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Diabetes (DM)DISCOVERNCT07261865

Identifying Diabetes and Impaired Glucose Tolerance in ICU Patients

An observational study of Diabetes (DM) and Critical Illness, run by University Medical Center Groningen at 2 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes (DM), Critical Illness
How many people
4,198 participants
Where
2 sitesNetherlands
Study dates
1 May 2024to 31 Dec 2025
How long will I take part?
3 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All adult patients admitted to the ICU

Who may be able to join

  • All adult patients admitted to the ICU

Who cannot join

  • None

Trial locations and contacts

2 sites in 1 country.

Netherlands2 sites

  • University Medical Center Groningen

    Groningen, Provincie Groningen, 9713GZ

  • Frisius MC

    Leeuwarden, Provincie Friesland, 8934AD

Other trials in Netherlands

About this study

Official title: Identifying Diabetes and Impaired Glucose Tolerance in ICU Patients and Assessing Their Impact on Organ Failure and Outcome.

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.

Read the detailed description

Diabetes is one of the most common comorbidities among patients admitted to the intensive care unit. Previous studies have found that patients with diabetes are at higher risk of severe complications including infections, delayed wound healing, cardiovascular events and ultimately death while in the ICU.

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 prevalence of chronic dysglycaemia among ICU patients. Therefore, the "true" prevalence and impact of various glycaemic states in ICU patients and how they influence acute and long-term outcomes remain underexplored. Within the general Dutch population, diabetes is diagnosed in 7% of individuals, while approximately 30% of those aged over 45 have prediabetes. In the ICU, 17% of admitted patients require medication for diabetes management, highlighting a higher prevalence compared to the general population's 7%. Given that most patients (~87%) admitted to the ICU are older than 45 years, it is likely that the prevalence of prediabetes is elevated in ICU patients as well. It is essential to avoid underestimating the incidence of diabetes and impaired glucose tolerance to ensure that patients are managed properly during ICU stay and importantly after leaving the ICU. Diabetes diagnosis typically relies on (fasting) glucose levels yet diagnosing diabetes in ICU patients poses challenges due to stress and acute illness impacting blood glucose levels, leading to stress-induced hyperglycaemia. The investigators found that upon admission to the ICU, 77% of patients without diabetes exhibited high blood glucose levels, with 20% of these patients experiencing severe hyperglycaemia. The underlying cause of this hyperglycaemia is currently uncertain, but it may stem from acute critical illness, the effect of medications, previously undiagnosed diabetes or prediabetes, or a combination of these factors.

Since the investigators are currently unable to accurately determine if patients entering the ICU have diabetes or prediabetes using standard glucose measurements, measuring glycated haemoglobin (HbA1c) which reflects the average blood glucose levels over the past two or three months may be an alternative method which together with anthropometric, glycaemic parameters, and other metabolic traits will assist in assessing the risk of associated complications and the impact on organ injury. Given the rising incidence of diabetes in the general population, there is an increasing likelihood that a greater number of individuals will be admitted to the ICU with diabetes and prediabetes in the coming years. Moreover, the prevalence and impact of various glycaemic states in ICU patients and how they influence acute critical illness outcomes remain underexplored.

Keywords
Critical Illness, Diabetes, DISCOVER
Medical subject headings
Diabetes Mellitus, Critical Illness

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Day 1

  2. 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

    Measured: Up to 1 year

Secondary outcomes (1)

  1. Impact of relative dysglycemia

    What is the impact of relative dysglycemia (glycemic ratio) on acute (mortality, organ injury) and long-term outcomes (1-year mortality)

    Measured: Up to 1-year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2025
  2. Study start1 May 2024
  3. Primary completion31 Dec 2025
  4. Study completion31 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
4,198 participants (actual)
Target duration
3 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07261865
Sponsor's protocol ID
20548
Acronym
DISCOVER
Status last verified
Apr 2026
First submitted
29 Sep 2025
Last updated
4 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 26977855

  • 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.

    PubMed 29581095

  • 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.

    PubMed 31735639

  • 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.

    PubMed 18807006

  • 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.

    PubMed 26465219

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes (DM) and Critical Illness, run by University Medical Center Groningen at 2 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

What is the prevalence of the various dysglycemic states in patients admitted to the ICU? (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07261865, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.

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