Insulin-Dependent Diabetes Mellitus 1NCT03437551
Prevalence of DRP and DME Among Type 1 Diabetics Treated With Long-term Intensified Insulin Therapy
An observational study of Insulin-Dependent Diabetes Mellitus 1, run by Vista Klinik at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insulin-Dependent Diabetes Mellitus 1
- What is being tested?
- cross-sectional observation
- How many people
- 150 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2012to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: male and female >18 years
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Insulin-Dependent Diabetes Mellitus 1
- Being tested
- cross-sectional observation
- Keywords
- Diabetes Mellitus 1, long-term intensified insulin therapy, diabetic retinopathy, diabetic macular edema
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cross-sectional observationOther
Also called observational study
cross-sectional ophthalmic examination
| Study group | Role | What they receive |
|---|---|---|
| no intervention | Cross-sectional Observation study Receives: Other: cross-sectional observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 hours (one cross-sectional examination only)
Secondary outcomes (6)
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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 2 hours (one cross-sectional examination only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study startSep 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin-Dependent Diabetes Mellitus 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vista Klinik
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Zürich
- Responsible party
- Principal investigator, Dr. med. Katja Hatz, Vista Klinik
- Investigators
- Christian Pruente, MD, Principal investigator, Vista Klinik Binningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03437551
- Sponsor's protocol ID
- DRP-2010-02 (ZH)
- Status last verified
- Jan 2018
- First submitted
- 25 Nov 2014
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03437551
- Acronym / sponsor ID
- DRP-2010-02 (ZH)
- Conditions
- Insulin-Dependent Diabetes Mellitus 1
- Keywords
- Diabetes Mellitus 1, long-term intensified insulin therapy, diabetic retinopathy, diabetic macular edema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Vista KlinikUniversity, hospital or other
- Collaborators
- University Hospital, Zürich
- Study start
- Sep 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 19 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| no intervention | – | Other: cross-sectional observationCross-sectional Observation study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- male and female >18 years
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cross-sectional observationAlso: observational studycross-sectional ophthalmic examination | Other | no intervention |
Primary outcome
prevalence (percentages) of the stages of diabetic retinopathy (DR)
Time frame: 2 hours (one cross-sectional examination only)
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)
6 secondary outcomes
prevalence (percentages) of the stages of diabetic macular edema (DME)
Time frame: 2 hours (one cross-sectional examination only)
means of individual average 5year-/10-years-/15year-/20year-/25year-HbA1c value (%)
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)
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
Time frame: 2 hours (one cross-sectional examination only)
mean contrast sensitivity score
Time frame: 2 hours (one cross-sectional examination only)
mean NEI-VFQ 25 score
Time frame: 2 hours (one cross-sectional examination only)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Pruente, MD principal investigator
Vista Klinik Binningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insulin-Dependent Diabetes Mellitus 1, run by Vista Klinik at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence (percentages) of the stages of diabetic retinopathy (DR) (time frame: 2 hours (one cross-sectional examination only)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2018.