benefits of self-monitoring blood glucose in the management of new-onset type 2 diabetes mellitus:...

ORIGINAL ARTICLE

Benefits of self-monitoring blood glucose in themanagement of new-onset Type 2 diabetes mellitus:The St Carlos Study, a prospective randomizedclinic-based interventional study with parallel groupsAlejandra DURAN, Patricia MARTIN, Isabelle RUNKLE, Natalia PEREZ, Rosario ABAD,Mercedes FERNANDEZ, Laura DEL VALLE, Maria Fuencisla SANZ and Alfonso Luis CALLE-PASCUAL

Department of Endocrinology and Nutrition, Hospital Clınico San Carlos, Madrid, Spain

Introduction

Intensive therapy of patients with Type 2 diabetes

mellitus (T2DM) facilitates b-cell recovery.1,2 Further-

more, both the Steno-2 and UKPDS (UK Prospective

Diabetes Study) studies have reported that patients

who attained near-normal glycemic levels from the

moment T2DM was detected presented lower long-

term cardiovascular mortality than patients with worse

initial control, possibly due to metabolic memory.3–5

Different therapeutic algorithms can be used to man-

age T2DM,6,7 but none includes the self-monitoring

of capillary blood glucose (SMBG). Currently,

SMBG is not considered obligatory for patients not

Correspondence

Alfonso L. Calle-Pascual, Department of

Endocrinology and Nutrition,

1aS, Hospital, Clınico San Carlos,

c ⁄ Prof. Martin Lagos s ⁄ n,

E-28040 Madrid, Spain.

Tel: +34 91 3303281

Fax: +34 91 3303117

Email: [email protected]

Received 2 February 2010; revised 18 May

2010; accepted 2 June 2010.

doi: 10.1111/j.1753-0407.2010.00081.x

Abstract

Background: Intensive treatment of patients with Type 2 diabetes mellitus

(T2DM) from the moment of diagnosis facilitates b-cell recovery. Self-

monitoring of blood glucose (SMBG)-based educational and pharmacologi-

cal intervention may be better than conventional HbA1c algorithms in the

treatment of newly diagnosed T2DM.

Methods: Newly diagnosed T2DM patients were randomized to either an

SMBG-based intervention or an HbA1c-based control group (n = 99 and

62, respectively) and were followed for 1 year.

Results: Higher rates of diabetes regression (HbA1c < 6% on metformin

alone) and remission (HbA1c between 6.0% and 6.4%) were achieved

in the intervention compared with the control group (39% vs 5%

(P < 0.001) and 37% vs 30% (P < 0.01), respectively). Furthermore, sig-

nificantly greater reductions in median HbA1c (6.6% to 6.1%; P < 0.05)

and body mass index (29.6–27.9 kg ⁄m2; P < 0.001) were seen in the inter-

vention over the 1 year of therapy. The percentage of patients achieving a

lifestyle score >12 was significantly greater in the SMBG compared with

the control group (38.4% vs 9.7% respectively; P < 0.001). An inverse

correlation was observed between SMBG and HbA1c levels (P < 0.04).

Conclusions: The results indicate that SMBG-based structured educational

and pharmacological programs empower patients to achieve nutritional

and physical activity goals, and encourage physicians and patients to use

SMBG to optimize therapy. We believe that the concept of intensive treat-

ment of T2DM patients should be modified; instead of referring to the type

of treatment (insulin use), the term should reflect the intensity with which

we work to reach glucose objectives.

Keywords: intensive treatment, self-monitoring of blood glucose, Type 2

diabetes mellitus.

Journal of Diabetes 2 (2010) 203–211

ª 2010 Ruijin Hospital, Shanghai Jiaotong University School of Medicine and Blackwell Publishing Asia Pty Ltd 203

on insulin,8–13 perhaps because the glucose values

obtained are not necessarily used to modify diet, exer-

cise regimens, or pharmacological therapy. Informa-

tion from the SMBG can be used by both the patient

and the diabetes care team to improve glycemic con-

trol by altering treatment regimens.9,14 Furthermore,

wide oscillations in levels of glycemia per se are an

independent risk factor for diabetic complications15,16

and cannot be detected without monitoring.

