APPENDIX A. DATA COLLECTION FORMS 
VA-EPC Self-Monitoring of Blood Glucose 

Article Screener 

Article ID Reviewers: Assigned on: 

 

Citation: 

First Author:_____________________ 

*Complete Q7 & Q8 on ALL forms*

1. Is the study a test of efficacy or 

effectiveness of SMBG alone or as part of a 

multi-component intervention? 

 (Check all that apply) 

Alone..................................... 

Multi-component........................ 

No......................................... (STOP)

2. Study design 

(Circle one) 

RCT/CCT.................................1 

Review article: systematic or M-A....2 

Observational Study (cohort, 

case control, etc)...............3 (STOP)

Review article: Not systematic........4 (STOP)

Review article: letter, editorial, 

other syst review.............. 5 (STOP)

Other......................................6 (STOP)

2a. Is this a crossover study? 

(Circle one) 

Yes.......................................1 

No........................................0 

3. Is A1c reported as an outcome? 

(Circle one) 

Yes.......................................1 

No........................................0 

4. Is hypoglycemia reported as an outcome? 

(Circle one) 

Yes.......................................1 

No........................................0 

5. Is the frequency of SMBG testing reported? 

(Circle one) 

Yes.......................................1 

No........................................0 

6. If RCT/CCT or observational study, what is 

the duration of the follow up? 

(Circle one) 

< 12 weeks/not an RCT/CCT or 

observational study............0 (STOP)

12 weeks or greater ...................1 

If >=12 wks, write in the duration 

 Duration Units 

7. If this article meets no other criterion, 

should it be saved for background? 

(Circle one) 

Yes.......................................1 

No........................................0 

8. Are any of the subjects identified as 

Veterans? 

(Circle one) 

Yes.......................................1 

No........................................0 

Notes 

 ___ ___ ___ ___ ___ 

 Units

01. Days 04. Years 

02. Weeks 05. NR 

03. Months 
VA Self-Monitoring of Blood Glucose Project-Detailed Review Form

1. Do you think that this article might include the same data as another 

study? 

(CIRCLE ONE)

 Yes...................................................................................1 1  No....................................................................................2 2 

 If YES enter IDs: 

ID(s) : ________________________________ 

2. Design: (CIRCLE ONE)

 RCT..................................................................................1  CCT .................................................................................2  Other design......................................................... ..........3 (STOP) 

3. Is the study described as randomized? (CIRCLE ONE)

 Yes....................................................................................1 1  No ................................................................................... 2 4. If the study was randomized, was method of randomization 

appropriate? (CIRCLE ONE)

 Yes....................................................................................1 1  No.....................................................................................2 2  Method not described.......................................................8 8 

 Not applicable (not randomized) .................................... 9 5. Is the study described (with respect to SMBG)as: (CIRCLE ONE)

 Double blind.....................................................................1 1  Single blind, patient........................................................ 2  Single blind, outcome assessment ................................. 3  Single blind, not described ............................................. 4  Open..................................................................................5 5  Blinding not described......................................................8 8 Not applicable ....................................................................... 9 

6. If reported, was the method of double 

appropriate? 

 Yes.................................................... No..................................................... Double blinding method not describ Not applicable ..................................7. If study was randomized, did the meth

for concealment of allocation? 

 Yes..............................................

No ..............................................Concealment not described........Not applicable (not randomized) 

8. Are withdrawals (W) and dropouts (D Yes, reason described for all W 

Yes, reason described for some W Not described .............................

Not applicable .......................

9. Is the study a cross-over study design? 

 Yes.................................................... No.....................................................10. Sample size: (Enter 999 for not reported) 

 Enrolled: _____ _____ _____ 

 Followed-up/analyzed: _____ __

Article ID: Reviewer: First Author: 

 (Last Name Only) 

Study Number: ___of____Description:________________ 

(Enter ‘1of 1’ if only one) (if more than one study)

F
VA Self-Monitoring of Blood Glucose Project-Detailed Review Form

11. What were the characteristics of the patient population? A. Demographics: 

% women = ______ _____ 

(CHECK ALL THAT APPLY)

Caucasian ................................................. African Ancestry ...................................... Hispanic.................................................... 

Other (Specify: _________________________) ......  

