Early Automated Insulin Delivery (AID) Pilot for Newly Diagnosed T1D
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tandem Automated Insulin Delivery System.
- Who it may be relevant to
- Registry conditions: Type 1 Diabetes. Basic parameters: 2 years — 26 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Early AID Pilot for Newly Diagnosed T1D
Overview
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.
Interventions
- Device Tandem Automated Insulin Delivery System
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.
Primary outcome measures
- Number of participants who started AID System within 2 weeks [Time frame: 2 Weeks]
Secondary outcome measures (1)
- Number of participants who continue to use AID System after 1 year [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Does not have a clinical diagnosis of Type 1 diabetes
- Does not follow at Stanford Children's Pediatric Diabetes Clinic for clinical care
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Stanford Children's — Palo Alto
Identifiers
NCT: NCT07501338 · 84265 · 5K12DK122550