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

Conditions

• Diabetes Mellitus, Type 2
• Hyperglycemia Due to Type 2 Diabetes Mellitus
• Osteoarthritis, Knee

Eligibility Criteria

Sex

ALL

Age

40 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Insulin Isophane Human, NPH, Pre-emptive Algorithm — DRUG
  Human NPH insulin U-100 will be administered subcutaneously within 30 minutes after the knee injection at 0.10 units/kg actual body weight, rounded to the nearest whole unit, maximum 16 units. Doses are repeated approximately 24 and 48 hours later. For doses 2 and 3, predose glucose below 90 mg/dL requires withholding; 90 to 109 mg/dL requires 50% of the initial dose; 110 to 180 mg/dL requires 100%; 181 to 250 mg/dL requires 120%; and above 250 mg/dL requires 120%, maximum 20 units, plus clinician contact. Any glucose below 54 mg/dL or level 3 hypoglycaemia permanently discontinues study NPH.
• Triamcinolone Acetonide Knee Injection — DRUG
  A single 1 mL intra-articular injection of triamcinolone acetonide crystalline suspension 40 mg/mL, total dose 40 mg, will be administered into one index knee using a standardised landmark-guided procedure. Up to 2 mL lidocaine 1% without epinephrine may be used for skin and subcutaneous anaesthesia but will not be mixed with or injected into the joint. No repeat or additional injected corticosteroid is permitted through day 7.

Study Details

Steroid injections used to treat painful joints can temporarily increase glucose levels in people with type 2 diabetes. This study will test whether a short course of pre-emptive neutral protamine Hagedorn, NPH, insulin can reduce high glucose after a standard corticosteroid injection into the knee. Adults with type 2 diabetes who are scheduled to receive one intra-articular injection of triamcinolone acetonide 40 mg for knee osteoarthritis will be randomly assigned to one of two groups. The experimental group will receive a prespecified NPH insulin regimen beginning immediately after the injection and continuing for three doses. The comparison group will continue usual reactive diabetes management without pre-emptive NPH insulin. Both groups will use blinded continuous glucose monitoring and scheduled capillary glucose testing. The main outcome is the percentage of continuous glucose monitoring time above 180 mg/dL during the first 72 hours after the corticosteroid injection. Hypoglycaemia, rescue treatment, healthcare contacts, treatment burden, acceptability and adverse events will also be assessed.

Key Dates

First listed

Aug 11, 2026

Start date

Aug 10, 2026

Status verified

Aug 2026

Primary completion

Jan 1, 2027

Completion

Jan 30, 2027

Study Design

Enrollment

125 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Pre-emptive NPH Insulin Pathway
  Participants will receive three subcutaneous doses of human NPH insulin beginning within 30 minutes after intra-articular triamcinolone acetonide injection and repeated approximately 24 and 48 hours later. The initial dose is 0.10 units/kg, maximum 16 units. Subsequent doses are modified according to prespecified capillary-glucose and hypoglycaemia criteria. Participants will continue stable background diabetes medication and receive blinded continuous glucose monitoring, scheduled capillary glucose testing, safety contacts and the common rescue pathway.
• Active Comparator: Usual Reactive Diabetes Management
  Participants will continue stable background diabetes medication without pre-emptive NPH insulin. They will receive blinded continuous glucose monitoring, the same scheduled capillary glucose testing, safety instructions, study contacts and common rescue pathway as the experimental group. Additional non-emergency medication changes may be made by the treating diabetes clinician when clinically necessary and will be documented.

Primary Outcome Measure

Percentage of Continuous Glucose Monitoring Time Above 180 mg/dL During the First 72 Hours After Corticosteroid Injection [ Time Frame: From completion of the intra-articular corticosteroid injection through 72 hours after injection ]

Central Contacts

• Nadia Hussain, MD, PhD
  0505440153
  [email protected]

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