Early Automated Insulin Delivery (AID) Pilot for Newly Diagnosed T1D

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT07501338
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - 26 Years
Healthy Volunteers
Not accepted

Interventions

  • Tandem Automated Insulin Delivery System — DEVICE
    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 Details

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.

Key Dates

Start date
Mar 31, 2026
Status verified
Mar 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2031

Study Design

Enrollment
16 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Tandem Insulin Pump
    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.

Primary Outcome Measure

Number of participants who started AID System within 2 weeks [ Time Frame: 2 Weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford Children'sPalo AltoCalifornia94304-

Find similar trials in Palo Alto, CA

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Stanford Children's· Palo Alto, CA

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