[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641829":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":42,"locations":28,"responsibleParty":48,"collaborators":28,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":55,"sex":61,"minAge":62,"maxAge":28,"enrollmentInfo":63,"targetDuration":28,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":73,"overallStatus":80,"whyStopped":28,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":28},{"fullName":5,"class":6},"Hallym University","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"CareLevo CSII (Arm A)","EXPERIMENTAL","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.",[13,14,15],"Device: CareLevo Patch-type Insulin Pump","Drug: Fast-acting Insulin Aspart (Fiasp)","Device: CareSens Air Continuous Glucose Monitor",{"label":17,"type":18,"description":19,"interventionNames":20},"Lantus-based MDI (Arm B)","ACTIVE_COMPARATOR","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.",[21,14,15],"Drug: Insulin Glargine U-100 (Lantus)",[23,29,34,38],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DEVICE","CareLevo Patch-type Insulin Pump","CareLevo (CareMedi Inc., South Korea): tubeless patch pump, 300U reservoir, max 7-day wear, basal 0.05-15 U\u002Fhr, 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\u002F30\u002F45\u002F60\u002F75\u002F90g) 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.",[9],null,{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":28},"DRUG","Insulin Glargine U-100 (Lantus)","Lantus 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\u002FTresiba excluded due to prolonged time to steady-state (≥5 days) incompatible with 14-day protocol.",[17],{"type":30,"name":35,"description":36,"armGroupLabels":37,"otherNames":28},"Fast-acting Insulin Aspart (Fiasp)","Fiasp used as prandial and correction insulin in both arms. Meal bolus via carbohydrate-band selection (0\u002F30\u002F45\u002F60\u002F75\u002F90g). ICR: breakfast 45g\u002F(0.15×TDD); lunch\u002Fdinner 60g\u002F(0.20×TDD). ISF = 1500\u002FTDD (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\u002FCGM ≥300 mg\u002FdL sustained.",[9,17],{"type":24,"name":39,"description":40,"armGroupLabels":41,"otherNames":28},"CareSens Air Continuous Glucose Monitor","CareSens 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.",[9,17],[43],{"name":44,"role":45,"phone":46,"phoneExt":28,"email":47},"Hun Jee Choe MD, PhD","CONTACT","+82-10-9493-5703","hunjeechoe@gmail.com",{"type":49,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":52,"oldNameTitle":28,"oldOrganization":28},"PRINCIPAL_INVESTIGATOR","Hun Jee Choe","Assistant Professor","Hallym University Dongtan Sacred Heart Hospital","100641829","cgm-guided-patch-pump-vs-basal-bolus-injection-for-steroid-induced-hyperglycemia-in-sudden-sensorineural-hearing-loss-ship-trial-100641829",false,"NCT07652528","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)","SHIP","Inclusion Criteria:\n\n1. Age ≥19 years\n2. Idiopathic SSNHL: ≥30 dB sensorineural hearing loss across ≥3 consecutive frequencies within 72 hours\n3. Affected ear PTA4 (mean of 0.5\u002F1\u002F2\u002F4 kHz) ≥40 dB HL (moderate or greater)\n4. Planned methylprednisolone 48 mg\u002Fday orally once in the morning\n5. At least one of: known T2DM; HbA1c 5.7-10.0% within 3 months; POC glucose ≥140 mg\u002FdL ×2 (≥2h apart, ≥1 postprandial) within 24h of steroid\n6. If on prior insulin: outpatient TDD ≤30 U\u002Fday\n7. Able to eat ≥2 meals\u002Fday, wear CGM and patch pump, use smartphone\n8. Willing to undergo 2-night inpatient admission (Day 1-3)\n9. Written informed consent\n\nExclusion Criteria:\n\n1. Type 1 DM, LADA, pancreatogenic DM, DKA\u002FHHS within 12 months, ketonuria at enrollment\n2. Enrollment POC ≥350 mg\u002FdL or immediate IV insulin requirement\n3. HbA1c ≥10.0%\n4. eGFR \\\u003C30 mL\u002Fmin\u002F1.73m² or dialysis\n5. Pregnancy\u002Fbreastfeeding; women of childbearing potential: positive urine hCG\n6. ICU, sepsis, NPO, TPN\u002Fenteral nutrition\n7. Severe hepatic failure (Child-Pugh C)\n8. Dexamethasone, divided-dose, or pulse steroids planned\n9. Prior CSII or AID device user\n10. Skin adhesive allergy precluding CGM or patch pump use\n11. Insufficient cognitive function for device or dosing table use\n12. Planned MRI requiring repeated CGM\u002Fpump removal\n13. PTA \\>70 dB (profound hearing loss requiring combined intratympanic steroid)","ALL","19 Years",{"count":64,"type":65},44,"ESTIMATED","INTERVENTIONAL",[68],"NA","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\u002Fday).\n\nPatients 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.\n\nAll 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.\n\nParticipants meeting insulin activation criteria are randomized 1:1 to:\n\n* 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)\n* 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\n\nBoth arms use identical glycemic targets, carbohydrate-band bolus algorithm (ICR\u002FISF 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\u002FdL averaged over the 9-day high-dose steroid period (Day 1-9).",[71,72],"Sudden Sensorineural Hearing Loss (SSNHL)","Prediabetes \u002F Type 2 Diabetes",[74,75,76,77,78,79],"Sudden Sensorineural Hearing Loss","Glucocorticoid-Induced Hyperglycemia","Steroid-Induced Hyperglycemia","Continuous Glucose Monitoring","Insulin Pump Therapy","Patch Pump","NOT_YET_RECRUITING","2026-06-11",{"date":83,"type":84},"2026-06-17","ACTUAL",{"date":86,"type":65},"2026-08",{"date":88,"type":65},"2028-12",{"name":5,"class":6}]