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

N

Nantes University Hospital (NUH)

Status

Terminated

Conditions

Hypoglycemia
Type2 Diabetes
Elderly

Treatments

Device: glycemic sensor FREESTYLE Libre Pro

Study type

Interventional

Funder types

Other

Identifiers

NCT03020264
RC16_0351

Details and patient eligibility

About

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

Enrollment

161 patients

Sex

All

Ages

75+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

161 participants in 1 patient group

Patients older than 75 years
Experimental group
Description:
Collection of hypoglycaemia épisodes with the glycemic sensor FREESTYLE Libre Pro
Treatment:
Device: glycemic sensor FREESTYLE Libre Pro

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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