ClinicalTrials.gg
CompletedNCT02307110Updated Jan 3, 2018

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

An interventional study of cross-sectional observation in Insulin-Dependent Diabetes Mellitus 1, sponsored by Vista Klinik. Completed at 1 site in Switzerland. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2018-01-03.

Sponsored by Vista Klinik · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 4 years 3 months after the study started (first participant enrolled Aug 2010, registered Nov 2014).
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Not applicable
Ages
50 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 70 studies in Diabetes Mellitus, Type 1 with a site in Switzerland — 9 open to participants now, 10 under way, 4 of them phase 3. Diabetes Mellitus, Type 1 · Switzerland.

Enrollment
10th of 52
150 · median 29
Started
2010
with 2 others
No phase
25 of 70
1 open now
Registered
24th of 70
by date

Among the 70 studies in Diabetes Mellitus, Type 1 with a site in Switzerland, this one is the 10th largest by enrollment of the 52 interventional ones that give a count, is one of 3 that started in 2010, is one of 25 with no phase, and was the 24th registered.

Diabetes Mellitus, Type 1

3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.

Browse Diabetes Mellitus, Type 1 studies →

Open to participants now

9 of the 70 studies in Diabetes Mellitus, Type 1 with a site in Switzerland are open now. Recruiting first, the newest first:

4 more — sign in →

All 9 open studies →

A study can be open while its sites in Switzerland have not opened yet or have stopped. Only those recruiting at a site in Switzerland →

Who these studies take

Of the 411 Diabetes Mellitus, Type 1 studies recruiting now, 128 (31%) set no upper age limit and 257 (63%) stop at 75 or younger; 184 take children under 18; 64 take healthy volunteers.

This study: 50 Years and older · all sexes · no healthy volunteers.

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02

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 (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.

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)
03

Conditions studied

  • Insulin-Dependent Diabetes Mellitus 1

Keywords

  • Diabetes Mellitus 1
  • long-term intensified insulin therapy
  • diabetic retinopathy
  • diabetic macular edema
04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male or female patients >18 years of age who have signed an
  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (actual)

Study arms

  • Other
    1 arm study

    cross-sectional observation

    Other: cross-sectional observation

Interventions

  • Othercross-sectional observation

    cross-sectional opthalmic examination

    Also known as: observational study.

06

What researchers measure

Primary outcomes

  1. prevalence (percentages) of the stages of diabetic retinopathy (DR)

    Time frame: one cross-sectional examination only

Secondary outcomes

  1. 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: one cross-sectional examination only

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

    as a measure for long-term glycemic control

    Time frame: 5year-/10year-/15year-/20year-/25year

  3. the means of individual average 5year-/10year-/15year-/20year-/25year-blood pressure (mmHg)

    as a measure for long-term blood pressure control

    Time frame: 5year-/10year-/15year-/20year-/25year

  4. 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: one cross-sectional examination only

  5. 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: one cross-sectional examination only

  6. 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: one cross-sectional examination only

07

Study locations

1 site
  • Vista Klinik
    Binningen, 4102, Switzerland
08

References and documents

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. PubMed 30684505 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2010 to primary completion in Dec 2014, 52 months.

Of 844 non-industry interventional studies with no phase under Diabetes Mellitus, Type 1, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's 52 months is above that.

Counting every sponsor, half of 949 studies reached it within 18 months; a quarter within 9 and three quarters within 35.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 25, 2014
First posted
Dec 4, 2014
StartActual
Aug 2010
Primary completionActual
Dec 2014
CompletionActual
Dec 2014
Last update
Jan 3, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 3, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02307110
Lead sponsor
Vista Klinik
Responsible party
Dr. med. Katja Hatz (Prof. Dr. Christian Pruente, Vista Klinik) — Principal investigator
First posted
Dec 4, 2014
Start date
Aug 2010
Primary completion
Dec 2014
Completion
Dec 2014
Last update
Jan 3, 2018

Study contacts

Katja Hatz, MD
principal investigator · Vista Klinik Binningen

Oversight

Data monitoring committee
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.

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