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Active, Not Recruiting

NCT Number: NCT07681375

Evaluation of Basal Insulin Initialization and Titration in People With Type 2 Diabetes Wearing a Dexcom G6 Sensor

To evaluate the feasibility of the DexBasal Study System

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

San Diego Family Care (SDFC)

San Diego, California, 92111, United States

About this study

To evaluate the feasibility of the DexBasal Study System for recommending doses of basal insulin, embodied as a clinician facing Web portal.

Who can participate

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

  • 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.

Treatment and study plan

Basal Insulin

Drug

daily basal insulin dose

Other names: DexBasal

Dexcom Continuous Glucose Monitoring (CGM)

Device

Dexcom Continuous Glucose Monitoring (CGM) Sensor

Primary outcomes

  1. Measurement of participant safety while using the DexBasal Study System

    Time frame: Day 10 up to 8 weeks

    Subject safety measured by the number of Severe Adverse Events (SAEs)

  2. Measurement of system recommended dose

    Time frame: Day 10 up to 8 weeks

    System functionality measured by the generation of a recommended dose.

  3. Frequency of Physician approval of Dexbasal Study system's daily dose recommendation

    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.

  4. Subject reported insulin dose

    Time frame: Day 10 up to 8 weeks

    System functionality measured by the subject-reported basal insulin dose injections.

  5. Evaluation of the CGM Metrics based on average glucose

    Time frame: Baseline through end of study, an average of 96 days

    -Measure of Average glucose (mg/dL)

  6. Evaluation of the CGM Metrics using coefficient variation (CV)

    Time frame: Baseline through end of study, an average of 96 days

    • Measure of CV (%)
  7. Evaluation of the CGM Metrics for time in range (TIR)

    Time frame: Baseline through end of study, an average of 96 days

    • Measure of TIR (70-180 mg/dL) (%)
  8. Evaluation of the CGM Metrics of time spent very low

    Time frame: Baseline through end of study, an average of 96 days

    • Measure of Time spent very low (<54 mg/dL) (%)
  9. Evaluation of the CGM Metrics of time spent low

    Time frame: Baseline through end of study, an average of 96 days

    • Measure of Time spent low (54-69 mg/dL) (%)
  10. Evaluation of the CGM Metrics of time spent below 70 mg/dL

    Time frame: Baseline through end of study, an average of 96 days

    • Measure of Time spent low (<70 mg/dL) (%)
  11. Evaluation of the CGM Metrics of time spent high

    Time frame: Baseline through end of study, an average of 96 days

    • Measure of Time spent high (>180 mg/dL) (%)
  12. Evaluation of the CGM Metrics of time spent very high

    Time frame: Baseline through end of study, an average of 96 days

    • Measure of Time spent very high (>250 mg/dL) (%)
  13. Measure of glycemic control

    Time frame: Baseline through end of study, an average of 96 days

    Fasting Glucose

Secondary outcomes

  1. Gain understanding and perspective from study subjects with questionnaires

    Time frame: End of study, on average Day 96

    • Diabetes Treatment and Satisfaction Questionnaire change measures
  2. Gain understanding and perspective from study subjects through status questionnaire

    Time frame: Baseline

    • Diabetes Treatment and Satisfaction Questionnaire status measures
  3. Gain understanding and perspective from study subjects through Relationship Scale

    Time frame: 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.
  4. Gain understanding and perspective from study subjects through Satisfaction Survey

    Time frame: Baseline through end of study, an average of 96 days

    • Glucose Monitoring Satisfaction Survey
  5. Gain understanding and perspective from study subjects thru study specific items

    Time frame: Baseline through end of study, an average of 96 days

    • Study-specific items

Sponsors and collaborators

Lead sponsor

DexCom, Inc.

Industry

Registry information

Official study title

Evaluation of Basal Insulin Initialization and Titration in People With Type 2 Diabetes Wearing a Dexcom Sensor

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jul 2, 2026
Registry last updated
Jul 2, 2026

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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