Type 1 DiabetesPEDAP-AINCT06017089
The Pediatric Artificial Pancreas Automated Initialization Trial
A study testing AI-based Advisor system in people with Type 1 Diabetes, run by Marc Breton at 3 sites in United States.
Trial summary
The goal of this clinical trial is to obtain safety data and exploratory glycemic control data from use of an at-home closed loop control (CLC) system (t:slim X2 with Control-IQ Technology) with periodic parameter adjustments driven by an AI-based Advisor system in young children with Type 1 Diabetes. Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- AI-based Advisor system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 3 sitesUnited States
- Study dates
- 10 Nov 2023to 17 Jun 2024
- 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 2 to 5 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 1 month
- Familiarity and use of a carbohydrate ratio for meal boluses
- Age ≥2 and <6 years old
- Using a Dexcom CGM at the time of enrollment, with use on at least 21 out of the prior 28 days
- Living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff
- Parent/guardian has a phone that can run the Tandem t:connect Mobile App (typically Android 10 or above or iPhone Operating System (iOS) 15 or above)
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- Willingness to use the t:connect Mobile App as needed during the study and ensure connectivity for a data upload at least once per day
- 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 study162 provided Tandem pump during the study
- Total daily insulin dose (TDD) at least 5 Units/day
- Body weight at least 20 pounds (lbs)
- 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
- Parent/guardian proficient in reading and writing English
- Live in the United States, with no plans to move outside the United States during the study period
Who cannot join
- Concurrent use of any non-insulin glucose-lowering agent (including GLP-1 agonists, Symlin, DPP-4 inhibitors, 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 diabetic ketoacidosis (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 in the opinion of the investigator
- 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
- Participation in another pharmaceutical or device trial at the time of enrollment or during the study
- Having immediate family members employed by Tandem Diabetes Care, Inc. or Dexcom, 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
Charlottesville, Virginia, 22903
Stanford University
Stanford, California, 94305
About this study
Official title: The Pediatric Artificial Pancreas Automated Initialization Trial (PEDAP-AI): A Pilot Study of AI Advisor-Driven Pump Initiation and Parameter Adaptation in Young Children With Type 1 Diabetes
The goal of this clinical trial is to obtain safety data and exploratory glycemic control data from use of an at-home closed loop control (CLC) system (t:slim X2 with Control-IQ Technology) with periodic parameter adjustments driven by an AI-based Advisor system in young children with Type 1 Diabetes. The main endpoints this study aims to answer is the safety and efficacy of the use of the AI-driven pump parameters. Participants will use the study system (pump and Continuous Glucose Monitor) in closed-loop mode for eight weeks.
Read the detailed description
In this single-arm pilot study of an AI Advisor-driven closed loop system initiation and parameter adaptation in youth age 2 to <6 years old, participants will use the Tandem t:slim X2 with Control-IQ and t:connect mobile application and Dexcom G6 or G7 system, connected to the University of Virginia (UVA) cloud-based Physician Dashboard for eight weeks at home.The key safety outcomes are adverse events related to hypoglycemia and hyperglycemia, CGM-measured time spent below 54mg/dL, and CGM-measured time spent above 250 mg/dL. CGM-measured endpoints will be tested against baseline for non-inferiority.Glycemic outcomes including time in target range 70-180 mg/dL (TIR) and various other CGM measures of hypo- and hyperglycemia will be assessed and tested for superiority against baseline and a matched historical control population from the prior PEDAP study that did not involve the use of any AI-driven pump parameters. Up to 45 screened participants with the goal of at least 30 participants completing the study pump use period.
- Conditions
- Type 1 Diabetes
- Being tested
- AI-based Advisor system
- Keywords
- Type 1 Diabetes, Continuous Glucose Monitor (CGM), Tandem t:slim Insulin Pump with Control-IQ Technology, Control-IQ Technology (CIQ), Artificial Pancreas (AP), Artificial Intelligence (AI), Closed loop control (CLC), Diabetes Assistant (DiAs)
- 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.
