Type 1 DiabetesNCT04796779
The Pediatric Artificial Pancreas (PEDAP) Trial of Control-IQ Technology in Young Children in Type 1 Diabetes
A study of Type 1 Diabetes, run by Marc Breton at 3 sites in United States.
Trial summary
The purpose of this study is to learn whether an investigational automated insulin delivery system ("study system") for young children (2 yo to less than 6 yo) with type 1 diabetes can safely improve blood glucose (sometimes called blood sugar) control. Read more about this study
- Who is it for?
- Ages 24 to 71 months
- Conditions the study is for
- Type 1 Diabetes
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 3 sitesUnited States
- Study dates
- 21 Apr 2021to 31 Jul 2022
- 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 24 to 71 months
- 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 6 months and using insulin for at least 6 months
- Familiarity and use of a carbohydrate ratio for meal boluses.
- Age ≥2 and <6 years old
- Living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff.
- Investigator has confidence that the parent 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 a study-provided Tandem pump during the study.
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- Study will not be providing insulin; therefore, participants will need to have access to either lispro or aspart
- Total daily insulin dose (TDD) at least 5 U/day
- Body weight at least 20 lbs.
- Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial (see section 2.3)
- Participant and parent(s)/guardian(s) willingness to participate in all training sessions as directed by study staff.
- Parent/guardian proficient in reading and writing English.
Who cannot join
- Concurrent use of any non-insulin glucose-lowering agent (including Glucagon-like peptide-1 [GLP-1] agonists, Symlin, Dipeptidyl peptidase-4 [DPP-4] inhibitors, Sodium-glucose Cotransporter-2 (SGLT-2) inhibitors, sulfonylureas).
- Hemophilia or any other bleeding disorder
- History of >1 severe hypoglycemic event with seizure or loss of consciousness in the last 3 months
- History of >1 DKA event in the last 6 months not related to illness, infusion set failure, or initial diagnosis
- History of chronic renal disease or currently on hemodialysis
- History of adrenal insufficiency
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- Hypothyroidism that is not adequately treated
- Use of oral or injectable steroids within the last 8 weeks
- Known, ongoing adhesive intolerance
- Plans to receive blood transfusions or erythropoietin injections during the course of the study
- A condition, which in the opinion of the investigator or designee, would put the participant or study at risk (specified in the study procedure manual)
- Currently using any closed-loop system, or using an insulin pump that is incompatible with use of the study CGM
- 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
3 sites in 1 country.
United States3 sites
Barbara Davis Center, University of Colorado
Aurora, Colorado, 80045
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, 22903
Stanford University
Stanford, California, 94304
About this study
Official title: The Pediatric Artificial Pancreas (PEDAP) Trial: A Randomized Controlled Comparison of the Control-IQ Technology Versus Standard of Care in Young Children in Type 1 Diabetes
The purpose of this study is to learn whether an investigational automated insulin delivery system ("study system") for young children (2 yo to less than 6 yo) with type 1 diabetes can safely improve blood glucose (sometimes called blood sugar) control.
Read the detailed description
Participants will be randomized to closed loop control (CLC) system (t:slim X2 with Control-IQ Technology) or to standard of care where the children will continue to use his or her personal insulin pump or multiple daily injections. Both groups will use a continuous glucose monitor (CGM) throughout the study. The study system will also use a study insulin pump and a software algorithm to automatically give insulin and control blood glucose. This system is also sometimes called a "closed-loop" system.
This study will take about 6-7 months for the child to complete. Study visits can be completed from home via videoconference (e.g. Zoom) without visiting the clinic or in-person at the clinic.
A subset of participants will be asked to join an ancillary study with Meal Bolus and Exercise challenges during the extension phase. Data collected from the start of each of these challenges until the following morning will be excluded from the analysis of the extension phase.
