DM: Blood Glucose Self-Monitoring (2007)
Citation:
Study Design:
Class:
- Click here for explanation of classification scheme.
Quality Rating:
Research Purpose:
- To investigate the frequency of self-monitoring of blood glucose (SMBG) in patients with type 2 diabetes
- To determine its effect on metabolic control measured as glycosylated hemoglobin level (A1C)
Inclusion Criteria:
- Type 2 diabetes
- Reported to Outpatient Department for diabetes at the Institute of Agricultural Medicine during February 2002 and April 2003
- Expressed consent in study
Exclusion Criteria:
- Not discussed
Description of Study Protocol:
Recruitment
- Not discussed
Design
- Cross-sectional study
Blinding used (if applicable)
- Not applicable
Intervention (if applicable)
- Not applicable
Statistical Analysis
- Kruskal-Wallis non-parametric test was used to compare qualitative parameters between groups
- Differences in the frequency of occurance of specified parameters were evaluated by means of c2 test; p <0.05 considered statistically significant
Data Collection Summary:
Timing of Measurements
- Questionaire completed at time of study consent
- A1C retrieved from medical records
Dependent Variables
- A1C
Independent Variables
- Frequency of SMBG, questionnaire not shown to be validated
Control Variables
- Not discussed
Description of Actual Data Sample:
Initial N: 218 (68.81% female)
Attrition (final N): Not applicable
Mean Age: 62.28 ± 10.24 years
Ethnicity: Polish
Other relevant demographics: The four study groups did not differ in age or gender distribution.
Anthropometrics: (see results table)
Location: Lublin
Summary of Results:
Testing =/> 1/day |
Testing =/> 1/week |
Testing < 1/week |
Never testing | P | |
Subjects (%) | 59.22 |
21.36 |
8.74 |
10.68 | |
A1C value (%) |
8.06 ± 1.14 |
7.38 ± 1.48 |
7.68 ± 1.58 |
8.13 ± 1.48 | NS |
Body mass index (BMI) k/m2 |
32.02 ± 5.75 |
30.38 ± 4.95 |
30.57 ± 5.51 |
31.54 ± 7.97 | NS |
Other Findings
- Significant differences were found between frequency of SMBG and education level (p=0.01), place of residence (p= 0.04), and type of occupation (p<0.01). The group that performed more frequent SMBG were higher educated, lived in urban settings, and had office-type jobs.
- Subjects that used insulin, alone or in combination with oral meds, performed SMBG more often than subjects that only used oral medication (p < 0.01).
- Of all the subjects that performed SMBG =/> 1/day, 68.85% had duration of diabetes > 10 years; of all subjects that did not perform SMBG, 27.26% had duration of diabetes > 10 years (p < 0.01).
Author Conclusion:
The intensity of SMBG did not exert an influence on diabetes control as measured by A1C.
Funding Source:
Reviewer Comments:
Questionnaire not shown to be valid or reliable.
Quality Criteria Checklist: Primary Research
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Relevance Questions | |||
1. | Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies) | N/A | |
2. | Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about? | Yes | |
3. | Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice? | Yes | |
4. | Is the intervention or procedure feasible? (NA for some epidemiological studies) | N/A | |
Validity Questions | |||
1. | Was the research question clearly stated? | Yes | |
1.1. | Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified? | Yes | |
1.2. | Was (were) the outcome(s) [dependent variable(s)] clearly indicated? | Yes | |
1.3. | Were the target population and setting specified? | Yes | |
2. | Was the selection of study subjects/patients free from bias? | ??? | |
2.1. | Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study? | Yes | |
2.2. | Were criteria applied equally to all study groups? | Yes | |
2.3. | Were health, demographics, and other characteristics of subjects described? | Yes | |
2.4. | Were the subjects/patients a representative sample of the relevant population? | ??? | |
3. | Were study groups comparable? | Yes | |
3.1. | Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT) | N/A | |
3.2. | Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline? | N/A | |
3.3. | Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.) | N/A | |
3.4. | If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis? | Yes | |
3.5. | If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.) | N/A | |
3.6. | If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")? | N/A | |
4. | Was method of handling withdrawals described? | N/A | |
4.1. | Were follow-up methods described and the same for all groups? | N/A | |
4.2. | Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.) | N/A | |
4.3. | Were all enrolled subjects/patients (in the original sample) accounted for? | N/A | |
4.4. | Were reasons for withdrawals similar across groups? | N/A | |
4.5. | If diagnostic test, was decision to perform reference test not dependent on results of test under study? | N/A | |
5. | Was blinding used to prevent introduction of bias? | No | |
5.1. | In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate? | N/A | |
5.2. | Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.) | N/A | |
5.3. | In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded? | No | |
5.4. | In case control study, was case definition explicit and case ascertainment not influenced by exposure status? | N/A | |
5.5. | In diagnostic study, were test results blinded to patient history and other test results? | N/A | |
6. | Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described? | Yes | |
6.1. | In RCT or other intervention trial, were protocols described for all regimens studied? | N/A | |
6.2. | In observational study, were interventions, study settings, and clinicians/provider described? | N/A | |
6.3. | Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect? | N/A | |
6.4. | Was the amount of exposure and, if relevant, subject/patient compliance measured? | N/A | |
6.5. | Were co-interventions (e.g., ancillary treatments, other therapies) described? | Yes | |
6.6. | Were extra or unplanned treatments described? | N/A | |
6.7. | Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups? | Yes | |
6.8. | In diagnostic study, were details of test administration and replication sufficient? | N/A | |
7. | Were outcomes clearly defined and the measurements valid and reliable? | ??? | |
7.1. | Were primary and secondary endpoints described and relevant to the question? | Yes | |
7.2. | Were nutrition measures appropriate to question and outcomes of concern? | N/A | |
7.3. | Was the period of follow-up long enough for important outcome(s) to occur? | N/A | |
7.4. | Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures? | ??? | |
7.5. | Was the measurement of effect at an appropriate level of precision? | Yes | |
7.6. | Were other factors accounted for (measured) that could affect outcomes? | No | |
7.7. | Were the measurements conducted consistently across groups? | Yes | |
8. | Was the statistical analysis appropriate for the study design and type of outcome indicators? | Yes | |
8.1. | Were statistical analyses adequately described and the results reported appropriately? | Yes | |
8.2. | Were correct statistical tests used and assumptions of test not violated? | Yes | |
8.3. | Were statistics reported with levels of significance and/or confidence intervals? | Yes | |
8.4. | Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)? | N/A | |
8.5. | Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? | ??? | |
8.6. | Was clinical significance as well as statistical significance reported? | No | |
8.7. | If negative findings, was a power calculation reported to address type 2 error? | N/A | |
9. | Are conclusions supported by results with biases and limitations taken into consideration? | No | |
9.1. | Is there a discussion of findings? | No | |
9.2. | Are biases and study limitations identified and discussed? | No | |
10. | Is bias due to study's funding or sponsorship unlikely? | ??? | |
10.1. | Were sources of funding and investigators' affiliations described? | No | |
10.2. | Was the study free from apparent conflict of interest? | ??? | |