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

NCT02486341 | Completed

• 2 other identifiers: CHUBX 2014/082014-A01765-42
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Keywords

continuous glucose monitoring system; basal insulin; diabetes mellitus; elderly

Outcome Measures

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.

  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

  5 days

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

  5 days

• Average number of diurnal hypoglycaemia defined by blood glucose <0.60g / l from 7am to 22 pm for all exploitable recording 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

  5 days

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

  5 days

Study Arms (2)

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.

Drug: Insulin

Long-acting basal insulin analogues

EXPERIMENTAL

Drug: Insulin

Interventions

Insulin DRUG

Continuous glucose monitoring system over 120-hour period.

Human Neutral Protamine Hagedorn (NPH); Long-acting basal insulin analogues

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

University Hospital of Bordeaux - Xavier Arnozan Hospital

Pessac, 33600, France

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Insulin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Marie DANET-LAMASOU, Dr

  Universitary Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2015
• First Posted: July 1, 2015
• Study Start: March 31, 2016
• Primary Completion: January 28, 2019
• Study Completion: January 28, 2019
• Last Updated: May 22, 2026

Record last verified: 2020-09

Locations

FR (1)