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Tiny study tests smart sugar tracking for breast cancer drug side effect

NCT ID NCT06083038

Symptom relief Sponsor: HealthPartners Institute 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at 8 adults with metastatic breast cancer who were starting the drug alpelisib. Alpelisib often causes high blood sugar, so researchers used a continuous glucose monitor (a small sensor worn on the arm) to track glucose levels day and night for at least 3 months. The goal was to understand when blood sugar spikes happen and to help manage them with a prevention plan.

What this could mean

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

Active substance
alpelisib
What this could lead to
If successful, this could lead to better ways to manage high blood sugar caused by alpelisib, making treatment more tolerable for breast cancer patients.
What could go wrong
This is a very small, completed observational study with only 8 participants, so results may not apply to everyone. It does not test a new treatment for cancer itself.

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.

Participants

8 people

The number who actually took part.

Started

Oct 2023

Finished

Apr 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

Subjects scheduled to receive standard of care alpelisib for treatment of metastatic breast cancer.

Ages

18 years and older

Sex

Anyone

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: 1. Adults aged 18 or older with a diagnosis of metastatic breast cancer that are initiating treatment with alpelisib. 2. Must be willing and able to comply with study visits and procedures. 3. Must meet standard clinical criteria for utilization of alpelisib including hormone-receptor positive/HER2 negative cancer with the presence of a PIK3CA mutation. 4. Oncologist plans to use alpelisib until progression of disease or unacceptable toxicity. 5. Patients must receive cancer care during alpelisib treatment phase with a HealthPartners oncologist and be willing to see IDC/HealthPartners Diabetes Education for diabetes management. 6. Must have a compatible smartphone, access to a compatible smartphone, or the ability to upload CGM reader from home or bring the reader in to a medical visit at least once a month for uploading, to allow for remote management of diabetes and data collection. 7. Life expectancy of at least 3 months Exclusion Criteria: 1. Known history of serious allergy to skin-adhesive material or previous cutaneous reaction to a continuous glucose monitor. 2. Known currently uncontrolled diabetes, defined as the most recent HbA1c over 10% or history of DKA within 6 months prior to enrollment. 3. Concurrent use of high-dose vitamin C, defined as ≥ 1g of oral vitamin C daily, or intravenous Vitamin C infusions. 4. Any other concurrent severe and/or uncontrolled medical condition that, in the opinion of the investigator, would cause unacceptable safety risk, compromise compliance with the protocol, or contraindicate participation in the study. One example being known requirement for high dose steroids at the time of possible enrollment into the study.

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm hyperglycemia

As listed by the trial registrant

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

Metastatic breast cancer

Contacts and locations

Locations

  • HealthPartners Cancer Research Center

    Saint Louis Park, Minnesota, 55426, United States

More trials for these conditions

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