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Dr L Meneghini
Correspondence to: Dr L Meneghini, University of Miami Miller School of Medicine, Miami, FL, USA; lmeneghi@med.miami.edu
STUDY DESIGN
Design:
cluster randomised controlled trial (PREDICTIVE 303* study).
Allocation:
unclear allocation concealment.†
Blinding:
unblinded.†
STUDY QUESTION
Setting:
1083 primary care practices in the USA.
Patients:
5604 patients ⩾18 years of age (mean age 59 y, 52% men) who had type 2 diabetes, haemoglobin (Hb) A1c concentration ⩽12%, and body mass index (BMI) ⩽45 kg/m2. Exclusion criteria were concomitant medication changes that would interfere with glucose metabolism, receipt of glucose-lowering medication that were not indicated with insulin, proliferative retinopathy or maculopathy, hypoglycaemia unawareness or recurrent major hypoglycaemia, pregnancy, lactation, or serious illness.
Intervention:
303 Algorithm (n = 2794) or standard of care (n = 2825). All patients were given insulin detemir once daily as add-on therapy to any other glucose-lowering regimen or replacement of previous basal insulin. Patients in the algorithm group …
Footnotes
Source of funding: Novo Nordisk.