Randomised controlled trialindependent cross-checkabstract checked★ key study I-DIAB-109 in-depth review
Checking blood ketones on sick days in young people with type 1 diabetes
Sick day management using blood 3-hydroxybutyrate (3-OHB) compared with urine ketone monitoring reduces hospital visits in young people with T1DM: a randomized clinical trial.
Overview
Laffel LM et al.. Diabet Med 2006 · PMID 16492211 · DOI 10.1111/j.1464-5491.2005.01771.x
Young people who checked blood ketones when sick needed hospital or emergency care about half as often as those using urine strips.
Does the study support the specific claim? No · Methodological quality: moderate
Plain-language summary
Study explained simply
- What did the researchers want to find out?
Compare blood vs urine ketone testing.
- How was the study done?
Randomised trial.
- How many people, animals or samples were studied?
123 young people.
- What was actually found?
38 vs 75 hospital/emergency visits per 100 patient-years.
- How large was the observed effect?
Rate ratio about 0.51.
- What do the results mean in everyday life?
Measuring ketones helps avoid emergencies.
- What are the study's limitations?
Small; borderline P.
- What does it say about Elawady's specific claim?
Contradicts 'no need to measure acetone'.
- Do the results apply to Germany and Europe?
Applicable.
- What can explicitly not be concluded from this study?
Cannot give exact size of benefit.
Scientific in-depth review
1. Full reference
- Authors
- Laffel LM et al.
- Journal
- Diabet Med
- Year
- 2006
- Identifier
- PMID 16492211 DOI 10.1111/j.1464-5491.2005.01771.x
- Verification
- verified – PubMed efetch 2026-10-26; Crossref 2026-10-26
- Retracted
- no
- Corrections
- none
- Extent checked
- abstract only
- Conflicts of interest and funding
Non-US government support (record).
2. Research question
Does blood ketone monitoring on sick days reduce hospitalisation/emergency assessment versus urine ketones?
3. Study design and population
- Study design
- Randomised controlled trial – Two-centre randomised clinical trial (6 months)
- Population
Children, adolescents and young adults 3-22 with T1D
- Country
USA (two centres)
- Period
6 months
- Sample size
123 (62 vs 61)
- Inclusion and exclusion criteria
T1D aged 3-22
4. Methods and endpoints
- Exposure / intervention
Blood 3-OHB meter
- Comparator
Urine ketone strips
- Endpoints
Hospitalisation/emergency assessment; ketone checking
- Statistical methods
Rate comparison
5. Actual results
- Results
Ketones checked on 90.8% vs 61.3% of sick days; hospitalisation/emergency assessment 38 vs 75 per 100 patient-years (P=0.05).
- Absolute risks
37 fewer hospital/emergency visits per 100 patient-years
- Authors' conclusion
Blood ketone monitoring can potentially reduce hospitalisation/emergency assessment.
6. Strengths
- Randomised
7. Weaknesses
- Small
- Borderline significance
- Not blinded
8. Risk of bias
- Orienting tool
- RoB 2
- Type of assessment
- simplified assessment (abstract only)
- Full formal assessment
- no
- Overall risk of bias
- some concerns
- Rationale
Open-label.
9. Assessment of the statistical interpretation
Rate ratio about 0.51; CI not recomputable (stats/C-DIAB-02_laffel.py).
10. Relevance to the specific claim
Measuring ketones during illness helps prevent emergencies; the opposite of 'no need to measure'.
11. Independent contrary findings
12. Transferability to Germany and Europe
Directly applicable; same biology and clinical standards in Europe.
13. Overall methodological judgement
Moderate-quality support for ketone monitoring.
| Multidimensional assessment | |
|---|---|
| Authenticity of the source | verified |
| Methodological quality | moderate |
| Risk of bias | some concerns |
| Precision of results | low |
| Directness | direct |
| Reproducibility | not replicated |
| Consistency with the overall evidence | consistent |
| Regional transferability | high |
| Adequacy of the interpretation (by the archive) | not applicable |
14. Open questions
15. Linked fact checks
- Laboratory values such as blood glucose and acetone are only signs of the body's changing strategy and not causes; there is no need to measure glucose or blood pressure. – Studies contradicting or limiting the claim