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

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age40-80
SponsorShifa International Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

Type 1 diabetes, latent autoimmune diabetes in adults, pancreatogenic diabetes or another specific diabetes type requiring insulin.

Current basal, prandial, premixed or pump insulin treatment.

Current sulfonylurea or meglitinide treatment.

HbA1c below 6.5% or above 9.0%.

Trial design

Treatments tested in this trial

  • Insulin Isophane Human, NPH, Pre-emptive Algorithm
  • Triamcinolone Acetonide Knee Injection

Treatment groups

125 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Shifa International Hospital

Lead sponsor

Al Ain University

Collaborator