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).
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
Type 1 DM, LADA, pancreatogenic DM, DKA/HHS within 12 months, ketonuria at enrollment
Enrollment POC ≥350 mg/dL or immediate IV insulin requirement
HbA1c ≥10.0%
eGFR <30 mL/min/1.73m² or dialysis
Parallel
CareLevo Patch-type Insulin Pump
DeviceCareLevo (CareMedi Inc., South Korea): tubeless patch pump, 300U reservoir, max 7-day wear, basal 0.05-15 U/hr, bolus 0.05-25 U, CareSens Air CGM integration via smartphone app. Steroid-wave basal profile (highest during 10:00-16:00, 35% of basal budget). App bolus calculator accepts CGM glucose + patient-selected carbohydrate band (0/30/45/60/75/90g) and computes dose based on ICR, ISF, and IOB. Provided free by manufacturer (CareMedi); manufacturer has no role in study design, data analysis, or publication.
Insulin Glargine U-100 (Lantus)
DrugLantus administered subcutaneously once daily in the morning with steroid intake. Dose = 45% of study TDD. De-escalated proportionally: Day 10-11 ×0.67, Day 12-13 ×0.33, Day 14 ×0.17 or discontinuation. Selected over NPH for practical utility and supply stability; evidence supports comparable efficacy to NPH for GIH in BBI framework (Ruiz de Adana et al. 2018). Toujeo/Tresiba excluded due to prolonged time to steady-state (≥5 days) incompatible with 14-day protocol.
Fast-acting Insulin Aspart (Fiasp)
DrugFiasp used as prandial and correction insulin in both arms. Meal bolus via carbohydrate-band selection (0/30/45/60/75/90g). ICR: breakfast 45g/(0.15×TDD); lunch/dinner 60g/(0.20×TDD). ISF = 1500/TDD (daytime), 2×ISF (night). Arm A: app auto-calculation with IOB. Arm B: pre-printed dose table (same algorithm). No routine postprandial correction. Rescue correction: ≥3h post-bolus + POC/CGM ≥300 mg/dL sustained.
CareSens Air Continuous Glucose Monitor
DeviceCareSens Air (i-SENS, South Korea), 15-day sensor attached Day 0. 5-minute interval glucose transmitted to smartphone and Sens365 platform for research team monitoring. Arm A: real-time CGM integrated into CareLevo bolus calculator. Primary endpoint (24h TAR) and key secondary endpoint (window TAR 10:00-22:00) computed from Sens365 raw export. 15-day sensor covers entire study period (Day 1-14) without sensor change. Provided free by manufacturer (i-SENS); manufacturer has no role in study design, analysis, or publication.
24-hour CGM Time Above Range (TAR) >180 mg/dL (%) - averaged over Day 1-9
Percentage of CGM readings exceeding 180 mg/dL over 24 hours, averaged across the 9-day high-dose corticosteroid period (Day 1-9). Calculated from 5-minute interval CareSens Air CGM raw data exported from Sens365 platform. 24-hour TAR is the standard CGM metric per international consensus guidelines and AGP reporting framework, enabling direct comparison with published literature on glucocorticoid-induced hyperglycemia. Minimum 70% CGM data completeness per day required for inclusion in primary analysis; days with \<70% completeness handled by multiple imputation in primary analysis and complete-case analysis as sensitivity analysis.
CGM TAR >180 mg/dL (%) during steroid pharmacodynamic window (10:00-22:00) - pre-specified exploratory analysis of the steroid-specific time period corresponding to peak methylprednisolone effect
Time In Range (TIR) 70-180 mg/dL (%, 24-hour)
Time Above Range >250 mg/dL (%, 24-hour)
Postprandial incremental AUC >180 mg/dL (breakfast, lunch, dinner - 2-4h post-meal)
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Hallym University
Lead sponsor
Hallym University Dongtan Sacred Heart Hospital
Sponsor institution
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