Comparison of a Low Dose to a Standard Dose of Insulin in Adult DKA in ICU to Reduce Metabolic Complications

NCT05443802 | Completed DMC

• 1 other identifier: APHP210081
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Ketoacidosis

Keywords

Diabetic ketoacidosis; Insulin deficiency; Hypoglycemia; Hypokalemia; Metabolic complications

Outcome Measures

Primary Outcomes (1)

• Metabolic complications

  Proportion of patients with metabolic complications (hypokalaemia \<3.5 mmol/L and/or hypoglycemia \<3.9 mmol/L) treated with a reduced dose of insulin (0.05 IU/kg/h) compared with the control group receiving the 0.10 IU/kg/h dose.

  48 hours

Secondary Outcomes (22)

• Resolution of diabetic ketoacidosis

  48 hours

• Episode of hypokalaemia

  48 hours

• Episode of hypoglycemia

  48 hours

• Episode of severe hypoglycemia

  48 hours

• Cardiac arrythmia diagnosed by EKG

  48 hours

Study Arms (2)

Experimental

EXPERIMENTAL

Reduced dose of rapid-acting insulin of 0.05 IU/kg/h from randomization until resolution of DKA

Drug: Insulin 0.05 IU/kg/h

Control

OTHER

Rapid-acting insulin dose of 0.10 IU/kg/h in accordance with usual recommendations until resolution of DKA

Drug: Insulin 0.10 IU/kg/h

Interventions

Insulin 0.05 IU/kg/h DRUG

In the experimental arm, the patients will be given an insulin dose of 0.05 IU/kg/h.

Experimental

Insulin 0.10 IU/kg/h DRUG

In the control arm, patients will receive an insulin dose of 0.10 IU/kg/h.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Non-diabetic ketoacidosis (fasting or alcoholic)
• Patient weighing less than 30 kg
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Louis Mourier Hospital

Colombes, 92700, France

Location

MeSH Terms

Conditions

Diabetic Ketoacidosis; Hypoglycemia; Hypokalemia

Interventions

Insulin

Condition Hierarchy (Ancestors)

Ketosis; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Water-Electrolyte Imbalance

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Damien Roux, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 5, 2022
• Study Start: August 16, 2022
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: May 29, 2025

Record last verified: 2025-05

Locations

FR (1)