Evidence Tables SM1Is self-monitoring effective in assisting in the management of people with type 2 diabetes?

ReferenceStudy type Evidence levelNumber of patientsPatient characteristicsInterventionComparisonLength of follow-upOutcome measuresEffect sizeSource of funding
Jansen JP. Self monitoring of glucose in type 2 diabetes mellitus: a Bayesian meta-analysis of direct and indirect comparisons. Current Medical Research and Opinion 2006; 22(4): 671–681

Ref ID: 4916
Systematic review 1+

Mixed treatment comparison meta- analysis.
N=12 studies

Including N=2011 patients
Study conducted both direct and indirect comparisons of strategies. Estimated the effect of SMUG vs no monitoring despite there being no pair-wise comparison.

Study inclusion criteria: Published RCT’s, study population all T2Ds independent of the type of treatment, intervention for at least one study group was SMBG, reported on outcomes HbA1c.

Baseline characteristics: each study was given a score of internal validity. There was no difference in this total quality score comparing different interventions. No other reported assessment of baseline characteristics of participants.

Mean score for internal validity 8.5 out of 13 points (median 9; SD 1.8; range 4–10)
N=3 studies compared SMBG with SMUG

N=8 studies SMBG vs no self monitoring

N=2 studies compared different SMBG with SMBG and feedback programmes
SMUG
No intervention SMBG with feedback
12 weeks to 12 monthsChange from baseline (CFB) in HbA1cPooled Δ HbA1c for no self monitoring: −0.47% (95% CI −0.66 to −0.28%)
Pooled Δ HbA1c for SMUG: −0.61% (95% CI −1.20 to −0.05%)
Pooled Δ HbA1c for SMBG: −0.87% (95% CI −1.14 to −0.58%)
Pooled Δ HbA1c for SMBG + feedback: −1.48% (95% CI −2.06 to −0.89%)

Relative efficacy of different monitoring strategies in all T2D patients
Roche diagnostics
Difference in Δ HbA1c1 (95% CI)Pr (%)2
SMUG vs NSM−0.02 (−0.70; 0.62)54
SMBG vs NSM−0.40 (−0.70; −0.07)99
SMBG + FB vs NSM−1.04 (−1.66; −0.36)>99
SMBG vs SMUG−0.38 (−1.00; 0.30)88
SMBG+ FB vs SMUG−1.01 (−1.77; −0.14)99
SMBG+ FB vs SMBG−0.63 (−1.22; −0.05)98
Relative efficacy of monitoring strategies among non-insulin requiring T2D patients
Difference in Δ HbA1c 3 (95% CI)Pr (%)4
SMUG vs NSM−0.14 (−0.90; 0.56)66
SMBG vs NSM−0.42 (−0.76; −0.03)98
SMBG + FB vs NSM−1.19 (−2.00; −0.42)>99
SMBG vs SMUG−0.28 (−0.91; 0.43)80
SMBG+ FB vs SMUG−1.07 (−1.88; −0.17)99
SMBG+ FB vs SMBG−0.78 (−1.49; −0.13)99
Sensitivity analyses conducted by adjusting for internal validity of the studies.
Cho JH, Chang SA, Kwon HS, Choi YH, Ko SH, Moon SD et al. Long-term effect of the Internet-based glucose monitoring system on HbA1c reduction and glucose stability: a 30-month follow-up study for diabetes management with a ubiquitous medical care system.
Diabetes Care 2006; 29(12):2625–2631.

Ref ID: 4911
RCT

1+
N=80

Korean population

ITT analysis

Drop put rate 11%

Adaptive randomisation

Not possible to blind assessors
Inclusion criteria: ≥ 30 years, type 2 diabetics, followed for > 6 months at a hospital diabetic centre

Exclusion criteria: disabling condition or diseases such as heart failure, hepatic function, creatinine >0.133 mmol/l, severe compilations of diabetes, treatment with an intensified insulin regimen, no internet access or no internet knowledge, previous participation in similar problems, use of any other web-based diabetes management programme.

