Microvascular complications of diabetes mellitus
Not Applicable
- Conditions
- microvascular complications in patients with diabetes type 1 and 2E14.3
- Registration Number
- DRKS00007880
- Lead Sponsor
- niversitätsklinikum Heidelberg, Klinik für Endokrinologie, Stoffwechsel und Klinische Chemie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 502
Inclusion Criteria
(1) Established diabetes mellitus type 1 or type 2
(2) Person who can understand this study plan enough, and the agreement by the person is possible.
Exclusion Criteria
(1) age of under 18 years
(2) limited or missing ability to cooperate
(3) monocular vision
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome measure was the evaluation of the proportion of diabetic patients meeting the inclusion criteria and referred to DR screening with a non-mydriatic, digital fundus camera (Nidek/Oculus AFC-230/210) from january to june 2013. Data concerning age, duration of diabetes, type of treatment, associated systemic risk factors and history of eye treatment or eye-examinations in the past were collected from each patient. To allow for stable quality, all images were taken and evaluated by the same trained technician throughout the study. The pictures were re-evaluated by an ophtalmologist once in a week. At least one non-dilated fundus photograph of each eye was taken. Prevalence and incidence of diabetic retinopathy was analyzed and progression rates were calculated.
- Secondary Outcome Measures
Name Time Method Prevalence and incidence of diabetic nephro- and neuropathy were analyzed and the ratio of newly diagnosed to pre-existing complications for all entities was calculated in order to differentiate natural progress from underdiagnosed DRs. Diabetic nephropathy was defined as microalbuminuria of more than 20 mg/l in two of three samples of morning urine obtained within twelve consecutive months. Patients with urinary infections were excluded. Absence or presence of neuropathy was assessed using neuropathy symptom score (NSS), neuropathy disability score (NDS) and Wagner-Armstrong classification.