Clinical trial NCT03020264: Frequency of Hypoglycemia in Patients With Type 2 Diabetes Under Insulin Therapy Older Than 75 Years in Real Life
Official title: Frequency of Hypoglycemia in Patients With Type 2 Diabetes Under Insulin Therapy Older Than 75 Years in Real Life
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Type2 Diabetes
Elderly
Hypoglycemia
Keywords: Type 2 Diabetes
Hypoglycemia
Elderly
Insulinotherapy
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2017-01-13
Enrollment: 161
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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


Eligibility criteria: 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.

Primary outcomes:
measure: Number of confirmed or severe hypoglycemia
timeFrame: 1 month
Secondary outcomes:
measure: number of events / patient / month of severe hypoglycemia
timeFrame: 1 month
measure: Number of hospitalizations due to hypoglycemia
timeFrame: 1 month
measure: Number of asymptomatic confirmed (blood glucose value <0.70g / L) hypoglycemia
timeFrame: 1 month
measure: Number of hypoglycaemia in elderly patients admitted to EHPAD
timeFrame: 1 month
measure: Number of confirmed nocturnal hypoglycaemia (occurring between 0h00-6h00)
timeFrame: 1 month
measure: Number of confirmed hypoglycaemia with a threshold blood glucose value <0.54g / L (neuroglucopenic threshold)
timeFrame: 1 month
measure: Number of pseudo-hypoglycaemia and unconfirmed hypoglycaemia (Symptoms consistent with hypoglycemia, but with a blood glucose value ≥ 70 mg / dL)
timeFrame: 1 month
measure: Score for fear of hypoglycemia in elderly diabetic patients
timeFrame: 1 month
measure: 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
timeFrame: 1 month
measure: Number of the transition to ER due to hypoglycemia
timeFrame: 1 month
measure: Number of falls due to hypoglycemia
timeFrame: 1 month
measure: Number of death due to hypoglycemia
timeFrame: 1 month
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes
state: Loire Atlantique
city: Ancenis
country: France
facility: CH d'Ancenis
city: Angers
country: France
facility: CHU d'Angers
city: Corbeil-Essonnes
country: France
facility: Hôpital Sud Francilien
city: Lille
country: France
facility: CHRU de Lille
city: Poitiers
country: France
facility: CHU de Poitiers
city: Toulouse
country: France
facility: CHU de Toulouse
Study officials:
affiliation: Nantes University Hospital
name: Bertrand CARIOU, Pr
role: PRINCIPAL_INVESTIGATOR
References: