Screening for Hypoglycemia in an Institutionalized Elderly Diabetic Population.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 29
- Locations
- 1
- Primary Endpoint
- Number of hypoglycemic events (<70 mg/dl) demonstrated by continuous interstitial glucose monitoring over the study period.
Study Overview
Brief Summary
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Number of hypoglycemic events (<70 mg/dl) demonstrated by continuous interstitial glucose monitoring over the study period.
Time Frame: Day 14
Number of hypoglycemic events (<70 mg/dl) detected by capillary blood glucose measurement or clinical signs suggestive of hypoglycemia.
Time Frame: Day 14
Secondary Outcomes
No secondary outcomes reported