Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-25 @ 3:54 AM
NCT ID:
NCT05443802
Brief 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.
Detailed Description:
Diabetic ketoacidosis (DKA), a frequent complication of diabetes, is the consequence of a profound insulin deficiency responsible for osmotic polyuria which leads to major losses of water, sodium and potassium as well as the generation of metabolic acidosis due to the uncontrolled production of ketonic acids. Management includes fluid replacement, insulin therapy and correction of metabolic disorders (including potassium loss and acidosis).
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 insulin resistance than absolute deficiency. However, international guidelines recommend a similar dosage 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.
A British study reported 27.6% hypoglycaemia and 55% hypokalemia during the first 24 hours of treatment. Comparable figures were observed by conducting a multicenter retrospective study of 122 patients: hypokalaemia and hypoglycaemia were observed in nearly two thirds of cases.
A pediatric study showed that a lower dose of insulin (0.05 IU/kg/h) reduced the rate of hypoglycaemia (20% vs 4%) and hypokalaemia (48% vs 20%) compared to at the standard dose (0.10 IU/kg/h) without modifying the time to resolution. But the very small number (25 children per arm), the questionable statistical analysis and the pediatric population (T1D only) do not make it possible to anticipate the potential benefit in a much more heterogeneous adult population.
The hypothesis of the research is that decreasing the insulin dose will reduce metabolic complications without influencing time to resolution in adult patients, regardless of diabetes type.
Study:
NCT05443802
Study Brief:
Protocol Section:
NCT05443802