NCT02244073

Brief Summary

During the last 2 decades, the management of hyperglycemia in critically ill patients has become one of the most discussed topics in the intensive-care field. The initial data suggesting significant benefit from the normalization of blood glucose levels in critically ill patients using intensive intravenous insulin therapy (Van den Berghe G et al. N Engl J Med. 2001) has been tempered by later studies (Finfer S et al. N Engl J Med. 2009). Some studies suggested that strict blood glucose control might benefit in non-diabetic patient and worsen outcomes in diabetics. We hypothesized that an individualized blood glucose target based on glycated hemoglobin measured at ICU admission would improve outcome when compared to a standard care of maintaining blood glucose bellow 10 mmol/l (180 mg/dl). We designed a randomized double blinded study in which Blood glucose control is piloted in both groups by a web-guided protocol that directly gives instruction to nurses (https://extranet.chu-lyon.fr/cpg). The study will enroll 4200 patients in 10 centers. Primary end point is 90 d outcome after randomization.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
2,069

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2015

Geographic Reach
1 country

12 active sites

Status
terminated

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

First Submitted

Initial submission to the registry

September 11, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 18, 2014

Completed
8 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

August 11, 2025

Status Verified

August 1, 2025

Enrollment Period

1.7 years

First QC Date

September 11, 2014

Last Update Submit

August 8, 2025

Conditions

Critical Illness

Keywords

blood glucose targetICUinsulinhypoglycemiahyperglycemiaglycated hemoglobin

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality

    90 days after randomization

Secondary Outcomes (4)

  • All-cause mortality

    28 days after randomization and at ICU discharge

  • Length of intensive care unit stay

    90 days

  • Need for respiratory support, vasopressor support, dialysis and non-prophylactic antibiotics

    during ICU stay (on average 10 days)

  • incidence and severity of severe hypoglycemia (less than 2.2 mmol/l)

    during ICU stay (on average 10 days)

Study Arms (2)

Individualized blood glucose target

EXPERIMENTAL

Maintain blood glucose in individualized target based on glycated hemoglobin level (A1c); Blood glucose level is maintained bellow 1.59 × A1c - 1.59 (mmol/l).

Drug: Human insulin - Insulin administration to control blood glucose level.

Conventional blood glucose target

ACTIVE COMPARATOR

Maintain blood glucose bellow 10 mmol/l.

Drug: Human insulin - Insulin administration to control blood glucose level.

Interventions

Human insulin - Insulin administration to control blood glucose level.DRUG

On ICU admission, the glycated hemoglobin level (A1c) is measured and insulin IV is possibly administered using a web based nurse driven insulin infusion protocol (https://extranet.chu-lyon.fr/cpg) to maintain blood glucose level below 10 mmol/l. Glycated hemoglobin result triggers patient randomization. Thereafter, during ICU stay, blood glucose level is maintained either below 1.59 × A1c - 1.59 (mmol/l) (Individualized blood glucose target group), or bellow 10 mmol/l (Conventional blood glucose target group).

Conventional blood glucose targetIndividualized blood glucose target

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient is 18 year old or older;
  • At time of the patient's admission to the ICU the treating ICU specialist expects the patient will require treatment in the ICU that extends beyond the calendar day following the day of admission.

You may not qualify if:

  • Patients will be EXCLUDED from the study if ONE or MORE of the following criteria are present:
  • Patient or legal surrogate decision maker does not accept the participation to the study;
  • Imminent death (anticipated in less than 48 hours);
  • The treating clinicians are not committed to full supportive care (no resuscitation, no renal replacement therapy limits in dose of vasoactive support);
  • Patient is expected to be eating before the end of the day following admission;
  • Admission in ICU for hypoglycemic encephalopathy or patient at risk for hypoglycaemia ( e.g. known insulin secreting tumour or history of unexplained or recurrent hypoglycaemia or fulminant hepatic failure);
  • If a patient has previously been enrolled in the CONTROLING Study (patients cannot be enrolled in the CONTROLING Study more than once).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Hôpital Nord Franche Comte

Belfort, France

Location

CH de Bourg-en-Bresse

Bourg-en-Bresse, 01012, France

Location

Centre Hospitalier de Bourgoin-Jallieu

Bourgoin, 38302, France

Location

CH Chartres

Chartres, France

Location

CHU de Clermont Ferrand - Gabriel Montpied

Clermont-Ferrand, 63003, France

Location

CHU de Dijon - Complexe Hospitalier du Bocage

Dijon, 21079, France

Location

CHU de Montpellier - Hôpital Lapeyronie

Montpellier, 34295, France

Location

CHU de Nice - Hôpital de l'Archet 1

Nice, 06202, France

Location

CH de Polynésie Française

Papeete, France

Location

Hospices Civils de Lyon - Centre Hospitalier Lyon Sud

Pierre-Bénite, 69310, France

Location

CHU de Saint Etienne - Hôpital Nord

Saint-Priest-en-Jarez, 42277, France

Location

Centre Hospitalier de Salon de Provence

Salon-de-Provence, 13658, France

Location

Related Publications (1)

  • Bohe J, Abidi H, Brunot V, Klich A, Klouche K, Sedillot N, Tchenio X, Quenot JP, Roudaut JB, Mottard N, Thiolliere F, Dellamonica J, Wallet F, Souweine B, Lautrette A, Preiser JC, Timsit JF, Vacheron CH, Ait Hssain A, Maucort-Boulch D; CONTROLe INdividualise de la Glycemie (CONTROLING) Study Group. Individualised versus conventional glucose control in critically-ill patients: the CONTROLING study-a randomized clinical trial. Intensive Care Med. 2021 Nov;47(11):1271-1283. doi: 10.1007/s00134-021-06526-8. Epub 2021 Sep 29.

    PMID: 34590159RESULT

Related Links

MeSH Terms

Conditions

Critical IllnessInsulin ResistanceHypoglycemiaHyperglycemia

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Julien BOHE, MD PhD

    Hospices Civils de Lyon - Centre Hospitalier Lyon Sud

    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

September 11, 2014

First Posted

September 18, 2014

Study Start

May 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

August 11, 2025

Record last verified: 2025-08

Locations

FR(12)