This study is evaluate the superior efficacy of a Continuous Glucose Monitor (CGM)-based advisory system in Type 1 Diabetes Mellitus (T1DM), as compared to Sensor Augmented Mode (SAM) therapy, and with characterizing the impact of psycho-behavioral factors on system performance, which will enable system individualization and lead to automated adaptation of advice delivery to optimize glycemic control and reduce the system's psychological impact.
Four cohorts of about 25 participants each (expected retention 20 per cohort). Each cohort will continue for \~7 months. Following recruitment, screening, and a run-in period of SAM, participants will be randomized into one of two groups: escalation vs. de-escalation of devices and function. Each treatment modality (SAM - Sensor-Augmented Mode, PF - Personalized Feedback, DSS - Decision Support Systems) will continue for about 8 weeks, with the last 4 weeks used to assess glucose variability (GV) from CGM data.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
88
Provides tailored information to the user about what glycemic risk they may be facing as well as how glycemic control and system use looked in the past week. Treatment decision and therapy changes are entirely left to the decision of the user.
CGM-based system that includes Personalized Feedback (PF) and further assists with treatment recommendations for common metabolic challenges
A mode in Diabetes Assistant (DiAs) that combines Diabetes Assistant, Insulin pump or Multiple Daily Injections, CGM, ketone meters, and glycemic treatment guidelines together to manage diabetes.
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, United States
Glycemic Outcomes
Glucose Variability (GV) as measured by CGM-based Coefficient of Variation (CV), as recommended by the International Consensus on Use of Continuous Glucose Monitoring.
Time frame: Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention
Percent Time in Clinical Hypoglycemia
Percentage of time blood glucose was below 54mg/dL as per CGM
Time frame: Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention
Percent Time Below Recommended Threshold
Percentage of time blood glucose was below 70mg/dL as per CGM
Time frame: Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention
Percent Time in Target Range
Percentage of time blood glucose was 70mg/dL and 180mg/dL as per CGM
Time frame: Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention
Percent Time Above Range
Percentage of time blood glucose was above 180mg/dL as per CGM
Time frame: Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention
Percent Time Above 250 mg/dL
Percentage of time blood glucose was above 250mg/dL as per CGM
Time frame: Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention
Average Glycemia
average of CGM values
Time frame: Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Low Blood Glucose Index
The low blood glucose index (LBGI) is based on a nonlinear transformation of blood glucose values that corrects for the asymmetry of the glucose scale. This transformation maps glucose values into a risk space (minimum risk = 0), where higher values correspond to higher risk. Values \<1 suggest low risk of hypoglycemia.
Time frame: Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention
High Blood Glucose Index
The high blood glucose index (HBGI) is based on a nonlinear transformation of blood glucose values that corrects for the asymmetry of the glucose scale. This transformation maps glucose values into a risk space (minimum risk = 0), where higher values correspond to higher risk. Values below 10 suggest low to moderate risk.
Time frame: Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention