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

NCT07501338 | Not Yet Recruiting DMC FDA Device

• 2 other identifiers: 842655K12DK122550
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Keywords

Type 1 Diabetes; Automated Insulin Delivery

Outcome Measures

Primary Outcomes (1)

• 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

  2 Weeks

Secondary Outcomes (1)

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

  1 year

Study Arms (1)

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.

Device: Tandem Automated Insulin Delivery System

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.

Also known as: Tandem Mobi, Tandem X2

Tandem Insulin Pump

Eligibility Criteria

• Age: 2 Years - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Does not have a clinical diagnosis of Type 1 diabetes
• Does not follow at Stanford Children's Pediatric Diabetes Clinic for clinical care

Sponsors & Collaborators

• Stanford University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Stanford Children's

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• David Maahs, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Pediatrics

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: March 30, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2031
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)