AI-based Advisor systemDevice
Tandem t:slim X2 with Control-IQ and t:connect mobile application and Dexcom G6 or G7 system, connected to UVA cloud-based Physician Dashboard with insulin pump parameters driven by an AI-based Advisor system.
| Study group | Role | What they receive |
|---|---|---|
| AI Advisor-driven at-home closed loop system initiation and parameter adaptation | Experimental | In this single-arm intervention trial, all participants will use the study system (t:slim X2 with Control-IQ Technology and Dexcom Continuous Glucose Monitor) in closed-loop mode for 8 weeks at home with periodic parameter adjustment driven by an AI-based Advisor system. Receives: Device: AI-based Advisor system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Endpoint (Tested for Non-inferiority Compared to Baseline) CGM Measured (a)
% of time below 54 mg/dL
Measured: Baseline and Weeks 1-8
Safety Endpoint (Tested for Non-inferiority Compared to Baseline) CGM Measured (b)
% of time above 250 mg/dL
Measured: Baseline and Weeks 1-8
Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (a)
% of time in range 70-180 mg/dL
Measured: Baseline and Weeks 1-8
Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (b)
Mean glucose
Measured: Baseline and Weeks 1-8
Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (c)
% of time >250 mg/dL
Measured: Baseline and Weeks 1-8
Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (d)
% of time <70 mg/dL
Measured: Baseline and Weeks 1-8
Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (e)
% of time <54 mg/dL
Measured: Baseline and Weeks 1-8
Secondary outcomes (15)
CGM Measured Time in Range
% of time spent within range 70 mg/dL-140 mg/dL.
Measured: Baseline and Weeks 1-8
CGM Measured (a)
% of time >180 mg/dL
Measured: Baseline and Weeks 1-8
CGM Measured (b)
% of time >300 mg/dL
Measured: Baseline and Weeks 1-8
CGM Measured (c)
% of time <60 mg/dL
Measured: Baseline and Weeks 1-8
CGM Measured (d)
Glucose standard deviation
Measured: Baseline and Weeks 1-8
CGM Measured (e)
Glucose coefficient of variation
Measured: Baseline and Weeks 1-8
CGM Measured (f)
The high blood glucose index (HBGI) is based on a nonlinear transformation of blood glucose values that corrects for the asymmetry of the glucose scale. This transformation maps glucose values into a risk space (minimum risk = 0), where higher values correspond to higher risk. Values below 10 suggest low to moderate risk.
Measured: Baseline and Weeks 1-8
CGM Measured (g)
The low blood glucose index (LBGI) is based on a nonlinear transformation of blood glucose values that corrects for the asymmetry of the glucose scale. This transformation maps glucose values into a risk space (minimum risk = 0), where higher values correspond to higher risk. Values <1 suggest low risk of hypoglycemia.
Measured: Baseline and Weeks 1-8
CGM Measured (h)
Weekly hyperglycemic event rate
Measured: Baseline and Weeks 1-8
CGM Measured (i)
Weekly hypoglycemic event rate
Measured: Baseline and Weeks 1-8
Binary Outcome 1
Number of participants whose % of time in range 70-180 mg/dL improved by 5% or more from baseline to 8 weeks.
Measured: Baseline and Weeks 1-8
Binary Outcome 2
Number of participants whose % of time in range 70-180 mg/dL improved by 10% or more from baseline to 8 weeks.
Measured: Baseline and Weeks 1-8
Binary Outcome 3
Participants with % of time in range 70-180 mg/dL >70% and % of time <70 mg/dL <4%
Measured: Baseline and Weeks 1-8
Total Daily Insulin
Total daily insulin (units/kg)
Measured: Baseline and Weeks 1-8
Basal Insulin
Percentage of total insulin delivered via basal administration.
Measured: Baseline and Weeks 1-8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start10 Nov 2023
- Primary completion17 Jun 2024
- Study completion17 Jun 2024
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 (1)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
- Not applicable
- Intervention model
- Single group
- Model description
- In this single-arm intervention trial, all participants will use the study system (pump and CGM) in closed-loop mode for 8 weeks.
