Type 1 Diabetes MellitusDCLP5NCT03844789

A Study of t:Slim X2 With Control-IQ Technology

A study of Type 1 Diabetes Mellitus, run by University of Virginia at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 6 to 13 years
Conditions the study is for: Type 1 Diabetes Mellitus
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 101 participants
Where: 4 sitesUnited States
Study dates: 6 Jun 2019to 20 Mar 2020
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 6 to 13 years
All sexes
No healthy volunteers
Child

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 6 months
Familiarity and use of a carbohydrate ratio for meal boluses.
Age ≥ 6 and ≤ 13 years old
Weight ≥25 kg and ≤140 kg
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.
Living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff.

Show all 15Show fewer

Willingness to suspend use of any personal closed loop system that they use at home for the duration of the clinical trial once the study CGM is in use
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 for participants using to t:slim X2. This includes:
Participants randomized to Control IQ
Participants on the SAP group on MDI treatment that will be provided a Tandem pump to switch to CSII
Participates that are already in Continuous Subcutaneous Insulin Infusion (CSII) randomized to SAP during the extension phase when transition to Control IQ
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
Participant and parent(s)/guardian(s) willingness to participate in all training sessions as directed by study staff.

Who cannot join

Concurrent use of any non-insulin glucose-lowering agent other than metformin (including glucagon-like peptide [GLP-1] agonists, Symlin, dipeptidyl peptidase 4 [DPP-4] inhibitors, sodium-glucose cotransporter-2 (SGLT2) 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 (specified on the study procedure manual)
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 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

4 sites in 1 country.

United States4 sites

Barbara Davis Center, University of Colorado
Aurora, Colorado, 80045
UVA Center for Diabetes Technology
Charlottesville, Virginia, 22903
Yale University
New Haven, Connecticut, 06511
Stanford University
Stanford, California, 94304

Other trials in United States

About this study

Official title: The International Diabetes Closed Loop (iDCL) Trial: Clinical Acceptance of the Artificial Pancreas in Pediatrics: A Study of t:Slim X2 With Control-IQ Technology

The purpose of this study is to learn whether an investigational automated insulin delivery system ("study system") for children with type 1 diabetes can safely improve blood glucose (sometimes called blood sugar) control. The system uses continuous glucose monitoring (CGM), an insulin pump, and a software algorithm to automatically give insulin and control blood glucose. This is called a "closed-loop control" system.

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 2-4 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 3:1 to the use of closed-loop control (CLC group) using t:slim X2 with Control-IQ Technology vs. Control Group for 16 weeks. The Control Group will be offered to transition to use CLC and the experimental arm will extend their use of CLC for 12 weeks.

Conditions: Type 1 Diabetes Mellitus
Being tested: t:slim X2 with Control-IQ Technology & Dexcom G6 CGM, Control Group
Keywords: Artificial Pancreas (AP), Control-IQ System, Insulin Pump, Closed Loop Control (CLC), Continuous Glucose Monitor (CGM), Multiple Daily Injections (MDI), 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
Also called Experimental
Eligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM
Control GroupDevice
Also called Sensor-Augmented Pump (SAP)
Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.

Study groups in NCT03844789
Study group	Role	What they receive
Closed Loop Control (CLC)	Experimental	Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 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 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. Receives: Device: t:slim X2 with Control-IQ Technology & Dexcom G6 CGM
Control Group	Active comparator	Eligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 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 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase. Receives: Device: Control Group

What is being measured

The primary outcome is the main question the study is designed to answer.

Continuous Glucose Monitor (CGM)-Measured Percent Time in Range 70-180mg/dL Over 16 Week Trial Period
The primary outcome for the first phase is percent of time participants spent in blood sugar target range 70-180 mg/dL as measured by CGM in Closed Loop Control (CLC) group vs. Control Group. Larger percentages of time spent in this range is considered to be a desirable outcome.
Measured: From randomization to data collection completion at the end of 16 weeks

Secondary outcomes (14)