- Conditions
- Type 1 Diabetes
- Being tested
- Tandem t:slim X2 with Control-IQ Technology Pro, Standard Care (SC), Tandem t:slim X2 with Control-IQ Technology V1.5
- Keywords
- Control-IQ Technology, Insulin Pump, Closed Loop Control (CLC), Continuous Glucose Monitor (CGM), Multiple Daily Injections (MDI)
- 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.
Tandem t:slim X2 with Control-IQ Technology ProDevice
The Tandem t:slim X2 with Control-IQ Technology Pro is an "artificial pancreas" (AP) application that uses advanced closed loop control algorithms to automatically manage blood glucose levels for people with Type 1 Diabetes. The system modulates insulin to keep blood glucose in a targeted range. The system components include the t:slim X2 with Control-IQ Technology and the Dexcom G6 CGM. The system is very similar to the commercially available t:sli X2 with Control-IQ but modified to accept the lower weight and Total Daily Insulin of the studied population.
Standard Care (SC)Device
Standard of Care consists in the participant existing insulin therapy (prior to enrollment) in conjunction with a study Dexcom G6 CGM. Existing insulin therapies are defined as multiple daily injections of insulin (MDI) or use of an insulin pump without hybrid closed-loop control capabilities (low-glucose suspend or predictive low-glucose suspend functionality is permitted).
Tandem t:slim X2 with Control-IQ Technology V1.5Device
The Tandem t:slim X2 with Control-IQ Technology V1.5 is an "artificial pancreas" (AP) application that uses advanced closed loop control algorithms to automatically manage blood glucose levels for people with Type 1 Diabetes. The system modulates insulin to keep blood glucose in a targeted range. The system components include the t:slim X2 with Control-IQ Technology and the Dexcom G6 CGM. The system is derived from the commercially available t:slim X2 with Control-IQ, with additional features.
| Study group | Role | What they receive |
|---|---|---|
| CLC Group | Experimental | Participants who skip or successfully complete the run-in will be randomly assigned 2:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Standard of Care (SC group) for 3 weeks. Participants randomized to the intervention group will use the Tandem t:slim X2 with Control-IQ Technology v1.0 during the first 13 weeks of the study (RCT phase, weeks 1-13) and then use Tandem t:slim X2 insulin pump with Control-IQ Technology v1.5 for the remaining 13 weeks of the study (extension phase, weeks 14-26). Receives: Device: Tandem t:slim X2 with Control-IQ Technology Pro; Device: Tandem t:slim X2 with Control-IQ Technology V1.5 |
| SC Group | Active comparator | Participants who skip or successfully complete the run-in will be randomly assigned 2:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Standard of Care (SC group) for 3 weeks. Participants randomized to the SC group will use their existing insulin therapy in conjunction with study Dexcom G6 CGM during the first 13 weeks of the study (RCT phase, weeks 1-13). The SC group will then transition to using the Tandem t:slim X2 insulin pump with Control-IQ Technology v1.5 and study Dexcom G6 CGM for the remaining 13 weeks of the study (weeks 14-26). Receives: Device: Standard Care (SC); Device: Tandem t:slim X2 with Control-IQ Technology V1.5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in Range
Time in range is the amount of time spent in the target glucose range-between 70 and 180 mg/dL-as measured by CGM
Measured: 13 weeks
Secondary outcomes (5)
CGM-measured Percent Above 250 mg/dL
Percentage of time with a glucose above 250 mg/dL as measured by CGM
Measured: 13 weeks
CGM-measured Mean Glucose
Average glucose value measured by CGM
Measured: 13 weeks
HbA1c at 13 Weeks
HbA1c at 13 weeks
Measured: 13 weeks
CGM-measured Percent Below 70 mg/dL
Percentage of time with glucose below 70 mg/dL as measured by CGM
Measured: 13 weeks
CGM-measured Percent Below 54 mg/dL
Percentage of time with glucose below 54 mg/dL as measured by CGM
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start21 Apr 2021
- Primary completion12 Apr 2022
- Study completion31 Jul 2022
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 (3)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marc Breton
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Jaeb Center for Health Research, Tandem Diabetes Care, Inc.
