NCT03437551

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 25, 2014

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
Last Updated

February 28, 2018

Status Verified

January 1, 2018

Enrollment Period

2.2 years

First QC Date

November 25, 2014

Last Update Submit

February 26, 2018

Conditions

Insulin-Dependent Diabetes Mellitus 1

Keywords

Diabetes Mellitus 1long-term intensified insulin therapydiabetic retinopathydiabetic macular edema

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • prevalence (percentages) of the stages of diabetic macular edema (DME)

    2 hours (one cross-sectional examination only)

  • means of individual average 5year-/10-years-/15year-/20year-/25year-HbA1c value (%)

    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)

    2 hours (one cross-sectional examination only) then see also in retrospective data from 5year-/10-years-/15year-/20year-/25year

  • mean BCVA score

    2 hours (one cross-sectional examination only)

  • mean contrast sensitivity score

    2 hours (one cross-sectional examination only)

  • +1 more secondary outcomes

Study Arms (1)

no intervention

Cross-sectional Observation study

Other: cross-sectional observation

Interventions

cross-sectional observationOTHER

cross-sectional ophthalmic examination

Also known as: observational study
no intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

male and female \>18 years

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vista Diagnostics

Zurich, Switzerland

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetic Retinopathy

Interventions

Observation

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesRetinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes Complications

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Christian Pruente, MD

    Vista Klinik Binningen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Medical Retina Departement

Study Record Dates

First Submitted

November 25, 2014

First Posted

February 19, 2018

Study Start

September 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

February 28, 2018

Record last verified: 2018-01

Locations

CH(1)