San Diego Family Care (SDFC)
San Diego, California, 92111, United States
NCT Number: NCT07681375
To evaluate the feasibility of the DexBasal Study System
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Phase 1
San Diego, California, 92111, United States
To evaluate the feasibility of the DexBasal Study System for recommending doses of basal insulin, embodied as a clinician facing Web portal.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients with a diagnosis of Type 2 diabetes (T2D) mellitus
Exclusion criteria
daily basal insulin dose
Other names: DexBasal
Dexcom Continuous Glucose Monitoring (CGM) Sensor
Time frame: Day 10 up to 8 weeks
Subject safety measured by the number of Severe Adverse Events (SAEs)
Time frame: Day 10 up to 8 weeks
System functionality measured by the generation of a recommended dose.
Time frame: Day 10 up to 8 weeks
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
System functionality measured by the subject-reported basal insulin dose injections.
Time frame: Baseline through end of study, an average of 96 days
-Measure of Average glucose (mg/dL)
Time frame: Baseline through end of study, an average of 96 days
Time frame: Baseline through end of study, an average of 96 days
Time frame: Baseline through end of study, an average of 96 days
Time frame: Baseline through end of study, an average of 96 days
Time frame: Baseline through end of study, an average of 96 days
Time frame: Baseline through end of study, an average of 96 days
Time frame: Baseline through end of study, an average of 96 days
Time frame: Baseline through end of study, an average of 96 days
Fasting Glucose
Time frame: End of study, on average Day 96
Time frame: Baseline
Time frame: Baseline through end of study, an average of 96 days
Time frame: Baseline through end of study, an average of 96 days
Time frame: Baseline through end of study, an average of 96 days
DexCom, Inc.
Industry
Evaluation of Basal Insulin Initialization and Titration in People With Type 2 Diabetes Wearing a Dexcom Sensor
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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