CGM-Measured Percent of Time Above 180 mg/dL Over 16 Week Trial Period
Continuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. Smaller percentages of CGM-measured time above 180 mg/dL is considered a positive outcome.
Measured: From randomization to data collection completion at the end of 16 weeks
CGM-Measured Mean Glucose Over 16 Week Trial Period
Continuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM metrics were calculated by pooling all CGM readings in the 16-week period starting from the randomization visit up through the 16 week visit. If a participant dropped out before completing the 16-week visit, all available data through the last visit date was included for calculating CGM metrics. Minimum 168 hours of CGM data was required to calculate CGM metrics. Lower mean glucose numbers as measured by CGM in mg/dL is considered a positive outcome.
Measured: From randomization to data collection completion at the end of 16 weeks
Glycated Hemoglobin A1C (HbA1c) Percent at End Of 16 Week Trial Period
Glycated Hemoglobin A1C (HbA1c) is a physiological marker of the percentage of red blood cells that have glycated (bonded with a sugar). HbA1c is used to measure changes in average blood sugar over the past three months. 5-6% is normal, 7% and above is correlated with negative long-term health outcomes.
Measured: At data collection completion at the end of 16 weeks
CGM-measured Percent of Time Below 70 mg/dL Over 16 Week Trial Period
Continuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM measured blood sugar values below 70 mg/dL are considered to be somewhat dangerous due to the possibility of unconsciousness and death at low blood sugar values. Thus, less time spent below 70mg/dL is considered a positive outcome.
Measured: From randomization to data collection completion at the end of 16 weeks
CGM-measured Median and Interquartile Range of Percent of Time Below 54 mg/dL Over 16 Week Trial Period
GM measured blood sugar values below 54 mg/dL have the potential to lead to unconsciousness or death. Thus, less time below 54 mg/dL is considered a better outcome.
Measured: From randomization to data collection completion at the end of 16 weeks
CGM-measured Percent of Time Above 250 mg/dL Over 16 Week Trial Period
CGM measured blood sugar values above 250 mg/dL are considered to be undesirable. Thus, less time spent above 250mg/dL is considered a positive outcome.
Measured: From randomization to data collection completion at the end of 16 weeks
Continuous Glucose Monitor (CGM)-Measured Glucose Variability Measured With the Coefficient of Variation (CV) Over 16 Week Trial Period
Continuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM metrics were calculated by pooling all CGM readings in the 16-week trial period starting from randomization visit to week 16 visit. If a participant drops out before completing the 16-week visit, all available data through the last visit date will be included for calculating CGM metrics. Minimum 168 hours of CGM data were required to calculate CGM metrics. Coefficient of Variability (CV) is the ratio of the standard deviation to the mean of the blood sugar values of each participant as measured by CGM. The reported value is the mean and standard deviation of the participant outcomes multiplied by 100. This shows the extent of the mean variability of the blood sugar values in the population. Higher CV values (up to 100) indicate greater dispersion of CGM values, which would indicate more blood sugar variability, which is considered a negative outcome. Minimum value is 0.
Measured: From randomization to data collection completion at the end of 16 weeks
CGM-measured Percent of Time Above 180 mg/dL Over 12 Week Trial Extension Period
Continuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM metrics were calculated by pooling all CGM readings in the 12-week period starting from the 16 week visit at the end of the main study up through the 28th week visit. If a participant drops out before completing the 28-week visit, all available data through the last visit date will be included for calculating CGM metrics. Minimum 168 hours of CGM data will be required to calculate CGM metrics. Smaller percentages of CGM-measured percentages of time above 180 mg/dL is considered a positive outcome.
Measured: From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks
CGM-measured Mean Glucose Over 12 Week Trial Extension Period
Continuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. Lower mean glucose numbers as measured by CGM in mg/dL is considered a positive outcome.
Measured: From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks
Glycated Hemoglobin Percent (HbA1c) at Conclusion of 12 Week Trial Extension Period
Hemoglobin A1C (HbA1c) is a physiological marker of the percentage of red blood cells that have glycated (bonded with a sugar). HbA1c is used to measure changes in average blood sugar over the past three months. 5-6% is normal, 7% and above is correlated with negative long-term health outcomes.
Measured: At completion of the extension study, end of week 28
CGM-measured Percent of Time Below 70 mg/dL Over 12 Week Trial Extension Period
Continuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM measured blood sugar values below 70 mg/dL are considered to be undesirable. Thus, less time spent below 70mg/dL is considered a positive outcome.
Measured: From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks
CGM-measured Percent of Time Below 54 mg/dL Over 12 Week Trial Extension Period
Continuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM measured blood sugar values below 54 mg/dL have the potential to lead to unconsciousness or death. Thus, time below 54 mg/dL suggests that the person may have been close to danger.
Measured: From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks
CGM-measured Percent of Time Above 250 mg/dL Over 12 Week Trial Extension Period
Continuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM measured blood sugar values above 250 mg/dL are considered to be undesireable. Thus, less time spent above 250mg/dL is considered a positive outcome.
Measured: From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks
Continuous Glucose Monitor (CGM)-Measured Glucose Variability Percentage Measured With the Coefficient of Variation (CV) Over 12 Week Trial Extension Period
Continuous Blood Glucose Monitor (CGM) values are generated every 5 minutes over the course of the study. CGM metrics were calculated by pooling all CGM readings in the 12-week trial extension period starting from 16 week visit to week 28 visit. If a participant drops out before completing the 32-week visit, all available data through the last visit date will be included for calculating CGM metrics. Minimum 168 hours of CGM data were required to calculate CGM metrics. Coefficient of Variability (CV) is the ratio of the standard deviation to the mean of the blood sugar values of each participant as measured by CGM. The reported value is the mean and standard deviation of the participant outcomes multiplied by 100. This shows the extent of the mean variability of the blood sugar values in the study group. Higher CV values (up to 100) indicate greater dispersion of CGM values, which would indicate more blood sugar variability, which is considered a negative outcome. Minimum value is 0.
Measured: From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jun 201920 Mar 2020

First posted18 Feb 2019
Study start6 Jun 2019
Primary completion20 Dec 2019
Study completion20 Mar 2020

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 (8)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
Masking: None (open label)
Enrolment: 101 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03844789
Sponsor's protocol ID: DCLP5
Acronym: DCLP5
Status last verified: Mar 2023
First submitted: 14 Feb 2019
Last updated: 10 Apr 2023
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

Breton MD, Kanapka LG, Beck RW, Ekhlaspour L, Forlenza GP, Cengiz E, Schoelwer M, Ruedy KJ, Jost E, Carria L, Emory E, Hsu LJ, Oliveri M, Kollman CC, Dokken BB, Weinzimer SA, DeBoer MD, Buckingham BA, Chernavvsky D, Wadwa RP; iDCL Trial Research Group. A Randomized Trial of Closed-Loop Control in Children with Type 1 Diabetes. N Engl J Med. 2020 Aug 27;383(9):836-845. doi: 10.1056/NEJMoa2004736.
PubMed 32846062
Kanapka LG, Wadwa RP, Breton MD, Ruedy KJ, Ekhlaspour L, Forlenza GP, Cengiz E, Schoelwer MJ, Jost E, Carria L, Emory E, Hsu LJ, Weinzimer SA, DeBoer MD, Buckingham BA, Oliveri M, Kollman C, Dokken BB, Chernavvsky D, Beck RW; iDCL Trial Research Group. Extended Use of the Control-IQ Closed-Loop Control System in Children With Type 1 Diabetes. Diabetes Care. 2021 Feb;44(2):473-478. doi: 10.2337/dc20-1729. Epub 2020 Dec 21.
PubMed 33355258
Schoelwer MJ, Kanapka LG, Wadwa RP, Breton MD, Ruedy KJ, Ekhlaspour L, Forlenza GP, Cobry EC, Messer LH, Cengiz E, Jost E, Carria L, Emory E, Hsu LJ, Weinzimer SA, Buckingham BA, Lal RA, Oliveri MC, Kollman CC, Dokken BB, Chernavvsky DR, Beck RW, DeBoer MD; iDCL Trial Research Group. Predictors of Time-in-Range (70-180 mg/dL) Achieved Using a Closed-Loop Control System. Diabetes Technol Ther. 2021 Jul;23(7):475-481. doi: 10.1089/dia.2020.0646. Epub 2021 Mar 9.
PubMed 33689454
Bilionis I, Berrios RC, de Arriba Munoz A, Fernandez-Luque L, Castillo C. A framework for assessing algorithmic discrimination risks in training data: a case of pediatric type 1 diabetes. JAMIA Open. 2026 Jul 14;9(4):ooag125. doi: 10.1093/jamiaopen/ooag125. eCollection 2026 Aug.
PubMed 42459945
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 37067353
Cobry EC, Bisio A, Wadwa RP, Breton MD. Improvements in Parental Sleep, Fear of Hypoglycemia, and Diabetes Distress With Use of an Advanced Hybrid Closed-Loop System. Diabetes Care. 2022 May 1;45(5):1292-1295. doi: 10.2337/dc21-1778.
PubMed 35202468
Schoelwer MJ, Bisio A, Breton MD, DeBoer MD. Assessment for Predictors of Rise in Hemoglobin A1c During Extended Use of a Closed-Loop Control System. Diabetes Technol Ther. 2022 Apr;24(4):285-288. doi: 10.1089/dia.2021.0405.
PubMed 34962164
Cobry EC, Kanapka LG, Cengiz E, Carria L, Ekhlaspour L, Buckingham BA, Hood KK, Hsu LJ, Messer LH, Schoelwer MJ, Emory E, Ruedy KJ, Beck RW, Wadwa RP, Gonder-Frederick L; iDCL Trial Research Group. Health-Related Quality of Life and Treatment Satisfaction in Parents and Children with Type 1 Diabetes Using Closed-Loop Control. Diabetes Technol Ther. 2021 Jun;23(6):401-409. doi: 10.1089/dia.2020.0532. Epub 2021 Jan 28.
PubMed 33404325

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The International Diabetes Closed Loop (iDCL) Trial: Clinical Acceptance of the Artificial Pancreas in Pediatrics: A Study of t:Slim X2 With Control-IQ Technology
ClinicalTrials.gov ID: NCT03844789
Acronym / sponsor ID: DCLP5 / DCLP5
Conditions: Type 1 Diabetes Mellitus
Keywords: Artificial Pancreas (AP), Control-IQ System, Insulin Pump, Closed Loop Control (CLC), Continuous Glucose Monitor (CGM), Multiple Daily Injections (MDI), Sensor Augmented Pump (SAP)
Study type: Interventional
Recruitment status: Completed
Enrolment: 101 participants (actual)
Lead sponsor: University of VirginiaUniversity, hospital or other
Collaborators: Tandem Diabetes Care, Inc., DexCom, Inc., Jaeb Center for Health Research
Study start: 6 Jun 2019 (actual)
Primary completion: 20 Dec 2019 (actual)
Study completion: 20 Mar 2020 (actual)
First posted: 18 Feb 2019 (actual)
Results: Posted 10 Apr 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Closed Loop Control (CLC)	Experimental	Device: t:slim X2 with Control-IQ Technology & Dexcom G6 CGMEligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 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 3:1 to the use of closed-loop control (CLC group) system using Tandem Control-IQ Technology \& Dexcom G6 CGM vs Control Group for 16 weeks. Participants randomized to the closed loop control (CLC) arm will use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM for 16 weeks. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
Control Group	Active comparator	Device: Control GroupEligible participants not currently using an insulin pump and Dexcom G4, G5 or Dexcom G6 CGM with minimum data requirements will initiate a run-in phase of 2 to 4 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 3:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Control Group for 16 weeks. All participants will be provided the option of using t:slim X2 with Control-IQ system in a 12 week Extension Phase.

Who may qualify

Ages: 6 to 13 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (15 listed)

Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 6 months
Familiarity and use of a carbohydrate ratio for meal boluses.
Age ≥ 6 and ≤ 13 years old
Weight ≥25 kg and ≤140 kg
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.

Key exclusion criteria (5 listed)

Concurrent use of any non-insulin glucose-lowering agent other than metformin (including glucagon-like peptide [GLP-1] agonists, Symlin, dipeptidyl peptidase 4 [DPP-4] inhibitors, sodium-glucose cotransporter-2 (SGLT2) 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 (specified on the study procedure manual)
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 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 CGMAlso: ExperimentalEligible participants will be use the t:slim X2 with Control-IQ Technology \& Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology \& Dexcom G6 CGM	Device	Closed Loop Control (CLC)
Control GroupAlso: Sensor-Augmented Pump (SAP)Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.	Device	Control Group

Primary outcome

Continuous Glucose Monitor (CGM)-Measured Percent Time in Range 70-180mg/dL Over 16 Week Trial Period
Time frame: From randomization to data collection completion at the end of 16 weeks
The primary outcome for the first phase is percent of time participants spent in blood sugar target range 70-180 mg/dL as measured by CGM in Closed Loop Control (CLC) group vs. Control Group. Larger percentages of time spent in this range is considered to be a desirable outcome.

