Screening for Hypoglycemia in an Institutionalized Elderly Diabetic Population.

NCT ID: NCT03656887

Last Updated: 2020-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

29 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-08

Study Completion Date

2019-06-11

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Continuous interstitial glucose sensor

Installing and removing the sensor

Intervention Type DEVICE

Sensor Scan

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu Dijon Bourogne

Dijon, , France

Site Status

Countries

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France

Other Identifiers

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BOUILLET 2018

Identifier Type: -

Identifier Source: org_study_id