Steroid-induced Hyperglycemia Management With Insulin Patch Pump in Sudden Sensorineural Hearing Loss: a CGM-guided Exploratory Randomized Controlled Trial (SHIP Trial)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
研究概览
简要总结
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).
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Pregnancy/breastfeeding; women of childbearing potential: positive urine hCG
- •ICU, sepsis, NPO, TPN/enteral nutrition
- •Severe hepatic failure (Child-Pugh C)
- •Dexamethasone, divided-dose, or pulse steroids planned
- •Prior CSII or AID device user
- •Skin adhesive allergy precluding CGM or patch pump use
- •Insufficient cognitive function for device or dosing table use
- •Planned MRI requiring repeated CGM/pump removal
- •PTA >70 dB (profound hearing loss requiring combined intratympanic steroid)
研究组 & 干预措施
CareLevo CSII (Arm A)
Participants are fitted with the CareLevo patch pump loaded with Fiasp. A steroid-wave basal profile concentrates insulin delivery during afternoon-evening (10:00-22:00) to match methylprednisolone pharmacodynamics, while minimizing overnight basal. Meal bolus uses a carbohydrate-band calculator integrated with CareSens Air CGM. IOB is reflected in all bolus decisions. Patch replaced Day 8. Insulin tapered proportionally to steroid reduction from Day 10.
干预措施: Fast-acting Insulin Aspart (Fiasp) (Drug)
CareLevo CSII (Arm A)
Participants are fitted with the CareLevo patch pump loaded with Fiasp. A steroid-wave basal profile concentrates insulin delivery during afternoon-evening (10:00-22:00) to match methylprednisolone pharmacodynamics, while minimizing overnight basal. Meal bolus uses a carbohydrate-band calculator integrated with CareSens Air CGM. IOB is reflected in all bolus decisions. Patch replaced Day 8. Insulin tapered proportionally to steroid reduction from Day 10.
干预措施: CareLevo Patch-type Insulin Pump (Device)
CareLevo CSII (Arm A)
Participants are fitted with the CareLevo patch pump loaded with Fiasp. A steroid-wave basal profile concentrates insulin delivery during afternoon-evening (10:00-22:00) to match methylprednisolone pharmacodynamics, while minimizing overnight basal. Meal bolus uses a carbohydrate-band calculator integrated with CareSens Air CGM. IOB is reflected in all bolus decisions. Patch replaced Day 8. Insulin tapered proportionally to steroid reduction from Day 10.
干预措施: CareSens Air Continuous Glucose Monitor (Device)
Lantus-based MDI (Arm B)
Participants receive Lantus (insulin glargine U-100) once daily in the morning (45% of study TDD) with steroid. Fiasp prandial bolus via insulin pen using a pre-printed dose table based on the same carbohydrate-band algorithm as Arm A. Correction via the same fixed printed table. Insulin tapered from Day 10 proportionally to steroid taper.
干预措施: Insulin Glargine U-100 (Lantus) (Drug)
Lantus-based MDI (Arm B)
Participants receive Lantus (insulin glargine U-100) once daily in the morning (45% of study TDD) with steroid. Fiasp prandial bolus via insulin pen using a pre-printed dose table based on the same carbohydrate-band algorithm as Arm A. Correction via the same fixed printed table. Insulin tapered from Day 10 proportionally to steroid taper.
干预措施: Fast-acting Insulin Aspart (Fiasp) (Drug)
Lantus-based MDI (Arm B)
Participants receive Lantus (insulin glargine U-100) once daily in the morning (45% of study TDD) with steroid. Fiasp prandial bolus via insulin pen using a pre-printed dose table based on the same carbohydrate-band algorithm as Arm A. Correction via the same fixed printed table. Insulin tapered from Day 10 proportionally to steroid taper.
干预措施: CareSens Air Continuous Glucose Monitor (Device)
研究者
Hun Jee Choe
Assistant Professor
Hallym University Dongtan Sacred Heart Hospital