- Responsible party
- Sponsor-investigator, Marc Breton, University of Virginia
- Investigators
- John Lum, MS, Study director, Jaeb Center for Health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04796779
- Sponsor's protocol ID
- 200433
- Other IDs
- 1U01DK127551-01, RFA-DK-19-036
- Status last verified
- Jun 2023
- First submitted
- 15 Feb 2021
- Last updated
- 28 Jun 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
Wadwa RP, Reed ZW, Buckingham BA, DeBoer MD, Ekhlaspour L, Forlenza GP, Schoelwer M, Lum J, Kollman C, Beck RW, Breton MD; PEDAP Trial Study Group. Trial of Hybrid Closed-Loop Control in Young Children with Type 1 Diabetes. N Engl J Med. 2023 Mar 16;388(11):991-1001. doi: 10.1056/NEJMoa2210834.
PubMed 36920756Bilionis 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 42459945Beck 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pediatric Artificial Pancreas (PEDAP) Trial: A Randomized Controlled Comparison of the Control-IQ Technology Versus Standard of Care in Young Children in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04796779
- Acronym / sponsor ID
- 200433
- Conditions
- Type 1 Diabetes
- Keywords
- Control-IQ Technology, Insulin Pump, Closed Loop Control (CLC), Continuous Glucose Monitor (CGM), Multiple Daily Injections (MDI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Marc BretonUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Jaeb Center for Health Research, Tandem Diabetes Care, Inc.
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 12 Apr 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 15 Mar 2021 (actual)
- Results
- Posted 28 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn whether an investigational automated insulin delivery system ("study system") for young children (2 yo to less than 6 yo) with type 1 diabetes can safely improve blood glucose (sometimes called blood sugar) control.
Detailed description
Participants will be randomized to closed loop control (CLC) system (t:slim X2 with Control-IQ Technology) or to standard of care where the children will continue to use his or her personal insulin pump or multiple daily injections. Both groups will use a continuous glucose monitor (CGM) throughout the study. The study system will also use a study insulin pump and a software algorithm to automatically give insulin and control blood glucose. This system is also sometimes called a "closed-loop" system.
This study will take about 6-7 months for the child to complete. Study visits can be completed from home via videoconference (e.g. Zoom) without visiting the clinic or in-person at the clinic.
A subset of participants will be asked to join an ancillary study with Meal Bolus and Exercise challenges during the extension phase. Data collected from the start of each of these challenges until the following morning will be excluded from the analysis of the extension phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CLC Group | Experimental | Device: Tandem t:slim X2 with Control-IQ Technology Pro, Device: Tandem t:slim X2 with Control-IQ Technology V1.5Participants who skip or successfully complete the run-in will be randomly assigned 2:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Standard of Care (SC group) for 3 weeks. Participants randomized to the intervention group will use the Tandem t:slim X2 with Control-IQ Technology v1.0 during the first 13 weeks of the study (RCT phase, weeks 1-13) and then use Tandem t:slim X2 insulin pump with Control-IQ Technology v1.5 for the remaining 13 weeks of the study (extension phase, weeks 14-26). |
| SC Group | Active comparator | Device: Standard Care (SC), Device: Tandem t:slim X2 with Control-IQ Technology V1.5Participants who skip or successfully complete the run-in will be randomly assigned 2:1 to the use of closed-loop control (CLC group) system using Tandem t:slim X2 with Control-IQ Technology vs Standard of Care (SC group) for 3 weeks. Participants randomized to the SC group will use their existing insulin therapy in conjunction with study Dexcom G6 CGM during the first 13 weeks of the study (RCT phase, weeks 1-13). The SC group will then transition to using the Tandem t:slim X2 insulin pump with Control-IQ Technology v1.5 and study Dexcom G6 CGM for the remaining 13 weeks of the study (weeks 14-26). |
Who may qualify
- Ages
- 24 to 71 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least 6 months and using insulin for at least 6 months
- Familiarity and use of a carbohydrate ratio for meal boluses.
