Randomised controlled trialindependent cross-checkabstract checked★ key study I-DIAB-111 in-depth review
Daily finger-prick tests in type 2 diabetes without insulin
Glucose Self-monitoring in Non-Insulin-Treated Patients With Type 2 Diabetes in Primary Care Settings: A Randomized Trial.
Overview
Young LA et al.. JAMA Intern Med 2017 · PMID 28600913 · DOI 10.1001/jamainternmed.2017.1233
For people with type 2 diabetes not using insulin, daily self-testing did not improve HbA1c or quality of life over one year.
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?
Test routine SMBG in non-insulin T2D.
- How was the study done?
Pragmatic RCT.
- How many people, animals or samples were studied?
450 patients.
- What was actually found?
No HbA1c difference.
- How large was the observed effect?
-0.05% (-0.27 to 0.17).
- What do the results mean in everyday life?
Routine self-testing is not always needed in type 2 diabetes without insulin; regular HbA1c checks still are.
- What are the study's limitations?
Moderately controlled patients only.
- What does it say about Elawady's specific claim?
Supports a narrow kernel; not 'no measurement at all'.
- Do the results apply to Germany and Europe?
Applicable.
- What can explicitly not be concluded from this study?
Cannot justify stopping monitoring in insulin users.
Scientific in-depth review
1. Full reference
- Authors
- Young LA et al.
- Journal
- JAMA Intern Med
- Year
- 2017
- Identifier
- PMID 28600913 DOI 10.1001/jamainternmed.2017.1233
- Verification
- verified – PubMed efetch 2026-10-26; Crossref 2026-10-26
- Retracted
- no
- Corrections
- none
- Extent checked
- abstract only
- Conflicts of interest and funding
Not stated in abstract.
2. Research question
Does SMBG improve HbA1c or quality of life in non-insulin-treated T2D?
3. Study design and population
- Study design
- Randomised controlled trial – Pragmatic open-label randomised trial (Monitor Trial), 15 practices
- Population
Adults >30 with non-insulin-treated T2D, HbA1c 6.5-9.5%
- Country
USA (North Carolina)
- Period
2014-2016
- Sample size
450
- Inclusion and exclusion criteria
Non-insulin-treated T2D in primary care
4. Methods and endpoints
- Exposure / intervention
Once-daily SMBG (with or without tailored messaging)
- Comparator
No SMBG
- Endpoints
HbA1c and HRQOL at 52 weeks
- Statistical methods
Adjusted mean differences
5. Actual results
- Results
No significant HbA1c differences (P=.74): SMBG with messaging vs none -0.09% (-0.31 to 0.14); SMBG vs none -0.05% (-0.27 to 0.17); no differences in HRQOL, hypoglycaemia, health-care use or insulin initiation.
- Absolute risks
not reported
- Authors' conclusion
In non-insulin-treated T2D, routine SMBG gave no clinically or statistically significant benefit at 1 year.
6. Strengths
- Pragmatic RCT
- 92.9% completion
7. Weaknesses
- Moderate HbA1c range only
- 1 year
8. Risk of bias
- Orienting tool
- RoB 2
- Type of assessment
- simplified assessment (abstract only)
- Full formal assessment
- no
- Overall risk of bias
- low
- Rationale
Open label; objective HbA1c outcome.
9. Assessment of the statistical interpretation
Precise null for HbA1c.
10. Relevance to the specific claim
Correct kernel: routine daily finger-prick testing adds little for people with type 2 diabetes who do not use insulin and are moderately controlled. This does not extend to insulin users, ketone testing, HbA1c or blood pressure.
11. Independent contrary findings
12. Transferability to Germany and Europe
Directly applicable; same biology and clinical standards in Europe.
13. Overall methodological judgement
Supports a narrow part of the claim.
| Multidimensional assessment | |
|---|---|
| Authenticity of the source | verified |
| Methodological quality | high |
| Risk of bias | low |
| Precision of results | high |
| Directness | direct |
| Reproducibility | replicated |
| Consistency with the overall evidence | consistent |
| Regional transferability | high |
| Adequacy of the interpretation (by the archive) | not applicable |