Trial reportIntensive care medicine2009
A prospective randomised multi-centre controlled trial on tight glucose control by intensive insulin therapy in adult intensive care units: the Glucontrol study.
Trial report in Intensive care medicine, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 309 papers, 10 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multi-Center Study Comparing the Effects of Two Glucose Control Regimens by Insulin in Intensive Care Unit Patients
Control of Hyperglycemia After Cardiac Surgery: CHyCS Trial
Time in Glucose Hospital Target (TIGHT) - A Randomized Clinical Trial to Evaluate the Use of CGM to Achieve a Mean Glucose Target of 90 to 130 mg/dL Without Hypoglycemia in Hospitalized Adults With Type 2 Diabetes
Who cites it
309 citing papers in PubMed, 10 syntheses or guidelines pooled it.
- American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update.Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists · 2022Guideline
- [S3 Guideline Sepsis-prevention, diagnosis, therapy, and aftercare : Long version].Medizinische Klinik, Intensivmedizin und Notfallmedizin · 2020Guideline
- Is intensive glucose control bad for critically ill patients? A systematic review and meta-analysis.International journal of biological sciences · 2020Pooled it
- Tight glycemic control in critically ill pediatric patients: a meta-analysis and systematic review of randomized controlled trials.Pediatric research · 2018Pooled it
- Pooled it
- Tight glycemic control in critically ill pediatric patients: a meta-analysis and systematic review of randomized controlled trials.Pediatric research · 2018Pooled it
- Glycaemic control targets after traumatic brain injury: a systematic review and meta-analysis.Critical care (London, England) · 2018Pooled it
- Prevention of acute kidney injury and protection of renal function in the intensive care unit: update 2017 : Expert opinion of the Working Group on Prevention, AKI section, European Society of Intensive Care Medicine.Intensive care medicine · 2017Pooled it
- Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016.Intensive care medicine · 2017Guideline
- Glycemic control, mortality, and hypoglycemia in critically ill patients: a systematic review and network meta-analysis of randomized controlled trials.Intensive care medicine · 2017Pooled it
- Automated versus conventional perioperative glycemic control in adult diabetic patients undergoing open heart surgery.BMC anesthesiology · 2022Trial
- Individualised versus conventional glucose control in critically-ill patients: the CONTROLING study-a randomized clinical trial.Intensive care medicine · 2021Trial
- Feasibility of automated insulin delivery guided by continuous glucose monitoring in preterm infants.Archives of disease in childhood. Fetal and neonatal edition · 2020Trial
- Long-Term Neurobehavioral and Quality of Life Outcomes of Critically Ill Children after Glycemic Control.The Journal of pediatrics · 2020Trial
- Intraoperative glycemic control in patients undergoing Orthotopic liver transplant: a single center prospective randomized study.BMC anesthesiology · 2020Trial
- A Randomized Controlled Trial on the Safety and Efficacy of Exenatide Therapy for the Inpatient Management of General Medicine and Surgery Patients With Type 2 Diabetes.Diabetes care · 2019Trial
- Accuracy and reliability of a subcutaneous continuous glucose monitoring device in critically ill patients.Journal of clinical monitoring and computing · 2018Trial
- Hyperinsulinemic Normoglycemia during Cardiac Surgery Reduces a Composite of 30-day Mortality and Serious In-hospital Complications: A Randomized Clinical Trial.Anesthesiology · 2018Trial
- Cerebral metabolic effects of strict versus conventional glycaemic targets following severe traumatic brain injury.Critical care (London, England) · 2018Trial
- Software-guided versus nurse-directed blood glucose control in critically ill patients: the LOGIC-2 multicenter randomized controlled clinical trial.Critical care (London, England) · 2017Trial
249 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
14 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeAn optimal target for glucose control in ICU patients remains unclear. This prospective randomized controlled trial compared the effects on ICU mortality of intensive insulin therapy (IIT) with an intermediate glucose control.
methodsAdult patients admitted to the 21 participating medico-surgical ICUs were randomized to group 1 (target BG 7.8-10.0 mmol/L) or to group 2 (target BG 4.4-6.1 mmol/L).
resultsWhile the required sample size was 1,750 per group, the trial was stopped early due to a high rate of unintended protocol violations. From 1,101 admissions, the outcomes of 542 patients assigned to group 1 and 536 of group 2 were analysed. The groups were well balanced. BG levels averaged in group 1 8.0 mmol/L (IQR 7.1-9.0) (median of all values) and 7.7 mmol/L (IQR 6.7-8.8) (median of morning BG) versus 6.5 mmol/L (IQR 6.0-7.2) and 6.1 mmol/L (IQR 5.5-6.8) for group 2 (p < 0.0001 for both comparisons). The percentage of patients treated with insulin averaged 66.2 and 96.3%, respectively. Proportion of time spent in target BG was similar, averaging 39.5% and 45.1% (median (IQR) 34.3 (18.5-50.0) and 39.3 (26.2-53.6)%) in the groups 1 and 2, respectively. The rate of hypoglycaemia was higher in the group 2 (8.7%) than in group 1 (2.7%, p < 0.0001). ICU mortality was similar in the two groups (15.3 vs. 17.2%).
conclusionsIn this prematurely stopped and therefore underpowered study, there was a lack of clinical benefit of intensive insulin therapy (target 4.4-6.1 mmol/L), associated with an increased incidence of hypoglycaemia, as compared to a 7.8-10.0 mmol/L target. (ClinicalTrials.gov # NCT00107601, EUDRA-CT Number: 200400391440).
Indexed as
Identifiers
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.