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

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ClinicalTrials.gov Identifier: NCT02486341
Recruitment Status : Recruiting
First Posted : July 1, 2015
Last Update Posted : November 28, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Diabetes Drug: Insulin Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Daily Glycaemic Variability in Frail or Disabled Older Patients With Diabetes Over 75 Treated With Basal Insulin
Study Start Date : February 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Disabilities

Arm Intervention/treatment
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02486341


Contacts
Contact: Frédéric PERRY +33(0)5 57 82 11 58 frederic.perry@chu-bordeaux.fr

Locations
France
University Hospital of Bordeaux - Xavier Arnozan Hospital Recruiting
Pessac, France, 33600
Contact: Marie DANET-LAMASOU, Dr    +33(5) 57 65 65 71    marie.danet@chu-bordeaux.fr   
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Marie DANET-LAMASOU, Dr Universitary Hospital

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT02486341     History of Changes
Other Study ID Numbers: CHUBX 2014/08
First Posted: July 1, 2015    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 2018

Keywords provided by University Hospital, Bordeaux:
continuous glucose monitoring system
basal insulin
diabetes mellitus
elderly

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs