Insulin Delivery With Self-Adjusting Closed-Loop and Behavioral Glycemic Control Enhanced by Prediction

Summary

This study is a randomized cross-over trial comparing AIDANET with Anticipation to AIDANET in FCL without Anticipation. Participants will complete 4 weeks of AID data collection which will be used to establish baseline and initialize the control algorithm. Participants will then be randomized to one of two groups: Group A: AIDANET in FCL with Anticipation (AIDANET+ACL), and Group B: AIDANET in FCL without Anticipation (AIDANET+FCL). The study duration of each group is 4 weeks each. The order of these two phases will be dependent upon randomization.

Conditions

• Type 1 Diabetes (T1D)

Interventions

DEVICE

Automated Insulin Delivery (AID)

Usual Care

DEVICE

AIDANET + Fully Closed Loop (FCL)

All participants will use AIDANET in FCL mode with instructions to avoid announcing meal boluses whenever possible during the four weeks.

DEVICE

AIDANET + Anticipatory Closed Loop (ACL)

All insulin will be delivered automatically. The algorithm will review past behaviors to determine the amount of insulin that will be needed for a meal.

Sponsors & Collaborators

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

  collaborator NIH

• Tandem Diabetes Care, Inc.

  collaborator INDUSTRY

• DexCom, Inc.

  collaborator INDUSTRY

• Sue Brown

  lead OTHER

Principal Investigators

• Sue A Brown, MD · University of Virginia Center for Diabetes Technology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-14

Primary Completion

2026-12-31

Completion

2026-12-31

FDA Device

Yes

Countries

• United States

Study Locations