NCT07652528Not yet recruiting
CGM-guided Patch Pump vs Basal-Bolus Injection for Steroid-Induced Hyperglycemia in Sudden Sensorineural Hearing Loss: SHIP Trial
Steroid-induced Hyperglycemia Management With Insulin Patch Pump in Sudden Sensorineural Hearing Loss: a CGM-guided Exploratory Randomized Controlled Trial (SHIP Trial)
Source: ClinicalTrials.gov · Last updated 22 Jul 2026
Brief summary (registry, in English)
This exploratory randomized controlled trial evaluates whether a CGM-guided temporary patch pump (CareLevo CSII) reduces glucocorticoid-induced hyperglycemia (GIH) compared to a Lantus-based basal-bolus injection (MDI) regimen in patients with sudden sensorineural hearing loss (SSNHL) and type 2 diabetes or prediabetes receiving high-dose systemic corticosteroids (methylprednisolone 48 mg/day). Patients with SSNHL are treated with high-dose oral corticosteroids as standard of care, which often causes significant postprandial hyperglycemia - particularly in patients with pre-existing diabetes or prediabetes. No randomized trial has investigated the optimal insulin delivery strategy for this specific clinical scenario. All enrolled participants undergo a 2-night inpatient admission (Day 1-3) for safe insulin initiation and device education, followed by outpatient management (Day 4-14). All participants wear a CareSens Air continuous glucose monitor (CGM, 15-day sensor) throughout Day 1-14. Participants meeting insulin activation criteria are randomized 1:1 to: * Arm A (CSII): CareLevo patch pump using a steroid-wave basal profile and carbohydrate-band meal bolus via the app's bolus calculator (CGM-integrated, IOB-adjusted) * Arm B (MDI): Insulin glargine U-100 (Lantus) qAM plus Fiasp prandial bolus via pen using a pre-printed dose table with identical carbohydrate-band algorithm Both arms use identical glycemic targets, carbohydrate-band bolus algorithm (ICR/ISF identical), and correction rules. The primary difference is insulin delivery (patch pump vs. pen injection) and basal profile (steroid-wave CSII vs. flat glargine). The primary outcome is 24-hour CGM Time Above Range (TAR) \>180 mg/dL averaged over the 9-day high-dose steroid period (Day 1-9).
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 11 Jun 2026
- Start date
- Aug 2026
- Primary completion date
- Jun 2028
- Lead sponsor
- Hallym University
- Diseases
- Type 2 diabetes
- NCT number
- NCT07652528
What you commit to
- Study type: Interventional
- Planned participants: 50
- From Aug 2026 to the primary completion date, Jun 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Dexamethasone, divided-dose, or pulse steroids planned
- Prior CSII or AID device user
- PTA \>70 dB (profound hearing loss requiring combined intratympanic steroid)
Other illness
- Severe hepatic failure (Child-Pugh C)
- Skin adhesive allergy precluding CGM or patch pump use
Lab values
- Enrollment POC ≥350 mg/dL or immediate IV insulin requirement
- HbA1c ≥10.0%
- eGFR \<30 mL/min/1.73m² or dialysis
Other
- Type 1 DM, LADA, pancreatogenic DM, DKA/HHS within 12 months, ketonuria at enrollment
- Pregnancy/breastfeeding; women of childbearing potential: positive urine hCG
- ICU, sepsis, NPO, TPN/enteral nutrition
- Insufficient cognitive function for device or dosing table use
- Planned MRI requiring repeated CGM/pump removal
Who the study is looking for
- Age ≥19 years
- Idiopathic SSNHL: ≥30 dB sensorineural hearing loss across ≥3 consecutive frequencies within 72 hours
- Affected ear PTA4 (mean of 0.5/1/2/4 kHz) ≥40 dB HL (moderate or greater)
- Planned methylprednisolone 48 mg/day orally once in the morning
- 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
- If on prior insulin: outpatient TDD ≤30 U/day
- Able to eat ≥2 meals/day, wear CGM and patch pump, use smartphone
- Willing to undergo 2-night inpatient admission (Day 1-3)
- Written informed consent
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.