CGM-guided Patch Pump vs Basal-Bolus Injection for Steroid-Induced Hyperglycemia in Sudden Sensorineural Hearing Loss: SHIP Trial

Overview

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).

BACKGROUND SSNHL is treated with high-dose systemic corticosteroids (methylprednisolone 48 mg/day, prednisolone-equivalent 60 mg/day). In patients with diabetes or prediabetes, GIH is characterized by afternoon-to-evening postprandial predominance. Despite guideline recommendations for insulin-based management, no randomized evidence exists to guide optimal insulin delivery for this short-term, high-dose steroid course. ADA Standards of Care 2026 acknowledges glargine- or NPH-based basal-bolus insulin as established approaches for GIH; however, neither addresses the potential advantage of steroid-wave basal profiling achievable with CSII. STUDY DESIGN Single-center, open-label, exploratory RCT. Day 1-3: 2-night inpatient admission. Day 4-14: outpatient management with fixed discharge dosing plan provided at Day 3. STEROID PROTOCOL (standard of care): Day 1-9: Methylprednisolone 48 mg/day \| Day 10-11: 32 mg/day \| Day 12-13: 16 mg/day \| Day 14: 8 mg/day \| Day 15\~: discontinuation CGM: All participants: CareSens Air CGM (i-SENS, South Korea), 15-day sensor, attached on Day 0 (study-funded). CGM data collected Day 1-14. Primary endpoint computed from Day 1-9 24-hour data. Steroid-wave window (10:00-22:00) TAR is a pre-specified key secondary endpoint. INSULIN PROTOCOLS - COMMON ELEMENTS: Initial study TDD: 0.35-0.40 U/kg/day (T2DM insulin-naïve, PE ≥60 mg/day); 0.20-0.25 U/kg/day (prediabetes). Upper limit: 0.50 U/kg/day or 60 U/day. Basal budget: 35-45% of study TDD for both arms (delivery method differs). Carbohydrate-band meal bolus: Patients select from 6 meal-size categories (0/30/45/60/75/90g). ICR: breakfast \~45g/(0.15×TDD); lunch/dinner \~60g/(0.20×TDD). Identical algorithm for both arms. Correction: ISF = 1500/TDD (daytime); 2×ISF (nighttime). Fixed correction table provided at discharge (calculated once; not recalculated during outpatient period). No routine post-meal correction. Rescue correction only: ≥3h after last bolus, sustained POC/CGM ≥300 mg/dL. Arm A (CSII): CareLevo patch pump with fast-acting insulin aspart (Fiasp). Steroid-wave basal profile: 00:00-04:00 8%, 04:00-07:00 12%, 07:00-10:00 15%, 10:00-16:00 35%, 16:00-22:00 25%, 22:00-24:00 5% of basal budget. Bolus calculator integrated with CGM; patient selects carbohydrate band. IOB reflected in all bolus calculations. Patch replaced Day 8. Arm B (MDI): Insulin glargine U-100 (Lantus) qAM = 45% of TDD, administered with morning steroid. Fiasp prandial bolus via insulin pen using pre-printed dose table (same carbohydrate-band algorithm as Arm A). Fixed correction table provided at discharge. SAMPLE SIZE: 44 participants (22 per arm). Two-sided α=0.05, 80% power, assumed Δ=15%p (MDI TAR=55%, CSII TAR=40%), SD=16%, 20% dropout (Cohen's d=0.94). ANCOVA covariates: baseline POC glucose, HbA1c, diabetes category, BMI.