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

NCT07757464 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2026-08-11

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

Insulin Isophane Human, NPH, Pre-emptive Algorithm

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.

DRUG

Triamcinolone Acetonide Knee Injection

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.

Sponsors & Collaborators

  • Al Ain University

    collaborator UNKNOWN

  • Shifa International Hospital

    lead OTHER

Principal Investigators

  • Saima Abbass, MD, PhD · Shifa hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-10
Primary Completion
2027-01-01
Completion
2027-01-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07757464 on ClinicalTrials.gov