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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02307110 |
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Date of registration:
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25/11/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Prevalence of DRP and DME Among Type 1 Diabetics Treated With Long-term Intensified Insulin Therapy
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Scientific title:
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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 |
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Date of first enrolment:
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August 2010 |
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Target sample size:
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150 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02307110 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Katja Hatz, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Vista Klinik Binningen |
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Key inclusion & exclusion criteria
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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:
- 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
Age minimum:
50 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Insulin-Dependent Diabetes Mellitus 1
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Intervention(s)
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Other: cross-sectional observation
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Primary Outcome(s)
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prevalence (percentages) of the stages of diabetic retinopathy (DR)
[Time Frame: one cross-sectional examination only]
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Secondary Outcome(s)
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mean contrast sensitivity score
[Time Frame: one cross-sectional examination only]
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mean NEI-VFQ 25 score
[Time Frame: one cross-sectional examination only]
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means of individual average 5year-/10year-/15year-/20year-/25year-HbA1c value (%)
[Time Frame: 5year-/10year-/15year-/20year-/25year]
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the means of individual average 5year-/10year-/15year-/20year-/25year-blood pressure (mmHg)
[Time Frame: 5year-/10year-/15year-/20year-/25year]
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mean BCVA score
[Time Frame: one cross-sectional examination only]
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prevalence (percentages) of the stages of diabetic macular edema (DME)
[Time Frame: one cross-sectional examination only]
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Secondary ID(s)
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DRP-2010-02
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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