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OpenTrials
Completed

NCT Number: NCT03656887

Screening for Hypoglycemia in an Institutionalized Elderly Diabetic Population.

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.

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Key information

Conditions

Old Age Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hypoglycemia Hypoglycemic Syndrome Institutionalized in EHPAD (French Nursing Home) Metabolic Diseases Nutritional and Metabolic Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Dijon Bourogne

Dijon, 21000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous interstitial glucose sensor

Device

Installing and removing the sensor

Sensor Scan

Other

Scan of the sensor, using the Freestyle Pro free version reader, at installation then before removal after 14 days.

Primary outcomes

  1. Number of hypoglycemic events (<70 mg/dl) demonstrated by continuous interstitial glucose monitoring over the study period.

    Time frame: Day 14

  2. Number of hypoglycemic events (<70 mg/dl) detected by capillary blood glucose measurement or clinical signs suggestive of hypoglycemia.

    Time frame: Day 14

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: HAGED

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 4, 2018
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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