14 secondary outcomes

CGM-Measured Percent of Time Above 180 mg/dL Over 16 Week Trial Period
Time frame: From randomization to data collection completion at the end of 16 weeks
CGM-Measured Mean Glucose Over 16 Week Trial Period
Time frame: From randomization to data collection completion at the end of 16 weeks
Glycated Hemoglobin A1C (HbA1c) Percent at End Of 16 Week Trial Period
Time frame: At data collection completion at the end of 16 weeks
CGM-measured Percent of Time Below 70 mg/dL Over 16 Week Trial Period
Time frame: From randomization to data collection completion at the end of 16 weeks
CGM-measured Median and Interquartile Range of Percent of Time Below 54 mg/dL Over 16 Week Trial Period
Time frame: From randomization to data collection completion at the end of 16 weeks
CGM-measured Percent of Time Above 250 mg/dL Over 16 Week Trial Period
Time frame: From randomization to data collection completion at the end of 16 weeks
Continuous Glucose Monitor (CGM)-Measured Glucose Variability Measured With the Coefficient of Variation (CV) Over 16 Week Trial Period
Time frame: From randomization to data collection completion at the end of 16 weeks
CGM-measured Percent of Time Above 180 mg/dL Over 12 Week Trial Extension Period
Time frame: From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks
CGM-measured Mean Glucose Over 12 Week Trial Extension Period
Time frame: From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks
Glycated Hemoglobin Percent (HbA1c) at Conclusion of 12 Week Trial Extension Period
Time frame: At completion of the extension study, end of week 28
CGM-measured Percent of Time Below 70 mg/dL Over 12 Week Trial Extension Period
Time frame: From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks
CGM-measured Percent of Time Below 54 mg/dL Over 12 Week Trial Extension Period
Time frame: From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks
CGM-measured Percent of Time Above 250 mg/dL Over 12 Week Trial Extension Period
Time frame: From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks
Continuous Glucose Monitor (CGM)-Measured Glucose Variability Percentage Measured With the Coefficient of Variation (CV) Over 12 Week Trial Extension Period
Time frame: From completion of the first 16 weeks of the main study to data collection completion at the end of 12 weeks

Results and safety

Results posted to the registry on 10 Apr 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Closed Loop Control (CLC)	78	78
Control Group	23	22

Primary outcome: Continuous Glucose Monitor (CGM)-Measured Percent Time in Range 70-180mg/dL Over 16 Week Trial Period

Time frame: From randomization to data collection completion at the end of 16 weeks. Mean (Standard Deviation). Unit: Percentage of Time

Measure	Closed Loop Control (CLC) n = 78	Control Group n = 22
Value	67 (10)	55 (13)

Population analysed: One participant in the control group was missing follow-up data.

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: 28 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Closed Loop Control up to 16 Weeks (Main Study)	1 of 78 (1.3%)	15 of 78 (19.2%)	0 of 78
Standard of Care up to 16 Weeks (Main Study)	0 of 23 (0%)	2 of 23 (8.7%)	0 of 23
Continued Closed Loop Control Week 16 to Week 28 (Extension Study)	0 of 78 (0%)	6 of 78 (7.7%)	0 of 78
Standard of Care to Closed Loop Control Week 16 to Week 28 (Extension Study)	0 of 22 (0%)	2 of 22 (9.1%)	0 of 22

