Table 1—

Characteristics of randomized controlled trials on the effectiveness of SMBG in patients with type 2 diabetes who are not using insulin

StudyInterventionPatients (n)Duration of studyBaseline characteristics (mean ± SD)Outcomes (mean ± SD)Changes between baseline and outcomes (mean ± SD)Comments
Fontbonne (14), 1989, FranceSMBG: measurements twice every other day. SMUG: measurements twice every other day. Control: regular HbA1c determinations every 2 months at physician, no self-monitoringSMBG 68, SMUG 72, control 686 monthsSMBG: HbA1c 8.2 ± 2.5%, BMI 27.1 ± 4.1 kg/m2, age 54.5 ± 10.7 years, diabetes duration 12.2 ± 6.6 years; SMUG: HbA1c 8.6 ± 2.5%, BMI 26.0 ± 3.4 kg/m2, age 54.9 ± 10.2 years, diabetes duration 13.3 ± 6.8 years; control: HbA1c 8.2 ± 2.5%, BMI 27.0 ± 4.1 kg/m2, age 56.3 ± 9.1 years, diabetes duration 12.7 ± 0.8 yearsSMBG: HbA1c 7.84%; SMUG: HbA1c 8.47%; control: HbA1c 7.7%SMBG: HbA1c −0.36 ± 3.14%; SMUG: HbA1c −0.13 ± 2.20%; control: HbA1c −0.5 ± 1.54%Withdrawals: 44 patients (21%) lost to follow-up (SMBG 12, SMUG 18, control 14). Compliance: expected number to be used = 182 (SMBG 91 strips, SMUG 79 strips, P < 0.01, poor compliance)
Allen (30), 1990, U.S.SMBG: at least 36 blood glucose determinations/ month, before each meal every other day. SMUG: at least 36 urine glucose determinations/month, before each meal every other day. Both groups: standardized treatment program including diet and exercise counseling. Use of an algorithm for treatment alterations by physicianSMBG 27, SMUG 276 monthsSMBG: HbA1c 12.4 ± 3.3%, FPG 12.0 ± 2.4 mmol/l, age 58.2 ± 9.7 years, diabetes duration 6.8 ± 6.5 years; SMUG, HbA1c 11.7 ± 3.0%, FPG 12.0 ± 2.6 mmol/l, age 57.9 ± 10.7 years, diabetes duration 9.0 ± 10.3 yearsSMBG: HbA1c 10.4 ± 2.9%, FPG 10.6 ± 3.6 mmol/l; SMUG: HbA1c 9.7 ± 2.6%, FPG 10.5 ± 3.0 mmol/lSMBG: HbA1c −2.0 ± 3.4%, FPG −1.4 ± 3.2 mmol/l; SMUG: HbA1c −2.0 ± 2.4%, FPG −1.5 ± 2.8 mmol/lWithdrawals: 7 patients. Compliance: records complete in 87% of visits for SMBG and in 90% of visits for SMUG. Attendance at monthly visits: 98% in both groups
Muchmore (29), 1994, U.S.SMBG: individual and group teaching on carbohydrate counting and SMBG, measured six times daily for 4 weeks. Reduce to pre- and postprandial testing of a single meal per day for weeks 4–20. Beyond week 20, individual’s election. Control: identical amount of attention, focus on general principles of diabetes nutritionSMBG 12, control 1128 weeks and follow-up until 44 weeksSMBG: HbA1c 10.29 ± 1.1%, BMI 35.1 ± 4.8 kg/m2, age 57.3 ± 8.0 years, diabetes duration 5.7 ± 4.8 years, quality of life* satisfaction 3.1, impact 4, worry-diabetes related 4, worry-social/ vocational related 4.6; control: HbA1c 10.45 ± 1.5%, BMI 33.3 ± 4.3 kg/m2, age 60.1 ± 7.3 years, diabetes duration 5.2 ± 4.6 years, quality of life* satisfaction 3, impact 3.9, worry-diabetes related 4.1, worry-social/vocational related 4.3SMBG: HbA1c 8.75 ± 1.66%, quality of life* satisfaction 2.7, impact 4.1, worry-diabetes related 4.6, worry-social/vocational related 4.6; control: HbA1c 9.6 ± 2.09%, quality of life* satisfaction 2.7, impact 3.9, worry-diabetes related 4.5, worry-social/vocational related 4.6SMBG: HbA1c −1.54 ± 1.46%, quality of life satisfaction −0.4, impact +0.1, worry-diabetes related +0.6, worry-social/ vocational related ±0; control: HbA1c −0.85 ± 1.87%, quality of life satisfaction −0.3, impact ±0, worry-diabetes related +0.4, worry-social/vocational related +0.3Withdrawals: 6 patients of 29 recruited dropped out prior to or at the time of randomization. Compliance: data ascertainment for HbA1c was 96% complete. One control group individual did not complete group meetings. High compliance with carbohydrate counting. Average performance of testing blood glucose (4.67 times per week)
