Microvascular complications of diabetes mellitus

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00007880

Enrollment

502

Registered

2015-04-15

Start date

2014-01-06

Completion date

Unknown

Last updated

2025-10-06

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

Conditions

microvascular complications in patients with diabetes type 1 and 2 E14.3

Interventions

Group 1: Screening and diagnosing of diabetic retinopathy through a non-mydriatic, digital, fundus camera (Nidek/Oculus AFC 230/210)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

Exclusion criteria: (1) age of under 18 years (2) limited or missing ability to cooperate (3) monocular vision

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Germany

Contacts

Public ContactPia Roser

Universitätsklinikum Heidelberg, Klinik für Endokrinologie, Stoffwechsel und Klinische Chemie

p.roser@uke.de+49 (40) 7410 - 0

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026