Introduction
Disease burden of DM in India is increasing. Long-term complications, which form the main burden of disease, can be reduced by maintaining a good glycemic control. |
What is SMBG?
SMBG technique
Problem/error | Advice/recommendation |
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Test strip not fully inserted into glucose meter | Remove the test strip and reinsert it. Always ensure that the test strip is fully inserted in the glucose meter |
Not enough blood was drawn into the test strip for measurement | Discard the test strip and repeat the test |
Problem in patient sample site, for example the fingertip is contaminated with sugar | Always clean and dry the site before sampling |
Not enough blood applied to strip | Repeat test with a new strip |
Batteries low on power | Change batteries and repeat the test |
Sites other than fingertips used | Results from alternative sites may not match fingerstick results |
Site validated by the manufacturer must be used |
Structured SMBG
SMBG is an important tool for monitoring blood glucose levels. SMBG should be structured for it to be effective. |
What are the advantages of SMBG?
SMBG helps in maintaining a good glycemic control by generating data for therapeutic and lifestyle adjustments. It detects acute hypoglycemia/hyperglycemia and protects patients against extreme glucose variations. |
What are the challenges associated with SMBG and how to overcome them?
Challenges of SMBG can be overcome by a proper communication between the clinician and the patient and by ensuring that SMBG is carried out in a structured manner. |
Importance of accuracy of SMBG systems
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Within ± 15 mg/dL of laboratory results at concentrations < 100 mg/dL
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Within ± 15% of laboratory results at concentrations ≥ 100 mg/dL
SMBG systems compliant with ISO 15197:2013 should be used to ensure that the results obtained are reliable. |
What is the evidence of effectiveness of SMBG?
In type 1 DM patients
In type 2 DM patients on insulin therapy
In type 2 DM patients on non-insulin therapy
SMBG is essential in the management of type 1 DM patients and those patients with type 2 DM who are on insulin. Also, there is emerging evidence to support the use of SMBG in type 2 patients on non-insulin therapy. |
Study | Summary of study | Number of participants | Duration | Main outcome measures | Results/conclusion |
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Parsons et al. [82] | RCT to assess the efficacy of sSMBG in patients on non-insulin therapy with poor glycemic control (HbA1c ≥ 7.5 ≤ 13%) | 446 | 1 year | HbA1c at 12 months | Clinically and statistically significant benefits were obtained with sSMBG with a mean reduction in HbA1c of 0.9% (95% CI − 1.18 to − 0.62; p < 0.001) |
Miller et al. [67] | Large database of type 1 DM Exchange clinic registry to evaluate the relationship between the number of SMBG measurements per day and HbA1c levels | 20,555 | Association between the number of SMBG measurements per day and HbA1c levels | Higher number of SMBG measurements per day was strongly associated with a lower HbA1c level (p < 0.001); association was present in all age groups and in both insulin pump and injection users | |
Kesavadev et al. [48] | Retrospective cohort study using electronic health records to assess the effectiveness, safety, and costs of SMBG via Diabetes Tele Management System (DTMS) in type 2 DM | 1000 | 6 months | HbA1c at 6 months; hypoglycemia incidence; cost | The mean ± SD HbA1c value was reduced from 8.5 ± 1.4% to 6.3 ± 0.6% at 6 months (p < 0.0001) The rate of SMBG values < 70 mg/dL was ~ 0.04/patient/month; 84% patients reported no hypoglycemia Extra cost to patients for DTMS was equivalent to US$9.66/month |
Polonsky et al. (SteP) [36] | Multicenter cluster-randomized study to assess the effectiveness of structured SMBG in poorly controlled (HbA1c ≥ 7.5%), non-insulin-treated type 2 DM | 483 | 1 year | Difference in HbA1c level after 12 months | Structured SMBG (vs. active control group) significantly improved glycemic control (per protocol analysis, reduction in mean HbA1c; 21.3 vs. 20.8%; p < 0.003) without decreasing general well-being |
Franciosi et al. (ROSES) [87] | Randomized study lead by diabetes nurses to evaluate the efficacy of SMBG in patients with type 2 DM with oral agent monotherapy | 62 | 6 months | Mean change in HbA1c levels | Absolute mean difference in HbA1c reduction between groups (SMBG vs. usual care) was − 5% (95% CI − 0.9 to − 0.0%; p = 0.04) |
Durán et al. (St. Carlos Study) [86] | Newly diagnosed type 2 DM patients were randomized to either SMBG-based intervention or HbA1c-based control group | 161 | 1 year | Significantly greater reductions in median HbA1c (6.6 to 6.1%; p < 0.05) and BMI (29.6–27.9 kg/m2; p < 0.001) were found in the SMBG group | |
