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Patch pump vs. shots: can a smart insulin device tame Steroid-Related blood sugar spikes?

NCT ID NCT07652528

Disease control Sponsor: Hallym University 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jul 23, 2026 · Updated 3 times

Summary

This study looks at whether a wearable insulin patch pump, guided by a continuous glucose monitor, can better control high blood sugar caused by high-dose steroids in people with sudden hearing loss and diabetes or prediabetes. About 44 participants will be randomly assigned to either the patch pump or standard insulin injections. The goal is to see which method keeps blood sugar in a safer range during the 9-day steroid treatment.

What this could mean

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

Active substance
Insulin patch pump (CareLevo) and insulin glargine (Lantus) injections
What this could lead to
If successful, this could show that a patch pump is a better way to manage temporary high blood sugar caused by steroids in people with hearing loss and diabetes.
What could go wrong
This is a small, early-stage trial with only 44 participants, so results may not apply to everyone. The pump is new and may have technical issues or not work better than standard injections.

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

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

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

19 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: 1. Age ≥19 years 2. Idiopathic SSNHL: ≥30 dB sensorineural hearing loss across ≥3 consecutive frequencies within 72 hours 3. Affected ear PTA4 (mean of 0.5/1/2/4 kHz) ≥40 dB HL (moderate or greater) 4. Planned methylprednisolone 48 mg/day orally once in the morning 5. At least one of: known T2DM; HbA1c 5.7-10.0% within 3 months; POC glucose ≥140 mg/dL ×2 (≥2h apart, ≥1 postprandial) within 24h of steroid 6. If on prior insulin: outpatient TDD ≤30 U/day 7. Able to eat ≥2 meals/day, wear CGM and patch pump, use smartphone 8. Willing to undergo 2-night inpatient admission (Day 1-3) 9. Written informed consent Exclusion Criteria: 1. Type 1 DM, LADA, pancreatogenic DM, DKA/HHS within 12 months, ketonuria at enrollment 2. Enrollment POC ≥350 mg/dL or immediate IV insulin requirement 3. HbA1c ≥10.0% 4. eGFR \<30 mL/min/1.73m² or dialysis 5. Pregnancy/breastfeeding; women of childbearing potential: positive urine hCG 6. ICU, sepsis, NPO, TPN/enteral nutrition 7. Severe hepatic failure (Child-Pugh C) 8. Dexamethasone, divided-dose, or pulse steroids planned 9. Prior CSII or AID device user 10. Skin adhesive allergy precluding CGM or patch pump use 11. Insufficient cognitive function for device or dosing table use 12. Planned MRI requiring repeated CGM/pump removal 13. PTA \>70 dB (profound hearing loss requiring combined intratympanic steroid)

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Conditions

The condition(s) this trial relates to.

prediabetes syndrome sudden sensorineural hearing loss type 2 diabetes mellitus

As listed by the trial registrant

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

Prediabetes / type 2 diabetes Sudden sensorineural hearing loss (SSNHL)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

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