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

• Status: Completed
• Trial end date: 2019-01-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Bordeaux
• Treatments: Insulin; Insulin, Globin Zinc

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.