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Completed

NCT Number: NCT02486341

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

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.

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Key information

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Bordeaux - Xavier Arnozan Hospital

Pessac, 33600, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Insulin

Drug

Continuous glucose monitoring system over 120-hour period.

Primary outcomes

  1. 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

Secondary outcomes

  1. Intraday glycemic variability measured by the average standard deviation of blood glucose every day of exploitable recording by the participant

    Time frame: 5 days

  2. Inter-day glucose variability assessed by Mean Differences of Daily per participant for every day of exploitable recording

    Time frame: 5 days

  3. 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

  4. 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. Average time (minutes / day) per day pass in hypoglycemia (<0.60g / l)

    Time frame: 5 days

  6. Nutritional status: a composite outcome measure consisting of multiple measures with Mini Nutritional Assessment, calf circumference, abdominal circumference, albumin

    Time frame: At inclusion

  7. 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

  8. Evaluation of Cognition with Mini Mental Status Examination (MMSE)

    Time frame: At inclusion

  9. Fragility level (Rockwood criteria)

    Time frame: At inclusion

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: VARQUOGLY

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jul 1, 2015
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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