Barnett et al. (DINAMIC 1 study) [64] | Multicenter RCT to determine whether SMBG results in greater reduction in HbA1c compared to non-use of SMBG | 610 | 27 weeks | Difference between groups in HbA1c | HbA1c decreased from 8.12 to 6.95% in the SMBG group and from 8.12 to 7.20% in the non-SMBG group with a statistically significant difference between 2 groups (0.25%; 95% CI, 0.06–1.03; p = 0.0097). |
O’Kane et al. (ESMON study) [54] | RCT to assess the effect of SMBG on patients with newly diagnosed type 2 DM | 184 | 1 year | Differences in HbA1c between groups, psychological indices, use of oral hypoglycemic drugs, BMI, and reported hypoglycemia rates | No significant differences between groups at any time point for any of the outcome measures SMBG was associated with a 6% higher score on the depression subscale of the well-being questionnaire (p = 0.01) |
Farmer et al. (DiGEM study) [90] | Three-arm, open, parallel group randomized trial to determine whether SMBG alone or with instruction in incorporating results into self-care, is more effective than usual care in improving glycemic control in non-insulin-treated type 2 DM | 453 | 3 years | Difference in HbA1c level measured at 12 months | The differences in HbA1c level between the three groups were not statistically significant (p = 0.12) |
Martin et al. (ROSSO) [47] | Observational study to obtain epidemiological data on SMBG in type 2 DM and to investigate the relationship of SMBG with disease-related morbidity and mortality | 3268 | 6.5 years | Diabetes-related morbidity (non-fatal myocardial infarction, stroke, foot amputation, blindness, or hemodialysis) and all-cause mortality | SMBG group had a lower rate of non-fatal events (7.2 vs. 10.4%, p = 0.002) and fatal events (2.7 vs. 4.6%, p = 0.004) than the non-SMBG group. SMBG was an independent predictor of morbidity and mortality (hazard ratios (HR] 0.68; 95% CI 0.51–0.91, p = 0.009 and HR 0.49; 95% CI 0.31–0.78; p = 0.003, respectively) |
Karter et al. [65] | Observational study to assess longitudinal association between SMBG and glycemic control in diabetic patients (new users and ongoing users) | 16,091 new users + 15,347 ongoing users | 4 years | Glycemic control measured by HbA1c | Greater SMBG frequency was associated with a graded decrease in HbA1c regardless of diabetes therapy in new users (p < 0.0001) and only in pharmacologically treated patients in ongoing users (p < 0.0001) |
Schwedes et al. [69] | Multicenter RCT to evaluate the effect of meal-related SMBG on glycemic control and well-being in non-insulin-treated type 2 DM 2 groups: experimental group used SMBG device, kept a blood glucose/eating diary, and received standardized counseling; control group received non-standardized counseling on diet and lifestyle | 250 | 6 months | Change in HbA1c; Changes in body weight, lipids, and microalbumin; Changes in treatment satisfaction and well-being | Use of SMBG significantly reduced HbA1c levels by 1.0 ± 1.08% vs. 0.54 ± 1.41% for the control group (p = 0.0086). SMBG also caused a marked improvement in general well-being (p = 0.053). There was statistically significant improvement in depression (p = 0.032) and lack of well-being (p = 0.02) No statistically significant difference in the 2 groups for other parameters |
The Diabetes Control and Complications Trial Research Group [71] | RCT to evaluate whether intensive treatment (guided by SMBG) with the goal of maintaining blood glucose levels close to the normal range could decrease the frequency and severity of long-term microvascular and neurologic complications | 1441 | Appearance and progression of retinopathy, nephropathy, neuropathy | Risk for development of retinopathy was reduced by 76% (95% CI 62–85) in patients with no retinopathy at baseline. In patients with mild retinopathy, progression was slowed by 54% (95% CI 39–66). Occurrence of microalbuminuria albuminuria, and clinical neuropathy was reduced by 39% (95% CI 21–52), 54% (95% CI 19–74), 60% (95% CI 38–74), respectively |
Emerging technologies
What do the RSSDI recommendations on SMBG say?
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SMBG is useful to people with diabetes who have the required knowledge, skills, and willingness to use the information obtained through testing to actively adjust treatment with the help of the treating physician and to enhance understanding of diabetes and assess the effectiveness of the management plan on glycemic control.
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The purpose of performing SMBG and using SMBG data should be agreed between the person with diabetes and the healthcare provider.
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SMBG should be available on an ongoing basis to those using insulin.