- Age ≥2 and <6 years old
- Living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff.
- Investigator has confidence that the parent can successfully operate all study devices and is capable of adhering to the protocol
Key exclusion criteria (14 listed)
- Concurrent use of any non-insulin glucose-lowering agent (including Glucagon-like peptide-1 [GLP-1] agonists, Symlin, Dipeptidyl peptidase-4 [DPP-4] inhibitors, Sodium-glucose Cotransporter-2 (SGLT-2) inhibitors, sulfonylureas).
- Hemophilia or any other bleeding disorder
- History of >1 severe hypoglycemic event with seizure or loss of consciousness in the last 3 months
- History of >1 DKA event in the last 6 months not related to illness, infusion set failure, or initial diagnosis
- History of chronic renal disease or currently on hemodialysis
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 |
|---|---|---|
| Tandem t:slim X2 with Control-IQ Technology ProThe Tandem t:slim X2 with Control-IQ Technology Pro is an "artificial pancreas" (AP) application that uses advanced closed loop control algorithms to automatically manage blood glucose levels for people with Type 1 Diabetes. The system modulates insulin to keep blood glucose in a targeted range. The system components include the t:slim X2 with Control-IQ Technology and the Dexcom G6 CGM. The system is very similar to the commercially available t:sli X2 with Control-IQ but modified to accept the lower weight and Total Daily Insulin of the studied population. | Device | CLC Group |
| Standard Care (SC)Standard of Care consists in the participant existing insulin therapy (prior to enrollment) in conjunction with a study Dexcom G6 CGM. Existing insulin therapies are defined as multiple daily injections of insulin (MDI) or use of an insulin pump without hybrid closed-loop control capabilities (low-glucose suspend or predictive low-glucose suspend functionality is permitted). | Device | SC Group |
| Tandem t:slim X2 with Control-IQ Technology V1.5The Tandem t:slim X2 with Control-IQ Technology V1.5 is an "artificial pancreas" (AP) application that uses advanced closed loop control algorithms to automatically manage blood glucose levels for people with Type 1 Diabetes. The system modulates insulin to keep blood glucose in a targeted range. The system components include the t:slim X2 with Control-IQ Technology and the Dexcom G6 CGM. The system is derived from the commercially available t:slim X2 with Control-IQ, with additional features. | Device | CLC Group, SC Group |
Primary outcome
Time in Range
Time frame: 13 weeks
Time in range is the amount of time spent in the target glucose range-between 70 and 180 mg/dL-as measured by CGM
5 secondary outcomes
CGM-measured Percent Above 250 mg/dL
Time frame: 13 weeks
CGM-measured Mean Glucose
Time frame: 13 weeks
HbA1c at 13 Weeks
Time frame: 13 weeks
CGM-measured Percent Below 70 mg/dL
Time frame: 13 weeks
CGM-measured Percent Below 54 mg/dL
Time frame: 13 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 36920756Wadwa RP, Reed ZW, Buckingham BA, DeBoer MD, Ekhlaspour L, Forlenza GP, Schoelwer M, Lum J, Kollman C, Beck RW, Breton MD; PEDAP Trial Study Group. Trial of Hybrid Closed-Loop Control in Young Children with Type 1 Diabetes. N Engl J Med. 2023 Mar 16;388(11):991-1001. doi: 10.1056/NEJMoa2210834.
- 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.
- Study ResultsLink provided by the sponsor.
- 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.
John Lum, MS study director
Jaeb Center for Health Research
3 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, run by Marc Breton at 3 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 12 inclusion and 14 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 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 Jun 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?
Time in Range (time frame: 13 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 NCT04796779, which also lists 3 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 Jun 2023.