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Anti-inflammatory drug to prevent complications in type 1 diabetes
EU CTIS ID: 2025-521397-34-00
What this study is testing
The main objective of this trial is to determine whether colchicine can affect markers of microvascular complications (diabetic retinopathy and nephropathy) in people with type 1 diabetes and high glycemic variability.
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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)
You likely can't join if
- Presence of other auto-inflammatory/-immune disease, except for celiac disease, vitiligo, or well-treated thyroid disease
- 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))
- 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
- Regular use of CYP3A4 inhibitors, P-glycoprotein inhibitors, fibrates, ciclosporin, and digoxin, as a contraindication for colchicine
See the full eligibility criteria
- 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)
- Presence of other auto-inflammatory/-immune disease, except for celiac disease, vitiligo, or well-treated thyroid disease
- 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))
- 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
- Regular use of CYP3A4 inhibitors, P-glycoprotein inhibitors, fibrates, ciclosporin, and digoxin, as a contraindication for colchicine
- Nephropathy (G3aA2 or worse)
- Having moderate to severe hepatic disease
- 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)
- Habitual smoking, i.e. one or more cigarettes per day (in the last half year)
- Current or history of alcohol and/or drugs abuse (i.e. >14 units per week)
- Proliferative diabetic retinopathy or presence of (diabetic) macula edema
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.