Screening for Hypoglycemia in an Institutionalized Elderly Diabetic Population.

Completed

• Conditions: Institutionalized in EHPAD (French Nursing Home); Hypoglycemic Syndrome; Old Age; Diabetes

• Registration Number: NCT03656887
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-31
• Study First Submitted QC: 2018-08-31
• Study First Posted: 2018-09-04
• Study Start: 2019-01-08
• Primary Completion: 2019-06-11
• Study Completion: 2019-06-11
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-23
• Last Update Posted: 2020-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of hypoglycemic events (<70 mg/dl) demonstrated by continuous interstitial glucose monitoring over the study period.	Day 14
Number of hypoglycemic events (<70 mg/dl) detected by capillary blood glucose measurement or clinical signs suggestive of hypoglycemia.	Day 14

Trial Locations

Locations (1)

Chu Dijon Bourogne; 🇫🇷 Dijon, France