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

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

Study Overview

• Status: Terminated
• Conditions: Hypoglycemia; Elderly; Type2 Diabetes
• Intervention / Treatment: Device: glycemic sensor FREESTYLE Libre Pro

• Study Type: Interventional
• Enrollment (Actual): 161
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Ancenis, France, 44150
    • CH d'Ancenis
  • Angers, France, 49100
    • CHU d'Angers
  • Corbeil-Essonnes, France, 91106
    • Hôpital Sud Francilien
  • Lille, France, 59037
    • CHRU de Lille
  • Poitiers, France, 86021
    • CHU de Poitiers
  • Toulouse, France
    • CHU de Toulouse
  • Loire Atlantique
    • Nantes, Loire Atlantique, France, 44000
      • CHU de Nantes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients older than 75 years; Collection of hypoglycaemia épisodes with the glycemic sensor FREESTYLE Libre Pro	Device: glycemic sensor FREESTYLE Libre Pro; Collection of hypoglycemia episodes with glycemic sensor FREESTYLE Libre Pro

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Bertrand CARIOU, Pr, CHU de Nantes

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2017
• Primary Completion (Actual): June 18, 2020
• Study Completion (Actual): June 18, 2020

Study Registration Dates

• First Submitted: January 9, 2017
• First Submitted That Met QC Criteria: January 11, 2017
• First Posted (Estimate): January 13, 2017

Study Record Updates

• Last Update Posted (Actual): June 26, 2020
• Last Update Submitted That Met QC Criteria: June 24, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Elderly; Hypoglycemia; Type 2 Diabetes; Insulinotherapy
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemia
• Other Study ID Numbers: RC16_0351

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No