Daily Glycaemic Variability in Frail or Disabled Older Patients With Diabetes Over 75 Treated With Basal Insulin (VARQUOGLY)

May 18, 2026 updated by: University Hospital, Bordeaux

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Pessac, France, 33600
        • University Hospital of Bordeaux - Xavier Arnozan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 .

Exclusion Criteria:

  • 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 :
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Human Neutral Protamine Hagedorn (NPH)
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.
Drug: Insulin
Continuous glucose monitoring system over 120-hour period.
Experimental: Long-acting basal insulin analogues
Drug: Insulin
Continuous glucose monitoring system over 120-hour period.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
5 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Intraday glycemic variability measured by the average standard deviation of blood glucose every day of exploitable recording by the participant
Time Frame: 5 days
5 days
Inter-day glucose variability assessed by Mean Differences of Daily per participant for every day of exploitable recording
Time Frame: 5 days
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
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
5 days
Average time (minutes / day) per day pass in hypoglycemia (<0.60g / l)
Time Frame: 5 days
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
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
At inclusion
Evaluation of Cognition with Mini Mental Status Examination (MMSE)
Time Frame: At inclusion
At inclusion
Fragility level (Rockwood criteria)
Time Frame: At inclusion
At inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Bordeaux

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marie DANET-LAMASOU, Dr, Universitary Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 31, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 28, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 28, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 9, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHUBX 2014/08
  • 2014-A01765-42 (Other Identifier: ANSM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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