Pre-emptive Insulin to Prevent High Glucose After a Knee Steroid Injection in Adults With Type 2 Diabetes

Korábbi kezelés

• Level 3 hypoglycaemia requiring third-party assistance during the previous 6 months.
• Oral, intravenous or intramuscular corticosteroid use within 30 days before the study injection.
• Any intra-articular, epidural, periarticular or soft-tissue corticosteroid injection within 30 days before the study injection.
• Planned additional systemic or injected corticosteroid exposure before the day-7 assessment.

Más betegség

• Type 1 diabetes, latent autoimmune diabetes in adults, pancreatogenic diabetes or another specific diabetes type requiring insulin.
• Acute febrile illness, active systemic infection or acute deterioration in health at screening or injection.
• Suspected septic arthritis, infection over the injection site, prosthetic index knee, uncontrolled bleeding disorder or another contraindication to knee injection.
• Known allergy or clinically significant hypersensitivity to triamcinolone acetonide, human NPH insulin, insulin aspart, protamine, lidocaine or required excipients.
• Any condition that, in the investigator's documented judgement, makes participation unsafe for a reason not otherwise captured above.

Laborértékek

• HbA1c below 6.5% or above 9.0%.
• Capillary glucose below 90 mg/dL or above 250 mg/dL immediately before injection.
• Fasting glucose above 250 mg/dL, random glucose above 300 mg/dL, clinically significant ketonaemia or hyperglycaemia requiring immediate treatment during screening.
• Severe hepatic impairment or another condition expected to materially alter insulin clearance or hypoglycaemia risk.
• Known allergy to continuous glucose monitoring adhesive or a skin condition preventing sensor use.
• Cognitive, visual, physical or social limitation that would prevent safe glucose testing, insulin administration, hypoglycaemia treatment or study contact.
• Participation in another interventional study likely to affect glucose or corticosteroid response.

Egyéb

• Current basal, prandial, premixed or pump insulin treatment.
• Current sulfonylurea or meglitinide treatment.
• Estimated glomerular filtration rate below 45 mL/min/1.73 m².
• Documented impaired awareness of hypoglycaemia.
• Pregnancy, planned pregnancy during study participation or breastfeeding.

• Age 40 to 80 years at consent.
• Documented diagnosis of type 2 diabetes for at least 6 months.
• HbA1c from 6.5% through 9.0% measured within 30 days before randomisation.
• Symptomatic osteoarthritis of one knee for which the treating clinician has independently determined that an intra-articular corticosteroid injection is clinically indicated.
• Planned administration of one intra-articular injection of triamcinolone acetonide crystalline suspension 40 mg into the index knee.
• Diabetes managed without insulin, sulfonylureas or meglitinides.
• Permitted glucose-lowering medications at stable doses for at least 30 days before randomisation.
• Estimated glomerular filtration rate at least 45 mL/min/1.73 m² within 60 days before randomisation.
• Capillary glucose from 90 through 250 mg/dL immediately before the injection.
• Ability and willingness to perform scheduled capillary glucose testing, administer or receive subcutaneous insulin if assigned, follow hypoglycaemia instructions and remain contactable through day 7.
• Ability to wear the study continuous glucose monitoring device and provide informed consent.