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

Insulin-Dependent Diabetes Mellitus 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03437551
• Other study ID #: DRP-2010-02 (ZH)
• Status: Completed
• Phase: N/A
• First received: November 25, 2014
• Last updated: February 26, 2018
• Start date: September 2012
• Est. completion date: December 2014

Study information

• Verified date: January 2018
• Source: Vista Klinik
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or female patients >18 years of age who have signed an informed consent

2. 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:

1. 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.

2. 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).

3. 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).

4. History of allergy to fluorescein.

5. Inability to obtain fundus photographs, fluorescein angiograms or OCT images of sufficient quality to be analyzed and graded.

6. Inability to comply with study procedures.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetic Retinopathy
• Insulin-Dependent Diabetes Mellitus 1

Intervention

Other:
• cross-sectional observation
cross-sectional ophthalmic examination

Locations

Country	Name	City	State
Switzerland	Vista Diagnostics	Zürich

Sponsors (2)

Lead Sponsor	Collaborator
Vista Klinik	University Hospital, Zürich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevalence (percentages) of the stages of diabetic retinopathy (DR)	the outcome is evaluated for different patient groups relating to the duration of diabetic retinopathy disease (5-10 years, 11-15 years, more than 15 years)	2 hours (one cross-sectional examination only)
Secondary	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)	2 hours (one cross-sectional examination only)
Secondary	means of individual average 5year-/10-years-/15year-/20year-/25year-HbA1c value (%)	as a measure for long-term glycemic control	2 hours (one cross-sectional examination only) then see also in retrospective data from 5year-/10-years-/15year-/20year-/25year
Secondary	the means of individual average 5year-/10-years-/15year-/20year-/25year-blood pressure (mmHg)	as a measure for long-term blood pressure control	2 hours (one cross-sectional examination only) then see also in retrospective data from 5year-/10-years-/15year-/20year-/25year
Secondary	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)	2 hours (one cross-sectional examination only)
Secondary	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).	2 hours (one cross-sectional examination only)
Secondary	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).	2 hours (one cross-sectional examination only)