Randomised controlled trialindependent cross-checkabstract checked★ key study I-INS-123 in-depth review
ACCORD nine years later
Nine-Year Effects of 3.7 Years of Intensive Glycemic Control on Cardiovascular Outcomes.
Overview
ACCORD Study Group. Diabetes Care 2016 · PMID 26822326 · DOI 10.2337/dc15-2283
Very intensive sugar lowering in high-risk type 2 diabetes still showed more cardiovascular deaths after 9 years, but overall deaths were no longer different.
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?
Follow ACCORD participants long term.
- How was the study done?
Post-trial follow-up.
- How many people, animals or samples were studied?
8,601 people.
- What was actually found?
CV death HR 1.20; all-cause death neutral.
- How large was the observed effect?
HR 1.20 (1.03-1.39).
- What do the results mean in everyday life?
Very aggressive targets are not advisable for high-risk patients.
- What are the study's limitations?
Post-trial care varied.
- What does it say about Elawady's specific claim?
Supports caution; adds that total mortality became neutral.
- Do the results apply to Germany and Europe?
Applicable.
- What can explicitly not be concluded from this study?
Cannot attribute harm to insulin alone.
Scientific in-depth review
1. Full reference
- Authors
- ACCORD Study Group
- Journal
- Diabetes Care
- Year
- 2016
- Identifier
- PMID 26822326 DOI 10.2337/dc15-2283
- Verification
- verified – PubMed efetch 2026-10-26; Crossref 2026-10-26
- Retracted
- no
- Corrections
- none
- Extent checked
- abstract only
- Conflicts of interest and funding
Not stated in abstract.
2. Research question
What are the long-term effects of 3.7 years of intensive glycaemic control?
3. Study design and population
- Study design
- Randomised controlled trial – Post-trial follow-up (ACCORDION) of the ACCORD RCT, intention-to-treat
- Population
High-risk T2D (ACCORD survivors without primary outcome)
- Country
USA and Canada
- Period
Median 8.8 years from randomisation
- Sample size
8,601
- Inclusion and exclusion criteria
98% of eligible ACCORD participants
4. Methods and endpoints
- Exposure / intervention
Former intensive glycaemic control
- Comparator
Former standard control
- Endpoints
MI, stroke, CV death, all-cause death
- Statistical methods
ITT Cox models
5. Actual results
- Results
Neutral long-term effect on the primary composite and on death from any cause; CV mortality excess decreased from HR 1.49 (1.19-1.87) during the active phase to HR 1.20 (1.03-1.39) overall.
- Absolute risks
not reported
- Authors' conclusion
In high-risk T2D, 3.7 years of intensive control had a neutral effect on death and nonfatal CV events but increased CV death.
6. Strengths
- Randomised origin
- 98% follow-up
7. Weaknesses
- Post-trial treatment uncontrolled
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
ITT follow-up.
9. Assessment of the statistical interpretation
CI symmetric (stats/C-INS-04_accord.py).
10. Relevance to the specific claim
Confirms that aggressive near-normal targets in high-risk T2D carried a lasting excess of CV death, while all-cause mortality became neutral over 9 years.
11. Independent contrary findings
12. Transferability to Germany and Europe
Directly applicable; same biology and clinical standards in Europe.
13. Overall methodological judgement
Refines the archive's ACCORD statement.
| Multidimensional assessment | |
|---|---|
| Authenticity of the source | verified |
| Methodological quality | high |
| Risk of bias | low |
| Precision of results | moderate |
| Directness | direct |
| Reproducibility | partly replicated |
| Consistency with the overall evidence | consistent |
| Regional transferability | high |
| Adequacy of the interpretation (by the archive) | not applicable |