Individualized Blood Glucose Control in ICU. The CONTROLING Study. A Double Blinded Multicentric Randomized Study.

NCT ID: NCT02244073

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2069 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2017-01-31

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.

Conditions

Critical Illness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Individualized blood glucose target

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).

Group Type: EXPERIMENTAL

Human insulin - Insulin administration to control blood glucose level.

Intervention Type: 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 target

Maintain blood glucose bellow 10 mmol/l.

Group Type: ACTIVE_COMPARATOR

Human insulin - Insulin administration to control blood glucose level.

Intervention Type: 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).

Interventions

Human insulin - Insulin administration to control blood glucose level.

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).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Patients are eligible for INCLUSION in the study if ALL the following criteria are met:

• 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.

Exclusion Criteria

• 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julien BOHE, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon - Centre Hospitalier Lyon Sud

Locations

Hôpital Nord Franche Comte

Belfort, , France

CH de Bourg-en-Bresse

Bourg-en-Bresse, , France

Centre Hospitalier de Bourgoin-Jallieu

Bourgoin, , France

CH Chartres

Chartres, , France

CHU de Clermont Ferrand - Gabriel Montpied

Clermont-Ferrand, , France

CHU de Dijon - Complexe Hospitalier du Bocage

Dijon, , France

CHU de Montpellier - Hôpital Lapeyronie

Montpellier, , France

CHU de Nice - Hôpital de l'Archet 1

Nice, , France

CH de Polynésie Française

Papeete, , France

Hospices Civils de Lyon - Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

CHU de Saint Etienne - Hôpital Nord

Saint-Priest-en-Jarez, , France

Centre Hospitalier de Salon de Provence

Salon-de-Provence, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 34590159 (View on PubMed)

Related Links

https://extranet.chu-lyon.fr/

Related Info

Other Identifiers

2013-A00806-39

Identifier Type: OTHER

Identifier Source: secondary_id

2013.808

Identifier Type: -

Identifier Source: org_study_id