To evaluate the feasibility of the DexBasal Study System
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: Patients with a diagnosis of Type 2 diabetes (T2D) mellitus
* Ages equal or greater 18 years ("age" determined at the time of the Screening Visit)
* Bodyweight between 30-450 kg
* Comfortable with and willing to administer basal insulin injections, once a day, for approximately 75 consecutive days, and log daily injections in the Dexcom CGM mobile application.
* Willing to wear Dexcom CGM for duration of study
Exclusion Criteria:
* Recent severe hypoglycemia, complicated by seizure(s) or loss of consciousness, in the past 3 months
* Subjects with any contraindications for starting or continuing basal insulin therapy
* Glomerular filtration rate (eGFR) \< 30 ml/min/1.73m2 (within 6 months of insertion) or on hemodialysis
* Introducing or increasing glucose lowering medications simultaneously
* Any condition that, in the opinion of the Investigator, would interfere with a subject's participation in the trial or pose excessive risk to subject and/or study staff
* For subjects of child-bearing potential: Pregnancy, demonstrated by a positive test no more than 72 hours prior to Clinic Visit 1
* Has used prandial insulin in the last 30 days.
* Anticipated addition of medications that could have significant impact on insulin sensitivity such as atypical antipsychotics.
Primary outcome measure(s)
Measurement of participant safety while using the DexBasal Study System — Day 10 up to 8 weeks Subject safety measured by the number of Severe Adverse Events (SAEs)
Measurement of system recommended dose — Day 10 up to 8 weeks System functionality measured by the generation of a recommended dose.
Frequency of Physician approval of Dexbasal Study system's daily dose recommendation — Day 10 up to 8 weeks System functionality measured by the physician review and physician approval of daily dose recommendations in Phase 2.
Subject reported insulin dose — Day 10 up to 8 weeks System functionality measured by the subject-reported basal insulin dose injections.
Evaluation of the CGM Metrics based on average glucose — Baseline through end of study, an average of 96 days -Measure of Average glucose (mg/dL)
Evaluation of the CGM Metrics using coefficient variation (CV) — Baseline through end of study, an average of 96 days \- Measure of CV (%)
Evaluation of the CGM Metrics for time in range (TIR) — Baseline through end of study, an average of 96 days \- Measure of TIR (70-180 mg/dL) (%)
Evaluation of the CGM Metrics of time spent very low — Baseline through end of study, an average of 96 days \- Measure of Time spent very low (\<54 mg/dL) (%)
Evaluation of the CGM Metrics of time spent low — Baseline through end of study, an average of 96 days \- Measure of Time spent low (54-69 mg/dL) (%)
Evaluation of the CGM Metrics of time spent below 70 mg/dL — Baseline through end of study, an average of 96 days \- Measure of Time spent low (\<70 mg/dL) (%)
Evaluation of the CGM Metrics of time spent high — Baseline through end of study, an average of 96 days \- Measure of Time spent high (\>180 mg/dL) (%)
Evaluation of the CGM Metrics of time spent very high — Baseline through end of study, an average of 96 days \- Measure of Time spent very high (\>250 mg/dL) (%)
Measure of glycemic control — Baseline through end of study, an average of 96 days Fasting Glucose
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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