Type 2 DiabetesPhase 1NCT07681375
Evaluation of Basal Insulin Initialization and Titration in People With Type 2 Diabetes Wearing a Dexcom G6 Sensor
A Phase 1 study testing Basal insulin and Dexcom Continuous Glucose Monitoring (CGM) in people with Type 2 Diabetes, run by DexCom, Inc. at 1 site in United States.
Trial summary
To evaluate the feasibility of the DexBasal Study System Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Basal insulin and Dexcom Continuous Glucose Monitoring (CGM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2023to 15 Jan 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
San Diego Family Care (SDFC)
San Diego, California, 92111
About this study
Official title: 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
Read the detailed description
To evaluate the feasibility of the DexBasal Study System for recommending doses of basal insulin, embodied as a clinician facing Web portal.
- Conditions
- Type 2 Diabetes
- Being tested
- Basal insulin, Dexcom Continuous Glucose Monitoring (CGM)
- Keywords
- diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basal insulinDrug
Also called DexBasal
daily basal insulin dose
Dexcom Continuous Glucose Monitoring (CGM)Device
Dexcom Continuous Glucose Monitoring (CGM) Sensor
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Basal insulin; Device: Dexcom Continuous Glucose Monitoring (CGM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of participant safety while using the DexBasal Study System
Subject safety measured by the number of Severe Adverse Events (SAEs)
Measured: Day 10 up to 8 weeks
Measurement of system recommended dose
System functionality measured by the generation of a recommended dose.
Measured: 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.
Measured: Day 10 up to 8 weeks
Subject reported insulin dose
System functionality measured by the subject-reported basal insulin dose injections.
Measured: Day 10 up to 8 weeks
Evaluation of the CGM Metrics based on average glucose
-Measure of Average glucose (mg/dL)
Measured: Baseline through end of study, an average of 96 days
Evaluation of the CGM Metrics using coefficient variation (CV)
- Measure of CV (%)
Measured: 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) (%)
Measured: 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) (%)
Measured: 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) (%)
Measured: 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) (%)
Measured: 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) (%)
Measured: 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) (%)
Measured: Baseline through end of study, an average of 96 days
Measure of glycemic control
Fasting Glucose
Measured: Baseline through end of study, an average of 96 days
Secondary outcomes (5)
Gain understanding and perspective from study subjects with questionnaires
- Diabetes Treatment and Satisfaction Questionnaire change measures
Measured: End of study, on average Day 96
Gain understanding and perspective from study subjects through status questionnaire
- Diabetes Treatment and Satisfaction Questionnaire status measures
Measured: 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.
Measured: Baseline through end of study, an average of 96 days
Gain understanding and perspective from study subjects through Satisfaction Survey
- Glucose Monitoring Satisfaction Survey
Measured: Baseline through end of study, an average of 96 days
Gain understanding and perspective from study subjects thru study specific items
- Study-specific items
Measured: Baseline through end of study, an average of 96 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start11 Apr 2023
- Primary completion16 Jan 2026
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- DexCom, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07681375
- Sponsor's protocol ID
- PTL-1000125
- Status last verified
- Jun 2026
- First submitted
- 18 May 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Oser SM, Crystal C, Hames KC, Li X, Gao P, Crawford MA, Hicks C, Gerber M, Gautier T, Colmegna P, Yang L, Singh H, Johnson ML, Beck SE. Continuous Glucose Monitoring-Informed Basal Insulin Optimization System in Adults with Type 2 Diabetes: Initial Evaluation of Efficacy, Safety, and Impact on Patient-Reported Outcomes. Diabetes Ther. 2026 Aug 10. doi: 10.1007/s13300-026-01901-4. Online ahead of print.
PubMed 42573729
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Basal Insulin Initialization and Titration in People With Type 2 Diabetes Wearing a Dexcom Sensor
- ClinicalTrials.gov ID
- NCT07681375
- Acronym / sponsor ID
- PTL-1000125
- Conditions
- Type 2 Diabetes
- Keywords
- diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (actual)
- Lead sponsor
- DexCom, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Apr 2023 (actual)
- Primary completion
- 16 Jan 2026 (actual)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 2 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dexbasal | Other | Drug: Basal insulin, Device: Dexcom Continuous Glucose Monitoring (CGM)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Basal insulinAlso: DexBasaldaily basal insulin dose | Drug | Dexbasal |
| Dexcom Continuous Glucose Monitoring (CGM)Dexcom Continuous Glucose Monitoring (CGM) Sensor | Device | Dexbasal |
Primary outcome
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)
Measurement of system recommended dose
Time frame: 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
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.
Subject reported insulin dose
Time frame: 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
Time frame: 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)
Time frame: Baseline through end of study, an average of 96 days
- Measure of CV (%)
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) (%)
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) (%)
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) (%)
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) (%)
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) (%)
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) (%)
Measure of glycemic control
Time frame: Baseline through end of study, an average of 96 days
Fasting Glucose
5 secondary outcomes
Gain understanding and perspective from study subjects with questionnaires
Time frame: End of study, on average Day 96
Gain understanding and perspective from study subjects through status questionnaire
Time frame: Baseline
Gain understanding and perspective from study subjects through Relationship Scale
Time frame: Baseline through end of study, an average of 96 days
Gain understanding and perspective from study subjects through Satisfaction Survey
Time frame: Baseline through end of study, an average of 96 days
Gain understanding and perspective from study subjects thru study specific items
Time frame: Baseline through end of study, an average of 96 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Derived from this study: PubMed 42573729Oser SM, Crystal C, Hames KC, Li X, Gao P, Crawford MA, Hicks C, Gerber M, Gautier T, Colmegna P, Yang L, Singh H, Johnson ML, Beck SE. Continuous Glucose Monitoring-Informed Basal Insulin Optimization System in Adults with Type 2 Diabetes: Initial Evaluation of Efficacy, Safety, and Impact on Patient-Reported Outcomes. Diabetes Ther. 2026 Aug 10. doi: 10.1007/s13300-026-01901-4. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Basal insulin and Dexcom Continuous Glucose Monitoring (CGM) in people with Type 2 Diabetes, run by DexCom, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of participant safety while using the DexBasal Study System (time frame: Day 10 up to 8 weeks). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07681375, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.