 Demographics not reported....................... 12. What was reported for the following questions regarding 

 subjects’ ages? (Enter number 999 for not reported)

Mean Age................................. __________ Median Age.............................. __________ Age Range........__________ to __________ 

13. Was BMI reported? 

(CIRCLE ONE)

 Yes..................................................................................1 1  No...................................................................................2 2 

If yes, please enter the following: (Enter number 999 for not 

reported)

Mean BMI................................ __________ Median BMI............................. __________ BMI Range.......__________ to __________ 

14. Was weight reported? 

(CIRCLE ONE)

 Yes...................................................................................1 1  No....................................................................................2 2 

If yes, please enter the following: W

Mean weight............................. _____Median weight ......................... _____Weight Range...__________ to ____

15. Was duration of diabetes reported? 

 Yes............................................................. No..............................................................

If yes, please enter the following: T

Mean time..............................______Median time...........................______Time Range...__________ to ______

16. Which of the following co-morbidities we

Myocardial infarction........................Congestive Heart Failure ..................Peripheral vascular disease ...............Cerobrovascular disease....................Dementia...........................................Chronic pulmonary disease...............Rheumatologic disease......................Peptic ulcer disease ...........................Mild liver disease..............................Hemiplegia or paraplegia .................Renal disease ....................................Malignancy, leukemia, lymphoma ...

 Moderate-severe liver disease...........

AIDS .................................................
VA Self-Monitoring of Blood Glucose Project-Detailed Review Form

Enter sample size and intervention/exposure data for each arm beginning with CONTROL/USUAL CARE for arm 1, tFor observational studies answer only columns denoted with asterisks (*): 

Arm/ Group Sample size * 

Components * 

(check all that apply) 

Total # of 

Visits Frequency of SMBG 

Number of 

Days per 

week 

Duration of * treatment 

P PY __________________ CNTRL N ENTERING

1 

CASES __________________ 

N COMPLETING

SMBG............ Exercise............

Dietician......... Other................

Pt Control....... Not applicable..

Not Reported.. 

Diabetes counseling/Education.......... 

____ 

Control 

______ ______ 

P PY __________________ CNTRL N ENTERING

2 

CASES __________________ 

N COMPLETING

SMBG............ Exercise............

Dietician......... Other................

Pt Control....... Not applicable..

Not Reported.. 

Diabetes counseling/Education..........

____ 

GD...... BID......TID..... QID.....

PP....... Other...

Before/After meals...

NR........... 

______ ______ 

P PY __________________ CNTRL N ENTERING

3 

CASES __________________ 

N COMPLETING

SMBG............ Exercise............

Dietician......... Other................

Pt Control....... Not applicable..

Not Reported.. 

Diabetes counseling/Education..........

____ 

GD...... BID......TID..... QID.....

PP....... Other...

Before/After meals...

NR...........

______ ______ 

P PY __________________ CNTRL N ENTERING

4 

CASES __________________ 

N COMPLETING

SMBG............ Exercise............

Dietician......... Other................

Pt Control....... Not applicable..

Not Reported.. 

Diabetes counseling/Education..........

____ 

GD...... BID......TID..... QID.....

PP....... Other...

Before/After meals...

NR...........

______ ______ 

Enter a number for N entering and N completing or enter 9999 if not reported. If observational study, circle appropriate unit of measurement: P Persons PY People years CNTRL Control CASES Cases 

 Enter # of visits 

or contact s 

Enter a number 997. Variable 998. ND 999. NA 

Enter a number 997. Variable 998. ND 999. NA 
VA Male OP Project-Detailed Review Form- Diagnostic Studies

Outcomes  17. Please check the type of outcomes measured. For case control enter the outcome that defines the study: 

(CHECK ALL THAT APPLY)

HbA1c..................................................................... Fasting glucose .......................................................  Fructose................................................................... BMI/Weight loss.....................................................  Fast v. meal glucose................................................ Health related quality of life ...................................  

Evaluation 

18. When, relative to the start of the intervention, were outcomes reported?

 (Enter the number/code in the appropriate box) 

 Control Intervention  Numbe

r 

Units Numb

er 

Units 

1st followup 2nd followup 3rd followup 4th followup 5th followup 6th followup Additional follow-ups 

Adverse Events19. Were any of the following adverse Hypoglycemia ......................................Other adverse events ............................No Adverse events ...............................Not described .......................................Not applicable ......................................20. Is there a reference that needs t

Yes ............................................