We postulated that the SMBG should form an integral

part of the treatment of newly diagnosed T2DMpatients,

enabling the patient to adapt his ⁄her lifestyle more effec-

tively to obtain better glycemic control (educational

tool). Furthermore, in combination with simple algo-

rithms that modify the doses of glucose-lowering medica-

tion, SMBG can prevent acute complications, such as

hypoglycemia, as well as alerting the patient when spe-

cialist help and support are needed (therapeutic tool).

The use of SMBG as both an educational and therapeu-

tic tool empowers patients, permitting them to take on a

more active role in disease control and to learn how to

make lifestyle changes to control SMBG values.

In the present study, we report data obtained after

1 year of follow-up of new-onset T2DM patients

included in an SMBG-based teaching and treatment

program.

Methods

The present study was designed as a prospective ran-

domized clinic-based interventional study with parallel

groups in which all diabetic patients who attended

the Endocrinology outpatients’ clinic between January

2006 and December 2007and who meet the inclusion

criteria were invited to participate in the study. The

inclusion criteria were: (i) newly diagnosed T2DM

after two fasting glucose plasma values >125 mg ⁄dL;(ii) age 18–80 years; (iii) <6 months from the first

fasting plasma glucose value >126 mg ⁄dL; and

(iv) the absence of ketones in two-first morning urine

samples. Patients were excluded from the study if they

had had any fasting glucose levels >125 mg ⁄dL in

previous 12 months, if they had HbA1c levels >8% at

diagnosis (because these patients are more like to start

on insulin within a short period of time), or if they

were unable to perform SMBG. In addition, patients

were excluded from the study if they had a life-threat-

ening disease. The study was conducted in accordance

with the Declaration of Helsinki and was approved by

the Hospital San Carlos Ethics Committee.

Newly diagnosed T2DM patients who were eligible

for inclusion in the study were randomly (2:1) assigned

to one of two groups: (i) an intervention group that

received lifestyle intervention and used the SMBG as

an educational tool to adhere to lifestyle changes, as

well as a therapeutic tool to apply step-by-step phar-

macological treatment; or (ii) a control group who

received standard treatment based on HbA1c values

without SMBG. All patients were treated with 850 mg

metformin (half a tablet at breakfast, nothing at lunch

and another half tablet at dinner; ½–0–½). Adjust-

ments to the randomization were made for age, body

mass index (BMI), and HbA1c values. The structure

of the clinical trial is shown in Fig. 1.

Initially, 250 eligible newly diagnosed T2DM

patients attending our outpatient clinic between Janu-

ary 2006 and December 2007 were recruited to the

study. Thirty-four patients were excluded from the

study and 21 patients declined to participate. The

remaining 195 patients were randomized to the SMBG

group (n = 130) and to the HbA1c group (n = 65).

In addition, a supervised exercise program was offered

to half the patients in the SMBG group (we expected a

1:1 allocation in these subgroups) but, surprisingly,

only 29 patients agreed to participate. Given the small

number of SMBG patients in the exercise program and

the possible influence of physical activity on the three

endpoints evaluated, the patients in this subgroup were

excluded from subsequent analysis. Five patients, two

from the SMBG group and three from the HbA1c

group, failed to complete the first year of the study.

Herein, we report data obtained at the 1-year follow-

up of 99 patients in the SMBG group [45 men, 54

women; median age 62 years (range 55–70 years)] and

Figure 1 Structure of the clinical trial. SMBG, self-monitoring of

blood glucose.

SMBG in Type 2 diabetes mellitus A. DURAN et al.

204 ª 2010 Ruijin Hospital, Shanghai Jiaotong University School of Medicine and Blackwell Publishing Asia Pty Ltd

62 patients in the HbA1c group [29 men, 33 women;

median age 67 years (range 58–72 years)].

