Frequency of Hypoglycemia in Patients With Type 2 Diabetes Under Insulin Therapy Older Than 75 Years in Real Life (HYPOAGE)
Primary Purpose
Type2 Diabetes, Elderly, Hypoglycemia
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
glycemic sensor FREESTYLE Libre Pro
Sponsored by
About this trial
This is an interventional other trial for Type2 Diabetes focused on measuring Type 2 Diabetes, Hypoglycemia, Elderly, Insulinotherapy
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.
Sites / Locations
- CHU de Nantes
- CH d'Ancenis
- CHU d'Angers
- Hôpital Sud Francilien
- CHRU de Lille
- CHU de Poitiers
- CHU de Toulouse
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients older than 75 years
Arm Description
Collection of hypoglycaemia épisodes with the glycemic sensor FREESTYLE Libre Pro
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Number of hospitalizations due to hypoglycemia
Number and duration of hospital stays
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
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.
Number of confirmed nocturnal hypoglycaemia (occurring between 0h00-6h00)
Confirmed nocturnal hypoglycaemia (events / patient / month), symptomatic or asymptomatic, occurring in patients
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
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
Score for fear of hypoglycemia in elderly diabetic patients
Score for fear of hypoglycaemia (HFS-II)
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
Number of the transition to ER due to hypoglycemia
Number and duration of emergency stays
Number of falls due to hypoglycemia
Number of falls and loss of autonomy (no home support)
Number of death due to hypoglycemia
Full Information
NCT ID
NCT03020264
First Posted
January 9, 2017
Last Updated
June 24, 2020
Sponsor
Nantes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03020264
Brief Title
Frequency of Hypoglycemia in Patients With Type 2 Diabetes Under Insulin Therapy Older Than 75 Years in Real Life
Acronym
HYPOAGE
Official Title
Frequency of Hypoglycemia in Patients With Type 2 Diabetes Under Insulin Therapy Older Than 75 Years in Real Life
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Terminated
Why Stopped
COVID-19
Study Start Date
November 28, 2017 (Actual)
Primary Completion Date
June 18, 2020 (Actual)
Study Completion Date
June 18, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes, Elderly, Hypoglycemia
Keywords
Type 2 Diabetes, Hypoglycemia, Elderly, Insulinotherapy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
161 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients older than 75 years
Arm Type
Experimental
Arm Description
Collection of hypoglycaemia épisodes with the glycemic sensor FREESTYLE Libre Pro
Intervention Type
Device
Intervention Name(s)
glycemic sensor FREESTYLE Libre Pro
Intervention Description
Collection of hypoglycemia episodes with glycemic sensor FREESTYLE Libre Pro
Primary Outcome Measure Information:
Title
Number of confirmed or severe hypoglycemia
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
number of events / patient / month of severe hypoglycemia
Description
Number of confirmed severe hypoglycaemia episodes (events / patient / month), symptomatic or asymptomatic, occurring in patients during 4 weeks of prospective follow-up.
Time Frame
1 month
Title
Number of hospitalizations due to hypoglycemia
Description
Number and duration of hospital stays
Time Frame
1 month
Title
Number of asymptomatic confirmed (blood glucose value <0.70g / L) hypoglycemia
Description
Confirmed asymptomatic hypoglycaemia (events / patient / month) occurring in patients collected with the FREESTYLE Libre Pro glucose sensor
Time Frame
1 month
Title
Number of hypoglycaemia in elderly patients admitted to EHPAD
Description
Confirmed hypoglycaemia (events / patient / month), symptomatic or asymptomatic, occurring in patients hospitalized in long-term geriatric care sector.
Time Frame
1 month
Title
Number of confirmed nocturnal hypoglycaemia (occurring between 0h00-6h00)
Description
Confirmed nocturnal hypoglycaemia (events / patient / month), symptomatic or asymptomatic, occurring in patients
Time Frame
1 month
Title
Number of confirmed hypoglycaemia with a threshold blood glucose value <0.54g / L (neuroglucopenic threshold)
Description
Confirmed neuroglucopenic hypoglycaemia (events / patient / month), symptomatic or asymptomatic, occurring in patients
Time Frame
1 month
Title
Number of pseudo-hypoglycaemia and unconfirmed hypoglycaemia (Symptoms consistent with hypoglycemia, but with a blood glucose value ≥ 70 mg / dL)
Description
Confirmed pseudo-hypoglycaemia and unconfirmed hypoglycaemia (events / patient / month), occurring in patients
Time Frame
1 month
Title
Score for fear of hypoglycemia in elderly diabetic patients
Description
Score for fear of hypoglycaemia (HFS-II)
Time Frame
1 month
Title
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
Description
Confirmed hypoglycaemia (events / patient / month), symptomatic or asymptomatic, occurring in patients
Time Frame
1 month
Title
Number of the transition to ER due to hypoglycemia
Description
Number and duration of emergency stays
Time Frame
1 month
Title
Number of falls due to hypoglycemia
Description
Number of falls and loss of autonomy (no home support)
Time Frame
1 month
Title
Number of death due to hypoglycemia
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bertrand CARIOU, Pr
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nantes
City
Nantes
State/Province
Loire Atlantique
ZIP/Postal Code
44000
Country
France
Facility Name
CH d'Ancenis
City
Ancenis
ZIP/Postal Code
44150
Country
France
Facility Name
CHU d'Angers
City
Angers
ZIP/Postal Code
49100
Country
France
Facility Name
Hôpital Sud Francilien
City
Corbeil-Essonnes
ZIP/Postal Code
91106
Country
France
Facility Name
CHRU de Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
CHU de Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
CHU de Toulouse
City
Toulouse
Country
France
12. IPD Sharing Statement
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Frequency of Hypoglycemia in Patients With Type 2 Diabetes Under Insulin Therapy Older Than 75 Years in Real Life
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