 No............................................. If YES, which one(s) :  ___________________________

(Enter reference # and/or author or 9999 i

Units

1. Hour 5. Year 2. Day 8. ND 3. Week 9. NA 4. Month 999. NR 
SMBG Project- Randomized Controlled Trials Quality Measurement

1. Treatment Allocation  a. Was a method of randomization performed? 

 Yes ........................................................................  No..........................................................................  Don’t know ........................................................... 

 b. Was the treatment allocation concealed? 

 Yes ........................................................................ 

 No..........................................................................  Don’t know ........................................................... 

2. Were the groups similar at baseline regarding the most important prognostic indicators? 

Yes ........................................................................

 No..........................................................................  Don’t know ........................................................... 

3. Were the eligibility criteria specified? 

Yes ........................................................................

 No..........................................................................  Don’t know ........................................................... 

4. Was the outcome assessor blinded? 

Yes ........................................................................

 No..........................................................................  Don’t know ........................................................... 

5. Was the care provider blinded? 

Yes ......................................................

 No........................................................ Don’t know .........................................

6. Was the patient blinded? 

Yes ......................................................

 No........................................................ Don’t know .........................................

7. Were point estimates and measures of variprimary outcome measures? 

Yes ......................................................

 No........................................................ Don’t know .........................................

8. Did the analysis include an intention-to-tre

Yes ......................................................

 No........................................................ Don’t know .........................................

Article ID: Reviewer: 

First Author: ____________________________________

PILOT 03/14
APPENDIX B. PEER REVIEW COMMENTS TABLE 
Peer Review Comments Table 1. 

Reviewer Section Comment 

Pogach Background The investigators frame the background in terms of targets and measures. I would suggest that the background by Guerci 

the ASIA study frames the question better: “Theoretically, SMBG can improve compliance with recommendations on die

exercise and medication regimens. The American Diabetes Association has recommended that the optimal frequency of 

SMBG for patients with type 2 diabetes should be adequate to facilitate reaching glucose goals. This hypothesis is based 

the fact that lifestyle changes are facilitated by SMBG. Under these conditions, we should expect an improvement of glyccontrol SMBG increases patient management costs, and because of the high prevalence of type 2 diabetes, efforts to estabthe efficacy of SMBG in type 2 diabetes mellitus are of greater relevance.” 

Pogach Background If the investigators want to include a discussion of targets, their reliance on ADA Clinical Practice Recommendations is 

incomplete, and needs to take into account other guidelines and be more complete in describing the ADA recommendatioThe authors frame the ADA recommendations to bias the reviewer towards tight control for most. “The Association (ADArecommends an A1c goal of <7% for “patients in general” but adds that, “for the individual patient,” intensive therapy to achieve an A1c as close to normal (<6%) without hypoglycemia is the goal, although the latter recommendation is based weaker or incomplete evidence.4 “. To be evidence explicit and transparent, the investigators need to note (to be evidencexplicit) that multiple guidelines, including the ADA, American Geriatric Society, and VHA-DOD discuss the need for lstringent targets based upon life expectancy (AGS and VA) or age (ADA >65 years of age), comorbid conditions, and sieffects (including hypoglycemia). The ADA “in general” thus refers to individuals who are younger without contraindicaMoreover, the NHLBI study permits an A1c between 7.0-7.9%(expected mean 7.5%) in the control group. 

Aron Introduction This evidence review is being performed by VA. Therefore, it is quite surprising that the recommendations of the Americ

Diabetes Association are so prominently stated. The recent article in the New York Times related to conflicts of interest i

determining performance measures should give us pause. I realize that this is in the introduction and meant to provide con

but I would rather have seen studies cited, e.g., DCCT and UKPDS rather than the ADA (or any other advocacy organiza

Pogach Background I don’t understand why performance measurement is pertinent to the introduction. Only NCQA recommends public repor

for A1c <7% (see Pogach, Engelgau, Aron JAMA 2007). Thus, I would recommend removing references to performance measures as being not relevant. 

Aron Study 

Identification/ Study Selection 

Some of the criteria for study inclusion were not explicit. I am referring here specifically to the statement that studies not included in other meta-analyses/reviews were included in this one. The reasons why are not included. 

Pogach Study 

Identification/ Study Selection 

I am not satisfied with the investigators’ explanation that “we included studies rejected by Balk and/or by Welschen for a 

variety of reasons (italics mine)”. 

