Case series / case reportcited by the Tayebat archiveabstract only checked A-INS-18 standard review
Intensive insulin in 14 patients
Intensive conventional insulin therapy for type II diabetes. Metabolic effects during a 6-mo outpatient trial.
Overview
Henry RR et al.. Diabetes Care 1993 · PMID 8422777 · DOI 10.2337/diacare.16.1.21
Blood sugar normalised but patients gained almost 9 kg in six months.
Does the study support the specific claim? Partly · Methodological quality: very low
Plain-language summary
Study explained simply
- What did the researchers want to find out?
Metabolic effects of intensive conventional insulin in type 2 diabetes
- How was the study done?
Uncontrolled 6-month clinical study
- How many people, animals or samples were studied?
14; Type 2 diabetes outpatients
- What was actually found?
Glucose improved; +8.7 kg.
- How large was the observed effect?
+8.7 kg
- What do the results mean in everyday life?
Insulin works but can cause substantial weight gain.
- What are the study's limitations?
n=14; No control; 1993 regimen
- What does it say about Elawady's specific claim?
Kernel of C-INS-01.
- Do the results apply to Germany and Europe?
Old US regimen.
- What can explicitly not be concluded from this study?
General conclusions.
Scientific in-depth review
1. Full reference
- Authors
- Henry RR, Gumbiner B, Ditzler T, Wallace P, Lyon R, Glauber HS
- Journal
- Diabetes Care
- Year
- 1993
- Identifier
- PMID 8422777 DOI 10.2337/diacare.16.1.21
- Verification
- verified – PubMed E-utilities efetch, 2026-10-25
- Retracted
- no
- Corrections
- none
- Extent checked
- abstract only
- Conflicts of interest and funding
not stated in abstract; grants: NCRR NIH HHS, NIDDK NIH HHS
2. Research question
Metabolic effects of intensive conventional insulin in type 2 diabetes
3. Study design and population
- Study design
- Case series / case report – Uncontrolled 6-month clinical study
- Population
Type 2 diabetes outpatients
- Country
USA
- Period
6 months
- Sample size
14
- Inclusion and exclusion criteria
As described in the abstract; details not available in abstract.
4. Methods and endpoints
- Exposure / intervention
Split-dose NPH/regular insulin
- Comparator
Baseline (no control group)
- Endpoints
Glucose, HGO, glucose disposal, weight
- Statistical methods
Paired comparisons
5. Actual results
- Results
Mean glucose 17.5 -> 7.7 mmol/L; hypoglycaemia 4.1 -> 1.3 events/month; insulin dose 86-100 U; weight 93.5 -> 102.2 kg (P<0.001); weight gain correlated with insulin dose (r=0.62).
- Absolute risks
not reported
- Authors' conclusion
Intensive insulin rapidly improves control without unacceptable hypoglycaemia but requires large doses, with hyperinsulinaemia and progressive weight gain.
6. Strengths
- Detailed metabolic measurements
7. Weaknesses
- n=14
- No control
- 1993 regimen
8. Risk of bias
- Orienting tool
- none applicable
- Type of assessment
- simplified assessment (abstract only)
- Full formal assessment
- no
- Overall risk of bias
- high
- Rationale
Uncontrolled small study.
9. Assessment of the statistical interpretation
Small sample.
10. Relevance to the specific claim
Kernel of C-INS-01.
11. Independent contrary findings
12. Transferability to Germany and Europe
Old US regimen.
13. Overall methodological judgement
Small but consistent with larger data.
| Multidimensional assessment | |
|---|---|
| Authenticity of the source | verified |
| Methodological quality | very low |
| Risk of bias | high |
| Precision of results | low |
| Directness | direct |
| Reproducibility | replicated |
| Consistency with the overall evidence | consistent |
| Regional transferability | moderate |
| Adequacy of the interpretation (by the archive) | correctly reported |
14. Open questions
None beyond those stated.
15. Linked fact checks
Use by the Tayebat archive
Note: according to the archive, the studies were compiled by the archive operators. Whether Dr. Elawady himself cited this study is not established.
- What the archive says about the study
Listed in the archive bibliography for 'insulin-injections' without its own interpretation; used as general support for the claim that insulin intensification harms.
- A. What was actually studied?
Metabolic effects of intensive conventional insulin in type 2 diabetes
- B. What did the authors find?
Glucose improved; +8.7 kg.
- C. What conclusions do the authors themselves draw?
Intensive insulin rapidly improves control without unacceptable hypoglycaemia but requires large doses, with hyperinsulinaemia and progressive weight gain.
- D. What does the archive derive from it?
Supports insulin weight gain.
- E. Is this derivation scientifically justified?
Justified for weight gain; it also shows insulin effectively lowered glucose.
- Adequacy of the interpretation (by the archive)
- correctly reported