Status:
COMPLETED
Evaluation of a Health Education Program for Type 2 Diabetes Patients
Lead Sponsor:
Association for Innovation and Biomedical Research on Light and Image
Conditions:
Retinopathy, Diabetic
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
The goal of this, Retrospective and Prospective Low- Interventional study, is to implement health education interventions to promote self-care and reduce disease complications in DM Type 2 patients at...
Detailed Description
Diabetic retinopathy (DR) is the most frequent complication of Diabetes mellitus and the main cause of legal blindness in working populations in industrialized countries. A diagnosis of diabetes has ...
Eligibility Criteria
Inclusion
- Subjects with type 2 DM participating in STAR (CEC/008/16) and EYEMARKER (CEC/009/17)
- Higher risk patients through the RetinaRisk ® app ≥ 3%
- Age ≥50 years
- Body mass index (IMC) ≥ 25;
- Glycated hemoglobin (HbA1C): ≥6.5%; (7)
- Arterial hypertension (HTA): ≥ 139-89 (8)
- Presence of mild to moderate NPDR with presence of visible retina lesions (microaneurysms, hemorrhages, hard exudates and soft exudates)
- Subjects capable of understanding the information about the study and giving their informed consent to enter the study.
- Subjects willing and able to comply with the study.
Exclusion
- Type 1 DM
- Moderately Severe NPDR;
- Presence of DME or PDR
- Other retinal vascular diseases than DR
Key Trial Info
Start Date :
October 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 29 2024
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT06066021
Start Date
October 13 2023
End Date
March 29 2024
Last Update
July 31 2024
Active Locations (1)
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1
AIBILI-CEC (AIBILI- Clinical Trials Centre)
Coimbra, Portugal, 3000-548