- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03656887
Screening for Hypoglycemia in an Institutionalized Elderly Diabetic Population. (HAGED)
Diabetes is a major public health problem that has been growing steadily in recent years. Its prevalence is very high in the elderly, in whom there is an increased risk of hypoglycemia.
Hypoglycaemia in elderly diabetics has serious consequences:
- increased mortality,
- increased cardiovascular morbidity,
- increased risk of falling,
- impairment of quality of life.
- Hypoglycaemia is also a risk factor for dementia in type 2 diabetes. The frequency of asymptomatic and atypical hypoglycemia has been shown to be greater in the elderly, but the exact prevalence of hypoglycemia in the elderly remains unknown.
Elderly diabetic patients in institutions are particularly fragile and have more frequent cognitive problems than non-diabetic subjects. A study conducted in this population of patients showed that a third of them had HbA1C <6.5%, which suggests a higher frequency of hypoglycemia though the figures were not available.
We therefore decided to conduct a study to assess the frequency of hypoglycemia in order to better understand the contributing factors and to improve the management of this fragile population.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Dijon, France, 21000
- Chu Dijon Bourogne
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- written consent
- diabetic patient receiving treatment which could result in hypoglycemia: insulin and/or sulfonamide and/or glinides
- institutionalized patient in an EHPAD
- patient over 60 years of age
Exclusion Criteria:
- person not affiliated to a national health insurance
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of hypoglycemic events (<70 mg/dl) demonstrated by continuous interstitial glucose monitoring over the study period.
Time Frame: Day 14
|
Day 14
|
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Number of hypoglycemic events (<70 mg/dl) detected by capillary blood glucose measurement or clinical signs suggestive of hypoglycemia.
Time Frame: Day 14
|
Day 14
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BOUILLET 2018
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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