Type 2 Diabetes
Conditions
Keywords
diabetes
Brief summary
To evaluate the feasibility of the DexBasal Study System
Detailed description
To evaluate the feasibility of the DexBasal Study System for recommending doses of basal insulin, embodied as a clinician facing Web portal.
Interventions
DRUGBasal insulin
daily basal insulin dose
DEVICEDexcom Continuous Glucose Monitoring (CGM)
Dexcom Continuous Glucose Monitoring (CGM) Sensor
Sponsors
DexCom, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) (%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gain understanding and perspective from study subjects with questionnaires | End of study, on average Day 96 | \- Diabetes Treatment and Satisfaction Questionnaire change measures |
| Gain understanding and perspective from study subjects through Relationship Scale | Baseline through end of study, an average of 96 days | \- Patient-Doctor Depth of Relationship Scale minimum score is zero, maximum score is 32. Higher score means a better outcome. |
| Gain understanding and perspective from study subjects through Satisfaction Survey | Baseline through end of study, an average of 96 days | \- Glucose Monitoring Satisfaction Survey |
| Gain understanding and perspective from study subjects thru study specific items | Baseline through end of study, an average of 96 days | \- Study-specific items |
| Gain understanding and perspective from study subjects through status questionnaire | Baseline | \- Diabetes Treatment and Satisfaction Questionnaire status measures |
Countries
United States
Outcome results
None listed