This is a single arm study comprised of a series of feasibility studies.
Feasibility Study Part 2 (i.e. Feasibility 2): Feasibility 2 is the focus of the current version of the study protocol. This study will include 2 separate Cohorts of individuals, based on the algorithms being studied: Cohort A: The main purpose of this cohort is to test the Digital Twin insulin delivery algorithm adaptation Cohort C: The main purpose of this cohort is to test a meal prediction algorithm
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
126
Test safety and effectiveness of the Digital Twin and Meal Prediction algorithms
Loma Linda University Medical Center
Loma Linda, California, United States
Diablo Clinical Research
Walnut Creek, California, United States
Barbara Davis Center - Adults
Aurora, Colorado, United States
Number of Severe Hypoglycemic Event - Cohort A
Number of severe hypoglycemic events occurred in the study in Cohort A
Time frame: approximately 3.5 months
Number of Diabetic Ketoacidosis (DKA) Event - Cohort A
Number of Diabetic Ketoacidosis (DKA) event occurred in the study in Cohort A
Time frame: approximately 3.5 months
Percentage of Time in Euglycemia - Cohort A
The overall mean percentage of time in Euglycemia (70-180 mg/dL) in Cohort A
Time frame: approximately 3.5 months
Number of Severe Hypoglycemic Event - Cohort C
Number of severe hypoglycemic events occurred in the study in Cohort C
Time frame: approximately 3.5 months
Number of Diabetic Ketoacidosis (DKA) Event - Cohort C
Number of Diabetic Ketoacidosis (DKA) event occurred in the study in Cohort C
Time frame: approximately 3.5 months
Percentage of Time in Euglycemia - Cohort C
The overall mean percentage of time in Euglycemia (70-180 mg/dL) in Cohort C
Time frame: approximately 3.5 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Barbara Davis Center / Pediatric
Aurora, Colorado, United States
University of South Florida Diabetes Center
Tampa, Florida, United States
Atlanta Diabetes Associates
Atlanta, Georgia, United States
Endocrine Research Solutions, Inc.
Roswell, Georgia, United States
Rocky Mountain Diabetes
Idaho Falls, Idaho, United States
Mayo Clinic
Rochester, Minnesota, United States
Park Nicollet International Diabetes Center
Saint Louis Park, Minnesota, United States
...and 2 more locations