Retinal Function in Relation to Long Term Changes in the Glucose Level
1 other identifier
observational
30
1 country
1
Brief Summary
The purpose of this study is to measure the amplitude and implicit time of electroretinogram (ERG), darkadaptation and the calibre of retinal vessels before and after optimized medical treatment of diabetic individuals (a lower blood glucose level) over a period of 12 months. Newly diagnosed type 1 and type 2 diabetics as well as dysregulated type 1 and type 2 diabetic individuals will be included. Retinal vessel calibre measurements will be used as an estimation of changes in the retinal perfusion.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2009
Shorter than P25 for all trials
1 active site
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, 2009
CompletedFirst Submitted
Initial submission to the registry
September 8, 2009
CompletedFirst Posted
Study publicly available on registry
September 9, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedSeptember 24, 2009
September 1, 2009
9 months
September 8, 2009
September 23, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in amplitude/implicit times, retinal vessel diameter, dark adaptation and OCT
1 week, 1 month, 4 months, 1 year
Study Arms (1)
Diabetic individuals
Interventions
Patients receive an insulin pump that optimizes their glucose control.
Eligibility Criteria
30 type 1 diabetics without diabetic retinopathy, with dysregulated metabolic status that is to be medically optimized.
You may qualify if:
- Dysregulated type 1 diabetic individuals and newly diagnosed type 1 diabetics. Age \>17 \< 60 years
You may not qualify if:
- Test individuals with significant cataract, prior surgery to the eye, diabetic retinopathy, other serious eye disease, hypertension, other serious systemic disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Glostrup Hospital
Glostrup Municipality, 2600, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 8, 2009
First Posted
September 9, 2009
Study Start
September 1, 2009
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
September 24, 2009
Record last verified: 2009-09