Interventions

Lifestyle interventions were similar for all patients and

were developed after a 2-h session for each patient

individually and were reinforced at each follow-up

visit. A questionnaire was developed to evaluate adher-

ence to recommended lifestyle changes (see Appendix

I). Each of the 18 items on the questionnaire were

assigned a score of 1, 0 or )1, with a score of 1 indi-

cating that the beneficial recommendation was regu-

larly performed, )1 indicating that the beneficial

recommendation had not been adopted or that patients

were persisting with an unhealthy habit, and 0 indicat-

ing intermediate consumptions or exercise frequency

between healthy and unhealthy adults. Different com-

posite variables from the questionnaire were assessed,

including a Physical Activity score (items 1–3), a

Nutrition score (items 4–15), a Low Glycemic Index

score (items 4, 5, 9, and 10), an Unsaturated Fat score

(items 6–8), and an overall Lifestyle score (all items).

This questionnaire is based on American Diabetes

Association (ADA) evidence-based nutrition recom-

mendations17 adapted to the Spanish population fol-

lowing the Diabetes Nutrition and Complications Trial

(DNCT), as reported previously18–20 and validated.21

The aim was to achieve a lifestyle score >12 and ⁄oran increase in lifestyle score >7.

SMBG group

Patients attended an additional 1-h session to learn how

to perform SMBG and how to collect data. Patients’

know-how and methodology were reviewed at each visit

and confounding factors that could have impacted on

glycemic values were evaluated. Finger sites were tested

and the accuracy and timing of the recorded SMBG val-

ues were checked. We recommended six-point profiles

every 3 days, before and 2 h after breakfast, lunch, and

(a)

(b)

Figure 2 Algorithm for the initiation and

adjustment of therapy. SMBG, self-monitor-

ing of blood glucose; FBG, fasting blood glu-

cose; PPBG, postprandial blood glucose;

DPP-4, dipeptidyl peptidase 4.

A. DURAN et al. SMBG in Type 2 diabetes mellitus


dinner, as well as after any change in pharmacological

therapy.22 Therapy based on SMBG values is shown in

Fig. 2a. The trigger to initiate or change therapy was set

as patients failing to achieve fasting and preprandial cap-

illary glucose values between 70 and 110 mg ⁄dL and ⁄or2-h postprandial capillary glucose values between 70 and

145 mg ⁄dL in 60% of SMBG determinations (i.e. three

of five). If fasting SMBG values were outside the target

levels, metformin was titrated if tolerated. If this was

insufficient, then pioglitazone was added. If glucose lev-

els were still not within target values, basal insulin was

added. If postprandial SMBG values were high, treat-

ment with glinide, a dipeptidyl peptidase (DPP)-4 inhibi-

tor, or sulphonlyurea was considered. If this step was

insufficient, bolus insulin was initiated. Glucose objec-

tives were considered to be mean glycemia <125 mg ⁄dLand HbA1c < 6%. After stabilization, defined as when

five complete SMBG profiles were on target in two suc-

cessive visits, patients were recommended to construct at

least one profile every 2 weeks if they were on metformin

or metformin plus pioglitazone or at least one profile per

week if they were receiving some form of treatment other

than metformin and ⁄or pioglitazone. Patients were fol-

lowed-up every 2 weeks during the first 3 months to

evaluate five SMBG profiles, and then every 3 months.

HbA1c group

After recommendations regarding lifestyle changes,

all diabetic patients were started on metformin. Treat-

ment regimens were changed on the basis of HbA1c

levels determined every 3–6 months. The target was

HbA1c < 6.5%. SMBG was started when the diabetes

care team considered it appropriate and always with

insulin treatment. The algorithm used for this group is

shown in Fig. 2. Patients were followed-up for between

3 and 6 months.

To evaluate how much disease control was interfer-

ing with patients’ lifestyles, three different scales (i.e.

workplace activity, family time, and social activities),

with scores ranging from 0 to 100. If disease control

and therapy did not impact on a patient’s workplace

activity, the work score was 100; however, if a patient

could not continue working, the score was 0. If disease

control and therapy did not change the amount and

quality of the time patients spent with their family, the

family score was 100; however, if the patient could not

spend any time with his ⁄her family, the score was 0. If

disease control and therapy did not interfere with a

patient’s social life [including leisure activities, such as

going out to the movies, to dinner, to concerts, and on

dates, holidays, trips, bar hopping (tapas) etc.], the lei-

sure score was 100; however, if the patient no longer

had a social life, the score was 0. The global satisfac-

tion scale was determined as the sum of scores for all

three scales. All scores were determined twice: once

when patients were first enrolled in the study and then

again 12 months later. The two scores were compared.

