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

NCT ID: NCT02486341

Last Updated: 2020-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2019-01-28

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.

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.

Conditions

Diabetes

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Insulin

Intervention Type: DRUG

Continuous glucose monitoring system over 120-hour period.

Long-acting basal insulin analogues

Group Type: EXPERIMENTAL

Insulin

Intervention Type: DRUG

Continuous glucose monitoring system over 120-hour period.

Interventions

Insulin

Continuous glucose monitoring system over 120-hour period.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marie DANET-LAMASOU, Dr

Role: PRINCIPAL_INVESTIGATOR

Universitary Hospital

Locations

University Hospital of Bordeaux - Xavier Arnozan Hospital

Pessac, , France

Countries

France

Other Identifiers

CHUBX 2014/08

Identifier Type: -

Identifier Source: org_study_id