DiabetesVARQUOGLYNCT02486341
Daily Glycaemic Variability in Frail or Disabled Older Patients With Diabetes Over 75 Treated With Basal Insulin
A study testing Insulin in people with Diabetes, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Basal insulin is widely used in older patients with diabetes. Human insulin Neutral Protamine Hagedorn (NPH) has been proposed as basal insulin in older (75 years or older) frail and dependent patients due to its shorter action. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- Insulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 31 Mar 2016to 28 Jan 2019
- 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
- Age> or equal to 75 years,
- Diabetes mellitus diagnosed or Glycated hemoglobin (HbA1c) > 7% or 2 fasting blood glucose > to 1.26g/l,
- Treated with basal insulin associated or not with metformin (one or two injections per day, in the morning and/or evening before meals)
- Subject affiliated or beneficiary of a social security system,
- Free consent, informed and signed by the participant or by the surrogate of the patient and the investigator,
- Patient in the 4th or higher categories of frailty according to Rockwood .
Who cannot join
- Refusal of wearing a continuous glucose monitoring system,
- Total autonomy (mobility according to Rosow and Breslau scale, instrumental activities of daily living according to Lawton scale, activities of daily living according to Barthel score),
- Treatment with insulinosecretors Dipeptidyl peptidase-4 inhibitor, Glucagon-like peptide-1 analogues, sulfonylurea) or rapid insulin (human or rapid analogue),
- Daily dose of basal insulin with change of 20% or more in the last 7 days,
- Current treatment with corticosteroids,
- Acute pathology in the last 7 days :
Show all 14Show fewer
- Infection treated with antibiotic
- New stroke in the last 7 days
- Cardio-respiratory decompensation: change in daily dose of diuretics or oxygenotherapy during the last 7 days,
- Clinically unstable patients according judgement of investigator,
- Behavioural disturbances like Agitation/Aggressivity according the Neuropsychiatric Inventory (NPI),
- All people who are under legal protection,
- All people who will be not able to finish the follow of the study,
- Currently participating in another clinical trial investigating.
Trial locations and contacts
1 site in 1 country.
France1 site
University Hospital of Bordeaux - Xavier Arnozan Hospital
Pessac, 33600
About this study
Basal insulin is widely used in older patients with diabetes. Human insulin Neutral Protamine Hagedorn (NPH) has been proposed as basal insulin in older (75 years or older) frail and dependent patients due to its shorter action. However, no study has analysed the glycaemic profile in elderly subjects according to the basal insulin used, particularly in frail or disabled patients.
The aim of this study is to measure intra-day glycaemic variability according basal insulin (human NPH or long acting analogues) in older (75 and older) frail or disabled patients with diabetes using continuous glucose monitoring system.
Read the detailed description
Increased prevalence of diabetes mellitus is in large part related to ageing: in France in 2009, 26% of patients with diabetes were 75 older or over. Moreover, diabetes prevalence is particularly high among institutionalized subjects with more than half of them treated with insulin.
Diabetes is source of activities limitations and participation restriction from the early stages of the disease and is responsible for 10% of direct health costs, with higher costs for older patients or insulin treated patients.
Older patients with diabetes may be robust (fully independent), frail or disabled. Studies with patients of 75 years or older included mainly robust subjects. Nevertheless older patients with diabetes are more frequently frail and a large proportion have a different metabolic profile than younger ones: they are leaner and present more often with beta-cellular insufficiency. Frail or dependent patients may also have different nutritional status than robust ones. Thus, this is difficult to extrapolate what is known about glycaemic profile in robust and young older (65-74 years old) insulin-treated patients to frail and dependent older ones (>74 years).
Continuous blood glucose monitoring systems give the opportunity to measure around the day the blood glucose variations in real-life and particularly nocturnal hypoglycaemia for these patients treated with various types of basal insulins.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsulinDrug
Continuous glucose monitoring system over 120-hour period.
| Study group | Role | What they receive |
|---|---|---|
| Human Neutral Protamine Hagedorn (NPH) | Experimental | The inclusion will be stratified into 2 groups according to the type of basal insulin being at baseline (ratio 1: 1): NPH human insulin / Long-acting basal insulin analogues. The type of insulin will not be changed by this protocol. Receives: Drug: Insulin |
| Long-acting basal insulin analogues | Experimental | Not described Receives: Drug: Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraday glycemic variability measured by the average of MAGE index (Mean amplitude of glycemic excursions) everyday of exploitable recording by the participant.
Measured: 5 days
Secondary outcomes (9)
Intraday glycemic variability measured by the average standard deviation of blood glucose every day of exploitable recording by the participant
Measured: 5 days
Inter-day glucose variability assessed by Mean Differences of Daily per participant for every day of exploitable recording
Measured: 5 days
Average number of diurnal hypoglycaemia defined by blood glucose <0.60g / l from 7am to 22 pm for all exploitable recording days
Measured: 5 days
Average number of nocturnal hypoglycemia, defined by blood glucose < 0.60g / l between 22h and 7h for every day of exploitable recording
Measured: 5 days
Average time (minutes / day) per day pass in hypoglycemia (<0.60g / l)
Measured: 5 days
Nutritional status: a composite outcome measure consisting of multiple measures with Mini Nutritional Assessment, calf circumference, abdominal circumference, albumin
Measured: At inclusion
Functional Status: a composite outcome measure consisting of multiple measures with scale Rosow and Breslau, Lawton Instrumental Activities of Daily Living Scale, score of Barthel for Activities of Daily Living score evaluation and SPPB Scale
Measured: At inclusion
Evaluation of Cognition with Mini Mental Status Examination (MMSE)
Measured: At inclusion
Fragility level (Rockwood criteria)
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study start31 Mar 2016
- Primary completion28 Jan 2019
- Study completion28 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie DANET-LAMASOU, Dr, Principal investigator, Universitary Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02486341
- Sponsor's protocol ID
- CHUBX 2014/08
- Other IDs
- 2014-A01765-42
- Acronym
- VARQUOGLY
- Status last verified
- Sep 2020
- First submitted
- 9 Jun 2015
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daily Glycaemic Variability in Frail or Disabled Older Patients With Diabetes Over 75 Treated With Basal Insulin
- ClinicalTrials.gov ID
- NCT02486341
- Acronym / sponsor ID
- VARQUOGLY / CHUBX 2014/08
- Conditions
- Diabetes
- Keywords
- continuous glucose monitoring system, basal insulin, diabetes mellitus, elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 31 Mar 2016 (actual)
- Primary completion
- 28 Jan 2019 (actual)
- Study completion
- 28 Jan 2019 (actual)
- First posted
- 1 Jul 2015 (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.
Basal insulin is widely used in older patients with diabetes. Human insulin Neutral Protamine Hagedorn (NPH) has been proposed as basal insulin in older (75 years or older) frail and dependent patients due to its shorter action. However, no study has analysed the glycaemic profile in elderly subjects according to the basal insulin used, particularly in frail or disabled patients.
The aim of this study is to measure intra-day glycaemic variability according basal insulin (human NPH or long acting analogues) in older (75 and older) frail or disabled patients with diabetes using continuous glucose monitoring system.
Detailed description
Increased prevalence of diabetes mellitus is in large part related to ageing: in France in 2009, 26% of patients with diabetes were 75 older or over. Moreover, diabetes prevalence is particularly high among institutionalized subjects with more than half of them treated with insulin.
Diabetes is source of activities limitations and participation restriction from the early stages of the disease and is responsible for 10% of direct health costs, with higher costs for older patients or insulin treated patients.
Older patients with diabetes may be robust (fully independent), frail or disabled. Studies with patients of 75 years or older included mainly robust subjects. Nevertheless older patients with diabetes are more frequently frail and a large proportion have a different metabolic profile than younger ones: they are leaner and present more often with beta-cellular insufficiency. Frail or dependent patients may also have different nutritional status than robust ones. Thus, this is difficult to extrapolate what is known about glycaemic profile in robust and young older (65-74 years old) insulin-treated patients to frail and dependent older ones (>74 years).
Continuous blood glucose monitoring systems give the opportunity to measure around the day the blood glucose variations in real-life and particularly nocturnal hypoglycaemia for these patients treated with various types of basal insulins.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Human Neutral Protamine Hagedorn (NPH) | Experimental | Drug: InsulinThe inclusion will be stratified into 2 groups according to the type of basal insulin being at baseline (ratio 1: 1): NPH human insulin / Long-acting basal insulin analogues. The type of insulin will not be changed by this protocol. |
| Long-acting basal insulin analogues | Experimental | Drug: Insulin |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Age> or equal to 75 years,
- Diabetes mellitus diagnosed or Glycated hemoglobin (HbA1c) > 7% or 2 fasting blood glucose > to 1.26g/l,
- Treated with basal insulin associated or not with metformin (one or two injections per day, in the morning and/or evening before meals)
- Subject affiliated or beneficiary of a social security system,
- Free consent, informed and signed by the participant or by the surrogate of the patient and the investigator,
Key exclusion criteria (14 listed)
- Refusal of wearing a continuous glucose monitoring system,
- Total autonomy (mobility according to Rosow and Breslau scale, instrumental activities of daily living according to Lawton scale, activities of daily living according to Barthel score),
- Treatment with insulinosecretors Dipeptidyl peptidase-4 inhibitor, Glucagon-like peptide-1 analogues, sulfonylurea) or rapid insulin (human or rapid analogue),
- Daily dose of basal insulin with change of 20% or more in the last 7 days,
- Current treatment with corticosteroids,
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 |
|---|---|---|
| InsulinContinuous glucose monitoring system over 120-hour period. | Drug | Human Neutral Protamine Hagedorn (NPH), Long-acting basal insulin analogues |
Primary outcome
Intraday glycemic variability measured by the average of MAGE index (Mean amplitude of glycemic excursions) everyday of exploitable recording by the participant.
Time frame: 5 days
9 secondary outcomes
Intraday glycemic variability measured by the average standard deviation of blood glucose every day of exploitable recording by the participant
Time frame: 5 days
Inter-day glucose variability assessed by Mean Differences of Daily per participant for every day of exploitable recording
Time frame: 5 days
Average number of diurnal hypoglycaemia defined by blood glucose <0.60g / l from 7am to 22 pm for all exploitable recording days
Time frame: 5 days
Average number of nocturnal hypoglycemia, defined by blood glucose < 0.60g / l between 22h and 7h for every day of exploitable recording
Time frame: 5 days
Average time (minutes / day) per day pass in hypoglycemia (<0.60g / l)
Time frame: 5 days
Nutritional status: a composite outcome measure consisting of multiple measures with Mini Nutritional Assessment, calf circumference, abdominal circumference, albumin
Time frame: At inclusion
Functional Status: a composite outcome measure consisting of multiple measures with scale Rosow and Breslau, Lawton Instrumental Activities of Daily Living Scale, score of Barthel for Activities of Daily Living score evaluation and SPPB Scale
Time frame: At inclusion
Evaluation of Cognition with Mini Mental Status Examination (MMSE)
Time frame: At inclusion
Fragility level (Rockwood criteria)
Time frame: At inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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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.
Marie DANET-LAMASOU, Dr principal investigator
Universitary Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insulin in people with Diabetes, run by University Hospital, Bordeaux at 1 site 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 6 inclusion and 14 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: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Intraday glycemic variability measured by the average of MAGE index (Mean amplitude of glycemic excursions) everyday of exploitable recording by the participant. (time frame: 5 days). 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 22 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.