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

What Was Tested

The trial (not phased) is built around Insulin (regular human).

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.

It had two arms (groups): Human Neutral Protamine Hagedorn (NPH) (experimental) and Long-acting basal insulin analogues (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.

The registry classes the interventions as drug.

More on the Plan

Moreover, diabetes prevalence is particularly high among institutionalized subjects with more than half of them treated with insulin.

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.

Who Took Part

The registry lists 30 actual participants took part.

It was open to people of any sex aged from 75 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age\> or equal to 75 years,. Treated with basal insulin associated or not with metformin (one or two injections per day, in the morning and/or evening before meals). 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 .

The full record lists 6 inclusion and 14 exclusion criteria; among the exclusions: refusal of wearing a continuous glucose monitoring system,; treatment with insulinosecretors dipeptidyl peptidase-4 inhibitor, glucagon-like peptide-1 analogues, sulfonylurea) or rapid insulin (human or rapid analogue),; current treatment with corticosteroids,.

How the Study Was Run

It was run as a non-randomized, parallel-group and open-label study.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.

It started in 2016-03-31 with completion listed for 2019-01-28.

It ran at 1 site in France.

Its stated primary purpose is health services research.

What Was Measured

The main thing measured (primary outcome): 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).

It also tracked 9 secondary outcomes, for example Inter-day glucose variability assessed by Mean Differences of Daily per participant for every day of exploitable recording, Evaluation of Cognition with Mini Mental Status Examination (MMSE) and Fragility level (Rockwood criteria).

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Insulin (regular human) in 30 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page, all human trials.