Critical IllnessCONTROLINGNCT02244073
Individualized Blood Glucose Control in ICU. The CONTROLING Study. A Double Blinded Multicentric Randomized Study.
A study of Critical Illness, run by Hospices Civils de Lyon at 12 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,069 participants
- Where
- 12 sitesFrance
- Study dates
- May 2015to Jan 2017
- Phase
- Interventional
- 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
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
Hôpital Nord Franche Comte
Belfort
CH de Bourg-en-Bresse
Bourg-en-Bresse, 01012
Centre Hospitalier de Bourgoin-Jallieu
Bourgoin, 38302
CH Chartres
Chartres
CHU de Clermont Ferrand - Gabriel Montpied
Clermont-Ferrand, 63003
CHU de Dijon - Complexe Hospitalier du Bocage
Dijon, 21079
CHU de Montpellier - Hôpital Lapeyronie
Montpellier, 34295
CHU de Nice - Hôpital de l'Archet 1
Nice, 06202
CH de Polynésie Française
Papeete
Hospices Civils de Lyon - Centre Hospitalier Lyon Sud
Pierre-Bénite, 69310
CHU de Saint Etienne - Hôpital Nord
Saint-Priest-en-Jarez, 42277
Centre Hospitalier de Salon de Provence
Salon-de-Provence, 13658
About this study
Official title: Individualized Blood Glucose Control in ICU.
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
- Being tested
- Human insulin - Insulin administration to control blood glucose level.
- Keywords
- blood glucose target, ICU, insulin, hypoglycemia, hyperglycemia, glycated hemoglobin
- Medical subject headings
- Critical Illness, Insulin Resistance, Hypoglycemia, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Human insulin - Insulin administration to control blood glucose level. |
| Conventional blood glucose target | Active comparator | Maintain blood glucose bellow 10 mmol/l. Receives: Drug: Human insulin - Insulin administration to control blood glucose level. |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Measured: 90 days after randomization
Secondary outcomes (4)
All-cause mortality
Measured: 28 days after randomization and at ICU discharge
Length of intensive care unit stay
Measured: 90 days
Need for respiratory support, vasopressor support, dialysis and non-prophylactic antibiotics
Measured: during ICU stay (on average 10 days)
incidence and severity of severe hypoglycemia (less than 2.2 mmol/l)
Measured: during ICU stay (on average 10 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2014 (estimated)
- Study startMay 2015
- Primary completionJan 2017
- Study completionJan 2017
Why it stopped: Data safety monitoring board decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2,069 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien BOHE, MD PhD, Principal investigator, Hospices Civils de Lyon - Centre Hospitalier Lyon Sud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02244073
- Sponsor's protocol ID
- 2013.808
- Other IDs
- 2013-A00806-39
- Acronym
- CONTROLING
- Status last verified
- Aug 2025
- First submitted
- 11 Sep 2014
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34590159
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Blood Glucose Control in ICU.
- ClinicalTrials.gov ID
- NCT02244073
- Acronym / sponsor ID
- CONTROLING / 2013.808
- Conditions
- Critical Illness
- Keywords
- blood glucose target, ICU, insulin, hypoglycemia, hyperglycemia, glycated hemoglobin
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Data safety monitoring board decision
- Enrolment
- 2,069 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 18 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individualized blood glucose target | Experimental | Drug: Human insulin - Insulin administration to control blood glucose level.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). |
| Conventional blood glucose target | Active comparator | Drug: Human insulin - Insulin administration to control blood glucose level.Maintain blood glucose bellow 10 mmol/l. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- Patients will be EXCLUDED from the study if ONE or MORE of the following criteria are present:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Drug | Conventional blood glucose target, Individualized blood glucose target |
Primary outcome
All-cause mortality
Time frame: 90 days after randomization
4 secondary outcomes
All-cause mortality
Time frame: 28 days after randomization and at ICU discharge
Length of intensive care unit stay
Time frame: 90 days
Need for respiratory support, vasopressor support, dialysis and non-prophylactic antibiotics
Time frame: during ICU stay (on average 10 days)
incidence and severity of severe hypoglycemia (less than 2.2 mmol/l)
Time frame: during ICU stay (on average 10 days)
Results and safety
The study was stopped early (reason given: Data safety monitoring board decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Results publication: PubMed 34590159Bohe 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julien BOHE, MD PhD principal investigator
Hospices Civils de Lyon - Centre Hospitalier Lyon Sud
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Critical Illness, run by Hospices Civils de Lyon at 12 sites in France.
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 3 inclusion and 7 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: stopped early, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. 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 was stopped early (reason given: Data safety monitoring board decision). Results are not available in the source record.
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?
All-cause mortality (time frame: 90 days after randomization). 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 NCT02244073, which also lists 1 linked publication.
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 11 Aug 2025.