Pogach Study 

Identification/ Study Selection 

If the investigators believe that their inclusion is still justified, in contrast to the AHRQ Evidence Synthesis (Balk report) 

investigators should provide an explicit explanation of the reasons why they disagreed. 

Pogach Study 

Identification/ Study Selection 

The investigators frame the meta-analysis by noting that it is to address SMBG in individuals on oral hypo-glycemic medications. It is unclear to me whether the Kwan study included individuals on insulin; the Cho study did include 7 out control groups on insulin (4 insulin only) and 11 of 40 intervention group (6 insulin only). If these studies are included, thneeds to be noted as a limitation of generalization of the study findings. In addition, the willingness and ability to use the internet to download meter results may prevent generalization to other populations with lower Socio-economic position. 

Aron Study 

Identification/ Study Selection 

P17. “Initial screening of the articles resulted in 13 RCTs that measured the effect of SMBG compared to a group not receiving SMBG and monitored A1c levels with at least three months of follow-up. Two were excluded; one because the presented duplicate data, the other because the trial compared a control group of SMBG to an intervention group of SMBplus other components. (Figure 1)” Unfortunately, this is not the case. The Cho study states: “We performed a diabetes education program again to standardize every patient’s education for diabetes management and the method and frequency self-monitoring of blood glucose (SMBG) according to glucose control.” The control group used SMBG. The only differwas that the experimental group had the internet intervention. Why is this study included? 
Peer Review Comments Table 1. Continued 

Reviewer Section Comment 

Pogach Study 

Identification/ Study Selection 

The investigators note that “Initial screening of the articles resulted in 13 RCTs that measured the effect of SMBG compato a group not receiving SMBG and monitored A1c levels with at least three months of follow-up. Two were excluded; obecause the trial presented duplicate data, the other because the trial compared a control group of SMBG to an interventiogroup of SMBG plus other components. (Figure 1).” By these criteria, the Kwon (2004) and Cho (2006) articles should bexcluded, since the control group and intervention group each received the same number of monitoring strips and receivesame instructions on monitoring. The intervention being tested was therefore the “Internet Based Blood Glucose MonitorSystem”, which essentially increased the frequency of access to the diabetes team; electronic case management in a sensemy perspective that the investigators are obligated to remove these studies from the main analysis. 

Pogach Study 

Identification/ Study Selection 

The investigators note that “Eligible study designs included controlled clinical trials, RCTs, and systematic reviews/metaanalyses. Observational studies, case reports, non-systematic reviews, letters to the editor and other similar contributions 

excluded.” This review separately comments on observational studies done in veterans, but not observational studies of n

veterans. The investigators need to be consistent; either remove them or separately discuss all observational studies. I sug

excluding them as not being relevant to the meta-analysis as defined. In addition, the investigators, in their criteria for 

inclusion, do not include observational studies. None the less, they include older retrospective VA studies. If they choose 

include VA studies, they should modify their inclusion/exclusion criteria to include others. Otherwise (and given that me

analyses of RCTs have significant limitations as well), I would exclude them. 

Aron Study 

Identification/ Study Selection 

P13 “Eligible study designs included controlled clinical trials, RCTs, and systematic reviews/meta-analyses. Observation

studies, case reports, non-systematic reviews, letters to the editor and other similar contributions were excluded.” Howev

discussing studies in veterans, observational studies were included. It is not clear why they were included here and not elsewhere. The reasons should be made explicit. That also raises the question about using observational studies in nonveterans. 

Aron Study 

Identification/ Study Selection 

Inconsistencies aside, it is an interesting philosophical issue what the appropriate control group should be in studies like tIndividuals with diabetes have free access to SMBG, i.e., can do it without a prescription. What is usual care in this regar

Pogach Data Synthesis A significant positive aspect of this study is to adjust for baseline A1c. This is welcome, and should be commented upon 

more detail (see also data synthesis). 

Pogach Data Synthesis The reviewer’s perspective is that adjusting for baseline HbA1c is an appropriate consideration and can be defended (see 

Bloomgarden Z et al Lower Baseline Glycemia Reduces Apparent Oral Agent Glucose-Lowering Efficacy: A meta-regreanalysis Diabetes Care 2006 29: 2137-2139. This should be commented upon in greater detail. 

