther. 2023 May;25(5):329-342. doi: 10.1089/dia.2022.0558. Epub 2023 Apr 12.
- Derived from this study: PubMed 35104166Kanapka 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.
- Derived from this study: PubMed 35020488Ekhlaspour 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.
- Derived from this study: PubMed 34115959Kudva 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.
- Derived from this study: PubMed 33216667Isganaitis 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.
- Derived from this study: PubMed 33155824O'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.
- Derived from this study: PubMed 31618560Brown 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.
- Individual participant dataSharing planned: Yes. Will follow the NIH Data Sharing Policy and Implementation Guidance on sharing research resources for research purposes to qualified individuals within the scientific community.
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Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sue A. Brown, MD principal investigator
University of Virginia
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensor-augmented pump (SAP) in people with Type 1 Diabetes Mellitus, run by University of Virginia at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in Target Range (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03563313, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2020.