No baseline differences between groups wrt clinical characteristics and mode of treatment.
N=40
Diabetes education programme to standardise knowledge of diabetes management and SMBG

Internet- based glucose monitoring system (IBGMS) and electronically organised circuit for diabetes management including both online and offline systems.

Patients uploaded SMBG results on an online chart.

Feedback given on this 2 weekly
N=40
Diabetes education programme to standardise knowledge of diabetes management and SMBG

Outpatient visit every 3 months

Conventional note keeping system
30 monthsHbA1c

HbA1c fluctuation index (HFI): SD of HbA1c levels for each subject representing the extent of change relative to the mean value (a new measure developed by the authors)
IBGMSControlPKorea Research Foundation
Grant
Mean HbA1c over study period6.9 ± 0.9%7.5 ± 1.0%0.0 09
Mean HbA1c if basal HbA1c < 7%6.2 ± 0.7 %6.9 ± 0.8%0.0 15
Mean HbA1c if basal HbA1c ≥7%7.3 ± 0.7%7.9 ± 1.0%0.0 23
HFI0.47 ± 0.230.78 ± 0.510.0 01
HFI if basal HbA1c < 7%0.39 ± 0.260.84 ± 0.670.0 3
HFI if basal HbA1c ≥7%0.51± 0.270.74 ± 0.400.0 15
Compliance5 with regular SMBG: Basal HbA1c level showed no significant difference between the GC and PC subgroups in either IBGMS or control group.
HFI: no difference between complicance groups in the IBGMS group; however in control group if basal HbA1c ≥7% GC group had significantly lower HFI (0.43 ± 0.20 vs. 0.93 ± 0.37; p<0.01)
Davis WA, Bruce DG, Davis TM. Is self-monitoring of blood glucose appropriate for all type 2 diabetic patients? The Fremantle Diabetes Study. Diabetes Care 2006; 29(8):1764–1770.

Ref ID: 4913
Cross- sectional study of T2D patients from FDS 3

Cohort study of sample of these T2Ds
2+
N=1286 baseline patients drawn from FDS

N=531 followed up over 5 years (not mentioned if these were randomly selected or were all patients who completed the 6 assessments)
From Freemantle Diabetes study cohort, N=1426, N=1294 (91%) T2D

Inclusion criteria: All T2D, reporting SMBG status at baseline.

Exclusion criteria: not described in this paper

Baseline characteristics: of the cross sectional study, participants who performed SMBG were more likely to be younger, married, exercising, on insulin therapy, to have self –reported episodes of hypoglycaemia, to have attended diabetes education and to have seen a diabetes specialist in the previous year than those who did not perform any SMBG.

The participants who completed the 5 follow up visits were significantly younger, more likely to be male, have shorter diabetes duration, better glycaemic control, fewer diabetes complications, less likely to have died during follow up (p≤ 0.001).
SMBG users6SMBG non- users5 yearsProportion performing SMBG, SMBG frequency, glycaemic control, hypoglycaemic episodes, diabetes quality of ilfe (DQOL) measured using modified DQOL scale and the Rosser index.Prevalence of SMBG: 70% reported performing SMBG.

Throughout follow up there was no difference in A1C or FPG either overall or within treatment groups in patient who used SMBG than those who did not (p≥0.05).

There were no differences in fasting plasma glucose (FPG) or A1C between adherent and non-adherent users by treatment group (p ≥0.09).

SBMG frequency was not associated with FPG (trend p=0.19)

There were no significant associations between FPG and A1C and SBMG frequency within diabetes treatment groups (p ≥0.08).
Raine Foundation, University of Western Australia
Kalergis M, Nadeau J, Pacaud D, Yared Z, Yale JF. Accuracy and reliability of reporting self- monitoring of blood glucose results in adults with type 1 and type 2 diabetes. Canadian Journal of Diabetes 2006; 30(3):241–247.

Ref ID: 4920
Case series 3N=60

N=45 T2D

N=15 T1D (results not reported here)
Inclusion criteria:
Patients 18–65 years, attending metabolic day centre, Quebec, Canada, adults with T2D recruited into an 8-month nutrition- education trial.
Participants were required to perform SMBG and record the results in a logbook as part of the trial.

Exclusion criteria: not mentioned

Baseline characteristics: age 57 ± 1.2
Sec (male:female) 30:15
T2D duration (years) 9 ± 1
BMI 30.2 ± 0.8
T2D patients8 monthsGlycaemic control: HbA1cThere was no significant relationship between frequency of monitoring and glycaemic control.

There was no significant relationship between accuracy of reporting and glycaemic control.

Reliability of reporting/proportion of values accurately reported at study end(%):
MediSense Inc provide d BG meters and test strips.
Very reliable (>90%)59
Fairly reliable (50–90%)17
Unreliable (<50%)24
Moreland EC, Volkening LK, Lawlor MT, Chalmers KA, Anderson BJ, Laffel LM. Use of a blood glucose monitoring manual to enhance monitoring adherence in adults with diabetes: a randomized controlled trial. Archives of Internal Medicine 2006; 166(6):689–695.

Ref ID: 4917
RCT 1+N=199

65% T2D
Inclusion criteria:
Adult diabetics at high risk (HbA1c≥8.0%)

Exclusion criteria:
Medical history of established renal disease (serum creatinine ≥2.0 mg/dL), major visual impairment, myocardial infarction within the last 6 months, or major psychiatric disorder, pregnancy.

Baseline characteristics:
Mean age 49.2 ± 13.0 yrs
Duration of diabetes 10.7 6.2 yrs
BMI 30.1 ± 6.3 kg/m2
HbA1c 9.1 ± 1.1%
T2D monitoring 1.6 ± 1.2 times/day

The 3 groups were similar with respect to age, sex, ethnicity, education level, BMI, type of diabetes, therapy, and duration of diabetes.

HbA1c was slightly higher in the BGM+ group compared with the SC group (p=0.06)

Not mentioned if ITT, do not mention randomisation method, allocation concealment, blinding, or loss to follow up.
N=50
Blood Glucose Monitoring Owners Manual (BGM+)

N=50
BG meter only (MT)

Both groups received a 30 min diabetes education session focussed on BG monitoring and support from a certified diabetes educator.
N=99
Standard care (SC) involving individual or group standard diabetes education accredited by ADA.
6 monthsPrimary outcome: frequency of BG monitoring

Secondary outcomes: glycaemic control, knowledge of HbA1c, affect regarding BG monitoring results.
Frequency of BG monitoring:
BGM+: 2.8 ± 1.5 times daily
MT: 2.0 ± 1.3 times daily (p=0.01 cf to BGM+)
SC: 2.1 ± 1.7 times daily (p=0.04 cf to BGM+)

InT2D frequency of BG monitoring increased from 1.5 ± 1.3 times daily to 2.3 ± 1.4 times daily (p=0.007).
No significant change in daily monitoring frequency in the MT group.

Glycaemic control:
HbA1c change
BGM+: −0.3 ± 1.28%
MT: −0.04 ± 1.31%
SC: 0.04 ± 1.10% (not reported if difference between arms is significant).
No significant differences between T1D and T2D.

In multivariate analyses, assignment to the BGM+ group was a significant predictor of improvement in glycaemic control (p=0.03), after controlling for age, sex, duration of diabetes, education level, socioeconomic status and baseline HbA1c level.
Roche Diagnostics, NIH, Charles H. Hood foundation, Katherine Adler Astrove Youth Education Fund.
Schutt M, Kern W, Krause U, Busch P, Dapp A, Grziwotz R et al. Is the frequency of self- monitoring of blood glucose related to long-term metabolic control? Multicentre analysis including 24,500 patients from 191 centers in Germany and Austria. Experimental & Clinical Endocrinology & Diabetes 2006; 114(7):384–388.

