Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05577650 |
Other study ID # |
DAC-013-TUNCKDD |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
January 9, 2023 |
Est. completion date |
February 12, 2023 |
Study information
Verified date |
May 2023 |
Source |
Dacima Consulting |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
In Tunisia, diabetes is a serious public health problem, its prevalence reaches 22.9% of
people aged 18 and over and is likely to affect a quarter of the population by 2045. Diabetic
kidney disease is the most common and severe complication of diabetes. It is both a major
cause of end-stage renal disease and a risk factor for mortality and cardiovascular
morbidity, thus becoming an additional public health concern. Early diagnosis of diabetic
kidney disease makes it possible to manage patients more effectively and in a
multidisciplinary way, to delay its progression to chronic renal failure.
Description:
In Tunisia, little data exist concerning the epidemiology of chronic kidney disease in
diabetics. It is then relevant to assess the incidence of chronic kidney disease among the
Tunisian diabetic population.
The study is an observational, multicentric, cross-sectional, and national project. The study
will be carried out for one month at medical departments and ambulatory clinics of general
physicians, family medicine specialists, endocrinologists, specialists in nutrition and
metabolic diseases, nephrologists, internal medicine physicians, cardiologists, or any
healthcare providers in charge of diabetic patients.
A Steering Committee helps investigators to monitor their patient inclusions, performs audit
trails and prepares the statistical analysis plan for the study. Collected data are managed
by the DACIMA Clinical SuiteĀ®, the electronic data capture platform which complies with the
FDA 21 CFR part 11 requirements (Food and Drug Administration 21 Code of Federal Regulations
part 11), the HIPAA specifications (Health Insurance Portability and Accountability Act), and
the ICH standards (International Conference on Harmonisation).