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

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

To evaluate the feasibility of the DexBasal Study System

Study Overview

• Status: Active, not recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: Basal insulin; Device: Dexcom Continuous Glucose Monitoring (CGM)

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92111
      • San Diego Family Care (SDFC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Dexbasal; 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; daily basal insulin dose; Other Names: DexBasal; Device: Dexcom Continuous Glucose Monitoring (CGM); Dexcom Continuous Glucose Monitoring (CGM) Sensor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gain understanding and perspective from study subjects with questionnaires	- Diabetes Treatment and Satisfaction Questionnaire change measures	End of study, on average Day 96
Gain understanding and perspective from study subjects through status questionnaire	- Diabetes Treatment and Satisfaction Questionnaire status measures	Baseline
Gain understanding and perspective from study subjects through Relationship Scale	- Patient-Doctor Depth of Relationship Scale minimum score is zero, maximum score is 32. Higher score means a better outcome.	Baseline through end of study, an average of 96 days
Gain understanding and perspective from study subjects through Satisfaction Survey	- Glucose Monitoring Satisfaction Survey	Baseline through end of study, an average of 96 days
Gain understanding and perspective from study subjects thru study specific items	- Study-specific items	Baseline through end of study, an average of 96 days

Collaborators and Investigators

• Sponsor: DexCom, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2023
• Primary Completion (Actual): January 16, 2026
• Study Completion (Estimated): January 15, 2027

Study Registration Dates

• First Submitted: May 18, 2026
• First Submitted That Met QC Criteria: June 26, 2026
• First Posted (Actual): July 2, 2026

Study Record Updates

• Last Update Posted (Actual): July 2, 2026
• Last Update Submitted That Met QC Criteria: June 26, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: diabetes
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Diabetes Mellitus
• Other Study ID Numbers: PTL-1000125

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No