Cohort studyindependent cross-checkfull text checked I-ODD-129 standard review
Egypt: no ketoacidosis in 61 patients starting SGLT2 drugs during Ramadan
First-Time Usage of SGLT2 Inhibitors in Patients With Type 2 Diabetes Who Are Fasting Ramadan: Efficacy and Safety.
Overview
Khalil HAM et al.. J Diabetes Res 2025 · PMID 40322737 · DOI 10.1155/jdr/4321423
No DKA, hypoglycaemia or dehydration under supervision; study small and uncontrolled.
Does the study support the specific claim? No · Methodological quality: low
Plain-language summary
Study explained simply
- What did the researchers want to find out?
Test SGLT2 inhibitor safety during Ramadan in Egypt.
- How was the study done?
Prospective before-after cohort.
- How many people, animals or samples were studied?
61 patients.
- What was actually found?
Better glucose control; no DKA.
- How large was the observed effect?
0/61 DKA.
- What do the results mean in everyday life?
With medical supervision and education, fasting on these drugs went without ketoacidosis in this small group.
- What are the study's limitations?
Small, no control group.
- What does it say about Elawady's specific claim?
Limits but does not refute the claim.
- Do the results apply to Germany and Europe?
Moderate.
- What can explicitly not be concluded from this study?
That the DKA risk is zero.
Scientific in-depth review
1. Full reference
- Authors
- Khalil HAM et al.
- Journal
- J Diabetes Res
- Year
- 2025
- Identifier
- PMID 40322737 DOI 10.1155/jdr/4321423
- Verification
- verified – PubMed efetch 2026-10-26; Crossref works API 2026-10-26
- Retracted
- no
- Corrections
- none
- Extent checked
- full text
- Conflicts of interest and funding
No funding; authors declare no conflicts (full text).
2. Research question
Are SGLT2 inhibitors started for the first time during Ramadan fasting effective and safe in Egyptian patients with type 2 diabetes?
3. Study design and population
- Study design
- Cohort study – Prospective single-centre uncontrolled cohort (registered as NCT06370247)
- Population
Egyptian Muslim adults with type 2 diabetes intending to fast at least 15 days of Ramadan
- Country
Egypt
- Period
Ramadan plus 6 weeks follow-up (year per registration; not restated here)
- Sample size
61
- Inclusion and exclusion criteria
Stable patients without contraindication to fasting; SGLT2i (empagliflozin or dapagliflozin) newly added to metformin or another oral agent; sulfonylurea doses adjusted; structured Ramadan education
4. Methods and endpoints
- Exposure / intervention
SGLT2 inhibitor started after Iftar
- Comparator
None (before-after)
- Endpoints
HbA1c, blood pressure, creatinine, eGFR, hypoglycaemia, dehydration, DKA
- Statistical methods
Paired comparisons; correlations
5. Actual results
- Results
HbA1c, blood pressure and creatinine fell; eGFR rose after Ramadan. Hypoglycaemia, dehydration and DKA did not occur in any patient. Internal inconsistency: drug split reported as 54.1% dapagliflozin and 59.02% empagliflozin in one place and 54.1%/45.9% in another.
- Absolute risks
0 DKA events in 61 patients (upper 95% bound by rule of three about 4.9%).
- Authors' conclusion
SGLT2 inhibitors are effective and safe during Ramadan fasting; controlled trials with longer follow-up are needed.
6. Strengths
- Egyptian population
- Fasting setting directly relevant
- Structured education and dose adjustment
7. Weaknesses
- Small, uncontrolled, single centre
- Short follow-up
- Internal reporting inconsistency
8. Risk of bias
- Orienting tool
- ROBINS-E
- Type of assessment
- simplified assessment (abstract only)
- Full formal assessment
- no
- Overall risk of bias
- high
- Rationale
No control group; too small to detect a rare event.
9. Assessment of the statistical interpretation
Zero events in 61 patients is compatible with a true DKA risk of up to about 5% over the period (rule of three); it cannot show safety for a rare event.
10. Relevance to the specific claim
Regional evidence that, under medical supervision with education and dose adjustment, SGLT2 inhibitor use during daytime fasting did not produce DKA in a small Egyptian cohort. It does not address prolonged fasting or very-low-carbohydrate eating without supervision.
11. Independent contrary findings
ADA 2026 lists prolonged fasting and very-low-carbohydrate diets as DKA risk factors; case review I-ODD-128 found fasting as the main trigger of low-glucose ketoacidosis.
12. Transferability to Germany and Europe
Egypt-specific; relevant to Ramadan fasting in Europe as well.
13. Overall methodological judgement
Weak but regionally relevant: supervised use during Ramadan appeared safe; does not refute the rare DKA risk.
| Multidimensional assessment | |
|---|---|
| Authenticity of the source | verified |
| Methodological quality | low |
| Risk of bias | high |
| Precision of results | low |
| Directness | direct |
| Reproducibility | unknown |
| Consistency with the overall evidence | consistent |
| Regional transferability | high |
| Adequacy of the interpretation (by the archive) | not applicable |
14. Open questions
Controlled data on DKA during fasting.
15. Linked fact checks
- SGLT2 inhibitors such as dapagliflozin (Forxiga) can cause ketoacidosis, sometimes with normal or low blood glucose. – Studies contradicting or limiting the claim