Cohort studyindependent cross-checkabstract only checked★ key study I-INS-04 in-depth review

How much long-term blood sugar matters (UKPDS 35)

Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study.

Overview

Stratton IM et al.. BMJ 2000 · PMID 10938048 · DOI 10.1136/bmj.321.7258.405

Each 1% lower HbA1c was linked to 21% fewer diabetes deaths and 37% fewer eye/kidney complications.

Does the study support the specific claim? No · Methodological quality: moderate

Original publication

Plain-language summary

Study explained simply
What did the researchers want to find out?

Relation of glycaemia over time to complications

How was the study done?

Prospective observational analysis within UKPDS (UKPDS 35)

How many people, animals or samples were studied?

4,585 (3,642 for RR); UKPDS patients (white, Asian Indian, Afro-Caribbean)

What was actually found?

Graded risk with HbA1c, no threshold.

How large was the observed effect?

-21% per 1% HbA1c

What do the results mean in everyday life?

High sugar damages the body.

What are the study's limitations?

Observational

What does it say about Elawady's specific claim?

Contradicts C-DIAB-01, C-DIAB-02, C-ODD-06 (hyperglycaemia causes complications incl. amputation).

Do the results apply to Germany and Europe?

UK.

What can explicitly not be concluded from this study?

That pushing HbA1c to normal is always safe.

Scientific in-depth review

1. Full reference

Authors
Stratton IM et al.
Journal
BMJ
Year
2000
Identifier
PMID 10938048 DOI 10.1136/bmj.321.7258.405
Verification
verified – PubMed efetch 2026-10-25 (this agent)
Retracted
no
Corrections
none
Extent checked
abstract only
Conflicts of interest and funding

not stated in abstract

2. Research question

Relation of glycaemia over time to complications

3. Study design and population

Study design
Cohort study – Prospective observational analysis within UKPDS (UKPDS 35)
Population

UKPDS patients (white, Asian Indian, Afro-Caribbean)

Country

UK

Period

UKPDS duration

Sample size

4,585 (3,642 for RR)

Inclusion and exclusion criteria

As described in the abstract; details not available in abstract.

4. Methods and endpoints

Exposure / intervention

Updated mean HbA1c

Comparator

Per 1% lower HbA1c

Endpoints

Diabetes-related endpoints, death, MI, stroke, amputation, microvascular

Statistical methods

Poisson/Cox adjusted

5. Actual results

Results

Per 1% HbA1c reduction: any diabetes endpoint -21% (17-24%), diabetes-related death -21% (15-27%), MI -14% (8-21%), microvascular -37% (33-41%); no threshold.

Absolute risks

not reported

Authors' conclusion

Risk of complications strongly associated with previous hyperglycaemia; any HbA1c reduction likely reduces risk, lowest risk in normal range.

6. Strengths

  • Large prospective dataset
  • Repeated HbA1c

7. Weaknesses

  • Observational

8. Risk of bias

Orienting tool
ROBINS-E
Type of assessment
simplified assessment (abstract only)
Full formal assessment
no
Overall risk of bias
some concerns
Rationale

Observational association.

9. Assessment of the statistical interpretation

Strong graded association.

10. Relevance to the specific claim

Contradicts C-DIAB-01, C-DIAB-02, C-ODD-06 (hyperglycaemia causes complications incl. amputation).

11. Independent contrary findings

ACCORD for extreme targets.

12. Transferability to Germany and Europe

UK.

13. Overall methodological judgement

Strong epidemiological evidence that high glucose is harmful.

Multidimensional assessment
Multidimensional assessment
Authenticity of the sourceverified
Methodological qualitymoderate
Risk of biassome concerns
Precision of resultshigh
Directnessdirect
Reproducibilityreplicated
Consistency with the overall evidenceconsistent
Regional transferabilityhigh
Adequacy of the interpretation (by the archive)not applicable

14. Open questions

None beyond those stated.

15. Linked fact checks