Severe hypoglycemic episodes, requiring assistance

from a third person, were recorded.

Statistical analysis

With a final number of 65 patients in each group, the

study had 80% power at 5% significance (two-sided) to

detect a clinically significant difference (20%) in the pri-

mary outcomes between the SMBG and HbA1c groups.

The primary outcome was to estimate the remission

and regression rate of T2DM. Regression was consid-

ered yearly when patients achieved an HbA1c of <6%

on metformin treatment. Remission was considered

yearly when patients achieved an HbA1c between 6.0%

and 6.4%. Secondary outcomes were to determine

changes in HbA1c, fasting insulin, homeostasis model

assessment of insulin resistance (HOMA-IR), total

cholesterol [high-density lipoprotein (HDL) and low-

density lipoprotein (LDL)], triglycerides, apolipoprotein

B, body weight, waist circumference, blood pressure,

and adherence to the suggested lifestyle changes.

Parametric, one-way analysis of variance and non-

parametric Mann–Whitney and Kruskall–Wallis tests

were used, as appropriate, to determine whether there

were any significant differences between two or more

independent groups.

Data are presented as the median or mean, with the

range or 95% confidence intervals given in parentheses.

Results

Patient characteristics at the time of study entry were

similar between the two groups, with the exception of

higher LDL–cholesterol levels in the SMBG compared

with the HbA1c group [120 (101–138) vs 105 (77–125)

mg ⁄dL, respectively; P < 0.05]. In the SMBG group,

96 of 99 patients (97%) performed a median of 251

capillary measurements (range 148–300) compared

with 21 of 62 patients (33.9%) in the control group

who performed a median of 68 SMBG measurements

(range 26–144) during follow-up. The median number

of provider visits in the control and SMBG groups

was 3.9 (3.1–5.4) and 8.6 (4.9–10.1), respectively.

After 1 year of follow-up, median HbA1c levels and

median BMI were significantly reduced in patients

in the intervention group (from 6.6% (5.8–7%) to 6.1%

(5.8–6.5%) and from 29.6 (26.2–32.8) to 27.9 (25.6–

31.1) kg ⁄m2, respectively; P < 0.05 and P < 0.01,

respectively), but not in the control group (Table 1).



The median Lifestyle score increased significantly

from –1 (–2, 4) to 11 (8, 14) in the intervention group

(P < 0.01) and from –2 (–8, 2) to 5 (1, 8.5) in the

HbA1c group (P < 0.01). The difference between the

two groups was significant (P < 0.001). Significant dif-

ferences between groups were also found for the Physi-

cal Activity score and scores for the consumption of

vegetables, nuts, high-fat fish, high-fiber cereals,

legumes, low-fat milk, and juices (Table 2). Further-

more, after follow-up, a higher percentage of patients

in the intervention group than in the control group

had increased their level of physical activity (76% vs

27%, respectively; P < 0.001) and consumption of

vegetables (72% vs 42%, respectively; P < 0.004),

nuts (68% vs 26%, respectively; P < 0.0001), and

high-fiber cereals (64% vs 21%, respectively; P <

0.0001). Similarly, higher rates of diabetes regression

and remission were found for the SMBG group (39%

and 37%, respectively) than the control group (5%

and 30%, respectively; P < 0.001 and P < 0.01;

respectively; Table 3). An inverse correlation was

observed between SMBG and HbA1c levels (P <

0.04), whereas a positive correlation was found

between SMBG and the Nutrition score (P < 0.02)

and Physical Activity score (P < 0.07).

After 1 year of follow-up, a total of 101 T2DM

patients remained on metformin alone, 64 (65%) from

the intervention group and 37 of 62 patients (59.7%)

from the control group. Four T2DM patients (4%)

from the intervention group were also on glinides, one

(1%) was on sulphonylureas, seven (7%) were on

pioglitazone and 23 (23%) were on insulin. In the

control group, nine T2DM patients (14%) were on

glinides, 13 of 62 patients (21%) were on sulpho-

nylureas, and three (5%) were on insulin. The pharma-

cological changes were earlier (P < 0.002) and more

frequent (P < 0.001) in the intervention group.