Schwedes (31), 2002, multicenter study in Germany and AustriaSMBG: measurements of blood glucose six times on 2 days per week and recordings of values obtained in a diary for blood glucose data and documentation of eating habits and state of well-being. Patients were seen every 4 weeks for counseling on use of the meter and regarding diet and lifestyle. Continual use of the glucose meter during the follow-up period. Control: nonstandardized counseling with a focus on diet and lifestyleSMBG 113, control 1106 months and 6 months of follow-upSMBG: HbA1c 8.47 ± 0.86%, BMI 31.0 ± 4.6 kg/m2, age 58.7 ± 7.6 years, diabetes duration 5.5 ± 4.8 years, quality of life general well-being 26.4 ± 5.4, satisfaction 27.6 ± 7.1; control: HbA1c 8.35 ± 0.75%, BMI 31.9 ± 5.5 kg/m2, age 60.5 ± 6.6 years, diabetes duration 5.2 ± 3.9 years, quality of life general well-being 26.5 ± 5.9, satisfaction 27.0 ± 6.6SMBG: HbA1c 7.47 ± 1.27%, quality of life general well-being 30.4, satisfaction 31.12; control: HbA1c 7.81 ± 1.52%, quality of life general well-being 28.5, satisfaction 30.6SMBG: HbA1c −1.0 ± 1.08%, quality of life general well-being +4.0, satisfaction +3.52; control: HbA1c −0.54 ± 1.41%, quality of life general well-being +2.0, satisfaction +3.6Withdrawals: 27 patients. Compliance: average number of weekly measurements 24.8 ± 3.9 per patient. Blood glucose/eating diary regularly used by 97.9% of the patients. During follow-up, 87% of the patients continued self-monitoring
Guerci (32), 2003, FranceSMBG: SMBG in addition to the conventional laboratory work-up. Education on weight loss and physical activity; treatment alterations by physician. Measurements at least six times per week, on 3 different days, including weekends. Control: conventional laboratory work-up based solely on laboratory measurement of HbA1c every 12 weeks. Education on weight loss and physical activity; treatment alterations by physicianSMBG 345, control 34424 weeksSMBG: HbA1c 9.0 ± 1.3%, FPG 7.2 ± 5.1 mmol/l, BMI 30.4 ± 6.1 kg/m2, age 60.9 ± 9.4 years, diabetes duration 7.7 ± 6.3 years; control: HbA1c 8.9 ± 1.3%, FPG 7.5 ± 4.8 mmol/l, BMI 29.7 ± 4.8 kg/m2, age 62.2 ± 9.1 years, diabetes duration 8.4 ± 6.6 yearsSMBG: HbA1c 8.1 ± 1.6%, FPG 6.66 ± 4.8 mmol/l, hypoglycemia 53 episodes; control: HbA1c 8.4 ± 1.4%, FPG 6.9 ± 4.6 mmol/l, hypoglycemia 25 episodesSMBG: HbA1c −0.9 ± 1.54%, FPG −0.54 mmol/l; control: HbA1c −0.5 ± 1.54%, FPG −0.6 mmol/lDropouts: SMBG 164 patients (48%), control 139 patients (40%). Compliance: not clear
Davidson (33), in press, U.S.SMBG: before and between 1 and 2 h after eating meals 6 days a week; two breakfasts, two lunches, and two suppers. Recordings of what was eaten. Control: regular HbA1c determinations every 2 months at physician, no self-monitoring. Both groups: five visits to dietician for education on nutrition. Support by nurse, unaware of SMBG status, according to detailed algorithms to make therapeutic decisionsSMBG 43, control 456 monthsSMBG: HbA1c 8.38 ± 2.12%, BMI 31.7 ± 6.7 kg/m2, age 49.8 ± 11.2 years, diabetes duration 5.5 ± 4.7 years; control: HbA1c 8.5 ± 2.2%, BMI 33.4 ± 7.0 kg/m2, age 50.9 ± 11.0 years, diabetes duration 5.8 ± 5.8 yearsSMBG: HbA1c 7.53 ± 1.55%; control: HbA1c 7.88 ± 1.5%SMBG: HbA1c −0.8 ± 1.6%; control: HbA1c −0.6 ± 2.1%Compliance: dietary visits: SMBG 4.0 ± 1.0, control 3.2 ± 0.9. SMBG averaged 129 of 288 readings (45%)
  • *

    * Quality of life measured by the diabetes quality-of-life inventory used by the Diabetes Control and Complications Trial with a range of 0 (worst) to 5 (best score) (45).

  • Quality of life measured by the Patient Well-being Questionnaire, which has a four-item scale with a range of 0 (worst score) to 36 (best score) (21), and the Diabetes Treatment Satisfaction Questionnaire, which has a six-item scale with a range from 0 (very dissatisfied) to 36 (very satisfied) (22).

  • Statistically significant difference between groups (P < 0.05). FPG, fasting plasma glucose.