Ref ID: 4914
Cross sectional study 3

N=191 centres in Germany
N=24
500

N=1949 1 T1D

N=5009 T2D (N=202 1 on insulin, N=2988 on OAD/diet)
Inclusion criteria:
Patients recruited from the DPV-Wiss-database.

No exclusion criteria mentioned

Baseline characteristics for T2D patients:
Mean duration: 5.8 years
HbA1c 8.5%
SMBG (insulin) 2.7/day
SMBG (OAD/diet) 2.0/day

Not mentioned on what basis these participants were selected from the database, or whether these were all the patients in the database.
German T1D and T2D on the DPV- Wiss- Database.n/an/aGlycaemic controlHbA1c change in T2D’s:
More frequent SMBG was associated with better metabolic control Insulin treated patients: HbA1c reduction of 0.16% for one additional SMBG/day (p<0.0001)

OAD/Diet patients: HbA1c increase of 0.14% for one additional SMBG/day (p<0.0001)
Siebolds M, Gaedeke O, Schwedes U, SMBG Study Group. Self- monitoring of blood glucose-- psychological aspects relevant to changes in HbA1c in type 2 diabetic patients treated with diet or diet plus oral antidiabetic medication. Patient Education & Counseling 2006; 62(1):104–110.

Ref ID: 4915
RCT 1+

Multicentre, parallel group study in Germany and Austria.
N=223

N=113 SMBG

N=110 no SMBG
Inclusion criteria: T2D, treated with diet alone or diet and oral antidiabetic agents.

Exclusion criteria: not mentioned

Baseline characteristics: Patients who were allocated to the no SMBG group were slightly older (60.5 ± 6.6 years vs. 58.7 ± 7.6 years) and had a shorter duration of diabetes (62.6 ± 47.3 months vs. 65.5 ± 57.2 months) but it is not mentioned if these differences were statistically significant.

Per-protocol analysis, drop out rate not reported.
SMBG group use a blood glucose device

Measure blood glucose 6 x on 2 days/week

Received structured counselling sessions
Unstructured counselling6 monthsChange in HbA1c after 24 weeks of SMBG

Body weight

QOL7
SMBGNo SMBGpBayer AG
HbA1c (%)−1.0 ± 1.08−0.54 ± 1.410.0086
Body weight (kg)−2.3 ± 3.3−1.6 ± 3.5-
Treatment satisfaction3.52 ± 7.193.6 ± 7.63-
General well being3.58 ± 7.011.75 ± 7.33-
Depression−0.83 ± 2.66−0.26 ± 2.230.032
There were no significant differences for other sub-scale scores including anxiety, energy and positive well-being.

There were different HbA1C response types identified: continuous responders, late responders and non-responders. How patients responded was also related to the psychological aspects raised in the counselling sessions.
1

Adjusted for baseline HbA1c and weighted for internal validity

2

Probability that 1st intervention results in a greater HbA1c reduction than the 2nd intervention.

3

Adjusted for baseline HbA1c and weighted for internal validity

4

Probability that 1st intervention results in a greater HbA1c reduction than the 2nd intervention.

5

Good compliance (GC) defined as compliance with SMBG ≥80% compared with the initially recommended rate.

6

Participants were identified as adherent SMBG users if they were wither treated with OHS’s and/or insulin and performed SMBG one or more times per day or were managed by diet and undertook any SMBG.

7

Measured by a patient well-being questionnaire (WBQ 22) and by the Diabetes Treatment Satisfaction Questionnaire (DTSQ)

From: Evidence Tables

Cover of Type 2 Diabetes
Type 2 Diabetes: National Clinical Guideline for Management in Primary and Secondary Care (Update).
NICE Clinical Guidelines, No. 66.
National Collaborating Centre for Chronic Conditions (UK).
Copyright © 2008, Royal College of Physicians of London.

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