CompletedNCT03437551Updated Feb 28, 2018

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

An observational study in Insulin-Dependent Diabetes Mellitus 1, sponsored by Vista Klinik. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-28.

Sponsored by Vista Klinik · Observational

Study type: Observational
Model: Case-crossover
Time perspective: Prospective
Enrollment: 150
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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)

Conditions studied

Insulin-Dependent Diabetes Mellitus 1

Browse trials for

Keywords

Diabetes Mellitus 1
long-term intensified insulin therapy
diabetic retinopathy
diabetic macular edema

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Probability sample

Study population

male and female >18 years

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

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 design

Observational model: Case-crossover
Time perspective: Prospective
Enrollment: 150 participants (actual)
Patient registry: No

Groups and cohorts

no intervention
Cross-sectional Observation study
Other: cross-sectional observation

Interventions

Othercross-sectional observation
cross-sectional ophthalmic examination
Also known as: observational study

What researchers measure

Primary outcomes

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)
Time frame: 2 hours (one cross-sectional examination only)

Secondary outcomes

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)
Time frame: 2 hours (one cross-sectional examination only)
means of individual average 5year-/10-years-/15year-/20year-/25year-HbA1c value (%)
as a measure for long-term glycemic control
Time frame: 2 hours (one cross-sectional examination only) then see also in retrospective data from 5year-/10-years-/15year-/20year-/25year
the means of individual average 5year-/10-years-/15year-/20year-/25year-blood pressure (mmHg)
as a measure for long-term blood pressure control
Time frame: 2 hours (one cross-sectional examination only) then see also in retrospective data from 5year-/10-years-/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)
Time frame: 2 hours (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).
Time frame: 2 hours (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).
Time frame: 2 hours (one cross-sectional examination only)

Study locations

1 site

Vista Diagnostics
Zürich, Switzerland

Registry details

Key details

Study ID: NCT03437551
Lead sponsor: Vista Klinik
Collaborators: University Hospital, Zürich
Responsible party: Dr. med. Katja Hatz (Head of Medical Retina Departement, Vista Klinik) — Principal investigator
First posted: Feb 19, 2018
Start date: Sep 2012
Primary completion: Dec 2014
Completion: Dec 2014
Last update: Feb 28, 2018

Study contacts

Christian Pruente, MD

principal investigator · Vista Klinik Binningen

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Diabetic Retinopathy→

Other studies from this sponsor

Vista Klinik

Start the discussion