Aron Data Synthesis It is an interesting issue whether or not to adjust for baseline A1c. I would have liked to see both adjusted and unadjusted 

analyses. 
Peer Review Comments Table 1. Continued 

Reviewer Section Comment 

Aron Conclusions To reiterate, it is not clear why observational studies are included and I don’t see how one can draw the conclusion that 

veteran patients may not be receiving the full possible benefits of SMBG. I happen to agree with the conclusion, but that 

comes more from my experience in clinic than from these studies. 

Pogach Conclusions In multiple sections of the report the investigators state that “The results of the studies with Veterans do not negate the 

evidence from RCTs that the addition of SMBG and education can result in a decrease in A1c levels of about 0.3% absolusix months and up to one year. As previously noted, I do not know why observational studies are included at all, and recommend that that the observational studies be removed. 

Pogach Conclusions The investigators, on multiple occasions state “that these studies do raise the question of whether veteran patients are rece

the full possible benefits of SMBG.” It should be removed. Further, these statements indicate to me a pre-conceived biasespecially since the issue of SMBG efficacy, in individuals who are diet controlled or stable is controversial, and cannot fully resolved by a meta-analysis. Furthermore, and this is more pertinent to the issue, the investigators indicated that “w

draw no conclusion about the effect of frequency of SMBG monitoring on A1c values, and judge the strength of the evide

to be very low.” 

Pogach Future Research One important limitation of the meta-analysis is that earlier studies from the early mid-90s used SMBG methodology that 

much more inconvenient than current methodology. Glucose meters from that era required substantially more blood, tranto the monitoring strip was more cumbersome, and data feedback from the meters less user friendly if present at all. All othese factors may have contributed to inconclusive results from early studies, and emphasizes the need for research in thiarea. 

Pogach Future Research The investigators note: “The evidence is insufficient to draw conclusions about which components of SMBG (additionaleducation, algorithms or other techniques to adjust medication) and frequency of testing are most associated with better 

results. More research is needed.” Agree, this limitation is important and should be better highlighted. 

Pogach Future Research “However, observational studies in the VA do not report differences in A1c levels between Veterans using or not using S

supplies. This raises the question about implementation: more research is needed to understand if implementation of SMBa typical VA clinic setting is sufficient for Veterans to receive the full benefit reported in clinical trials.” The more pertiissue is efficacy not effectiveness (see item 2). Please delete this statement. 

Pogach Future Research “Additionally, data are needed about the cost-effectiveness of SMBG in a VA setting.”. Unless I am mistaken doesn’t cos

effectiveness analysis depend upon efficacy data? This seems premature to me. Even if such data were available, it woulalso involve a number of assumptions that would have to be based upon Markov modeling. 

Pogach Future Research Impact of SMBG on medication adherence should be evaluated. Non-compliance with oral-antiglycemic medications is a 

recognized issue among veterans and among non-veterans. It is also possible the system interventions to improve adherenmay not need to incorporate increased frequency of SMBG. 

Pogach Future Research I have noted my comments about the Cho/Kwon study design in the previous section. Nonetheless, although I have some 

reservations about the study design for the purpose of this meta-analysis given the author’s inclusion/exclusion criteria, I 

that the study design is actually more relevant to what is now considered usual care; e.g., most persons with type 2 diabetwith training in SMBG and some supplies. (Key question 4). This might be mentioned under future research; i.e., that uscare (infrequent) for SMBG be the control group for persons with diabetes on oral agents. 
Peer Review Comments Table 1. Continued 

Reviewer Section Comment 

Aron Future Research This section seems pretty generic for the most part. More problematic is that SMBG is viewed completely in isolation. M

diabetes interventions are complex and involve more than activity. Moreover, other outcomes are relevant, e.g., behavior change. Finally, what does pramlintide have to do with this? That seemed to come out of the blue. 

Pogach Future Research I substantially disagree with the language of the research implications. 

“Our review of existing data support the beneficial effect of SMBG on A1c levels in the context of a clinical trial. Althouimprovement in A1c is modest, it is equivalent to that achieved with some of the newer medical therapies for diabetes, supramlintide.44,45” As noted previously, I believe that there is a bias by including the Cho and Kwan studies. However, upon the main analysis of this study, it is probably most pertinent to note that the benefit of SMBG [including bundled interventions] for persons on oral hypoglycemic agents is similar to that found for diabetes education interventions, many which included SMBG (Norris et al, Diabetes Care, 2002). Better designed prospective clinical trials, especially for individuals with stable glycemic control (e.g., at their target A1c) are necessary. Mentioning a specific medication is inappropriate. Please delete. 

