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Study design
Design:
randomised controlled trial (Minimally Invasive Trial: Role & Evaluation [MITRE] Study). Current Controlled Trials ISRCTN33678610.
Allocation:
concealed.*
Blinding:
blinded {data collectors and analysts}†.*
Study question
Setting:
diabetes clinics in 4 hospitals in 2 inner-city locations (urban, socioeconomically deprived area and affluent area with a large proportion of retired persons) in the UK.
Patients:
404 patients >18 years of age (median age 52 y, 55% men, 57% with type 1 diabetes) who had diabetes mellitus for >6 months, were receiving ⩾2 insulin injections daily, and had 2 consecutive glycosylated haemoglobin (HbA1c) concentrations ⩾7.5% in the past 15 months taken ⩾12 weeks and ⩽12 months apart. Exclusion criteria included inability to use capillary glucose meters or monitors, past use of the study devices, presence of abnormal haemoglobin (elevated concentrations of HbF or HbS), skin conditions at site of monitor use, dialysis, plans for major surgery within 3 months, and pregnancy.
Intervention
patients were allocated to 1 of 2 minimally invasive glucose monitoring devices (GlucoWatch, n = 100; MiniMed Continuous Glucose Monitoring System [CGMS], n = 102), attention control with standard care and nurse feedback (n = 100), or standard care alone (n = 102). All patients continued self-monitoring of blood glucose (SMBG). The GlucoWatch (G2 Biographer, Animas Corporation, West Chester, PA) could be worn anywhere on the body (ideally on the forearm) for ⩽13 hours and extracted fluid through the skin, displaying glucose values to the patient every 10 minutes. Patients were to wear the GlucoWatch ⩾4 times per month but ⩽4 …
Footnotes
Source of funding National Institute of Health Research and Health Technology Assessment Programme.
Source of funding National Institute of Health Research and Health Technology Assessment Programme.