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SMBG protocols (intensity and frequency) should be individualized to address each individual’s specific educational/behavioral/clinical requirements, specific needs, and goals (to identify/prevent/manage acute hyper- and hypoglycemia) and provider requirements for data on glycemic patterns and to monitor impact of therapeutic decision-making.
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Intensive/regular SMBG may be recommended in patients on multiple daily insulin injections, in case of pre-gestational/gestational diabetes on insulin, history of hypoglycemia unawareness, brittle diabetes, or with poor metabolic control on multiple oral antidiabetic agents (OADs) and/or basal insulin.
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SMBG should be performed at least as often as insulin is administered. Patients on intensive insulin regimens who are on multiple doses of insulin or on insulin pumps should be tested three or more times daily (all pre-meals, post-meals, bedtime, prior to exercise).
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SMBG plays an important role when low blood glucose is suspected or after treating low blood glucose until normoglycemia is achieved and prior to critical tasks such as driving. For many patients, this will require testing 6–10 (or more) times daily, although individual needs may vary.
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Pregnant women with insulin-treated diabetes should be advised to perform SMBG on a daily basis, failing which, at least weekly monitoring should be encouraged.
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Ideal SMBG is seven tests/day, i.e., three before and three after each meal and one test at 3 a.m. If this is not feasible, one fasting test and three tests each after breakfast, lunch, and dinner daily may be done, which can further be individualized to twice or thrice a week as the pregnancy advances.
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More frequent monitoring should be done in special situations like fever, vomiting, and persistent polyuria with uncontrolled blood glucose, especially if abdominal pain or rapid breathing is present. Ketone test should be performed as and when needed.
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SMBG accuracy is instrument and user-dependent, so it is important to evaluate each patient’s monitoring technique, both initially and at regular intervals thereafter. The ongoing need for and frequency of SMBG should be reevaluated at each routine visit.
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SMBG should be considered for people using oral glucose-lowering medications as an optional component of self-management and in association with HbA1c testing:
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To provide information on, and help avoid, hypoglycemia
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To assess changes in blood glucose control due to medications and lifestyle changes
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To monitor the effects of foods on post-prandial glycemia
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To monitor changes in blood glucose levels during intercurrent illness
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SMBG may be useful in type 2 DM during periods of acute illness; in patients using sulfonylureas or glinides as combination or monotherapy; to identify hypoglycemia especially in the first 3 months of starting sulfonylurea; in patients who experience episodes of hypoglycemia and who have reduced awareness of hypoglycemia; in drivers and those who fast; and in women under preconception care.
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Regular use of SMBG should not be considered part of routine care where diabetes is well-controlled by nutrition therapy or oral medications alone.
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Structured assessment of self-monitoring skills, the quality and use made of the results obtained, and of the equipment used should be made annually.
HbA1c | |
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Target | < 7.0% |
Fasting plasma glucose (mg/dL) | ≤ 115 |
Post-prandial glucose (mg/dL) | ≤ 160 |
Diabetes in pregnancy
Frequency and timing of SMBG
SMBG frequency and timing varies depending on the diabetes type, treatment approach, glycemic control, available resources, and patient’s level of education. |
SMBG practice in India and unmet need for country-specific guidelines and tool
Consensus methodology
Current SMBG practices is India are not ideal. Proper education and a simple tool, which will be easy to be followed and implemented is necessary. A panel of experts was convened to fulfill this unmet need. |
Recommendations by the expert panel
General recommendations
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RSSDI-recommended target levels should be adequately explained to the patient/provider and mutually agreed between the patient/provider and the clinician.
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SMBG technique should be properly explained to the patient.
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SMBG technique of the patients should be evaluated regularly and appropriate feedback given.
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SMBG device should comply with the ISO 15197:2013 requirements.
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The recommended target levels that should be followed for most diabetes patients for fasting blood glucose, post-prandial blood glucose, and HbA1c are ≤ 115 mg/dL, ≤ 160 mg/dL, and < 7.0%, respectively [93].
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Patients should be educated that the post-prandial blood glucose levels should be checked after 1/2 h from the start of the meal and not the end of the meal.
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Patients may be allowed to make minor adjustments to insulin dosage and changes in diet and exercise based on the SMBG readings.
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Annual structured assessment should be carried out to evaluate patient’s self-monitoring skills including monitoring technique, interpretation of blood glucose results, impact on patient’s quality of life, and continued benefit to the patient (a questionnaire will be developed for annual evaluation of the patients).
Recommendations for use of lancets/pricking devices
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Cover should be placed back on the needle immediately.
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Needle should not touch any surface apart from the inside of the needle cover.
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Cleaning the needle with alcohol should be avoided as it can make the point blunt.
