CompletedNot Applicable

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

France30 participantsStarted 2016-03-31

Plain-language 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.

Who can participate

Age range

75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Intraday glycemic variability measured by the average of MAGE index (Mean amplitude of glycemic excursions) everyday of exploitable recording by the participant.

Timeframe: 5 days

Trial details

NCT IDNCT02486341

SponsorUniversity Hospital, Bordeaux

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-01-28

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