Screening for Hypoglycemia in an Institutionalized Elderly Diabetic Population.

Diabetes Clinical Trial

— HAGED  

Official title:

Screening for Hypoglycemia in an Institutionalized Elderly Diabetic Population.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03656887
• Other study ID #: BOUILLET 2018
• Status: Completed
• Start date: January 8, 2019
• Est. completion date: June 11, 2019

Study information

• Verified date: November 2020
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: June 11, 2019
• Est. primary completion date: June 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Continuous interstitial glucose sensor
Installing and removing the sensor

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

Locations

Country	Name	City	State
France	Chu Dijon Bourogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of hypoglycemic events (<70 mg/dl) demonstrated by continuous interstitial glucose monitoring over the study period.		Day 14
Primary	Number of hypoglycemic events (<70 mg/dl) detected by capillary blood glucose measurement or clinical signs suggestive of hypoglycemia.		Day 14