Frequency of Hypoglycemia in Patients With Type 2 Diabetes Under Insulin Therapy Older Than 75 Years in Real Life

NCT ID: NCT03020264

Last Updated: 2024-07-26

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

TERMINATED

Clinical Phase

NA

Total Enrollment

161 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-28

Study Completion Date

2020-06-18

Brief Summary

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Diabetes is a chronic and progressive disease that affects nearly 3.5 million people in France.

Currently the investigators are seeing an aging of the population explained by the increase in life expectancy and thus an increasing incidence of diabetes in the elderly. However, the frequency of hypoglycemia in older vulnerable patients remains poorly characterized

Detailed Description

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Conditions

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Type2 Diabetes Elderly Hypoglycemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Patients older than 75 years

Collection of hypoglycaemia épisodes with the glycemic sensor FREESTYLE Libre Pro

Group Type EXPERIMENTAL

glycemic sensor FREESTYLE Libre Pro

Intervention Type DEVICE

Collection of hypoglycemia episodes with glycemic sensor FREESTYLE Libre Pro

Interventions

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glycemic sensor FREESTYLE Libre Pro

Collection of hypoglycemia episodes with glycemic sensor FREESTYLE Libre Pro

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Male or female ≥ 75 years of age;
* Type 2 diabetes for at least 1 year and treated with insulin for at least 6 months;
* Treated with basal insulin (ie glargine U100: Lantus®, Abasaglar®, glargine U300: Toujeo®, detemir: levemir®, NPH), premix (ie Novomix® and Humalog Mix®), and / Insulin associated or not with one or more oral and / or injectable antidiabetic agents (analog of GLP1...);
* Benefiting from at least 1 capillary glucose per day (carried out by the patient himself or a caregiver);
* Benefiting from a standardized geriatric assessment;
* Signature of informed consent
* Patient benefiting from a social security system.

Exclusion Criteria

* Male or female aged \<75 years;
* Person without diabetes or type 1 diabetes;
* Patient treated only lifestyle modifications and / or oral anti-diabetic drugs and / or GLP-1 receptor agonists alone;
* Subjects with secondary or corticosteroid-induced diabetes;
* Refusal to participate in the study or inability to collect consent;
* Patient for whom follow-up of the study procedures is impossible (glycemic record impossible or insufficient);
* Patient not eligible for geriatric assessment;
* Patient already participating in another study;
* Patient with a severe pathology limiting his life expectancy (palliative care ...) compromising his participation in the study at the discretion of the investigator;
* Patient benefiting from a safeguard of justice.
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bertrand CARIOU, Pr

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

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CHU de Nantes

Nantes, Loire Atlantique, France

Site Status

CH d'Ancenis

Ancenis, , France

Site Status

CHU d'Angers

Angers, , France

Site Status

Hôpital Sud Francilien

Corbeil-Essonnes, , France

Site Status

CHRU de Lille

Lille, , France

Site Status

CHU de Poitiers

Poitiers, , France

Site Status

CHU de Toulouse

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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RC16_0351

Identifier Type: -

Identifier Source: org_study_id

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