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NCT05704491: AimdR
AI Screening for Diabetic Retinopathy
trial testing artificial intelligence (AI) algorithm of the MONA DR model in Diabetes Mellitus in 100 participants. Currently enrolling.
31 December 2024
Quick facts
| Lead sponsor | West German Center of Diabetes and Health |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 100 |
| Start date | 30 January 2023 |
| Primary completion | 31 December 2024 |
| Estimated completion | 31 December 2025 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- artificial intelligence (AI) algorithm of the MONA DR model
Conditions studied
- Diabetes Mellitus — all drugs for Diabetes Mellitus →
Sponsor
West German Center of Diabetes and Health
Who can join
18 and older, any sex, with Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The increasing prevalence of diabetes mellitus represents a major health problem, especially since around 40% of diabetic patients develop diabetic retinopathy, which severely impairs vision and can lead to blindness. This development could be prevented by annual check-ups and timely referral for treatment. However, there are major differences in the quality of examinations and bottlenecks in examination appointments. A solution to the problem could be the use of artificial intelligence (AI), especially deep learning. Initial studies have shown that deep learning algorithms can be used successfully to detect diabetic retinopathy. However, it remains to be clarified whether the use of AI can achieve a sufficiently high level of accuracy in the detection of retinopathies. Therefore, in the present study, the positive predictive value (PPV), the negative predictive value (NPV), the sensitivity (SEN) and the specificity (SPEZ) of the AI algorithm 'MONA-DR-Model' in the detection of diabetic retinopathy should be measured. In addition, it is to be examined how well the classification into mild and severe retinopathy corresponds and how well this new examination method is accepted by the patients.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05704491
- Europe PMC full search
- ASCO Meeting Library
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Other West German Center of Diabetes and Health trials
Trials by the same sponsor.
- NCT06745362 — Weight Reduction With the Low-Insulin-Method - Self Monitoring of Breath Acetone · NA · not yet recruiting
- NCT05933759 — Weight Reduction With the Low-Insulin-Method · NA · completed
- NCT04707651 — Formula Diet Treatment for NASH Patients. · NA · active not recruiting
- NCT04593992 — HTEMS Treatment of Diabetic Polyneuropathy · NA · completed
- NCT04474808 — Foot Cream for the Care of Dry and Cracked Skin · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05704491 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by West German Center of Diabetes and Health
- Last refreshed: 11 July 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05704491.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing