Comparison of a Low Dose to a Standard Dose of Insulin in Adult DKA in ICU to Reduce Metabolic Co… (NCT05443802) | Clinical Trial Compass
CompletedNot Applicable
Comparison of a Low Dose to a Standard Dose of Insulin in Adult DKA in ICU to Reduce Metabolic Complications
France150 participantsStarted 2022-08-16
Plain-language summary
Diabetic ketoacidosis (DKA), a frequent complication of diabetes, is the consequence of a profound insulin deficiency responsible for osmotic polyuria and thus major losses of water, glucose, sodium and potassium as well as a metabolic acidosis due to the uncontrolled production of ketonic acids. Management includes fluid replacement, insulin therapy and correction of metabolic disorders (including potassium loss).
Initially described in patients with type 1 diabetes (T1D), it is now often observed in patients with type 2 diabetes (T2D) in whom it is more a matter of insulin resistance than an absolute deficiency. However, international guidelines recommend a similar dose of intravenous insulin (0.10 IU/kg/hour) regardless of the type of diabetes.
During treatment, metabolic complications are frequent and potentially serious, especially in T2D due to cardiovascular comorbidities.
The research hypothesis is that decreasing the insulin dose will reduce metabolic complications without influencing time to resolution in adult patients, regardless of diabetes type.
Who can participate
Age range
18 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:
* Patient aged 18 years or above
* Admission in Intense/Intermediate Care Unit
* Severe DKA due to all types of diabetes (T1D, T2D and secondary diabetes and inaugural ketoacidosis) defined by association of the following 3 parameters:
* glucose \> 11 mmol/L or affirmation of having diabetes
* ketonemia \> 3mmol/L or ketonuria ≥ 2
* bicarbonate \< 15 mmol/L and/or venous pH \< or=7.3
* Randomization possible before 15UI of insulin administrated in total
* Informed and written consent. In the absence of parent/ relative/ person of trust, the patient may be included via the emergency procedure and consent will be obtained as soon as possible
Exclusion Criteria:
* Non-diabetic ketoacidosis (fasting or alcoholic)
* Patient weighing less than 30 kg
* Hypokalemia \< 3.5 mmol/L at the time of inclusion
* Hyperosmolar hyperglycemic state (defined as efficient plasma osmolarity \> 320 mosmol/L)
* Absence of social security coverage
* Pregnant or breastfeeding patient
* Patient under tutelage or curators
* Patient deprived of liberty due to a judicial or administrative decision
* Patient with a renal disease requiring dialysis
* Acute or chronic liver failure with Factor V \< 50%
* Patient receiving a high dose of corticosteroids (≥ 0.5 mg/kg) daily
* Patient included in another interventional study
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.