An interventional study of CareLevo Patch-type Insulin Pump and Insulin Glargine U-100 (Lantus) in Sudden Sensorineural Hearing Loss (SSNHL) and Prediabetes / Type 2 Diabetes, sponsored by Hallym University. Not yet recruiting. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by Hallym University · Not applicable, Interventional, and Treatment
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:
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.
66 studies on the registry are indexed under Hearing Loss, Sudden; 25 are open to participants now.
This study's planned enrollment of 50 is below the median of 72 across 49 interventional studies indexed under Hearing Loss, Sudden.
Browse Hearing Loss, Sudden studies →Hallym University is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
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.
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.
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.
Time frame: Day 1 through Day 9 (24 hours per day)
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 frame: Day 1-9, 10:00-22:00 window
Time In Range (TIR) 70-180 mg/dL (%, 24-hour)
Time frame: Day 1-9
Time Above Range >250 mg/dL (%, 24-hour)
Time frame: Day 1-9
Postprandial incremental AUC >180 mg/dL (breakfast, lunch, dinner - 2-4h post-meal)
Time frame: 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
Time frame: Day 1-9
Nocturnal Time Below Range <70 mg/dL (00:00-06:00)
Time frame: Day 1-9
Severe hypoglycemia rate (requiring third-party assistance)
Time frame: Day 1-14
Glycemic variability: Coefficient of Variation (CV%), SD, MAGE
Time frame: Day 1-9
Number of daily needle punctures (bolus + correction injections/activations) - key treatment burden metric
Time frame: Day 1-14
Total daily insulin dose and correction insulin proportion
Time frame: Day 1-9
Rate of rescue therapy (protocol stop criteria reached)
Time frame: Day 1-14
CGM TAR >180 mg/dL and TBR <70 mg/dL during steroid taper period (Day 10-14) - exploratory safety
Time frame: Day 10-14
Hearing recovery: PTA change (4-frequency average 0.5/1/2/4 kHz)
Time frame: Baseline and Day 60 (±14 days)
Hearing recovery: Siegel criteria classification (Complete/Partial/Minimal/No Recovery)
Time frame: Day 60 (±14 days)
Salvage intratympanic steroid injection rate
Time frame: Day 60 (±14 days)
Treatment satisfaction and device burden: ITSQ Inconvenience of Regimen subscale (Q1-Q5) and Insulin Delivery Device Satisfaction subscale (Q17-Q22); Anderson et al. Clin Ther 2004. Permission obtained.
Time frame: Day 10-15 (outpatient visit)
CGM data completeness and device-related events (patch premature removal, occlusion - Arm A)
Time frame: Day 1-14
Treatment-related cost (CGM, insulin, device consumables)
Time frame: Day 1-15
No study locations are listed for this record.
Plan to share: No — Individual participant data sharing is not planned. De-identified aggregate results will be published in a peer-reviewed journal.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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