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Supervised ketogenic diet programme in type 2 diabetes over 2 years
Long-Term Effects of a Novel Continuous Remote Care Intervention Including Nutritional Ketosis for the Management of Type 2 Diabetes: A 2-Year Non-randomized Clinical Trial.
Overview
Athinarayanan SJ et al.. Front Endocrinol (Lausanne) 2019 · PMID 31231311 · DOI 10.3389/fendo.2019.00348
Many participants reduced or stopped diabetes medicines, including insulin, while doctors adjusted doses remotely; the study was not randomised.
Does the study support the specific claim? Partly · Methodological quality: low
Plain-language summary
Study explained simply
- What did the researchers want to find out?
Evaluate a remote ketogenic-care programme.
- How was the study done?
Non-randomised trial.
- How many people, animals or samples were studied?
349 adults with T2D.
- What was actually found?
Insulin use -62%; remission 17.6%.
- How large was the observed effect?
Within-group changes.
- What do the results mean in everyday life?
Medicines can sometimes be reduced in type 2 diabetes, but only with medical supervision.
- What are the study's limitations?
Not randomised; sponsor.
- What does it say about Elawady's specific claim?
Partly supports reduction of medication in T2D; not in T1D.
- Do the results apply to Germany and Europe?
US programme.
- What can explicitly not be concluded from this study?
Cannot show safety of unsupervised stopping.
Scientific in-depth review
1. Full reference
- Authors
- Athinarayanan SJ et al.
- Journal
- Front Endocrinol (Lausanne)
- Year
- 2019
- Identifier
- PMID 31231311 DOI 10.3389/fendo.2019.00348
- Verification
- verified – PubMed efetch 2026-10-26; Crossref 2026-10-26
- Retracted
- no
- Corrections
- none
- Extent checked
- abstract only
- Conflicts of interest and funding
Industry-sponsored (Virta Health) per trial context; not stated in abstract - conflict likely (not verified in full text).
2. Research question
What are the 2-year effects of a remotely supervised ketogenic-diet intervention in T2D?
3. Study design and population
- Study design
- Other – Open-label, non-randomised controlled trial (continuous care intervention vs usual care)
- Population
Adults with T2D
- Country
USA
- Period
2-year follow-up; NCT02519309
- Sample size
262 intervention; 87 usual care
- Inclusion and exclusion criteria
T2D adults
4. Methods and endpoints
- Exposure / intervention
Continuous remote care with nutritional ketosis and medication adjustment by physicians
- Comparator
Usual care
- Endpoints
Retention, HbA1c, weight, medication use, remission
- Statistical methods
ITT; P values
5. Actual results
- Results
Use of glycaemic medications other than metformin fell from 55.7% to 26.8%, including insulin (-62%) and sulfonylureas (-100%); 'reversal' 53.5%, remission 17.6% at 2 years; no changes in usual care.
- Absolute risks
not reported
- Authors' conclusion
Sustained improvements with less medication at 2 years.
6. Strengths
- 2-year follow-up
- Medication changes supervised by physicians
7. Weaknesses
- Not randomised
- Self-selected participants
- Sponsor involvement likely
8. Risk of bias
- Orienting tool
- ROBINS-I
- Type of assessment
- simplified assessment (abstract only)
- Full formal assessment
- no
- Overall risk of bias
- high
- Rationale
Non-randomised; selection bias.
9. Assessment of the statistical interpretation
Within-group changes; no randomised comparison.
10. Relevance to the specific claim
Supports that some people with T2D can reduce or stop insulin with an intensive dietary programme, but only with close medical supervision and remote glucose/ketone monitoring; T1D not included.
11. Independent contrary findings
12. Transferability to Germany and Europe
Directly applicable; same biology and clinical standards in Europe.
13. Overall methodological judgement
Weak design; partial, conditional support for T2D medication reduction under supervision.
| Multidimensional assessment | |
|---|---|
| Authenticity of the source | verified |
| Methodological quality | low |
| Risk of bias | high |
| Precision of results | moderate |
| Directness | direct |
| Reproducibility | not replicated |
| Consistency with the overall evidence | mixed |
| Regional transferability | moderate |
| Adequacy of the interpretation (by the archive) | not applicable |