Do we Need Enteral Diabetes Formulae? We do not Need Diabetes Enteral Formulae ! Burkhard Göke, M.D. Dept of Internal Medicine II, Ludwigs-Maximilians-Universität, Munich, Germany phone +49-89-7095-2390, fax +49-89-7095-8887, e-mail: bgoeke@med2.med.uni-muenchen.de Learning objectives To understand the arguments for nutrition therapy of diabetes mellitus To list indications for liquid enteral diets in diabetic patients To identify the problem of justifying the use of expensive diabetes enteral formulae without evidence based date advocating their use Our current understanding of the cornerstones of diabetes management comprises the firm belief that nutrition therapy is integral to diabetes care. However, it is striking that no proven strategy or method can be uniformly recommended to achieve the overall accepted goals such as stable weight loss and improvement of long term metabolic control. There is, for example, very little scientific evidence to support the widely held belief that in diabetes management "simple" sugars should be avoided and replaced by complex carbohydrates [1]. Recently, we have been provided with at least some evidence based data indicating that a moderate weight loss significantly reduces the likelyness to develop full blown type 2 diabetes from a state of impaired glucose tolerance [2]. The importance of lifestyle changes was stressed some years earlier in reports from Sweden and China [3,4]. In any case, long-term treatment over years was necessary to find measurable effects. Such long-term studies are not available for liquid diets in diabetes mellitus. Such diets are obviously needed when diabetic patients cannot, should not, or do not want to eat but who can drink. Enteral feeding is usually necessary only for secondary problems of diabetes due to gastrointestinal or neurological disorders, or for other medical conditions. Here, it can be difficult to maintain glycemic control since stressinduced increases in certain hormones other than insulin can make the prediction of insulin needs complicated. To address this situation special diabetes enteral formula diets were introduced by several companies. Such diets rapidly made a lot of money since they were used in a wide spectrum of clinical conditions - not only in the intensive care unit setting. Such special "diabetes formula diets" are making up in Germany for an estimated 50 million DM business. Neither for the acute administrition to patienst in the intensive care unit nor for the widespread use in other diabetes populations are there data published proving that clinically relevant end-points such as mortality are changed by such diets. Only a few trials studying small numbers of patients are published proving or even disproving that relevant postprandial blood sugar changes occur when feeding such diets. In these studies Hb1Ac plasma levels as surrogate indicator for metabolic improval are mostly lacking. Currently, my major objection against diabetes enteral formula is that basically no appropiately designed study exists to support their use and that no study shows that they might be superior to the standard regimen of frequent blood sugar testing combined with adjusted insulin infusion / injection. There might even be a potential problem to these diets carrying the label "diabetes" that care givers may be given a false sense of security. Moreover, such diets are much more expensive than standard liquid diets and may put an extra burden on our health care systems. References 1. American Diabetes Association. Nutrition recommendations and principles for people with diabetes mellitus. Diabetes Care 2000; 23: S42-S46 2. Tuomilehto J, Lindström J, Eriksson J, Valle G. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med 2001; 344: 1343-1350 3. Eriksson KF, Lindgarde F. Prevention of type 2(non-insulin-dependent) diabetes mellitus by diet and physical exercise. The 6-year Malmo feasibility study. Diabetologia 1991; 34: 891-899 4. Pan XR, Li GW, Hu YH et al. Effects of diet and exercise in preventing NIDDM in people with impaired glucose tolerance. The Da Quing IGT and Diabetes Group. Diabetes Care 1997; 20: 537-544