No severe hypoglycemic episodes requiring third-party

or medical assistance were reported in either group.

Scores obtained using visual scales to evaluate the

impact of SMBG on patients’ lives increased signifi-

cantly within each group during the study period, with

the final scores of all scales used significantly higher

for patients in the SMBG compared with the con-

trol group (P < 0.001). Specifically, the work score

increased from a median (range) of 36 (28–48) to 90

(90–95) in the intervention group compared with

an increase from 38 (25.5–55) to 65 (55–74.5) in the

control group (both P < 0.001). The family score also

improved, from a median of 26 (21–30) to 92 (90–95)

in the intervention group compared with an increase

from 36 (27–50) to 67 (58–75.5) in the control group

(both P < 0.001). The leisure score in the intervention

group increased from a median of 29 (27–35) to 90

(90–95) compared with and increase from 41 (28–55)

to 63 (55–69) in the control group (both P < 0.001).

The global satisfaction scale improved in both groups

from baseline, but the increase was significantly greater

in the SMBG group (P < 0.001). The global satisfac-

tion score increased from 30 (28–37) to 90 (90–97) in

Table 1 Changes in clinical and laboratory data from baseline to 1 year follow-up

Control group (n = 62) SMBG group (n = 99)

Baseline 1 year Baseline 1 year

Body weight (kg) 76 (67–89) 76.5 (64–91.7) 80.5 (69–87) 76 (68.8–85.7)*

BMI (kg ⁄ m2) 28.5 (25.9–30.7) 28.5 (25.9–29.8) 29.6 (26.2–32.8) 27.9 (25.6–31.1)**��

Waist circumference (cm)

Men 103 (99–108) 102 (99–109) 107 (101–113) 103 (97–110)**

Women 94 (88–109) 90 (84–108)** 98 (90–104) 93 (83–99)***

FP insulin (lIU ⁄ mL) 9 (6.9–14.5) 8.2 (4.8–12.7) 10 (5.7–16.3) 9.3 (5.9–13.9)

HOMA-IR 3.2 (2.5–7.2) 2.5 (1.1–4.7)** 4 (2.3–5.7) 2.7 (1.6–4.2)**

SBP (mmHg) 145 (132–163) 138 (132–159)** 141 (133–155) 137 (125–150)**

DBP (mmHg) 86 (75.8–88) 80 (71.5–84.8)* 83 (76–90) 79 (73–86)*

Total cholesterol (mg ⁄ dL) 194 (153–211) 164 (147–205)*** 196 (172–219) 178 (157–200)***

HDL-C (mg ⁄ dL) 53 (45–69) 54 (42–66) 52 (44–65) 53 (45–65)

LDL-C (mg ⁄ dL) 105 (77–125) 81.5 (70–112)** 120 (101–138)� 97 (81–118)***�

Triglycerides (mg ⁄ dL) 126 (93–166) 128 (96–148) 114 (85–144) 95 (82–134)*

Apolipoprotein B (mg ⁄ dL) 88 (77.8–109.5) 83 (74.5–98) 99 (84–115) 85 (73–98)**

Albumin:creatinine ratio 8 (6–19) 9 (5–21) 6 (3–11) 6 (4–15)

HbA1c (%) 6.6 (6.4–7.1) 6.6 (6.2–7.3) 6.6 (5.8–7) 6.1 (5.8–6.5)*��

Data are expressed as the median, with the first–third quartiles given in parentheses. *P < 0.05, **P < 0.01, ***P < 0.001 compared with

baseline; �P < 0.05, ��P < 0.01, ��P < 0.001 compared with the control group.

SMBG, self-monitoring of blood glucose; BMI, Body mass index; FP, fasting plasma; HOMA-IR, homeostasis model assessment of insulin

resistance; SBP, systolic blood pressure; DBP, diastolic blood pressure; HDL-C, high-density lipoprotein–cholesterol; LDL-C, low-density

lipoprotein–cholesterol.



the SMBG group and from 33 (27.5–48) to 59 (49.5–

67) in the HbA1c group (both P < 0.001 compared

with baseline).

