Type 1 DiabetesNCT07501338
Early Automated Insulin Delivery (AID) Pilot for Newly Diagnosed T1D
A study testing Tandem Automated Insulin Delivery System in people with Type 1 Diabetes, run by Stanford University at 1 site in United States.
Trial summary
Type 1 diabetes is a common chronic medical condition among youth in the US that requires intensive glycemic management to prevent long-term morbidity and mortality. Current pediatric diabetes care in the US underutilizes automated insulin delivery (AID) systems, which are the best available tools for promoting tight… Read more about this study
- Who is it for?
- Ages 2 to 26 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Tandem Automated Insulin Delivery System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2026to Mar 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 26 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Recent clinical diagnosis of type 1 diabetes within the past 2 weeks
- intent to follow at Stanford Children's Pediatric Diabetes Clinic for clinical care
Who cannot join
- Does not have a clinical diagnosis of Type 1 diabetes
- Does not follow at Stanford Children's Pediatric Diabetes Clinic for clinical care
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Early AID Pilot for Newly Diagnosed T1D
Type 1 diabetes is a common chronic medical condition among youth in the US that requires intensive glycemic management to prevent long-term morbidity and mortality. Current pediatric diabetes care in the US underutilizes automated insulin delivery (AID) systems, which are the best available tools for promoting tight glycemic control while reducing user burden. This proposal aims to support early and sustained use of AID systems by examining and optimizing conditions, evaluating glycemic outcomes, and identifying contextual facilitators and barriers of implementation.
- Conditions
- Type 1 Diabetes
- Being tested
- Tandem Automated Insulin Delivery System
- Keywords
- Type 1 Diabetes, Automated Insulin Delivery
- 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 Automated Insulin Delivery SystemDevice
Also called Tandem Mobi, Tandem X2
Participants will be required to initiate AID system within 2-4 weeks of diabetes diagnosis, use a simplified meal announcement (SMA) strategy for insulin dosing. AID combines a continuous glucose monitor, an insulin pump, and a dosing algorithm to continuously adjust insulin delivery based on current and predicted future glucose levels.
| Study group | Role | What they receive |
|---|---|---|
| Tandem Insulin Pump | Experimental | Participants will choose an automated Insulin Device either Tandem Mobi or Tandem X2. The participants will use the device to initiate early pump usage. Participants will use pump for approximately 2 Months, but may vary slightly upon individual insurances. The dose of insulin will vary between patient to patient based on food intake. Participants will complete surveys regarding their perspectives and experiences with the study intervention. Receives: Device: Tandem Automated Insulin Delivery System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who started AID System within 2 weeks
Timing of AID initiation will be measured by the number of participants initiating AID system within 2 weeks of diabetes diagnosis
Measured: 2 Weeks
Secondary outcomes (1)
Number of participants who continue to use AID System after 1 year
Sustained AID use will be measured by the number of participants using AID system after 1 year of diabetes diagnosis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Maahs, Stanford University
- Investigators
- David Maahs, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07501338
- Sponsor's protocol ID
- 84265
- Other IDs
- 5K12DK122550
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early AID Pilot for Newly Diagnosed T1D
- ClinicalTrials.gov ID
- NCT07501338
- Acronym / sponsor ID
- 84265
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 Diabetes, Automated Insulin Delivery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Mar 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2031 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Type 1 diabetes is a common chronic medical condition among youth in the US that requires intensive glycemic management to prevent long-term morbidity and mortality. Current pediatric diabetes care in the US underutilizes automated insulin delivery (AID) systems, which are the best available tools for promoting tight glycemic control while reducing user burden. This proposal aims to support early and sustained use of AID systems by examining and optimizing conditions, evaluating glycemic outcomes, and identifying contextual facilitators and barriers of implementation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tandem Insulin Pump | Experimental | Device: Tandem Automated Insulin Delivery SystemParticipants will choose an automated Insulin Device either Tandem Mobi or Tandem X2. The participants will use the device to initiate early pump usage. Participants will use pump for approximately 2 Months, but may vary slightly upon individual insurances. The dose of insulin will vary between patient to patient based on food intake. Participants will complete surveys regarding their perspectives and experiences with the study intervention. |
Who may qualify
- Ages
- 2 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Recent clinical diagnosis of type 1 diabetes within the past 2 weeks
- intent to follow at Stanford Children's Pediatric Diabetes Clinic for clinical care
Key exclusion criteria (2 listed)
- Does not have a clinical diagnosis of Type 1 diabetes
- Does not follow at Stanford Children's Pediatric Diabetes Clinic for clinical care
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 Automated Insulin Delivery SystemAlso: Tandem Mobi, Tandem X2Participants will be required to initiate AID system within 2-4 weeks of diabetes diagnosis, use a simplified meal announcement (SMA) strategy for insulin dosing. AID combines a continuous glucose monitor, an insulin pump, and a dosing algorithm to continuously adjust insulin delivery based on current and predicted future glucose levels. | Device | Tandem Insulin Pump |
Primary outcome
Number of participants who started AID System within 2 weeks
Time frame: 2 Weeks
Timing of AID initiation will be measured by the number of participants initiating AID system within 2 weeks of diabetes diagnosis
1 secondary outcome
Number of participants who continue to use AID System after 1 year
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No
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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.
David Maahs, MD, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tandem Automated Insulin Delivery System in people with Type 1 Diabetes, run by Stanford University at 1 site 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 2 inclusion and 2 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: opening soon, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of participants who started AID System within 2 weeks (time frame: 2 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.