Limitations and caveats (from the sponsor): Baseline Measures Overview - Missing data (CLC/SAP): annual household income 4 (5%)/2 (9%), TDI 1 (1%)/0 (0%). Very little missing CGM data: one participant was missing baseline data; another participant was missing follow-up data. Both participants were included in the model for the timepoint with available data so each had one record in the dataset instead of two. This direct likelihood method therefore maximizes the likelihood function integrated over possible values of the missing data.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 32846062Breton MD, Kanapka LG, Beck RW, Ekhlaspour L, Forlenza GP, Cengiz E, Schoelwer M, Ruedy KJ, Jost E, Carria L, Emory E, Hsu LJ, Oliveri M, Kollman CC, Dokken BB, Weinzimer SA, DeBoer MD, Buckingham BA, Chernavvsky D, Wadwa RP; iDCL Trial Research Group. A Randomized Trial of Closed-Loop Control in Children with Type 1 Diabetes. N Engl J Med. 2020 Aug 27;383(9):836-845. doi: 10.1056/NEJMoa2004736.
Results publication: PubMed 33355258Kanapka LG, Wadwa RP, Breton MD, Ruedy KJ, Ekhlaspour L, Forlenza GP, Cengiz E, Schoelwer MJ, Jost E, Carria L, Emory E, Hsu LJ, Weinzimer SA, DeBoer MD, Buckingham BA, Oliveri M, Kollman C, Dokken BB, Chernavvsky D, Beck RW; iDCL Trial Research Group. Extended Use of the Control-IQ Closed-Loop Control System in Children With Type 1 Diabetes. Diabetes Care. 2021 Feb;44(2):473-478. doi: 10.2337/dc20-1729. Epub 2020 Dec 21.
Results publication: PubMed 33689454Schoelwer MJ, Kanapka LG, Wadwa RP, Breton MD, Ruedy KJ, Ekhlaspour L, Forlenza GP, Cobry EC, Messer LH, Cengiz E, Jost E, Carria L, Emory E, Hsu LJ, Weinzimer SA, Buckingham BA, Lal RA, Oliveri MC, Kollman CC, Dokken BB, Chernavvsky DR, Beck RW, DeBoer MD; iDCL Trial Research Group. Predictors of Time-in-Range (70-180 mg/dL) Achieved Using a Closed-Loop Control System. Diabetes Technol Ther. 2021 Jul;23(7):475-481. doi: 10.1089/dia.2020.0646. Epub 2021 Mar 9.
Derived from this study: PubMed 42459945Bilionis I, Berrios RC, de Arriba Munoz A, Fernandez-Luque L, Castillo C. A framework for assessing algorithmic discrimination risks in training data: a case of pediatric type 1 diabetes. JAMIA Open. 2026 Jul 14;9(4):ooag125. doi: 10.1093/jamiaopen/ooag125. eCollection 2026 Aug.
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 35202468Cobry EC, Bisio A, Wadwa RP, Breton MD. Improvements in Parental Sleep, Fear of Hypoglycemia, and Diabetes Distress With Use of an Advanced Hybrid Closed-Loop System. Diabetes Care. 2022 May 1;45(5):1292-1295. doi: 10.2337/dc21-1778.
Derived from this study: PubMed 34962164Schoelwer MJ, Bisio A, Breton MD, DeBoer MD. Assessment for Predictors of Rise in Hemoglobin A1c During Extended Use of a Closed-Loop Control System. Diabetes Technol Ther. 2022 Apr;24(4):285-288. doi: 10.1089/dia.2021.0405.
Derived from this study: PubMed 33404325Cobry EC, Kanapka LG, Cengiz E, Carria L, Ekhlaspour L, Buckingham BA, Hood KK, Hsu LJ, Messer LH, Schoelwer MJ, Emory E, Ruedy KJ, Beck RW, Wadwa RP, Gonder-Frederick L; iDCL Trial Research Group. Health-Related Quality of Life and Treatment Satisfaction in Parents and Children with Type 1 Diabetes Using Closed-Loop Control. Diabetes Technol Ther. 2021 Jun;23(6):401-409. doi: 10.1089/dia.2020.0532. Epub 2021 Jan 28.
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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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.

Melissa J Schoelwer, MD principal investigator

University of Virginia

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study of Type 1 Diabetes Mellitus, run by University of Virginia at 4 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 15 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 10 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 10 Apr 2023). 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?

Continuous Glucose Monitor (CGM)-Measured Percent Time in Range 70-180mg/dL Over 16 Week Trial Period (time frame: From randomization to data collection completion at the end of 16 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 NCT03844789, which also lists 8 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 10 Apr 2023.