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

Early AID Pilot for Newly Diagnosed T1D

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07501338

Enrollment

Registered

2026-03-30

Start date

2026-03-01

Completion date

2031-03-01

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

Keywords

Type 1 Diabetes, Automated Insulin Delivery

Brief 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 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

DEVICETandem 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Years to 26 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Number of participants who started AID System within 2 weeks	2 Weeks	Timing of AID initiation will be measured by the number of participants initiating AID system within 2 weeks of diabetes diagnosis

Secondary

Measure	Time frame	Description
Number of participants who continue to use AID System after 1 year	1 year	Sustained AID use will be measured by the number of participants using AID system after 1 year of diabetes diagnosis

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORDavid Maahs, MD, PhD

Stanford University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026