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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03020264
Recruitment Status : Terminated (COVID-19)
First Posted : January 13, 2017
Last Update Posted : June 26, 2020
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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


Condition or disease Intervention/treatment Phase
Type2 Diabetes Elderly Hypoglycemia Device: glycemic sensor FREESTYLE Libre Pro Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 161 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Frequency of Hypoglycemia in Patients With Type 2 Diabetes Under Insulin Therapy Older Than 75 Years in Real Life
Actual Study Start Date : November 28, 2017
Actual Primary Completion Date : June 18, 2020
Actual Study Completion Date : June 18, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia

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




Primary Outcome Measures :
  1. Number of confirmed or severe hypoglycemia [ Time Frame: 1 month ]
    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.


Secondary Outcome Measures :
  1. number of events / patient / month of severe hypoglycemia [ Time Frame: 1 month ]
    Number of confirmed severe hypoglycaemia episodes (events / patient / month), symptomatic or asymptomatic, occurring in patients during 4 weeks of prospective follow-up.

  2. Number of hospitalizations due to hypoglycemia [ Time Frame: 1 month ]
    Number and duration of hospital stays

  3. Number of asymptomatic confirmed (blood glucose value <0.70g / L) hypoglycemia [ Time Frame: 1 month ]
    Confirmed asymptomatic hypoglycaemia (events / patient / month) occurring in patients collected with the FREESTYLE Libre Pro glucose sensor

  4. Number of hypoglycaemia in elderly patients admitted to EHPAD [ Time Frame: 1 month ]
    Confirmed hypoglycaemia (events / patient / month), symptomatic or asymptomatic, occurring in patients hospitalized in long-term geriatric care sector.

  5. Number of confirmed nocturnal hypoglycaemia (occurring between 0h00-6h00) [ Time Frame: 1 month ]
    Confirmed nocturnal hypoglycaemia (events / patient / month), symptomatic or asymptomatic, occurring in patients

  6. Number of confirmed hypoglycaemia with a threshold blood glucose value <0.54g / L (neuroglucopenic threshold) [ Time Frame: 1 month ]
    Confirmed neuroglucopenic hypoglycaemia (events / patient / month), symptomatic or asymptomatic, occurring in patients

  7. Number of pseudo-hypoglycaemia and unconfirmed hypoglycaemia (Symptoms consistent with hypoglycemia, but with a blood glucose value ≥ 70 mg / dL) [ Time Frame: 1 month ]
    Confirmed pseudo-hypoglycaemia and unconfirmed hypoglycaemia (events / patient / month), occurring in patients

  8. Score for fear of hypoglycemia in elderly diabetic patients [ Time Frame: 1 month ]
    Score for fear of hypoglycaemia (HFS-II)

  9. 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 [ Time Frame: 1 month ]
    Confirmed hypoglycaemia (events / patient / month), symptomatic or asymptomatic, occurring in patients

  10. Number of the transition to ER due to hypoglycemia [ Time Frame: 1 month ]
    Number and duration of emergency stays

  11. Number of falls due to hypoglycemia [ Time Frame: 1 month ]
    Number of falls and loss of autonomy (no home support)

  12. Number of death due to hypoglycemia [ Time Frame: 1 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03020264


Locations
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France
CHU de Nantes
Nantes, Loire Atlantique, France, 44000
CH d'Ancenis
Ancenis, France, 44150
CHU d'Angers
Angers, France, 49100
Hôpital Sud Francilien
Corbeil-Essonnes, France, 91106
CHRU de Lille
Lille, France, 59037
CHU de Poitiers
Poitiers, France, 86021
CHU de Toulouse
Toulouse, France
Sponsors and Collaborators
Nantes University Hospital
Investigators
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Principal Investigator: Bertrand CARIOU, Pr CHU de Nantes
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03020264    
Other Study ID Numbers: RC16_0351
First Posted: January 13, 2017    Key Record Dates
Last Update Posted: June 26, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nantes University Hospital:
Type 2 Diabetes
Hypoglycemia
Elderly
Insulinotherapy
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases