Randomised controlled trialindependent cross-checkabstract only checked I-FAST-13 standard review
DiRECT after two years
Durability of a primary care-led weight-management intervention for remission of type 2 diabetes: 2-year results of the DiRECT open-label, cluster-randomised trial.
Overview
Lean MEJ et al.. Lancet Diabetes Endocrinol 2019 · PMID 30852132 · DOI 10.1016/S2213-8587(19)30068-3
36% were still in remission after two years.
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?
Durability of remission at 24 months
- How was the study done?
Cluster-randomised trial, 2-year results (DiRECT)
- How many people, animals or samples were studied?
298 ITT; As DiRECT
- What was actually found?
Remission 36% vs 3%.
- How large was the observed effect?
aOR 25.82
- What do the results mean in everyday life?
Sustained weight loss keeps diabetes away.
- What are the study's limitations?
Open-label
- What does it say about Elawady's specific claim?
Supports C-DIAB-03.
- Do the results apply to Germany and Europe?
UK.
- What can explicitly not be concluded from this study?
Long-term outcomes.
Scientific in-depth review
1. Full reference
- Authors
- Lean MEJ et al.
- Journal
- Lancet Diabetes Endocrinol
- Year
- 2019
- Identifier
- PMID 30852132 DOI 10.1016/S2213-8587(19)30068-3
- Verification
- verified – PubMed efetch 2026-10-25 (this agent)
- Retracted
- no
- Corrections
- none
- Extent checked
- abstract only
- Conflicts of interest and funding
Diabetes UK.
2. Research question
Durability of remission at 24 months
3. Study design and population
- Study design
- Randomised controlled trial – Cluster-randomised trial, 2-year results (DiRECT)
- Population
As DiRECT
- Country
UK
- Period
24 months
- Sample size
298 ITT
- Inclusion and exclusion criteria
As described in the abstract; details not available in abstract.
4. Methods and endpoints
- Exposure / intervention
DiRECT programme
- Comparator
Usual care
- Endpoints
Weight loss >=15 kg; remission
- Statistical methods
Hierarchical ITT
5. Actual results
- Results
Weight >=15 kg 11% vs 2%; remission 36% vs 3% (aOR 25.82); of those maintaining >=10 kg loss, 64% in remission; fewer SAEs in year 2 (9 vs 22).
- Absolute risks
not reported
- Authors' conclusion
Remission sustained at 24 months in over a third; linked to sustained weight loss.
6. Strengths
- Randomised
7. Weaknesses
- 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
- some concerns
- Rationale
Open-label.
9. Assessment of the statistical interpretation
Durable effect.
10. Relevance to the specific claim
Supports C-DIAB-03.
11. Independent contrary findings
12. Transferability to Germany and Europe
UK.
13. Overall methodological judgement
Durable remission in a third.
| Multidimensional assessment | |
|---|---|
| Authenticity of the source | verified |
| Methodological quality | high |
| Risk of bias | some concerns |
| Precision of results | moderate |
| Directness | direct |
| Reproducibility | partly replicated |
| Consistency with the overall evidence | consistent |
| Regional transferability | moderate |
| Adequacy of the interpretation (by the archive) | not applicable |
14. Open questions
None beyond those stated.