M J O’Kane

Dr M J O’Kane, Altnagelvin Hospital, Londonderry, Northern Ireland; maurice.okane@esterntrust.hscni.net

STUDY DESIGN

Design:

randomised controlled trial (Efficacy of Self Monitoring On glycaemic control in Newly diagnosed type 2 diabetes [ESMON]).

Allocation concealment:

unclear allocation concealment.*

Blinding:

blinded (laboratory staff).*

STUDY QUESTION

Setting:

outpatient hospital diabetes clinics in Altnagelvin, Belfast City, Causeway, and Ulster, Northern Ireland.

Patients:

184 patients <70 years of age (mean age 59 y, 60% men) with newly diagnosed type 2 diabetes. Exclusion criteria were secondary diabetes, previous self-monitoring of blood glucose (SMBG), use of insulin, major illness in the past 6 months, chronic kidney or liver disease, and alcohol misuse.

Intervention:

SMBG (n = 96) or no monitoring (n = 88). The SMBG group made 4 fasting and 4 postprandial capillary blood glucose measurements per week and were provided dietary and exercise suggestions for high readings. All patients attended a structured education programme.

Outcomes:

changes in haemoglobin (Hb) A_1c concentrations, scores on psychological indices (depression, anxiety, treatment satisfaction, and attitude; measured on a 100-point scale), body mass index (BMI), rates of hypoglycaemia, and use of oral hypoglycaemic drugs.

Follow-up period:

1 year.

Patient follow-up:

98% (intention-to-treat analysis).

MAIN RESULTS

Patients in the SMBG group scored 6% higher on the depression subscale than did the no-monitoring group (p = 0.01). Groups did not differ for changes in HbA_1c concentration (table), anxiety, …