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

Not Applicable

Terminated

• Conditions: Elderly; Type2 Diabetes; Hypoglycemia
• Interventions: Device: glycemic sensor FREESTYLE Libre Pro

• Registration Number: NCT03020264
• Lead Sponsor: Nantes University Hospital

Brief Summary

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-01-09
• Study First Submitted QC: 2017-01-11
• Study First Posted: 2017-01-13
• Study Start: 2017-11-28
• Primary Completion: 2020-06-18
• Study Completion: 2020-06-18
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-25
• Last Update Posted: 2024-07-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 161

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients older than 75 years	glycemic sensor FREESTYLE Libre Pro	Collection of hypoglycaemia épisodes with the glycemic sensor FREESTYLE Libre Pro

Primary Outcome Measures

Name	Time	Method
Number of confirmed or severe hypoglycemia	1 month	Percentage of patients with at least one episode of confirmed and / or severe hypoglycaemia by measuring capillary blood glucose during 4 weeks of prospective follow-up.

Secondary Outcome Measures

Name	Time	Method
Number of asymptomatic confirmed (blood glucose value <0.70g / L) hypoglycemia	1 month	Confirmed asymptomatic hypoglycaemia (events / patient / month) occurring in patients collected with the FREESTYLE Libre Pro glucose sensor
Number of hypoglycaemia in elderly patients admitted to EHPAD	1 month	Confirmed hypoglycaemia (events / patient / month), symptomatic or asymptomatic, occurring in patients hospitalized in long-term geriatric care sector.
Score for fear of hypoglycemia in elderly diabetic patients	1 month	Score for fear of hypoglycaemia (HFS-II)
Number of confirmed nocturnal hypoglycaemia (occurring between 0h00-6h00)	1 month	Confirmed nocturnal hypoglycaemia (events / patient / month), symptomatic or asymptomatic, occurring in patients
number of events / patient / month of severe hypoglycemia	1 month	Number of confirmed severe hypoglycaemia episodes (events / patient / month), symptomatic or asymptomatic, occurring in patients during 4 weeks of prospective follow-up.
Number of confirmed hypoglycaemia with a threshold blood glucose value <0.54g / L (neuroglucopenic threshold)	1 month	Confirmed neuroglucopenic hypoglycaemia (events / patient / month), symptomatic or asymptomatic, occurring in patients
Number of hospitalizations due to hypoglycemia	1 month	Number and duration of hospital stays
Number of pseudo-hypoglycaemia and unconfirmed hypoglycaemia (Symptoms consistent with hypoglycemia, but with a blood glucose value ≥ 70 mg / dL)	1 month	Confirmed pseudo-hypoglycaemia and unconfirmed hypoglycaemia (events / patient / month), occurring in patients
Number of confirmed and severe hypoglycaemia in patients with type 2 diabetes aged 75 years and older in "vigorous" and "vulnerable" subgroups of patients according to a geriatric assessment score	1 month	Confirmed hypoglycaemia (events / patient / month), symptomatic or asymptomatic, occurring in patients
Number of the transition to ER due to hypoglycemia	1 month	Number and duration of emergency stays
Number of falls due to hypoglycemia	1 month	Number of falls and loss of autonomy (no home support)
Number of death due to hypoglycemia	1 month

Trial Locations

Locations (7)

CHU de Nantes; 🇫🇷 Nantes, Loire Atlantique, France

CHRU de Lille; 🇫🇷 Lille, France

CH d'Ancenis; 🇫🇷 Ancenis, France

CHU d'Angers; 🇫🇷 Angers, France

Hôpital Sud Francilien; 🇫🇷 Corbeil-Essonnes, France

CHU de Toulouse; 🇫🇷 Toulouse, France

CHU de Poitiers; 🇫🇷 Poitiers, France