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Trial · NCT05443802

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

NCT05443802, Not applicable, Completed, Assistance Publique - Hôpitaux de Paris

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Comparison of a Low Dose to a Standard Dose of Insulin in Adult DKA in ICU to Reduce Metabolic Complications. Trials, record NCT05443802. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05443802

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Comparison of a Low Dose to a Standard Dose of Insulin in Adult DKA in ICU to Reduce Metabolic Complications
NCT number
NCT05443802
Status
Completed
Phases
Not applicable
Enrollment
150 participants, actual
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Conditions
Diabetic Ketoacidosis
Interventions
Insulin 0.05 IU/kg/h, Insulin 0.10 IU/kg/h
First posted
2022-07-05
Last updated
2025-05-29

Source ClinicalTrials.gov

Registered outcomes23

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryMetabolic complications48 hours
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.
SecondaryResolution of diabetic ketoacidosis48 hoursTime in hours between randomisation and resolution of diabetic ketoacidosis (defined by ph\>7.3 and ketonemia \< 3 mmol/L and bicarbonates\> 15 mmol/L)
SecondaryEpisode of hypokalaemia48 hoursProportion of patients with at least one episode of hypokalaemia \< 3.5 mmol/L between randomization and resolution of DKA
SecondaryEpisode of hypoglycemia48 hoursProportion of patients with at least one episode of hypoglycemia \< 3.9 mmol/L between randomization and resolution of DKA
SecondaryEpisode of severe hypoglycemia48 hoursProportion of patients with at least one episode of hypoglycemia \< 2.9 mmol/L between randomization and resolution of DKA
SecondaryCardiac arrythmia diagnosed by EKG48 hoursProportion of patients with onset of new cardiac arrhythmia diagnosed by EKG analysis (atrial fibrillation and ventricular arrhythmia) and scopic monitoring between randomization and resolution of DKA
SecondaryGlucose infusion 1000mL48 hours
Proportion of patients who received more than 1000 mL of 10% glucose solution (indicating tendency of hypoglycemia) between randomization and resolution of DKA or 48h after inclusion if DKA is unresolved
SecondaryGlucose infusion of 30% glucose solution48 hoursProportion of patients who received one perfusion of 30% glucose solution between randomization and resolution of DKA or 48h after inclusion if DKA is unresolved
SecondaryAmount of glucose perfused48 hoursAmount of glucose perfused (in grams) (glucose 5%, 10% and 30%) between randomization and resolution of the DKA or 48 hours after inclusion if the DKA is not resolved
SecondaryPotassium intake48 hoursPotassium intake (in grams) orally and intravenously between patient randomization and resolution of DKA or 48 hours after inclusion if DKA is not resolved

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT05443802

GET https://conductscience.org/api/trials/v1/NCT05443802/registered?page=2