Discussion

The results of the present study indicate that using

SMBG in a step-by-step treatment program effectively

improves metabolic control in newly diagnosed T2DM

patients. The use of SMBG in a structured educational

program results in greater adherence to nutritional

recommendations and improves patient satisfaction

without increasing the risk of severe hypoglycemia. Fur-

thermore, it permits health personnel to detect the need

for a change in therapy (i.e. the use of insulin) when the

desired level of glucose control is not achieved, thus

explaining why more patients in the SMBG group ended

up on insulin than in the control group.

The program as described in the present study consid-

ered treatment changes when 60% of capillary glucose

values were not within the target range (i.e. three of five)

over a 2-week period. SMBG is a useful tool for the selec-

tion of the most adequate medication (targeting fasting

versus postprandial blood glucose control) and doses for

a given patient (therapeutic tool). Furthermore, SMBG

indicates optimal dietary and exercise changes for each

patient, helping diabetic patients chose food type, quan-

tity, timing, and preparation to best ensure optimal glu-

cose levels. Although HbA1c levels indicate the risk of

vascular disease,6,7,9 they do not provide real-time infor-

mation regarding hyper- or hypoglycemia and thus can-

not be used to adapt therapy to oscillations in glucose

Table 2 Changes in lifestyle score from baseline to 1 year follow-up

Control group (n = 62) SMBG group (n = 99)

Baseline 1 year Baseline 1 year

Walking time each day )1 ()1, 0) 1 (0, 1)* 0 ()1, 1) 1 (1, 1)*��

Climbing stairs )1 ()1, )1) )1 ()1, 0) )1 ()1, 0) 0 ()1, 1)*��

At least 30 min exercise of more than moderate intensity )1 ()1, )1) )1 ()1, )1) )1 ()1, )1) 1 (1, 1)***��

Physical activity score )3 ()3, )2) )1 ()2, 0)* )2 ()3, )1) 0 ()1, 2)***��

Dietary factors

Vegetable intake 0 (0, 0) 1 (0, 1)** 0 ()1, 0) 1 (1, 1)**��

Number of pieces of fruit (no juice) 0 (0, 1) 1 (1, 1)* 1 (0, 1) 1 (1, 1)

Nuts )1 ()1, )1) )1 ()1, 0) )1 ()1, 0) 1 (0, 1)***��

Olive oil 1 (1, 1) 1 (1, 1) 1 (1, 1) 1 (1, 1)

High-fat fish or Iberico ham )1 ()1, 0) 0 ()1, 1)* 0 ()1, 0) 1 (0, 1)**��

High-fiber bread and cereals )1 ()1, )1) )1 ()1, 0.5) )1 ()1, )1) 1 (0, 1)**��

Legumes 0 ()1, 0) 0 (0, 1)* 0 ()1, 0) 0 (0, 1)*

Low-fat milk and cheese )1 ()1, )1) 1 ()1, 1)** )1 ()1:1) 1 (1, 1)***��

Red meat 0.5 (0, 1) 1 (1, 1) 0.5 (0, 1) 1 (1, 1)

Sauces (no mayonnaise) 1 (1, 1) 1 (1, 1) 1 (1, 1) 1 (1, 1)

Cookies )1 ()1, 0.3) 1 (0, 1)** )0.5 ()1, 1) 1 (1, 1)**

Juices and sweets drinks )1 ()1, 0) 1 (0, 1)** )1 ()1, 1) 1 (1, 1)*�

Coffee 0 (0, 0) 0 (0, 0) 0 (0, 0) 1 (1, 1)

Alcoholic beverages 0 (0, 0) 0 (0, 0.5) 0 (0, 1) 0 (0, 1)

Water 1 (1, 1) 1 (0.5, 1) 1 (1, 1) 1 (1, 1)

Nutrition score )1 ()5, 0.25) 5 (1, 8)** 0 ()2, 3) 9 (6, 11)***��

Lifestyle score )2 ()8, 2) 5 (1, 8.5)** )1 ()2, 4) 11 (8, 14)**��

Data are expressed as the median, with the first–third quartiles given in parentheses. *P < 0.05, **P < 0.01, ***P < 0.001 compared with

baseline; �P < 0.05, ��P < 0.01, ��P < 0.001 compared with the control group.

SMBG, self-monitoring of blood glucose.

