TerminatedNot Applicable

Time To Complications Occurs in Diabetes

Stopped: Local regulations

Sweden17 participantsStarted 2012-04

Plain-language summary

Diabetes causing serious complications is well known. In this study the aim is to follow 950 patients with diabetes for 15 years to study when, in who and how the diabetes complications occurs.

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diabetes type 1, 2 or LADA: 18-75 years of age. * Group A: 150 Type 1 Diabetes, duration 15 years (+/-2 years) and 150 Type 2 * Diabetes 2 years (+/-2 years) (50% F/M) * Group B: 150 Type 1 Diabetes, duration 20 years (+/-2 years) and 150 Type 2 * Diabetes 7 years (+/-2 years) (50% F/M) * Group C: 150 Type 1 Diabetes, duration 25 years (+/-2 years) and 150 Type 2 * Diabetes 12 years (+/-2 years) (50% F/M) * Group D: 50 LADA, onset after 35 years of age, duration of 5-10 years (50% F/M) * Type 1 Diabetes: Positive ICA antibodies and/or GAD-antibodies and/or neg C-peptide. Debut \<30 years of age. * Type 2 Diabetes: Negative ICA-antibodies and GAD-antibodies and pos C-peptide (\>0.35 mmol/l). * LADA: Positive ICA-antibodies and/or GAD-antibodies. Debut \>35 years of age.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Time to nephropathy

Timeframe: 0, 3-5, 8-10 and 13-15 years

Time to autonomous neuropathic ulcers and Amputation

Timeframe: 0, 3-5, 8-10 and 13-15 years

Time to peripheral neuropathy

Timeframe: 0, 3-5, 8-10 and 13-15 years

Time to peripheral Macro-Vascular Disease, chronic Foot ulcers and Amputation

Timeframe: 0, 3-5, 8-10 and 13-15 years

Time to retinopathy

Timeframe: 0, 3-5, 8-10 and 13-15 years

Trial details

NCT IDNCT00969956

SponsorKarolinska Institutet

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2018-02

View on ClinicalTrials.gov More Retinopathy trials

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Time to nephropathy

Timeframe: 0, 3-5, 8-10 and 13-15 years

Time to autonomous neuropathic ulcers and Amputation

Timeframe: 0, 3-5, 8-10 and 13-15 years

Time to peripheral neuropathy

Timeframe: 0, 3-5, 8-10 and 13-15 years

Time to peripheral Macro-Vascular Disease, chronic Foot ulcers and Amputation

Timeframe: 0, 3-5, 8-10 and 13-15 years

Time to retinopathy

Timeframe: 0, 3-5, 8-10 and 13-15 years