NCT07261865

Brief Summary

In the Netherlands, patients admitted to the ICU are classified as having diabetes based on whether their medical records indicate glucose management medication use (Dutch National Intensive Care Evaluation (NICE) Registry). However, this approach does not identify patients with 1) undiagnosed diabetes, 2) uncontrolled diabetes, 3) patients managing their condition through lifestyle modifications, or 4) individuals with prediabetes, which is considered an early stage of diabetes. Consequently, this may lead to an underestimation of the "true" prevalence of chronic dysglycaemia among ICU patients and as a result the impact of various glycaemic states on acute outcomes remain underexplored.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,198

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2024

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2024

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 3, 2025

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

1.7 years

First QC Date

September 29, 2025

Last Update Submit

April 28, 2026

Conditions

Keywords

Critical IllnessDiabetesDISCOVER

Outcome Measures

Primary Outcomes (2)

  • What is the prevalence of the various dysglycemic states in patients admitted to the ICU?

    HbA1c 6%=normal, 6-6.4%=prediabetes, \>6.5%=diabetes

    Day 1

  • What is the impact of chronic hyperglycemic states on acute (ICU mortality and organ injury) and long-term outcomes?

    ICU mortality, organ injury during ICU stay (Acute Kidney Injury defined by the KDIGO criteria), and 1-year mortality

    Up to 1 year

Secondary Outcomes (1)

  • Impact of relative dysglycemia

    Up to 1-year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adult patients admitted to the ICU

You may qualify if:

  • All adult patients admitted to the ICU

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Frisius MC

Leeuwarden, Provincie Friesland, 8934AD, Netherlands

Location

University Medical Center Groningen

Groningen, Provincie Groningen, 9713GZ, Netherlands

Location

Related Publications (5)

  • Luethi N, Cioccari L, Tanaka A, Kar P, Giersch E, Deane AM, Martensson J, Bellomo R. Glycated Hemoglobin A1c Levels Are Not Affected by Critical Illness. Crit Care Med. 2016 Sep;44(9):1692-4. doi: 10.1097/CCM.0000000000001656.

    PMID: 26977855BACKGROUND
  • Yong PH, Weinberg L, Torkamani N, Churilov L, Robbins RJ, Ma R, Bellomo R, Lam QT, Burns JD, Hart GK, Lew JF, Martensson J, Story D, Motley AN, Johnson D, Zajac JD, Ekinci EI. The Presence of Diabetes and Higher HbA1c Are Independently Associated With Adverse Outcomes After Surgery. Diabetes Care. 2018 Jun;41(6):1172-1179. doi: 10.2337/dc17-2304. Epub 2018 Mar 26.

    PMID: 29581095BACKGROUND
  • Torkamani N, Churilov L, Robbins R, Jerums G, Beik V, Radcliffe N, Patterson S, Bellomo R, Burns J, Hart GK, Lam Q, Power DA, MacIsaac RJ, Johnson DF, Zajac J, Ekinci EI. Diabetes and higher HbA1c levels are independently associated with adverse renal outcomes in inpatients following multiple hospital admissions. J Diabetes Complications. 2020 Jan;34(1):107465. doi: 10.1016/j.jdiacomp.2019.107465. Epub 2019 Oct 22.

    PMID: 31735639BACKGROUND
  • Michalia M, Kompoti M, Koutsikou A, Paridou A, Giannopoulou P, Trikka-Graphakos E, Clouva-Molyvdas P. Diabetes mellitus is an independent risk factor for ICU-acquired bloodstream infections. Intensive Care Med. 2009 Mar;35(3):448-54. doi: 10.1007/s00134-008-1288-0. Epub 2008 Sep 20.

    PMID: 18807006BACKGROUND
  • Carpenter DL, Gregg SR, Xu K, Buchman TG, Coopersmith CM. Prevalence and Impact of Unknown Diabetes in the ICU. Crit Care Med. 2015 Dec;43(12):e541-50. doi: 10.1097/CCM.0000000000001353.

    PMID: 26465219BACKGROUND

MeSH Terms

Conditions

Diabetes MellitusCritical Illness

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jill Moser, PhD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 29, 2025

First Posted

December 3, 2025

Study Start

May 1, 2024

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

May 4, 2026

Record last verified: 2026-04

Locations