Randomised controlled trialcited by the Tayebat archiveabstract only checked A-INS-02 standard review
Very tight blood sugar control in intensive care
Intensive versus conventional glucose control in critically ill patients.
Overview
NICE-SUGAR Study Investigators; Finfer S et al.. N Engl J Med 2009 · PMID 19318384 · DOI 10.1056/NEJMoa0810625
Aiming for normal blood sugar in ICU patients raised deaths from 24.9% to 27.5%.
Does the study support the specific claim? Partly · Methodological quality: high
Plain-language summary
Study explained simply
- What did the researchers want to find out?
Optimal blood glucose target in critically ill ICU patients
- How was the study done?
International multicentre RCT
- How many people, animals or samples were studied?
6,104; Adult ICU patients expected to stay >=3 days
- What was actually found?
Higher 90-day mortality and 13-fold more severe hypoglycaemia with intensive control.
- How large was the observed effect?
OR 1.14 (1.02-1.28)
- What do the results mean in everyday life?
In very sick hospital patients, moderate sugar targets are safer.
- What are the study's limitations?
ICU population, not ambulatory diabetes; Open-label
- What does it say about Elawady's specific claim?
Supports that overly tight targets harm (C-INS-04); both arms received insulin, so it does not support insulin avoidance.
- Do the results apply to Germany and Europe?
Multinational/US/UK/European data; directly transferable to Germany/EU clinical practice.
- What can explicitly not be concluded from this study?
Anything about insulin therapy in people with diabetes at home.
Scientific in-depth review
1. Full reference
- Authors
- NICE-SUGAR Study Investigators, Finfer S, Chittock DR, Su SY, Blair D, Foster D, Dhingra V, Bellomo R, Cook D, Dodek P, Henderson WR, Hébert PC, Heritier S, Heyland DK, McArthur C, McDonald E, Mitchell I, Myburgh JA, Norton R, Potter J, Robinson BG, Ronco JJ
- Journal
- N Engl J Med
- Year
- 2009
- Identifier
- PMID 19318384 DOI 10.1056/NEJMoa0810625
- Verification
- verified – PubMed E-utilities efetch, 2026-10-25
- Retracted
- no
- Corrections
- none
- Extent checked
- abstract only
- Conflicts of interest and funding
not stated in abstract
2. Research question
Optimal blood glucose target in critically ill ICU patients
3. Study design and population
- Study design
- Randomised controlled trial – International multicentre RCT
- Population
Adult ICU patients expected to stay >=3 days
- Country
Australia, New Zealand, Canada, USA
- Period
not stated in abstract
- Sample size
6,104
- Inclusion and exclusion criteria
As described in the abstract; details not available in abstract.
4. Methods and endpoints
- Exposure / intervention
Intensive glucose control 81-108 mg/dL (insulin infusion)
- Comparator
Conventional control <=180 mg/dL
- Endpoints
90-day all-cause mortality
- Statistical methods
Odds ratio, intention to treat
5. Actual results
- Results
Death 829 (27.5%) vs 751 (24.9%); OR 1.14 (95% CI 1.02-1.28; P=0.02). Severe hypoglycaemia (<=40 mg/dL) 6.8% vs 0.5%.
- Absolute risks
2.6 percentage points higher 90-day mortality with intensive control (27.5% vs 24.9%; difference calculated).
- Authors' conclusion
Intensive glucose control increased mortality in ICU adults; target <=180 mg/dL resulted in lower mortality than 81-108 mg/dL.
6. Strengths
- Large RCT
- Hard endpoint
7. Weaknesses
- ICU population, not ambulatory diabetes
- Open-label
8. Risk of bias
- Orienting tool
- RoB 2
- Type of assessment
- simplified assessment (abstract only)
- Full formal assessment
- no
- Overall risk of bias
- low
- Rationale
Objective endpoint; large sample.
9. Assessment of the statistical interpretation
Modest but significant mortality increase.
10. Relevance to the specific claim
Supports that overly tight targets harm (C-INS-04); both arms received insulin, so it does not support insulin avoidance.
11. Independent contrary findings
Same trial shows conventional insulin-based control to <=180 mg/dL is the safer standard.
12. Transferability to Germany and Europe
Multinational/US/UK/European data; directly transferable to Germany/EU clinical practice.
13. Overall methodological judgement
High-quality RCT; indirect for outpatient diabetes.
| Multidimensional assessment | |
|---|---|
| Authenticity of the source | verified |
| Methodological quality | high |
| Risk of bias | low |
| Precision of results | high |
| Directness | indirect |
| Reproducibility | replicated |
| Consistency with the overall evidence | consistent |
| Regional transferability | high |
| Adequacy of the interpretation (by the archive) | partly correct but over-interpreted |
14. Open questions
None beyond those stated.
15. Linked fact checks
Use by the Tayebat archive
Note: according to the archive, the studies were compiled by the archive operators. Whether Dr. Elawady himself cited this study is not established.
- What the archive says about the study
Listed in the archive bibliography for 'insulin-injections' without its own interpretation; used as general support for the claim that insulin intensification harms.
- A. What was actually studied?
Optimal blood glucose target in critically ill ICU patients
- B. What did the authors find?
Higher 90-day mortality and 13-fold more severe hypoglycaemia with intensive control.
- C. What conclusions do the authors themselves draw?
Intensive glucose control increased mortality in ICU adults; target <=180 mg/dL resulted in lower mortality than 81-108 mg/dL.
- D. What does the archive derive from it?
Used implicitly to show tight glucose targets kill.
- E. Is this derivation scientifically justified?
Only partly: it concerns critically ill patients receiving IV insulin, not insulin therapy in diabetes; both arms used insulin.
- Adequacy of the interpretation (by the archive)
- partly correct but over-interpreted