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

NCT07757464 | Not Yet Recruiting Phase 1 DMC

• 2 other identifiers: SH-67214349SIAC-02812
• Study Type: interventional
• Target: 125
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Steroid-induced hyperglycaemia; Glucocorticoid-induced hyperglycaemia; Intra-articular corticosteroid injection; Triamcinolone acetonide; NPH insulin; Continuous glucose monitoring; Knee osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Percentage of Continuous Glucose Monitoring Time Above 180 mg/dL During the First 72 Hours After Corticosteroid Injection

  The numerator is the number of valid continuous glucose monitoring readings above 180 mg/dL from the recorded completion time of the intra-articular injection through exactly 72 hours. The denominator is the total number of valid readings during that window. The result is expressed as a percentage. A directly observed outcome requires at least 80% of expected readings and no uninterrupted data gap longer than 6 hours. Participants not meeting this requirement have a missing primary outcome for statistical handling; missing readings are not counted as being within or above range.

  From completion of the intra-articular corticosteroid injection through 72 hours after injection

Secondary Outcomes (12)

• Percentage of Continuous Glucose Monitoring Time Above 250 mg/dL

  From completion of the injection through 72 hours after injection

• Continuous Glucose Monitoring Area Under the Curve Above 180 mg/dL

  From completion of the injection through 72 hours after injection

• Mean Sensor Glucose

  From completion of the injection through 72 hours after injection

• Peak Sensor Glucose

  From completion of the injection through 72 hours after injection

• Time to Peak Sensor Glucose

  From completion of the injection through 72 hours after injection

Other Outcomes (3)

• Participant-Reported Treatment Acceptability

  Day 4

• Participants With Adverse Events

  From completion of the injection through day 7

• Participants With Serious Adverse Events

  From completion of the injection through day 7

Study Arms (2)

Pre-emptive NPH Insulin Pathway

EXPERIMENTAL

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.

Drug: Insulin Isophane Human, NPH, Pre-emptive Algorithm

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.

Drug: Triamcinolone Acetonide Knee Injection

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.

Also known as: Human NPH Insulin, Neutral Protamine Hagedorn Insulin

Pre-emptive NPH Insulin Pathway

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.

Also known as: Triamcinolone Acetonide Crystalline Suspension

Usual Reactive Diabetes Management

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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%.
• 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.
• Estimated glomerular filtration rate below 45 mL/min/1.73 m².
• Severe hepatic impairment or another condition expected to materially alter insulin clearance or hypoglycaemia risk.
• Level 3 hypoglycaemia requiring third-party assistance during the previous 6 months.
• Documented impaired awareness of hypoglycaemia.
• Pregnancy, planned pregnancy during study participation or breastfeeding.
• 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.
• Acute febrile illness, active systemic infection or acute deterioration in health at screening or injection.

Sponsors & Collaborators

• Shifa International Hospital: lead
• Al Ain University: collaborator

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Osteoarthritis, Knee

Interventions

Insulin, Isophane; Isophane Insulin, Human

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Regular, Human; Insulin; Proinsulin

Study Officials

• Saima Abbass, MD, PhD

  Shifa hospital

  STUDY DIRECTOR

Central Study Contacts

Nadia Hussain, MD, PhD

CONTACT

0505440153; nadia.hussain@aau.ac.ae

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants and clinicians administering or adjusting insulin will know the assigned intervention. Continuous glucose monitoring displays will be blinded to participants and treating clinicians. The statistician or outcomes assessor who derives the prespecified continuous glucose monitoring outcomes from coded data will remain masked to treatment assignment until the primary analysis dataset and derivation programs have been finalised.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director Endocrinology

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 11, 2026
• Study Start: August 10, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 30, 2027
• Last Updated: August 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Beginning 12 months after publication of the primary results and remaining available for 5 years.
• Access Criteria: Requests will be considered from qualified researchers who submit a methodologically sound proposal with clearly specified objectives, variables and analysis methods. Access will require approval by the sponsor or a designated data-access committee, execution of a data-use agreement, agreement not to attempt reidentification and compliance with any ethics or institutional requirements. Data will be provided through an approved controlled-access repository or secure transfer mechanism.