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

NCT07681375 | Active Not Recruiting Phase 1 DMC FDA Device

• 1 other identifier: PTL-1000125
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the feasibility of the DexBasal Study System

Conditions

Type 2 Diabetes

Keywords

diabetes

Outcome Measures

Primary Outcomes (13)

• Measurement of participant safety while using the DexBasal Study System

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

  Day 10 up to 8 weeks

• Measurement of system recommended dose

  System functionality measured by the generation of a recommended dose.

  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.

  Day 10 up to 8 weeks

• Subject reported insulin dose

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

  Day 10 up to 8 weeks

• Evaluation of the CGM Metrics based on average glucose

  -Measure of Average glucose (mg/dL)

  Baseline through end of study, an average of 96 days

• Evaluation of the CGM Metrics using coefficient variation (CV)

  \- Measure of CV (%)

  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) (%)

  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) (%)

  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) (%)

  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) (%)

  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) (%)

  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) (%)

  Baseline through end of study, an average of 96 days

• Measure of glycemic control

  Fasting Glucose

  Baseline through end of study, an average of 96 days

Secondary Outcomes (5)

• Gain understanding and perspective from study subjects with questionnaires

  End of study, on average Day 96

• Gain understanding and perspective from study subjects through status questionnaire

  Baseline

• Gain understanding and perspective from study subjects through Relationship Scale

  Baseline through end of study, an average of 96 days

• Gain understanding and perspective from study subjects through Satisfaction Survey

  Baseline through end of study, an average of 96 days

• Gain understanding and perspective from study subjects thru study specific items

  Baseline through end of study, an average of 96 days

Study Arms (1)

Dexbasal

OTHER

Subjects initiating basal insulin therapy or on basal insulin therapy maintenance and benefit from transitioning to a study-specific type of basal insulin within 72 hours of Phase 1.

Drug: Basal insulin; Device: Dexcom Continuous Glucose Monitoring (CGM)

Interventions

Basal insulin DRUG

daily basal insulin dose

Also known as: DexBasal

Dexbasal

Dexcom Continuous Glucose Monitoring (CGM) DEVICE

Dexcom Continuous Glucose Monitoring (CGM) Sensor

Dexbasal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• DexCom, Inc.: lead

Study Sites (1)

San Diego Family Care (SDFC)

San Diego, California, 92111, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: July 2, 2026
• Study Start: April 11, 2023
• Primary Completion: January 16, 2026
• Study Completion (Estimated): January 15, 2027
• Last Updated: July 2, 2026

Record last verified: 2026-06

Locations

US (1)