Type2 DiabetesHYPOAGENCT03020264
Frequency of Hypoglycemia in Patients With Type 2 Diabetes Under Insulin Therapy Older Than 75 Years in Real Life
A study testing glycemic sensor FREESTYLE Libre Pro in people with Type2 Diabetes and Elderly, run by Nantes University Hospital at 7 sites in France.
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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Type2 Diabetes, Elderly, Hypoglycemia
- What is being tested?
- glycemic sensor FREESTYLE Libre Pro
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 7 sitesFrance
- Study dates
- 28 Nov 2017to 18 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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 locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
CH d'Ancenis
Ancenis, 44150
CHU d'Angers
Angers, 49100
Hôpital Sud Francilien
Corbeil-Essonnes, 91106
CHRU de Lille
Lille, 59037
CHU de Nantes
Nantes, Loire Atlantique, 44000
CHU de Poitiers
Poitiers, 86021
CHU de Toulouse
Toulouse
About this study
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
- Conditions
- Type2 Diabetes, Elderly, Hypoglycemia
- Being tested
- glycemic sensor FREESTYLE Libre Pro
- Keywords
- Type 2 Diabetes, Hypoglycemia, Elderly, Insulinotherapy
- Medical subject headings
- Hypoglycemia, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glycemic sensor FREESTYLE Libre ProDevice
Collection of hypoglycemia episodes with glycemic sensor FREESTYLE Libre Pro
| Study group | Role | What they receive |
|---|---|---|
| Patients older than 75 years | Experimental | Collection of hypoglycaemia épisodes with the glycemic sensor FREESTYLE Libre Pro Receives: Device: glycemic sensor FREESTYLE Libre Pro |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (12)
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.
Measured: 1 month
Number of hospitalizations due to hypoglycemia
Number and duration of hospital stays
Measured: 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
Measured: 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.
Measured: 1 month
Number of confirmed nocturnal hypoglycaemia (occurring between 0h00-6h00)
Confirmed nocturnal hypoglycaemia (events / patient / month), symptomatic or asymptomatic, occurring in patients
Measured: 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
Measured: 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
Measured: 1 month
Score for fear of hypoglycemia in elderly diabetic patients
Score for fear of hypoglycaemia (HFS-II)
Measured: 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
Measured: 1 month
Number of the transition to ER due to hypoglycemia
Number and duration of emergency stays
Measured: 1 month
Number of falls due to hypoglycemia
Number of falls and loss of autonomy (no home support)
Measured: 1 month
Number of death due to hypoglycemia
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study start28 Nov 2017
- Primary completion18 Jun 2020
- Study completion18 Jun 2020
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 DiabetesStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bertrand CARIOU, Pr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03020264
- Sponsor's protocol ID
- RC16_0351
- Acronym
- HYPOAGE
- Status last verified
- Jul 2024
- First submitted
- 9 Jan 2017
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of Hypoglycemia in Patients With Type 2 Diabetes Under Insulin Therapy Older Than 75 Years in Real Life
- ClinicalTrials.gov ID
- NCT03020264
- Acronym / sponsor ID
- HYPOAGE / RC16_0351
- Conditions
- Type2 Diabetes, Elderly, Hypoglycemia
- Keywords
- Type 2 Diabetes, Hypoglycemia, Elderly, Insulinotherapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 28 Nov 2017 (actual)
- Primary completion
- 18 Jun 2020 (actual)
- Study completion
- 18 Jun 2020 (actual)
- First posted
- 13 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients older than 75 years | Experimental | Device: glycemic sensor FREESTYLE Libre ProCollection of hypoglycaemia épisodes with the glycemic sensor FREESTYLE Libre Pro |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| glycemic sensor FREESTYLE Libre ProCollection of hypoglycemia episodes with glycemic sensor FREESTYLE Libre Pro | Device | Patients older than 75 years |
Primary outcome
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.
12 secondary outcomes
number of events / patient / month of severe hypoglycemia
Time frame: 1 month
Number of hospitalizations due to hypoglycemia
Time frame: 1 month
Number of asymptomatic confirmed (blood glucose value <0.70g / L) hypoglycemia
Time frame: 1 month
Number of hypoglycaemia in elderly patients admitted to EHPAD
Time frame: 1 month
Number of confirmed nocturnal hypoglycaemia (occurring between 0h00-6h00)
Time frame: 1 month
Number of confirmed hypoglycaemia with a threshold blood glucose value <0.54g / L (neuroglucopenic threshold)
Time frame: 1 month
Number of pseudo-hypoglycaemia and unconfirmed hypoglycaemia (Symptoms consistent with hypoglycemia, but with a blood glucose value ≥ 70 mg / dL)
Time frame: 1 month
Score for fear of hypoglycemia in elderly diabetic patients
Time frame: 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
Time frame: 1 month
Number of the transition to ER due to hypoglycemia
Time frame: 1 month
Number of falls due to hypoglycemia
Time frame: 1 month
Number of death due to hypoglycemia
Time frame: 1 month
Results and safety
The study was stopped early (reason given: COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bertrand CARIOU, Pr principal investigator
Nantes University Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing glycemic sensor FREESTYLE Libre Pro in people with Type2 Diabetes and Elderly, run by Nantes University Hospital at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID-19). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of confirmed or severe hypoglycemia (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2024.