82
Participants
Start Date
September 28, 2020
Primary Completion Date
September 14, 2023
Study Completion Date
January 5, 2024
Tandem t:slim X2 with HCL or PLGS
"The system components include the t:slim X2 with Control-IQ Technology and the Dexcom CGM G6. The modular control algorithm has a safety supervision module that limits insulin delivery to prevent hypoglycemia at all times. The algorithm gradually decreases hyperglycemia from bedtime to reach a target of 120 mg/dL by waking time. During awake hours, the control algorithm attempts to maintain glucose within a target range (112.5 to 160 mg/dL) with meal time insulin boluses delivered based on usual bolus procedures undertaken by patients on an insulin pump (Hybrid closed loop).~The system components include the t:slim X2 with with Basal-IQ Technology and the Dexcom CGM G6. The PLGS System is able to stop and resume basal insulin delivery automatically in response to predicted or low sensor glucose values, thereby reducing the incidence and duration of hypoglycemic episodes. The pump includes the hypoglycemia minimization strategy that will issue insulin delivery commands."
SUNY Upstate, Syracuse
University of Pennsylvania, Philadelphia
AdventHealth Diabetes Institute, Orlando
Mayo Clinic, Rochester
Lead Sponsor
Collaborators (1)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
DexCom, Inc.
INDUSTRY
Tandem Diabetes Care, Inc.
INDUSTRY
University of Minnesota - Advanced Research and Diagnostic Laboratory
UNKNOWN
Mayo Clinic
OTHER
University of Pennsylvania
OTHER
AdventHealth Diabetes Institute
UNKNOWN
Washington State University
OTHER
Jaeb Center for Health Research
OTHER