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Wearable zaps could calm stomach pain in diabetes

NCT ID NCT05362578

Symptom relief Sponsor: University of Michigan Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 21, 2026 · Updated 3 times

Summary

This study tested a wearable device that delivers mild electrical pulses through the skin, similar to acupuncture, to help relieve stomach symptoms in people with diabetic gastroparesis. 41 participants used the device at either a treatment point or a sham point for 84 days. Researchers measured changes in nausea, fullness, pain, and vomiting to see if the device improves symptoms and quality of life.

What this could mean

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

Active substance
transcutaneous electrical acustimulation device
What this could lead to
If it works, this could offer a non-drug, wearable option to ease nausea, fullness, and pain in people with diabetic gastroparesis.
What could go wrong
This is a small, early-stage study with only 41 participants. The effect may be small or no better than a sham device, and results may not apply to everyone with gastroparesis.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

41 people

The number who actually took part.

Started

Sep 2022

Finished

Feb 2025

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.

Ages

18 to 80 years

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: * At least a 3-month history of diabetic gastroparesis symptoms on an on-going basis; at least one severe gastroparetic symptom or two moderate gastroparetic symptoms (e.g. vomiting, nausea, early satiety, bloating, or epigastric or abdominal pain) during the screening. * Documented delayed gastric emptying within past 3 years * Stable concomitant medications, defined as no changes in regimen for at least 2 weeks prior to the experiment (daily adjustments of insulin doses are permitted if patient has diabetes) Exclusion Criteria: * Currently receiving parenteral feeding or presence of a nasogastric or other enteral tube * History of gastric surgery such as fundoplication, gastrectomy, or vagotomy * Symptoms suggestive of gastroparesis with no diagnosis of diabetes * Pregnancy or expect to conceive during the course of the study * Uncontrolled diabetes mellitus (HbA1c \> 11%). * Having any implanted medical device, such as cardiac pacemaker or Entera device

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Conditions

The condition(s) this trial relates to.

gastroparesis

As listed by the trial registrant

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

Gastroparesis with diabetes mellitus

Contacts and locations

Locations

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

More trials for these conditions

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