Status:
COMPLETED
Prevalence of DRP and DME Among Type 1 Diabetics Treated With Long-term Intensified Insulin Therapy
Lead Sponsor:
Vista Klinik
Collaborating Sponsors:
University Hospital, Zürich
Conditions:
Insulin-Dependent Diabetes Mellitus 1
Eligibility:
All Genders
18+ years
Brief Summary
This study is designed to evaluate the prevalence of different stages of diabetic retinopathy and diabetic macular edema among patients suffering from type 1 diabetes (DM1) for 5 to 25 years and have ...
Detailed Description
Purpose: This study is designed to evaluate the prevalence of different stages of diabetic retinopathy and diabetic macular edema among patients suffering from type 1 diabetes for 5 to 25 years and ha...
Eligibility Criteria
Inclusion
- Male or female patients \>18 years of age who have signed an informed consent
- Patients with type 1 diabetes mellitus diagnosed between 5 and 25 years prior to screening who were on intensified insulin therapy (multiple daily insulin injections or insulin pump) from the beginning of the disease.
Exclusion
- Patients with hypertension and a change in antihypertensive treatment within 2 months pre-enrollment should not be enrolled unless blood pressure is maintained for at least 1 month below 160/100 mm Hg by antihypertensive treatment.
- Patients with a history of chronic renal failure requiring dialysis or kidney transplantation if there is a risk for the patient to perform fluorescein angiography (discretion of the endocrinological investigator).
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (\>5 mIU/ml).
- History of allergy to fluorescein.
- Inability to obtain fundus photographs, fluorescein angiograms or OCT images of sufficient quality to be analyzed and graded.
- Inability to comply with study procedures.
Key Trial Info
Start Date :
September 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03437551
Start Date
September 1 2012
End Date
December 1 2014
Last Update
February 28 2018
Active Locations (1)
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1
Vista Diagnostics
Zurich, Switzerland