Prevalence of DRP and DME Among Type 1 Diabetics Treated With Long-term Intensified Insulin Therapy
Primary Purpose
Insulin-Dependent Diabetes Mellitus 1
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
cross-sectional observation
Sponsored by
About this trial
This is an interventional diagnostic trial for Insulin-Dependent Diabetes Mellitus 1 focused on measuring Diabetes Mellitus 1, long-term intensified insulin therapy, diabetic retinopathy, diabetic macular edema
Eligibility Criteria
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
Sites / Locations
- Vista Klinik
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
1 arm study
Arm Description
cross-sectional observation
Outcomes
Primary Outcome Measures
prevalence (percentages) of the stages of diabetic retinopathy (DR)
Secondary Outcome Measures
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).
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
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).
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).
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).
Full Information
NCT ID
NCT02307110
First Posted
November 25, 2014
Last Updated
January 2, 2018
Sponsor
Vista Klinik
Collaborators
University Hospital, Basel, Switzerland
1. Study Identification
Unique Protocol Identification Number
NCT02307110
Brief Title
Prevalence of DRP and DME Among Type 1 Diabetics Treated With Long-term Intensified Insulin Therapy
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
August 2010 (Actual)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vista Klinik
Collaborators
University Hospital, Basel, Switzerland
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 (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.
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin-Dependent Diabetes Mellitus 1
Keywords
Diabetes Mellitus 1, long-term intensified insulin therapy, diabetic retinopathy, diabetic macular edema
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 arm study
Arm Type
Other
Arm Description
cross-sectional observation
Intervention Type
Other
Intervention Name(s)
cross-sectional observation
Other Intervention Name(s)
observational study.
Intervention Description
cross-sectional opthalmic examination
Primary Outcome Measure Information:
Title
prevalence (percentages) of the stages of diabetic retinopathy (DR)
Time Frame
one cross-sectional examination only
Secondary Outcome Measure Information:
Title
prevalence (percentages) of the stages of diabetic macular edema (DME)
Description
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
Title
means of individual average 5year-/10year-/15year-/20year-/25year-HbA1c value (%)
Description
as a measure for long-term glycemic control
Time Frame
5year-/10year-/15year-/20year-/25year
Title
the means of individual average 5year-/10year-/15year-/20year-/25year-blood pressure (mmHg)
Description
as a measure for long-term blood pressure control
Time Frame
5year-/10year-/15year-/20year-/25year
Title
mean BCVA score
Description
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
Title
mean contrast sensitivity score
Description
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
Title
mean NEI-VFQ 25 score
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katja Hatz, MD
Organizational Affiliation
Vista Klinik Binningen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vista Klinik
City
Binningen
ZIP/Postal Code
4102
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
30684505
Citation
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.
Results Reference
derived
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Prevalence of DRP and DME Among Type 1 Diabetics Treated With Long-term Intensified Insulin Therapy
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