Recommendations based on DM type, treatment approach, and glycemic control
Type 1 DM | Type 2 DM on OADs | Type 2 DM on insulin or insulin +OADs | |||
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Adults | Children | New onset DM/uncontrolled DM/DM during acute illness | Stable/well-controlled DM | New onset DM/uncontrolled DM/DM during acute illness | Stable/well-controlled DM |
• 2 to 8 times/day | • At least 4 times/day and should include pre-prandial and bedtime levels | Patients on SU or meglitinides • At least 4 times/day and should include pre-prandial and bedtime levels Patients on other OADs • At least FBG on alternate days | • At least 4 tests in a week on 4 consecutive days or on alternate days (including an FBG and 3 post-prandial values) | • At least 4 times/day and should include pre-prandial and bedtime levels • Must check whenever hypoglycemia is suspected | • Paired testing at least 3–4 days in a week (1 day/week pre and post breakfast, 1 day/week pre and post lunch, and 1 day/week pre and post dinner) or as frequently as possible. • Must check whenever hypoglycemia is suspected |
Type 1 DM | Type 2 DM on OADs | Type 2 DM on insulin or insulin + OADs | |||
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Adults | Children | New onset DM/uncontrolled DM/DM during acute illness | Stable/well-controlled DM | New onset DM/uncontrolled DM/ DM during acute illness | Stable/well-controlled DM |
• At least 4 times/day | • At least 3 times/day | Patients on SU or meglitinides • At least FBG alternate days Patients on other • At least FBG once a week | • At least 4 tests in a month—at least 1 test/week (including a FBG and 3 post-prandial values in a month) | • At least FBG and one more pre-prandial value every day • Must check whenever hypoglycemia is suspected | • At least one value on alternate days at different times of the day, with at least one FBG every week |
• Must check whenever hypoglycemia is suspected |
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Patients with frequent hypoglycemia or hypoglycemic symptoms
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Patients not at HbA1c target levels
Recommendations for diabetes in pregnancy
Patients on lifestyle modifications | Patients on OADs or insulin | ||
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Recommended care | Limited care | Recommended care | Limited care |
• A day profile once a week—FBG and 3 post-prandial values at least once a week or staggered over the week | • 1 FBG and one post-prandial value every week (any meal, preferably largest meal of the day) | • At least 4 times/day (FBG and 3 post-prandial values) | • Paired testing every day (pre- and post-breakfast on 1st day, pre- and post-lunch on 2nd day, pre- and post-dinner on 3rd day, and then keep repeating the cycle) |
Recommendations by the expert panel for patients on basal insulin
Fasting/pre-breakfast | Post-breakfast | Pre-lunch | Post-lunch | Pre-dinner | Post-dinner | 3 a.m. | SOS† | |
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Monday | ✓ | |||||||
Tuesday | ✓ | |||||||
Thursday | ✓ | |||||||
Friday | ✓ | |||||||
Saturday | ✓ | |||||||
Sunday | ✓ |
Recommendations by the expert panel for premix insulin or basal bolus
Fasting/pre-breakfast | Post-breakfast | Pre-lunch | Post-lunch | Pre-dinner | Post-dinner | 3 a.m. | SOS† | |
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Monday | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
Tuesday | ||||||||
Wednesday | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
Thursday | ||||||||
Friday | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
Saturday | ||||||||
Sunday | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
Recommendations by the expert panel for patients with brittle diabetes and hypoglycemia unawareness
Fasting/prebreakfast | Post-breakfast | Pre-lunch | Post-lunch | Pre-dinner | Post-dinner | 3 a.m.* | SOS† | |
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Monday | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
Tuesday | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
Wednesday | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
Thursday | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
Friday | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
Saturday | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
Sunday | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
Special situations/hemodynamically unstable conditions/end stage organ disease
Recommendations for elderly patients
Target glycemic levels | Healthy elderly | Elderly with intermediate health status | Elderly with poor health status |
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HbA1c | < 7.5% | < 8.0% | < 8.5% |
Fasting or pre-prandial glucose (mg/dL) | 90–130 | 90–150 | 100–180 |
Bedtime glucose (mg/dL) | 90–150 | 100–180 | 110–200 |
Fasting/pre-breakfast | Post-breakfast | Pre-lunch | Post-lunch | Pre-dinner | Post-dinner | 3 a.m. | SOS† | |
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Monday | ✓ | |||||||
Tuesday | ✓ | |||||||
Wednesday | ✓ | |||||||
Thursday | ✓ | |||||||
Friday | ✓ | |||||||
Saturday | ✓ | |||||||
Sunday | ✓ |