To evaluate the feasibility of the DexBasal Study System
To evaluate the feasibility of the DexBasal Study System for recommending doses of basal insulin, embodied as a clinician facing Web portal.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
45
daily basal insulin dose
Dexcom Continuous Glucose Monitoring (CGM) Sensor
San Diego Family Care (SDFC)
San Diego, California, United States
Measurement of participant safety while using the DexBasal Study System
Subject safety measured by the number of Severe Adverse Events (SAEs)
Time frame: Day 10 up to 8 weeks
Measurement of system recommended dose
System functionality measured by the generation of a recommended dose.
Time frame: Day 10 up to 8 weeks
Frequency of Physician approval of Dexbasal Study system's daily dose recommendation
System functionality measured by the physician review and physician approval of daily dose recommendations in Phase 2.
Time frame: Day 10 up to 8 weeks
Subject reported insulin dose
System functionality measured by the subject-reported basal insulin dose injections.
Time frame: Day 10 up to 8 weeks
Evaluation of the CGM Metrics based on average glucose
-Measure of Average glucose (mg/dL)
Time frame: Baseline through end of study, an average of 96 days
Evaluation of the CGM Metrics using coefficient variation (CV)
\- Measure of CV (%)
Time frame: Baseline through end of study, an average of 96 days
Evaluation of the CGM Metrics for time in range (TIR)
\- Measure of TIR (70-180 mg/dL) (%)
Time frame: Baseline through end of study, an average of 96 days
Evaluation of the CGM Metrics of time spent very low
\- Measure of Time spent very low (\<54 mg/dL) (%)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline through end of study, an average of 96 days
Evaluation of the CGM Metrics of time spent low
\- Measure of Time spent low (54-69 mg/dL) (%)
Time frame: Baseline through end of study, an average of 96 days
Evaluation of the CGM Metrics of time spent below 70 mg/dL
\- Measure of Time spent low (\<70 mg/dL) (%)
Time frame: Baseline through end of study, an average of 96 days
Evaluation of the CGM Metrics of time spent high
\- Measure of Time spent high (\>180 mg/dL) (%)
Time frame: Baseline through end of study, an average of 96 days
Evaluation of the CGM Metrics of time spent very high
\- Measure of Time spent very high (\>250 mg/dL) (%)
Time frame: Baseline through end of study, an average of 96 days
Measure of glycemic control
Fasting Glucose
Time frame: Baseline through end of study, an average of 96 days
Gain understanding and perspective from study subjects with questionnaires
\- Diabetes Treatment and Satisfaction Questionnaire change measures
Time frame: End of study, on average Day 96
Gain understanding and perspective from study subjects through status questionnaire
\- Diabetes Treatment and Satisfaction Questionnaire status measures
Time frame: Baseline
Gain understanding and perspective from study subjects through Relationship Scale
\- Patient-Doctor Depth of Relationship Scale minimum score is zero, maximum score is 32. Higher score means a better outcome.
Time frame: Baseline through end of study, an average of 96 days
Gain understanding and perspective from study subjects through Satisfaction Survey
\- Glucose Monitoring Satisfaction Survey
Time frame: Baseline through end of study, an average of 96 days
Gain understanding and perspective from study subjects thru study specific items
\- Study-specific items
Time frame: Baseline through end of study, an average of 96 days