Table 3 Changes in lifestyle patterns and targets of diabetes control

after 1 year in the control and self-monitoring of blood glucose groups

Control

group

(n = 62)

SMBG

group

(n = 99) P value

Increased climbing stairs 13 (21) 54 (55) 0.003

Increased physical exercise 4 (6) 41 (41) 0.002

Increased physical activity score 17 (27) 76 (77) 0.001

Increased consumption of

vegetables

26 (42) 71 (72) 0.004

Increased consumption of nuts 16 (26) 68 (69) 0.0001


high-fiber cereals

13 (21) 65 (66) 0.0001

Lifestyle score > 12 6 (10) 38 (38) 0.001

Increased Nutrition score >7 20 (32) 62 (63) 0.001

Increased consumption of low

glycemic index carbohydrates

24 (39) 61 (62) 0.006


unsaturated fat

33 (53) 79 (80) 0.002

HbA1c < 6% (regression) 3 (5) 39 (39) 0.001

HbA1c 6.0%–6.4% (remission) 19 (31) 37 (37) 0.01

HbA1c < 7% 46 (74) 91 (92) 0.04

HbA1c > 7% 16 (26) 8 (8) 0.01

Weight loss (>0.5 kg) 23 (37) 63 (64) 0.03

Data show the number of patients, with percentages given in

parentheses.

SMBG, self-monitoring of blood glucose.



levels.14–16 Data obtained with the SMBG reflect the true

state of glucose control, thereby enabling short-term

modifications of therapy. This improvement in glucose

control prevents increases in HbA1C% levels.23–25

The reason why the SMBG was so effective in the

present study is probably because it enabled timely and

appropriate treatment decisions to be made on the basis

of the values obtained. This is supported by the fact that

treatment decisions were made on a greater number of

visits for patients in the SMBG group, as well as the fact

that significantly fewer patients in the HbA1c group

were on insulin. Patients in the HbA1c group may not

have been seen often enough to enable the collection of

sufficient data to show that their treatment was no

longer effective. Only when insulin was prescribed to

patients in the HbA1c group was the SMBG used. The

reason why SMBG was not effective in lowering HbA1c

levels in patients in the HbA1c group who were not on

insulin is that in these patients SMBG data were not

used to make clinical decisions, only to educate patients.

According to the recent International Diabetes Federa-

tion (IDF) consensus statement,24 the present study

emphasized the importance of treatment decisions being

made on the basis of SMBG results. We believe that

ours is the first study to demonstrate that basing treat-

ment on SMBG results is very effective.

The diabetes regression rate in patients in the SMBG

group was almost 50%. The patients included in the

present study had moderate hyperglycemia at the time

of diagnosis and disease duration <1 year; therefore,

the regression of diabetes (i.e. HbA1c <6% on metfor-

min alone) may be expected after modifications of life-

style alone26,27 or in combination with metformin,27 as

has been reported in T2DM prevention trials.26,27

The improvement in glycemic control in the SMBG

group was unexpectedly associated with weight loss,

but this relationship was not evident in patients in

the HbA1c group. This difference can probably be

explained by the selection of lower calorie foods by

patients in the SMBG group (e.g. vegetables, food with

a high fiber content and a low glycemic index), increased

in physical activity, and the progressive application of

pharmacological treatment, thereby reducing the risk of

hypoglycemia.28 Thus, according to our results, SMBG

reinforces lifestyle changes that lead to weight loss.

A major issue in the cost–benefit analysis of using the

SMBG in T2DM patients is its impact on quality of life.

Some recent studies have reported no improvement in

glucose control in these patients, yet observed higher

anxiety levels and more cases of depression in those

using SMBG.10–13 The satisfaction scale used in the

present study has some limitations because of the sub-

jectivity of any visual analogue scale. However, any

tool, such as SMBG, directed towards making the dia-

betic patient more self-sufficient in the context of using

glucose levels to modify diet, exercise, and medication

could improve quality of life by both improving well

being and increasing patient empowerment. Finding

high glucose levels and not doing anything about it can

be discouraging; finding high glucose levels, knowing

what to do, and then observing an improvement can be

encouraging. Patients in the former category are more

dependent on their families and health personnel; those

in the latter category become progressively more self-

reliant. Our data show that SMBG induces an increment

in patient satisfaction, probably because the patients

know how to interpret the data obtained and what to

do, including with any unexpected glycemic values.

The lifestyle in Spain is extremely variable.29 This is

one of the reasons we recommended the use of SMBG

throughout the study to reinforce adherence to treat-

ment. The evaluation proposed at the beginning and

after any therapeutic change is at least one profile con-

sisting of six points each day every 3 days. We then rec-

ommend patients construct at least one profile every

2 weeks. Our results clearly show that SMBG induces an

improvement in the adherence to nutritional and physi-

cal recommendations and decreases HbA1c levels and

body weight without increasing the number of severe

hypoglycemic events. Most diabetes associations con-

sider diabetes education at the time of diagnosis a prior-

ity.6,7,24,25,30 Structured and continuous education that

involves patients in making decisions about their treat-

ment regimens and permits them to learn how to modify

doses is specifically recommended as a means to achieve

target HbA1c levels. We consider SMBG to be a basic,

essential part of T2DM education and self-management.

However, the use of SMBG remains suboptimal by

T2DM patients.31,32 Perhaps the concept of intensive

treatment of the T2DM patient should be modified, from

bolo-basal insulin treatment to intensive self-monitoring

of blood glucose several times a day, several days a week,

together with appropriate lifestyle modifications or phar-

macological treatment. What would define ‘‘intensive’’

would not be the specific therapy, but the intensity with

which we work to reach glucose objectives. The ‘‘inten-

sive’’ control of glucose levels by T2DM patients would

allow them to make the necessary changes in eating

habits, physical activity, and medication doses to opti-

mize their control, thereby improving their overall health

and sense of well being. Our findings support this

hypothesis and, according to the recent IDF consensus

statement,33 our study emphasized the importance of

treatment decisions being made on the basis of data

obtained by the SMBG. We think this is the first study

that demonstrates the effectiveness of basing treatment



on SMBG results and, consequently, we suggest that

SMBG-based programs should be extended to primary

care settings that routinely attend to diabetic patients.

Availability

Clinical trial number ISRCTN81672669 available

at http://www.controlled-trials.com/ISRCTN81672669

(accessed April 2009).

Acknowledgments

This work was supported by grants from the Ministe-

rio de Sanidad from Spain (Fondos de Cohesion 2008)

and the Fundacion de Estudios Endocrinometabolicos.

LdV was supported by a grant from the Ministerio de

Sanidad of Spain.

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Appendix I Lifestyle questionnaire

Score

+1 0 )1

Physical activity

1. Walking daily (>5 days ⁄ week) >1 h At least 30 min <30 min

2. Climbing stairs (no. floors ⁄ day, >5 days a week) >16 4–16 <4

3. At least 30 min of more than moderate intensity >3 days ⁄ week 2 or 3 days ⁄ week <2 days ⁄ week

Servings per week

4. Vegetables >12 6–12 <6

5. Fruits (pieces) >12 6–12 <6

6. Nuts >3 1–3 <1

7. Olive oil Daily >3 days <3 days

8. High-fat fish or Iberico ham >3 1–3 <1

9. Bread and cereals (high fiber content) >6 3–6 <3

10. Legumes >2 1–2 <1

11. Low-fat milk and cheeses >6 3–6 <3

12. Red meat <3 3–6 >6

13. Sauces (except mayonnaise) <2 2–4 >4

14. Juices and sugar-sweetened beverages <2 2–4 >4

15. Cookies <2 2–4 >4

16. Coffee >3 ⁄ day <3

17. Alcoholic beverages (no. servings ⁄ day)* 1–4 0 or >4 and <6 >6

18. Water� Exclusively In addition to other beverages Never

*If diabetic patients do not drink any alcoholic beverages, drinking is not recommended; however, the patients do drink, an intake of 1–4

servings ⁄ day (between 10 and 40 g alcohol) is recommended.�Water intake reflects the degree to which water is the usual beverage at meal time and with snacks, as opposed to juice, soft drinks, or

low-sugar beverages, but not as a substitute for coffee, tea, or alcoholic beverages.



benefits of self-monitoring blood glucose in the management of new-onset type 2 diabetes mellitus:...

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