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

Study Overview
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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

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

Conditions
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Type2 Diabetes, Elderly, Hypoglycemia

Intervention / Treatment
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* Device: glycemic sensor FREESTYLE Libre Pro


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients older than 75 years<br>Collection of hypoglycaemia épisodes with the glycemic sensor FREESTYLE Libre Pro | Device: glycemic sensor FREESTYLE Libre Pro<br>* Collection of hypoglycemia episodes with glycemic sensor FREESTYLE Libre Pro<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of confirmed or severe hypoglycemia | 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. | 1 month | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypoglycemia, Type 2 Diabetes, Elderly, Insulinotherapy