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Blood sugar rollercoaster in frail seniors: which insulin works best?

NCT ID NCT02486341

Knowledge-focused Sponsor: University Hospital, Bordeaux Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how much blood sugar levels go up and down during the day in frail or disabled patients over 75 with diabetes who use basal insulin. Researchers used a continuous glucose monitor for 5 days to compare two types of insulin: human NPH and long-acting analogues. The goal was to see if one type leads to more stable blood sugar levels, which could help guide better treatment for this vulnerable group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Insulin (NPH or long-acting analogues)
What this could lead to
If successful, this could help doctors choose the best basal insulin for frail elderly patients to reduce dangerous blood sugar swings.
What could go wrong
This is a small, observational study with only 30 participants, so results may not apply to all older patients. It does not test a new treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

30 people

The number who actually took part.

Started

Mar 2016

Finished

Jan 2019

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

75 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

diabetes mellitus type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes

Contacts and locations

Locations

  • University Hospital of Bordeaux - Xavier Arnozan Hospital

    Pessac, 33600, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.