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

What Was Tested

In this phase 1, phase 2 trial, researchers set out to test NPH Insulin (isophane).

It had two arms (groups): Pre-emptive NPH Insulin Pathway (experimental) and Usual Reactive Diabetes Management (active comparator).

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.

The registry classes the interventions as drug.

More on the Plan

Intra-articular corticosteroid injections can produce clinically important but transient hyperglycaemia in people with type 2 diabetes.

Participants will be randomly assigned 1:1 to a pre-emptive NPH insulin pathway or usual reactive diabetes management.

Both groups will continue stable background diabetes medication and will receive identical blinded continuous glucose monitoring, capillary glucose monitoring, safety instructions, scheduled contacts and rescue thresholds.

Continuous glucose monitoring data will be collected for a 72-hour baseline period and for at least 96 hours after injection.

Who Took Part

125 planned participants were the target.

It was open to people of any sex aged from 40 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age 40 to 80 years at consent. Documented diagnosis of type 2 diabetes for at least 6 months. Symptomatic osteoarthritis of one knee for which the treating clinician has independently determined that an intra-articular corticosteroid injection is clinically indicated. Diabetes managed without insulin, sulfonylureas or meglitinides. 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.

The full record lists 11 inclusion and 21 exclusion criteria; among the exclusions: 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.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

Because people in this NPH Insulin (isophane) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Only one side, usually the participants, was kept unaware of whether NPH Insulin (isophane) was given.

Those kept unaware of assignments: outcomes assessor.

It started in 2026-08-10 with completion listed for 2027-01-01.

It ran at 1 site in Pakistan.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percentage of Continuous Glucose Monitoring Time Above [amount hidden]/dL During the First 72 Hours After Corticosteroid Injection.

It also tracked 12 secondary outcomes, for example Mean Sensor Glucose, Peak Sensor Glucose, Time to Peak Sensor Glucose, Participants Requiring Rescue Glucose-Lowering Treatment, Number of Unscheduled Diabetes-Related Clinical Contacts or Healthcare Encounters and Participant-Reported Treatment Burden Score.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of NPH Insulin (isophane) in 125 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the NPH Insulin (isophane) compound page, all human trials.