HAGED: Screening for Hypoglycemia in an Institutionalized Elderly Diabetic Population.

• Sponsor: Centre Hospitalier Universitaire Dijon (Other)
• Overall Status: Completed
• CT.gov ID: NCT03656887
• Collaborator: (none)
• Enrollment: 29
• Location: 1
• Actual Duration (Months): 5.1
• Patients Per Site Per Month: 5.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Old Age; Institutionalized in EHPAD (French Nursing Home); Diabetes; Hypoglycemic Syndrome	Device: Continuous interstitial glucose sensor; Other: Sensor Scan

Study Design

• Study Type: Observational
• Actual Enrollment: 29 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Screening for Hypoglycemia in an Institutionalized Elderly Diabetic Population.
• Actual Study Start Date: Jan 8, 2019
• Actual Primary Completion Date: Jun 11, 2019
• Actual Study Completion Date: Jun 11, 2019

Outcome Measures

Primary Outcome Measures

1. Number of hypoglycemic events (<70 mg/dl) demonstrated by continuous interstitial glucose monitoring over the study period. [Day 14]

2. Number of hypoglycemic events (<70 mg/dl) detected by capillary blood glucose measurement or clinical signs suggestive of hypoglycemia. [Day 14]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chu Dijon Bourogne	Dijon		France	21000

Sponsors and Collaborators

• Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire Dijon
• ClinicalTrials.gov Identifier: NCT03656887
• Other Study ID Numbers: BOUILLET 2018
• First Posted: Sep 4, 2018
• Last Update Posted: Nov 24, 2020
• Last Verified: Nov 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypoglycemia

Study Results

No Results Posted as of Nov 24, 2020