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

NCT07652528 | Not Yet Recruiting

• 1 other identifier: HDSH-ENDO-2026-SHIP-001
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Sudden Sensorineural Hearing Loss (SSNHL); Prediabetes / Type 2 Diabetes

Keywords

Sudden Sensorineural Hearing Loss; Glucocorticoid-Induced Hyperglycemia; Steroid-Induced Hyperglycemia; Continuous Glucose Monitoring; Insulin Pump Therapy; Patch Pump

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 1 through Day 9 (24 hours per day)

Secondary Outcomes (18)

• 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

  Day 1-9, 10:00-22:00 window

• Time In Range (TIR) 70-180 mg/dL (%, 24-hour)

  Day 1-9

• Time Above Range >250 mg/dL (%, 24-hour)

  Day 1-9

• Postprandial incremental AUC >180 mg/dL (breakfast, lunch, dinner - 2-4h post-meal)

  Day 1-9

• Time Below Range (TBR) <70 mg/dL (%, 24-hour) - key safety outcome to verify TAR reduction is not accompanied by increased hypoglycemia

  Day 1-9

Study Arms (2)

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.

Device: CareLevo Patch-type Insulin Pump; Drug: Fast-acting Insulin Aspart (Fiasp); Device: CareSens Air Continuous Glucose Monitor

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.

Drug: Insulin Glargine U-100 (Lantus); Drug: Fast-acting Insulin Aspart (Fiasp); Device: CareSens Air Continuous Glucose Monitor

Interventions

CareLevo Patch-type Insulin Pump DEVICE

CareLevo (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.

CareLevo CSII (Arm A)

Insulin Glargine U-100 (Lantus) DRUG

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/Tresiba excluded due to prolonged time to steady-state (≥5 days) incompatible with 14-day protocol.

Lantus-based MDI (Arm B)

Fast-acting Insulin Aspart (Fiasp) DRUG

Fiasp 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.

CareLevo CSII (Arm A); Lantus-based MDI (Arm B)

CareSens Air Continuous Glucose Monitor DEVICE

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.

CareLevo CSII (Arm A); Lantus-based MDI (Arm B)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hallym University: lead

Related Publications (7)

• American Diabetes Association Professional Practice Committee for Diabetes*. 16. Diabetes Care in the Hospital: Standards of Care in Diabetes-2026. Diabetes Care. 2026 Jan 1;49(Supplement_1):S339-S355. doi: 10.2337/dc26-S016.

  PMID: 41358892 RESULT

• Chang LL, Umpierrez GE, Inzucchi SE. Management of Hyperglycemia in Hospitalized, Non-Critically Ill Adults. N Engl J Med. 2022 Sep 15;387(11):1040-1042. doi: 10.1056/NEJMclde2204691. No abstract available.

  PMID: 36103419 RESULT

• Anderson RT, Skovlund SE, Marrero D, Levine DW, Meadows K, Brod M, Balkrishnan R. Development and validation of the insulin treatment satisfaction questionnaire. Clin Ther. 2004 Apr;26(4):565-78. doi: 10.1016/s0149-2918(04)90059-8.

  PMID: 15189754 RESULT

• Cho JH, Suh S. Glucocorticoid-Induced Hyperglycemia: A Neglected Problem. Endocrinol Metab (Seoul). 2024 Apr;39(2):222-238. doi: 10.3803/EnM.2024.1951. Epub 2024 Mar 27.

  PMID: 38532282 RESULT

• Chandrasekhar SS, Tsai Do BS, Schwartz SR, Bontempo LJ, Faucett EA, Finestone SA, Hollingsworth DB, Kelley DM, Kmucha ST, Moonis G, Poling GL, Roberts JK, Stachler RJ, Zeitler DM, Corrigan MD, Nnacheta LC, Satterfield L. Clinical Practice Guideline: Sudden Hearing Loss (Update). Otolaryngol Head Neck Surg. 2019 Aug;161(1_suppl):S1-S45. doi: 10.1177/0194599819859885.

  PMID: 31369359 RESULT

• Kleinhans M, Albrecht LJ, Benson S, Fuhrer D, Dissemond J, Tan S. Continuous Glucose Monitoring of Steroid-Induced Hyperglycemia in Patients With Dermatologic Diseases. J Diabetes Sci Technol. 2024 Jul;18(4):904-910. doi: 10.1177/19322968221147937. Epub 2023 Jan 5.

  PMID: 36602041 RESULT

• Achanta M, Kasetti P, Fortune-Ely M, Ross T, Magos T, Manjaly JG. Adverse Effects of Steroid Therapy in Sudden Sensorineural Hearing Loss: A Scoping Review. Clin Otolaryngol. 2025 Sep;50(5):821-830. doi: 10.1111/coa.14339. Epub 2025 May 30.

  PMID: 40444483 RESULT

MeSH Terms

Conditions

Hearing Loss, Sudden; Prediabetic State; Diabetes Mellitus, Type 2

Interventions

Insulin Glargine; Insulin Aspart

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Short-Acting

Central Study Contacts

Hun Jee Choe MD, PhD

CONTACT

+82-10-9493-5703; hunjeechoe@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 17, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share