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

Elderly Clinical Trial

— HYPOAGE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03020264
• Other study ID #: RC16_0351
• Status: Terminated
• Phase: N/A
• Start date: November 28, 2017
• Est. completion date: June 18, 2020

Study information

• Verified date: June 2020
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 161
• Est. completion date: June 18, 2020
• Est. primary completion date: June 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Elderly
• Hypoglycemia
• Type2 Diabetes

Intervention

Device:
• glycemic sensor FREESTYLE Libre Pro
Collection of hypoglycemia episodes with glycemic sensor FREESTYLE Libre Pro

Locations

Country	Name	City	State
France	CH d'Ancenis	Ancenis
France	CHU d'Angers	Angers
France	Hôpital Sud Francilien	Corbeil-Essonnes
France	CHRU de Lille	Lille
France	CHU de Nantes	Nantes	Loire Atlantique
France	CHU de Poitiers	Poitiers
France	CHU de Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Number of hospitalizations due to hypoglycemia	Number and duration of hospital stays	1 month
Secondary	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
Secondary	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
Secondary	Number of confirmed nocturnal hypoglycaemia (occurring between 0h00-6h00)	Confirmed nocturnal hypoglycaemia (events / patient / month), symptomatic or asymptomatic, occurring in patients	1 month
Secondary	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
Secondary	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
Secondary	Score for fear of hypoglycemia in elderly diabetic patients	Score for fear of hypoglycaemia (HFS-II)	1 month
Secondary	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
Secondary	Number of the transition to ER due to hypoglycemia	Number and duration of emergency stays	1 month
Secondary	Number of falls due to hypoglycemia	Number of falls and loss of autonomy (no home support)	1 month
Secondary	Number of death due to hypoglycemia		1 month