- Masking
- None (open label)
- Enrolment
- 33 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, University of Colorado, Denver, Stanford University
- Responsible party
- Sponsor-investigator, Marc Breton, University of Virginia
- Investigators
- John Lum, MS, Study director, Jaeb Center for Health ResearchRaj P Wadwa, MD, Principal investigator, Barbara Davis Center, University of ColoradoMarc D Breton, Ph.D., Study chair, University of Virginia Center for Diabetes Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06017089
- Sponsor's protocol ID
- 230262
- Other IDs
- U01DK127551-03
- Acronym
- PEDAP-AI
- Status last verified
- Aug 2025
- First submitted
- 18 Aug 2023
- Last updated
- 15 Sep 2025
- 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 in the scientific community
Publications
Pavan J, Cobry E, Reed ZW, Villa-Tamayo MF, Diaz C JL, DeBoer MD, Schoelwer M, Jost E, Kingman R, Holmes V, Lum JW, Koravi CLK, Buckingham B, Beck R, Wadwa RP, Breton MD; PEDAP-AI Trial Study Group. Algorithm-Driven Initiation and Adaptation of Hybrid Closed-Loop in Young Children with Type 1 Diabetes: A Pilot Study. Diabetes Technol Ther. 2025 Aug;27(8):587-596. doi: 10.1089/dia.2024.0650. Epub 2025 Mar 28.
PubMed 40152109
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pediatric Artificial Pancreas Automated Initialization Trial (PEDAP-AI): A Pilot Study of AI Advisor-Driven Pump Initiation and Parameter Adaptation in Young Children With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT06017089
- Acronym / sponsor ID
- PEDAP-AI / 230262
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 Diabetes, Continuous Glucose Monitor (CGM), Tandem t:slim Insulin Pump with Control-IQ Technology, Control-IQ Technology (CIQ), Artificial Pancreas (AP), Artificial Intelligence (AI), Closed loop control (CLC), Diabetes Assistant (DiAs)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 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, University of Colorado, Denver, Stanford University
- Study start
- 10 Nov 2023 (actual)
- Primary completion
- 17 Jun 2024 (actual)
- Study completion
- 17 Jun 2024 (actual)
- First posted
- 30 Aug 2023 (actual)
- Results
- Posted 15 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to obtain safety data and exploratory glycemic control data from use of an at-home closed loop control (CLC) system (t:slim X2 with Control-IQ Technology) with periodic parameter adjustments driven by an AI-based Advisor system in young children with Type 1 Diabetes. The main endpoints this study aims to answer is the safety and efficacy of the use of the AI-driven pump parameters. Participants will use the study system (pump and Continuous Glucose Monitor) in closed-loop mode for eight weeks.
Detailed description
In this single-arm pilot study of an AI Advisor-driven closed loop system initiation and parameter adaptation in youth age 2 to <6 years old, participants will use the Tandem t:slim X2 with Control-IQ and t:connect mobile application and Dexcom G6 or G7 system, connected to the University of Virginia (UVA) cloud-based Physician Dashboard for eight weeks at home.The key safety outcomes are adverse events related to hypoglycemia and hyperglycemia, CGM-measured time spent below 54mg/dL, and CGM-measured time spent above 250 mg/dL. CGM-measured endpoints will be tested against baseline for non-inferiority.Glycemic outcomes including time in target range 70-180 mg/dL (TIR) and various other CGM measures of hypo- and hyperglycemia will be assessed and tested for superiority against baseline and a matched historical control population from the prior PEDAP study that did not involve the use of any AI-driven pump parameters. Up to 45 screened participants with the goal of at least 30 participants completing the study pump use period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- In this single-arm intervention trial, all participants will use the study system (pump and CGM) in closed-loop mode for 8 weeks.
| Arm | Type | Receives |
|---|---|---|
| AI Advisor-driven at-home closed loop system initiation and parameter adaptation | Experimental | Device: AI-based Advisor systemIn this single-arm intervention trial, all participants will use the study system (t:slim X2 with Control-IQ Technology and Dexcom Continuous Glucose Monitor) in closed-loop mode for 8 weeks at home with periodic parameter adjustment driven by an AI-based Advisor system. |
Who may qualify
- Ages
- 2 to 5 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 1 month
- Familiarity and use of a carbohydrate ratio for meal boluses
- Age ≥2 and <6 years old
- Using a Dexcom CGM at the time of enrollment, with use on at least 21 out of the prior 28 days
- Living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff
Key exclusion criteria (13 listed)
- Concurrent use of any non-insulin glucose-lowering agent (including GLP-1 agonists, Symlin, DPP-4 inhibitors, 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 diabetic ketoacidosis (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 |
|---|---|---|
| AI-based Advisor systemTandem t:slim X2 with Control-IQ and t:connect mobile application and Dexcom G6 or G7 system, connected to UVA cloud-based Physician Dashboard with insulin pump parameters driven by an AI-based Advisor system. | Device | AI Advisor-driven at-home closed loop system initiation and parameter adaptation |
Primary outcome
Safety Endpoint (Tested for Non-inferiority Compared to Baseline) CGM Measured (a)
Time frame: Baseline and Weeks 1-8
% of time below 54 mg/dL
Safety Endpoint (Tested for Non-inferiority Compared to Baseline) CGM Measured (b)
Time frame: Baseline and Weeks 1-8
% of time above 250 mg/dL
Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (a)
Time frame: Baseline and Weeks 1-8
% of time in range 70-180 mg/dL
Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (b)
Time frame: Baseline and Weeks 1-8
Mean glucose
Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (c)
Time frame: Baseline and Weeks 1-8
% of time >250 mg/dL
Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (d)
Time frame: Baseline and Weeks 1-8
% of time <70 mg/dL
Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (e)
Time frame: Baseline and Weeks 1-8
% of time <54 mg/dL
15 secondary outcomes
CGM Measured Time in Range
Time frame: Baseline and Weeks 1-8
CGM Measured (a)
Time frame: Baseline and Weeks 1-8
CGM Measured (b)
Time frame: Baseline and Weeks 1-8
CGM Measured (c)
Time frame: Baseline and Weeks 1-8
CGM Measured (d)
Time frame: Baseline and Weeks 1-8
CGM Measured (e)
Time frame: Baseline and Weeks 1-8
CGM Measured (f)
Time frame: Baseline and Weeks 1-8
CGM Measured (g)
Time frame: Baseline and Weeks 1-8
CGM Measured (h)
Time frame: Baseline and Weeks 1-8
CGM Measured (i)
Time frame: Baseline and Weeks 1-8
Binary Outcome 1
Time frame: Baseline and Weeks 1-8
Binary Outcome 2
Time frame: Baseline and Weeks 1-8
Binary Outcome 3
Time frame: Baseline and Weeks 1-8
Total Daily Insulin
Time frame: Baseline and Weeks 1-8
Basal Insulin
Time frame: Baseline and Weeks 1-8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 40152109Pavan J, Cobry E, Reed ZW, Villa-Tamayo MF, Diaz C JL, DeBoer MD, Schoelwer M, Jost E, Kingman R, Holmes V, Lum JW, Koravi CLK, Buckingham B, Beck R, Wadwa RP, Breton MD; PEDAP-AI Trial Study Group. Algorithm-Driven Initiation and Adaptation of Hybrid Closed-Loop in Young Children with Type 1 Diabetes: A Pilot Study. Diabetes Technol Ther. 2025 Aug;27(8):587-596. doi: 10.1089/dia.2024.0650. Epub 2025 Mar 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 in 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
Raj P Wadwa, MD principal investigator
Barbara Davis Center, University of Colorado
Marc D Breton, Ph.D. study chair
University of Virginia Center for Diabetes Technology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-based Advisor system in people with 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 15 inclusion and 13 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 15 Sep 2025. 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 15 Sep 2025). 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?
Safety Endpoint (Tested for Non-inferiority Compared to Baseline) CGM Measured (a) (time frame: Baseline and Weeks 1-8). The study lists 7 primary outcomes in all. 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 NCT06017089, which also lists 1 linked publication.
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 15 Sep 2025; AzTrials last refreshed its copy on 29 Oct 2026.