A Study of Pseudo-Intensive Care of Type 2 Diabetes
A recent news story from Reuters Health discussed the results of a study published in Diabetes Care, "Prevalence of Neuropathy and Peripheral Arterial Disease and the Impact of Treatment in People With Screen-Detected Type 2 Diabetes." According to the abstract, "intensive treatment" (IT) of 702 people with screen-detected type 2 diabetes over six years by Danish GPs did not result in improvement of measurements of neuropathy and of vascular disease compared to results found in 459 people treated with "routine care" (RC). Sounds terrible: all that work that must have been done for the IT group, and no improvement in two common complications was seen compared to RC.
But there's a huge clinker in the fine print in the actual article itself: A1C, cholesterol, weight, smoking status, and alcohol use didn't differ at the end of the study between the IT and the RC groups, proving (to me if not to the authors) that the interventions used in IT were not aggressive enough to differentiate those patients from the RC patients. Actually, the authors state that "median HbA1c did not change over the follow-up period in either group" which is quite a surprise as one usually assumes that "routine care" would result in gradual deterioration of A1C levels over 6 years - so one could even make the reverse argument that maybe the RC was as good as IT in preventing deterioration of A1C.
The fault clearly seems to lie in the definition of IT used in the study. The publication indicates that "The purpose of the IT was to provide the best possible evidence-based treatment in primary care. We aimed to educate and support general practitioners and practice nurses in target-driven management (using medication and promotion of healthy lifestyle) of hyperglycemia, blood pressure, and cholesterol... Intensive treatment was promoted through the addition of several features to existing diabetes care. Practice staff was provided with educational materials for patients, and patients were sent reminders if annual check-up appointments were overdue."
Having a busy GP or his nurse hand out educational materials, and sending a reminder card for overdue annual appointments, is not what I call IT. To me, IT would be forcing the A1C down as far as possible without provoking hypoglycemia, frequent self-monitoring of blood glucose levels, frequent medical visits, encouraging smoking cessation, weight loss and exercise, use of aspirin, and aggressive control of cholesterol and hypertension. Using an aggressive program such as I propose should have significantly lowered the A1C in the IT group, and cholesterol, blood pressure, weight and smoking status should have shown clear discrimination also, as IT would have pushed the patients to lose weight and quit smoking. Instead, the authors lamely mention that "treatment levels were high in both groups." They never define what they mean by treatment levels, but I assume they mean that both the IT and RC patients received equally good care.
Since the authors couldn't get discrimination between IT and RC, their conclusions about the neuropathic and vascular findings are useless. The study is useless. I'm surprised it was published.