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Rapid detection of chronic polyneuropathy in patients with diabetes mellitus or chronic kidney failure

Rapid detection of chronic polyneuropathy in patients with diabetes mellitus or chronic kidney failure - DE SNAP study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON56883
Enrollment
370
Registered
2024-07-12
Start date
2024-08-22
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

(peripheral) neuropathy nerve disease

Interventions

None listed

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age > 18 year and diagnosed with diagnosed with diabetes mellitus type 2 or type 1 for more than 10 year (fasting glucose >= 7.0 mmol/l or non-fasting glucose >= 11.0 mmol/l or use of any antidiabetics) and/or chronic kidney failure (eGFR

Exclusion criteria

Exclusion criteria: unable to fill in the symptom questionnaire (e.g. a language barrier or severe cognitive problems)

Design outcomes

Primary

MeasureTime frame
The main study parameter is the performance of the E-PSS expressed as area under the curve (AUC) and visualize this with a receiver operating characteristic (ROC) curve. Using the Youden*s J statistic we will determine the cut-off value with the best discrimination performance. We will evaluate the performance further with the sensitivity and specificity for this cut-off value.

Secondary

MeasureTime frame
Secondary objectives are: - the prevalence of polyneuropathy, - the proportion of underdiagnosed polyneuropathy - the prevalence of co-occurrence of risk factors - usage of neuropathic painkillers - the relationship between presence of polyneuropathy and severity, duration and treatment of the underlying disease

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)