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NCT Number: NCT07501338

Early Automated Insulin Delivery (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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

2 year–26 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford Children's

Palo Alto, California, 94304, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Tandem Mobi, Tandem X2

Primary outcomes

  1. 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

Secondary outcomes

  1. Number of participants who continue to use AID System after 1 year

    Time frame: 1 year

    Sustained AID use will be measured by the number of participants using AID system after 1 year of diabetes diagnosis

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Early AID Pilot for Newly Diagnosed T1D

Important dates

Study start
2026
Primary completion
2027
Study completion
2031
First posted
Mar 30, 2026
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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