A randomized cross-over trial assessing glycemic control on Automated insulin delivery as Adaptive Network (AIDANET) algorithm when used in three modes: AIDANET-Fully Closed Loop (FCL), AIDANET-Hybrid Closed Loop (HCL) and AIDANET allowing a mix between FCL and HCL. There will be an Automated Insulin Delivery (AID) phase with participants using their home devices and/or study continuous glucose monitor (CGM) and study-provided commercial Mobi system without AIDANET.
Age ≥18.0 years old at time of consent
Clinical diagnosis, based on investigator assessment, of Type 1 Diabetes for at least one year.
Having used an Food and Drug Administration (FDA) approved AID system within the last six months (can be intermittent use).
Currently using insulin for at least six months.
Plans to start a new non-insulin glucose-lowering agent (e.g. glucagon-like peptide-1 (GLP-1) receptor agonists, Symlin, (DPP-4 inhibitors, also known as dipeptidyl peptidase 4). Participants may be on a stable dose of such an agent for at least the past month.
Current use of sulfonylurea medications.
Current use of an Sodium-Glucose Cotransporter 2 (also known as a SGLT-2 or SGLT-1/2 inhibitor) due to risk of euglycemic diabetic ketoacidosis (DKA).
Hemophilia or any other bleeding disorder.
Sue Brown
Lead sponsor
University of Virginia
Sponsor institution
Tandem Diabetes Care, Inc.
Collaborator
DexCom, Inc.
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator