Screening for Hypoglycemia in an Institutionalized Elderly Diabetic Population.

NCT03656887 | Completed

• 1 other identifier: BOUILLET 2018
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

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.

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient institutionalized in EHPAD

You may qualify if:

• 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

You may not qualify if:

• \- person not affiliated to a national health insurance

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourogne

Dijon, 21000, France

Location

Related Publications (1)

• Bouillet B, Tscherter P, Vaillard L, Nonciaux C, Hourdain P, Ravier A, Rouland A, Petit JM, Verges B, Quilot E. Frequent and severe hypoglycaemia detected with continuous glucose monitoring in older institutionalised patients with diabetes. Age Ageing. 2021 Nov 10;50(6):2088-2093. doi: 10.1093/ageing/afab128.

  PMID: 34324624 RESULT

MeSH Terms

Conditions

Diabetes Mellitus; Hypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2018
• First Posted: September 4, 2018
• Study Start: January 8, 2019
• Primary Completion: June 11, 2019
• Study Completion: June 11, 2019
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

FR (1)