Pogach Future Research I would recommend, as noted previously, that future research include alternative study designs to reflect the fact that SM

is considered usual care for patients on medication (though not on diet alone). 

Pogach Future Research Use of SMBG in context of VHA Health Buddy would be an appropriate area of investigation. Pogach Overall 

Evaluation 

The investigators were thorough in their identification of possible trials for inclusion in their report, but the reviewer has 

concerns that the included randomized trials articles from Cho and Kwan did not meet the stated inclusion criteria. This introduces biases which are not fully addressed in their discussion/and conclusions. This is a significant flaw of the study 

written, and it needs to be more fully addressed. If the investigators wish to justify their inclusion, then the reviewer suggthat the meta-analysis should be presented with and without these studies to permit comparison with the AHRQ evidence 

synthesis. 
APPENDIX C. EVIDENCE TABLE 
Evidence Table 1. Randomized Controlled Trials Evaluating the Self-Monitoring of Blood Glucose 

Delphi List Quality Criteria Arm/ Group 

Method of 

Randomization 

Eligibility criteria 

specified 

Allocation 

Concealment 

Outcome assessor blind 

Point estimates & 

measures of variability 

for primary outcome 

variable 

Care provider blind 

Author, Year

Sample 

Size 

Enroll/ 

Followup

Dur. of 

Diabetes

inYears

Mean 

Age 

Mean 

Weight 

(kg) 

/ BMI

% 

Women 

/ 

Race

Similarity at Baseline 

between groups Patients blinded 

Did analysis included 

intention to treat 

analysis 

Sample 

Size 

entering Components 

# 

Visit 

Yes Yes Yes 25 Exercise Counseling/Edu 20 

No No 

No 

Wing RR et al., 1986 19 50 / 45 NR 54 98 / NR 78% / NR 

No 

No 

No 25 

SMBG Exercise Pt Control led Counseling/Edu 

20 

No Yes Yes 68 Counseling/Edu 4 No No 

No 

Fontbonne A et al., 1989 20

208 / 164 13 55 73 / 27 42% / NR Yes No No 68 SMBG Counseling/Edu 4 

No Yes Yes 83 NR NA No No 

No 

Rutten G et al., 1990 23

149 / 127 8.1 63 75 / NR 65% / NR 

No No 

No 66 

SMBG Dietician Counseling/Edu 

Variable 

Yes Yes Yes 14 Dietician Counseling/Edu 8 

No No 

No 

Muchmore DB et al., 1994 24

29 / 23 5 59 99 / 34 61% / NR 

Yes No 

Yes 15 

SMBG Dietician Counseling/Edu 

8 

No Yes Yes 22 NR 2 No No 

No 

Jaber LA et al., 1996 25 45 / 39 6 62 90 / 33 

70% / African Ancestry Yes No 

No 23 

SMBG Pt Controlled Counseling/Edu 

NR 

No Yes Yes 32 Counseling/Edu 19 No No 

No 

Kibriya MG, et al., 1999 27 64 / 64 NR 50 60 / 24 45% / NR 

No No 

No 32 

SMBG Pt Control led Counseling/Edu 

7 

Yes Yes Yes 110+ Counseling/Edu 6 

No No 

No 

Schwedes U, et al., 2002 29

250 / 223 5.3 60 89 / 31 48% / NR 

Yes No 

No 113+

SMBG Dietician Counseling/Edu 

6 

No Yes Yes 344+ Counseling/Edu 5 No No 

No 

Guerci B, et al., 2003 30

988 / 689 8.1 62 83 / 30 45% / NR Yes No Yes 345+ SMBG Counseling/Edu 5 

No Yes Yes 45 Dietician Other 13 No Yes 

Yes 

Davidson MB, et al., 2005 32

89 / 88 5.6 50 82.3 / 32.5 

74% / African 

Ancestry, Hispanic, Other Yes No 

Yes 43 

SMBG Dietician Other 

13 

Yes Yes 152 Usual Care NR Yes No Yes 150 SMBG NR 

No 

Farmer A et al., 200733

453 / 453 3 66 NR / 31.3 43% / NR 

Yes No Yes 151 SMBG Patient Control NR 

ND=Not Described, NR=Not Reported, NA=Not applicable, *HRQOL=Health Related Quality of Life, +No entering sample size reported, this is the sample size completing the trial