Prevalence of DRP and DME Among Type 1 Diabetics Treated With Long-term Intensified Insulin Therapy

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

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.

Study Overview

• Status: Completed
• Conditions: Insulin-Dependent Diabetes Mellitus 1
• Intervention / Treatment: Other: cross-sectional observation

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 have been treated with intensified insulin therapy aiming near-normal blood glucose levels for the whole duration of disease.

Objectives: The primary objective is to examine the prevalence (percentages) of the stages of diabetic retinopathy (DR) and diabetic macular edema (DME) within one cross-sectional examination. Key secondary/exploratory objectives are the prevalence (percentages) of the stages of diabetic macular edema (DME), the means of individual average 5year-/10year-/15year-/20year-/25year-HbA1c value (%) as a measure for long-term glycemic control, the means of individual average 5year-/10year-/15year-/20year-/25year-blood pressure (mmHg) as a measure for long-term blood pressure control, mean BCVA score, mean contrast sensitivity score, mean NEI-VFQ 25 score (for further details see section Objectives).

Study design: Non-interventional cross-sectional investigator initiated study. The study will be conducted at Vista Klinik Binningen/Switzerland (ophthalmological evaluations) and the Department of Endocrinology of the University Hospital Basel/Switzerland (patient recruitment).

Study population: All patients with DM Type 1 with a least 5 years and maximum 25 years disease duration and intensified insulin therapy for the whole duration of disease, who are currently in follow-up for their DM1 at Department of Endocrinology of the University Hospital Basel/Switzerland. In order to prevent selection bias, patients will be screened for enrollment consecutively. For In-/exclusion criteria see section Eligibility.

Investigational and reference therapy: None.

Assessments:

• Visual acuity measurements using the ETDRS-like testing charts at a test distance of 4 meters
• Contrast sensitivity
• Ophthalmic examinations (slit lamp exam with fundus biomicroscopy, intraocular pressure)
• High resolution optical coherence tomography (Spectralis-OCT)
• Stereoscopic fundus photography
• Fluorescein angiography
• NEI-VFQ 25 (25-item National Eye Institute Vision Function Questionnaire)

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Binningen, Switzerland, 4102
    • Vista Klinik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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 Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 1 arm study; cross-sectional observation	Other: cross-sectional observation; cross-sectional opthalmic examination; Other Names: observational study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
prevalence (percentages) of the stages of diabetic retinopathy (DR)	one cross-sectional examination only

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
prevalence (percentages) of the stages of diabetic macular edema (DME)	The outcome is evaluated for different patient groups relating to the duration of DM1 disease (5-10 years, 11-15 years, more than 15 years).	one cross-sectional examination only
means of individual average 5year-/10year-/15year-/20year-/25year-HbA1c value (%)	as a measure for long-term glycemic control	5year-/10year-/15year-/20year-/25year
the means of individual average 5year-/10year-/15year-/20year-/25year-blood pressure (mmHg)	as a measure for long-term blood pressure control	5year-/10year-/15year-/20year-/25year
mean BCVA score	The outcome is evaluated for different patient groups relating to the duration of DM1 disease (5-10 years, 11-15 years, more than 15 years).	one cross-sectional examination only
mean contrast sensitivity score	The outcome is evaluated for different patient groups relating to the duration of DM1 disease (5-10 years, 11-15 years, more than 15 years).	one cross-sectional examination only
mean NEI-VFQ 25 score	The outcome is evaluated for different patient groups relating to the duration of DM1 disease (5-10 years, 11-15 years, more than 15 years).	one cross-sectional examination only

Collaborators and Investigators

• Sponsor: Vista Klinik
• Collaborators: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Katja Hatz, MD, Vista Klinik Binningen

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2010
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: November 25, 2014
• First Submitted That Met QC Criteria: December 2, 2014
• First Posted (Estimate): December 4, 2014

Study Record Updates

• Last Update Posted (Actual): January 3, 2018
• Last Update Submitted That Met QC Criteria: January 2, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: diabetic macular edema; diabetic retinopathy; Diabetes Mellitus 1; long-term intensified insulin therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Retinal Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetic Retinopathy
• Other Study ID Numbers: DRP-2010-02