Anti-inflammatory drug to prevent complications in type 1 diabetes

Prior treatment

• Regular use of CYP3A4 inhibitors, P-glycoprotein inhibitors, fibrates, ciclosporin, and digoxin, as a contraindication for colchicine
• Colchicine or other anti-inflammatory drug use
• Active infection or illness in the past 14 days before blood collection (timing of blood collection can be adjusted)
• Any vaccination in the past 4 weeks before blood collection (timing of blood collection can be adjusted)
• Ophthalmological treatments in the past: retinal surgery, panretinal or focal laser photocoagulation, intravitreal injections with steroids or intravascular endothelial growth factor inhibitors
• Any other ophthalmological treatments in the past 3 months prior to the start of the study or planned during the study period

Other illness

• Presence of other auto-inflammatory/-immune disease, except for celiac disease, vitiligo, or well-treated thyroid disease
• Having moderate to severe hepatic disease
• Current or history of alcohol and/or drugs abuse (i.e. >14 units per week)

Age

• Any other ophthalmological condition that can interfere with the diagnosis or progression of diabetic retinopathy (vascular occlusions, age-related macular degeneration, intra- or subretinal fluid, severe glaucoma, significant media opacities that hinder visualisation of the retina (e.g. mature cataract))

Other

• Women who are pregnant, breastfeeding, or trying to conceive in the period between the screening and until 3 months after the last study visit (self-reported)
• Male partners of women trying to conceive in the period between the screening and until 6 months after the last study visit (self-reported)
• Known blood dyscrasias
• Nephropathy (G3aA2 or worse)
• Habitual smoking, i.e. one or more cigarettes per day (in the last half year)
• Proliferative diabetic retinopathy or presence of (diabetic) macula edema

• Type 1 diabetes for at least 1 year
• Age 18-70 years
• HbA1c lower or equal to 100 mmol/mol
• High glycemic variability: coefficent of variation of at least 30%
• Use of continuous glucose monitor for at least 3 months prior to start of the study
• Refractive error between -6 and +6 Diopters (calculated as spherical equivalent and before any treatments)