A Cross Sectional Study Assessing the Prevalence of Different Stages of Diabetic Retinopathy and Diabetic Macular Edema Among Type 1 Diabetic Patients Treated With Long-term Intensified Insulin Therapy
Sponsor study identifier
interventional
150
1 country
1
Study Start
August 2010
Actual (reported)Primary Completion
December 2014
Actual (reported)Study Completion
December 2014
Actual (reported)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 (DM 1) for 5 to 25 years and have been treated with intensified insulin therapy aiming near-normal blood glucose levels for the whole duration of disease. Prevalence of different stages of diabetic retinopathy and diabetic macular edema is assessed using the modified Airlie House classification and the Early Treatment Diabetic Retinopathy Study (ETDRS) retinopathy severity scheme. Results of this study will provide the basis for designing further studies as well as staging and screening guidelines for diabetic retinopathy/diabetic macular edema.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2014
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2010
Actual (reported)November 25, 2014
Actual (reported)December 2014
Actual (reported)December 2014
Actual (reported)December 4, 2014
Actual (reported)prevalence (percentages) of the stages of diabetic retinopathy (DR)
one cross-sectional examination only
prevalence (percentages) of the stages of diabetic macular edema (DME)
one cross-sectional examination only
means of individual average 5year-/10year-/15year-/20year-/25year-HbA1c value (%)
5year-/10year-/15year-/20year-/25year
the means of individual average 5year-/10year-/15year-/20year-/25year-blood pressure (mmHg)
5year-/10year-/15year-/20year-/25year
mean BCVA score
one cross-sectional examination only
mean contrast sensitivity score
one cross-sectional examination only
cross-sectional observation
cross-sectional opthalmic examination
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Vista Klinik
Binningen, 4102, Switzerland
Hatz K, Minder AE, Lehmann R, Drescher T, Gerendas B, Schmidt-Erfurth U, Kaider A, Pruente C, Zulewski H. The prevalence of retinopathy in patients with type 1 diabetes treated with education-based intensified insulin therapy and its association with parameters of glucose control. Diabetes Res Clin Pract. 2019 Feb;148:234-239. doi: 10.1016/j.diabres.2019.01.016. Epub 2019 Jan 23.
Katja Hatz, MD
Vista Klinik Binningen
150 participants (actual enrollment reported by the registry).
First Submitted
November 25, 2014
First Posted
December 4, 2014
Study Start
August 2010
Actual (reported)Effect of Formoterol on the Counterregulatory Hormonal Response to Hypoglycemia in Type 1 Diabetes.
Contact the study team to confirm eligibility.
Primary Completion
December 2014
Actual (reported)Study Completion
December 2014
Actual (reported)Last Updated
January 3, 2018
Record last verified: 2018-01
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Source: ClinicalTrials.gov.
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