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Smart insulin dosing system aims to simplify diabetes management

NCT ID NCT07681375

Disease control Sponsor: DexCom, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 02, 2026 · Last updated Jul 02, 2026

Summary

This study tests a system that combines a continuous glucose monitor (CGM) with daily insulin dose recommendations for people with type 2 diabetes who are starting basal insulin. Participants wear a Dexcom CGM sensor and receive suggested insulin doses through the DexBasal system, which a physician reviews. The goal is to see if the system is safe and works well for managing blood sugar levels.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Basal insulin (DexBasal)
What this could lead to
If successful, this system could help people with type 2 diabetes manage their blood sugar more easily and safely by automating insulin dose adjustments.
What could go wrong
This is a small, early-phase feasibility study, so the system may not work as intended or may not improve outcomes. Risks include low blood sugar (hypoglycemia) and device issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

45 people

The number who actually took part.

Started

Apr 2023

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

diabetes mellitus type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Type 2 diabetes

Contacts and locations

Locations

  • San Diego Family Care (SDFC)

    San Diego, California, 92111, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.