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Lost in translation: UK intervention for diabetes not practical in US?

An open-label cluster-randomized clinical trial in the United Kingdom evaluated the effectiveness of an intensive primary care behavioral intervention (Counterweight Plus) comparedwith usual care in adults with a new diagnosis of non–insulin-dependent type 2 diabeteswithin 6 years (N5286). Patients were 27 to 65 years old with a body mass index of 27 to 45 kg/m. The intervention included a total diet replacement phase (825–853 kcal/d, shakes provided) for 3 to 5 months followed by a food reintroduction phase.Monthly dietary counseling sessions were provided by trained staff and antidiabetic and antihypertension medications were stopped as tolerated. Patient-oriented outcomes included weight loss, remission of type 2 diabetes (HbA1c of ,6.5% after 2 months without medication), quality of life, andmedication changes. Theprimary outcomeof a 15 kgweight loss at 12 months was observed in 36 participants in the intervention group and 0 in the control group. The difference in average weight losswas –8.8 kg (95%CI, –10.3 to –7.3;P,.001) in the intervention group compared with control group. Diabetes remission occurred in 68 participants in the intervention group and six in the control group (odds ratio 19.7; 95% CI, 7.8–49.8; P,.001). Patients in the intervention group reported statistically, but not clinically, greater improvement on a quality of life visual analog scale. More patients in the intervention group stopped antidiabetic medications compared with the control group (74% vs 18%; P5.003). One patient reported biliary colic potentially related to the intervention, and other adverse events were similar. Bottom line: A staff-intensive behavioral intervention with meal replacements provided to patients resulted in significant weight loss and remission of type 2 diabetes. As studied, this type of intensive program would be difficult to implement in U.S. primary care practices. However, the results may support referral to intensive behavioral programs if patients can afford and access those services.